24 Hour Fitness Re-Launches Apex Product Line


24 Hour Fitness Re-Launches Apex Product Line
Simplified Ingredients, New, Clean Packaging and Bold, New Brand Image Revealed
SAN RAMON, Calif., Aug. 18, 2015 /PRNewswire/ — Apex, the exclusive supplement brand of 24 Hour Fitness, is introducing new products that align more closely with consumer desire for product ingredient transparency and straightforward formulations. Produced in the U.S. under strict USDA guidelines, the product line benefits all ages and fitness levels.

The new Apex product formulations reduce the formerly lengthy ingredient list to as few as seven identifiable ingredients. Among the products launched are two protein powder formulations: 100% whey isolate and a whey concentrate/isolate blend, as well as fitness supplements that support performance. A vegan formulation is currently in development. “We invested significant time researching the latest advancements in formulations and flavoring, then collaborated with sports nutrition experts to develop clean products with clear purpose and exceptional taste,” said Andrew Dottermusch, Senior Director, Retail, 24 Hour Fitness. Aside from its role supporting the development of lean muscle, increasing evidence links whey protein supplementation to overall health, providing support to the immune system, and aiding in management of blood pressure and stress. With proper use, a protein supplement can also help curb appetite and support metabolic function, assisting with weight loss goals.*

In addition to new formulations, Apex will launch a bold, new brand image and modern packaging. The protein powder has been redesigned in a tall, two pound jug with clean lines and a built in handle—reusable and recyclable. The product is also available in single serve multi-packs—handy when traveling or on the go. Additional supplement powders feature a similar bold, modern packaging design and easy open cap.

While the attractive, new Apex product packaging represents an evolutionary brand advancement, it leaves plenty of room to showcase the simplified ingredient list, appealing taste, and broad range of flavors (Traditional–Classic Chocolate, Gourmet Vanilla, Fruit Punch, Unflavored; New-Tiramisu, Cookie Dough, Guava Lemongrass, to name a few).

Dottermusch added, “We conducted a national member survey to determine protein powder preferences and what motivates use. As a result, these are quality products at a great value that appeal to first-time buyers as well as those more experienced in the use of supplements. We want to take the mystery out of protein powder and supplements and are investing in educational tools and staff training to further consumer understanding, confidence and product use to serve all fitness levels and everyday life.”

Apex products are available in all clubs now with additional supplements, including vitamins, scheduled to launch in clubs by year end. Apex products contain no proprietary blends, and they are manufactured in the USA to conform to strict USDA production protocols. Additional information: apexfitness.com

*Statements have not been evaluated by the Food and Drug Administration. Products are not intended to diagnose, treat, cure or prevent any disease.

About 24 Hour Fitness
Headquartered in San Ramon, Calif., 24 Hour Fitness is a leading health club industry pioneer, serving nearly 4 million members in 450 clubs across the U.S. For more than 30 years, the company has been dedicated to helping members change their lives and reach their individual fitness goals. With convenient club locations, personal training services, popular group exercise classes and a variety of strength, cardio and functional training equipment, 24 Hour Fitness offers fitness solutions for everyone.



FDA Proposes Additional Revisions to the Nutrition Facts Label


July 24, 2015 – The U.S. Food and Drug Administration is proposing additional revisions to the Nutrition Facts label for packaged foods. The supplemental proposal would, among other things, require declaration of the percent daily value (%DV) for added sugars. The proposed rule is a supplement to the March 3, 2014 proposed rule on updating the Nutrition Facts label. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families.

The percent daily value would be based on the recommendation that the daily intake of calories from added sugars not exceed 10 percent of total calories.

The 2015 Dietary Guidelines Advisory Committee (DGAC) recently summarized scientific data related to added sugars. The FDA considered the scientific evidence that the DGAC used, which showed that it is difficult to meet nutrient needs while staying within calorie requirements if one exceeds 10 percent of total calories from added sugar, and has determined that this information supports this daily value for added sugars. The DGAC also recommended that Americans limit their added sugars intake to less than 10 percent of total calories. This and other recommendations from the DGAC, which is an independent advisory committee, will be considered in the development of the final 2015 Dietary Guidelines.

The FDA’s initial proposal to include the amount of added sugars on the Nutrition Facts label is now further supported by newly reviewed studies suggesting healthy dietary patterns, including lower amounts of sugar-sweetened foods and beverages, are strongly associated with a reduced risk of cardiovascular disease.

The FDA is also proposing to change the current footnote on the Nutrition Facts label to help consumers understand the percent daily value concept. In addition, the FDA is releasing results of its consumer studies on the declaration of added sugars and the footnote.

The FDA is seeking public comment on the proposal for 75 days. The agency continues to review comments received on the 2014 proposed rule and is reopening the comment period on its March 2014 proposal for 60 days to invite public comment on two consumer studies related to label formats. The agency will consider comments on the original and this supplemental proposed rule before issuing a final rule.

The FDA is accepting public comments starting July 27, 2015.

To electronically submit comments to the docket, visit http://www.regulations.gov.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2012-N-1210 on each page of your written comments.

Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852



Inergetics and Muscle Maker Grill Launch New Product Line of Booster Supplements


Inergetics and Muscle Maker Grill Launch New Product Line of Booster Supplements
NEWARK, N.J., May 19, 2015 /PRNewswire/ — Inergetics, Inc. (OTCBB: NRTI), a world-class developer of nutritional and consumer health products, today announced the launch of a new product line of booster supplements at Muscle Maker Grill locations across the U.S.

The Muscle Maker Grill booster supplements are intended to meet the growing consumer demand for customized smoothies and protein shakes as well as help Muscle Maker Grill franchisees expand their drink menu and profitability.

“We are excited to grow our partnership with Muscle Maker Grill, the leading fast casual chain that shares our company’s focus on promoting health and fitness,” said Jim Kras, CMO of Inergetics. “This new product line will allow Muscle Maker Grill to sell its branded booster products as a retail item direct to consumers opening a whole new sales channel for the franchisees.”

Inergetics will continue to support the new product offerings with free in-store promotional materials.

About Inergetics, Inc.
Inergetics’ portfolio of brands includes: Martha Stewartâ„¢ Essentials, a complete line of NSF® Certified, whole-food-based supplements created specifically for women; Surgex® Sports Nutrition, the preferred nutritional supplement of Army Sports; Bikini Ready®, a leader in active lifestyle solutions; SlimTrim, the affordable, premium value diet brand; OmEssentials®, a line of scientifically advanced nutritional supplements designed to further the health and wellness of yoga practitioners and active individuals; and Nuliefâ„¢, a line of Cannabidiol (CBD)-based nutritional supplements. Inergetics’ brands are available domestically and internationally at thousands of premier locations including Akins, Bed Bath & Beyond, Bi-Lo, Cardinal Health, Discount Drug Mart, Drug Emporium, Fruth Pharmacy, H-E-B, Harmon, Harris Teeter, Harveys, Ingles, Lewis Drugs, Meijer, Navarro Pharmacies, Price Chopper, PriceSmart, Schnucks Markets, ShopRite, Walgreens, Weis Markets, Whole Foods and Winn-Dixie as well as leading e-tailers such as Amazon, Bodybuilding.com, Bulu Box, CVS.com, Drugstore.com, iHerb, LuckyVitamin.com, Swanson, Vitacost and Zulily.

To learn more about Inergetics, visit www.inergetics.com, and the Inergetics brands’ websites at: www.marthastewartessentials.com, www.surgexsports.com, www.surgexsportsblitz.com, www.slimtrim1.com, www.bikinireadylifestyle.com, www.kahunasands.com, www.omessentials.com, and www.nuliefcbd.com.

About Muscle Maker Grill
Muscle Maker Grill is one of the country’s fastest-growing franchises with 57 units in New Jersey, New York and Florida. Muscle Maker Grill has sold 200 units nationwide to date. It enjoys food service sales from its large menu of low-calorie, protein-packed healthful fare, as well as retail sales of protein supplements and packaged foods from retail sections within each restaurant. The chain’s management seeks our restaurant sites inside or near to health clubs and fitness centers, which puts Muscle Maker in proximity to its target customer base-consumers committed to healthy lifestyles. To learn more about Muscle Maker Grill, visit www.musclemakergrill.com.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, including, without limitation, those with respect to the objectives, plans and strategies of Inergetics set forth herein and those preceded by or that include the words “believes,” “expects,” “given,” “targets,” “intends,” “anticipates,” “plans,” “projects,” “forecasts,” or similar expressions, are “forward-looking statements.” Although Inergetics’ management believes that such forward-looking statements are reasonable, it cannot guarantee that such expectations are, or will be, correct. These forward-looking statements involve a number of risks and uncertainties, which could cause Inergetics’ future results to differ materially from those anticipated. Inergetics assumes no obligation to update any of the information contained or referenced in this press release.

SOURCE Inergetics, Inc.



Quest Nutrition Announces New Flavored Bar


enjoymint
The most popular protein bar on the market will be adding a new member to their family on Tuesday, April 21st. Quest Nutrition has been teasing fans over the past few days about a new flavor and today they announced the new flavor. On their social media outlets Quest Nutrition asked, “Are you excited for this double dose of deliciousness?! ‪#‎Enjoymint‬”

While we haven’t tried the new bar yet but if it tastes half as good as they make it looking in their new marketing materials. Sign us up! The bars will only be available on questnutrition.com, at least for the first 30 or so days.

new quest bar

Images FB



Tips on Eating for You – And for Two


It’s no surprise it’s important to eat right, but good nutrition is especially important for women looking to conceive and during pregnancy. Nutrient needs change to make way for baby, and mom needs to alter her diet to help her baby grow healthy from day 1. From folic acid and fiber to prenatal vitamins, what are the best nutritional choices you can make when you are pregnant or planning to become pregnant?

Foods high in fiber
Keep your body moving with high fiber foods including beans, whole-grain breads, fresh fruits, fresh vegetables and high fiber cereals. The USDA recommends pregnant women eat 6-11 servings of grains and 4+ servings of vegetables a day.

Dairy (or non-dairy alternatives)
Drink your calcium! Whether you choose cow’s milk or non-dairy drinks like rice milk, soy milk, or almond milk, make sure you drink at least four servings a day so that you reach the necessary 1000-1300 mg of calcium that your body needs during this time. Yogurt and cheese are other excellent sources of calcium, but be aware that some yogurt is loaded with sugar.

Iron-rich foods
Enjoy iron rich foods that are also high in protein including meat, poultry, seafood and eggs, but make sure they are fully cooked or pasteurized (see Foods to Avoid, below). You should be getting 27 mg of iron each day. Take your iron with vitamin C rich foods to ensure good absorption.

Foods high in vitamin C and vitamin A
Did you know that a green pepper has more vitamin C than an orange? To get the daily recommended 70 mg of vitamin C, eat plenty of fruits and vegetables. Orange vegetables and green vegetables will help you meet your vitamin A requirements.

Folic acid
Many cereals are fortified with folic acid, but you can find it naturally in beans and dark green leafy vegetables like kale and spinach. It is vital to start taking folic acid before you conceive to decrease the risk of birth defects.

Prenatal Vitamins
Even if you do eat a healthy diet, the USDA and doctors recommend taking a prenatal multivitamin every day. A prenatal vitamin like Rainbow Light’s Prenatal One™ Multivitamin or Complete Prenatal System™ Multivitamin provides the extra folic acid, iron and other nutrients that support the important nutritional needs that your growing baby requires.

Tips on Eating for You – And for Two
By Marci Clow, MS, RDN of Rainbow Light



Ronda Rousey’s Meal Plan


What does the leading lady in the UFC eat when preparing for a fight? Ronda Rousey shared her meal plan and daily schedule with espnW’s Allison Glock during a recent interview. Rousey shared, “I try to keep healthy-ish, but I’m so on point when I’m in camp that having a vegetable wrap would actually only be healthy-ish because of the wrap on it.” She’s not all the different from a physique competition by sticking to a healthy plan.

Ronda Rousey Diet:
8:00 am: Two teaspoons oat bran, two teaspoons chia seeds, two teaspoons hemp seeds
10:00 am: Train
11:45 am: Post-exercise smoothie
12:00 pm: Farmer’s scramble: one whole egg, plus two egg whites, two sides of turkey bacon
4:00 pm: Snack: one apple, one-fourth cup raw almonds, one-fourth cup raw cashews
6:00 pm: Train – Post-exercise smoothie, da, da, da.
Before bed: Chamomile tea.

Ronda Rousey: Everything’s got an hour, an amount, everything.

Allison Glock: And you follow it to the letter?
Ronda Rousey: Yeah. And instead of vitamins, I have this giant shake twice a day, so it’s all fresh vegetables and fruits: a whole beet, a whole apple, two carrots, four strawberries, one cup of blueberries, two handfuls of red grapes, one whole lemon, one handful of spinach, one handful of kale, one-fourth handful of parsley, two stalks of celery, two tablespoons of hemp seeds, two tablespoons of chia seeds, one tablespoon of coconut oil, one chard leaf, no stem.

Check out the entire interview on espnW and learn more about the UFC champ. Props to espnW for the excellent interview.



5 Ways to Kick Cravings


Kick Cravings With Healthy Alternatives
Nutrition Expert Explains How To Tame Your Junk Food Urges

Now that 2015 is well under way, millions of people have all but abandoned their New Year’s resolutions to eat healthy and lose weight. However, with recent statistics showing that the obesity rate in the United States has reached 27.7% (the highest obesity rate ever), now is not the time to give into your cheese fry cravings.

Luckily, it is possible to eat healthy and drop pounds without suffering. Celebrity fitness/nutrition expert and creator of The Lifestyle Renovation Joey Thurman explains how:

5 Ways to Kick Cravings

1.  Start Smart. People say that breakfast is the most important meal of the day. “That may be true,” says Thurman, “But all too often I see people use this mantra as an excuse to load up on Sausage McMuffins or donuts in the office break room. That’s not doing your waist (or your heart) any favors. Instead, get up 15 minutes earlier and make yourself a warm breakfast at home, be that steel-cut oats with fresh fruit or an omelet with sweet potato hash.”

2.  Eat for the Body You Want, Not The Body You Have. “People have a defeatist attitude when it comes to their body. They think ‘I am already fat, why not have another slice of pizza? But this type of thinking is what keeps people stuck in unhealthy lifestyles,” says Thurman, “Ask yourself: ‘If I was 10 pounds lighter, what would I eat for lunch today? Would I have the burger or the salad?’ Think with your thin self in mind.”

3.  Think Clean. Counting calories can be overwhelming and boring. “Instead of reading labels and counting points, just start focusing on eating clean, whole foods,” says Thurman. “Stop buying processed foods and eating out. Make your own dinner and bring your lunch. You will save money and look better as a result.”

4.  Stop Giving Up. “If you are tired of starting over, stop giving up,” says Thurman. “It’s time to stop thinking about this as a temporary diet. It’s a lifestyle change, a total and complete renovation.”

5. Harness the Power of Juicing. “I love fresh fruits and veggies, especially when they are juiced (or blended,) and easy for me to take on the go. For example, I blend my veggies in a Nutribullet or blender to make sure I get all of the nutrients AND fiber! I often blend pineapple, lemon, spinach, cucumber, and cayenne pepper whenever I want energy…best of all, it boosts the metabolism as well!”

About Joey Thurman:
Joey Thurman is a health, fitness, and nutrition expert and the creator of The Lifestyle Renovation, a website dedicated to helping people achieve their health and fitness goals. He has appeared on CBS, FOX, ABC, and WCIU sharing his insights as a celebrity fitness trainer and published author. Joey’s work has been featured in publications such as BodyBuilding.com, Racked, TimeOut Chicago, RedEye, and American Global Traveler. Joey is a fashion model represented by Chosen Model Management where he works with brands including Neiman Marcus, Abercrombie, Jockey, and Carson Pirie Scott. He has also appeared on the covers of Healthy for Men and TimeOut Chicago. Joey is a Certified Personal Trainer (CPT) with the American Council on Exercise, a Fitness Nutrition Specialist (FNS) and a FITchef. For more information, please visit www.thelifestylerenovation.com and follow Joey on Instagram and Twitter at @JoeyThurmanFit.



Bodybuilding.com Launches Their Own Supplement Line


True Grit Supplements
It seems there’s a new supplement line announced every month and why would 2015 be any different? It’s not. Bodybuilding.com has become the largest online retailer of nutritional supplements and has decided to venture back into the world of  supplements with their own line. About ten years  ago, Bodybuilding.com had their own supplement line called “Higher Power”. It was cheaper, dare I say “generic” alternative to other brands. It was a bit like Target with a cheaper alternative next to the big name brand of xyx product.

There newest line is taking a different approach and it appears it will will be heavily promoted on the site. The new line was the top promo in an e-newsletter and holds one of the three rotator positions on the site’s homepage. The packaging isn’t generic in its look and has a comparative feel to other brands. True GRIT’s messaging is similar despite claims of being “unlike any supplement”. Many companies claim their products are made for “true athletes” (Muscle Pharm, Gifted Nutrition and others) and backed by science (nearly every supplement at some point in their marketing).

There are five products in the initial launch with two products listed as coming soon. Available now are a pre-workout, whey protein (in 2 and 4 pounds), post-workout and a fat burner. The multi-vitamin and testosterone booster are scheduled to be released in February. Look for the True GRIT brand to shoot up to the top of the site’s Top Sellers list in no time.

NEWS RELEASE – BODYBUILDING.COM LAUNCHES TRUE GRIT
BOISE, Idaho, Jan. 27, 2015 Bodybuilding.com the Internet’s most-visited fitness site and largest online retailer of nutritional supplements, is proud to release the most science-based, research-backed, results-oriented supplement line available, True GRIT. The new line, True GRIT includes the following:

• Whey protein powders to support muscle building.
• Pre-workout powder for improved workouts.
• A test booster to support healthy testosterone levels.
• A thermogenic to help support body composition.

“Each True GRIT supplement contains premium and fully dosed ingredients, so there will never be a question of what you’re putting in your body,” stated Ryan DeLuca, founder and CEO of Bodybuilding.com. “True GRIT is backed by today’s best science and research to bring you the best products possible.”

True GRIT is unlike any supplement because it was made for the true athlete in mind. It was created from advanced supplement research, using clinical studies performed at leading universities and sports performance labs around the world. These studies revealed some of the most effective physique altering and performance-enhancing ingredients currently available. To get your first look at these scientific supplements, please click here.

About Bodybuilding.com
Based in Boise, Idaho, Bodybuilding.com is the world’s largest online sports nutrition store. The site carries more than 13,500 health and fitness supplements and accessories, shipping to customers in more than 155 countries. Bodybuilding.com helps more than 29 million people every month achieve their health, fitness and appearance goals by offering over 35,000 pages of FREE information, including more than 25,000 articles and 10,000 videos, expert-designed online training programs, and new content added daily. For more information, please visit www.bodybuilding.com.



Iovate Launches New, 100% Vegan Brand – Nature’s Foodâ„¢


Nature's Food

Iovate Launches New, 100% Vegan Brand – Nature’s Foodâ„¢ – Exclusively at GNC and GNC.com Stores Nationwide
Full line developed to meet the needs of active consumers seeking world-class plant-based formulas, with no GMOs or preservatives

OAKVILLE, ON, – Iovate Health Sciences International has introduced Nature’s Foodâ„¢, a new line of plant-based, 100% vegan products designed for the active, health-minded individual. These products will be available exclusively at GNC stores across the United States and GNC.com beginning in December 2014. Nature’s Foodâ„¢ supplements feature hand-selected, premium ingredients that are free of lactose, dairy, soy, gluten, preservatives, artificial flavors and artificial sweeteners.

Nature’s Foodâ„¢ was developed to meet the needs of consumers seeking world-class 100% plant-based formulas without genetically modified organisms (GMOs) or preservatives.

“We are honored to become GNC’s premier brand of complete vegan products with Nature’s Foodâ„¢ only at GNC,” says Vito Sanzone, the Chief Marketing Officer at Iovate Health Sciences International Inc. “Our research and development team, alongside our flavor specialists, have developed the definitive plant-based brand with Nature’s Foodâ„¢. And the dynamic and colorful labels make Nature’s Foodâ„¢ easy to find on the GNC shelf.”

The Nature’s Foodâ„¢ brand includes:
• Organic Protein, a USDA organic-certified protein powder exclusively featuring brown rice protein
• All-in-One Meal, a plant-based meal replacement with rice protein, flax, vitamins & minerals, and more
• Plant-Based Fit Protein, a 100% vegan lean protein with scientifically researched green coffee for diet support
• Herbal Diet, a 100% vegan pill for diet support

Nature’s Foodâ„¢ delivers truly best-in-class formulas with only high-quality ingredients and the best taste. For more information on the Nature’s Foodâ„¢ line, visit www.naturesfoodnutrition.com. Available exclusively at GNC stores across the United States and GNC.com beginning December 2014.

Natures food

About Iovate Health Sciences International Inc.
Iovate Health Sciences is a dynamic, leading-edge nutritional supplement company that delivers some of the highest quality, most innovative and effective supplements in the world.

Iovate Health Sciences International is a sports nutrition and weight loss leader based in Ontario, Canada. Iovate brands are sold in over 130 countries globally, and include the sports nutrition brands MuscleTech® and Six Star® Pro Nutrition. More information can be found at www.iovate.com.

SOURCE Iovate Health Sciences International Inc.



FDA Issues Final Menu and Vending Machine Labeling Requirements


The FDA has issued its final menu and vending machine label requirements. The key points…

  • Menu labeling final rule: Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.
  • Vending machine final rule: Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemptions.

NEWS RELEASE
FDA Issues Final Menu and Vending Machine Labeling Requirements

November 25, 2014

The U.S. Food and Drug Administration has finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments and vending machines to help consumers make informed decisions about meals and snacks.

The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. A restaurant or similar retail food establishment is generally defined as a retail establishment that offers for sale restaurant-type food, which is generally defined as food that is usually eaten on the premises of the establishment, while walking away, or soon after arriving at another location. Examples of restaurants and similar retail food establishments include sit-down and fast-food restaurants, bakeries, coffee shops and grocery and convenience stores. The menu labeling final rule also requires calorie labeling for certain alcoholic beverages and certain foods sold at entertainment venues such as movie theaters and amusement parks. The FDA also clarifies in the menu labeling final rule that certain foods purchased in grocery stores or other retail food establishments that are typically intended for more than one person to eat and require additional preparation before consuming, such as pounds of deli meats and cheeses and large-size deli salads, are not covered.

To help consumers understand the significance of the calorie information in the context of a total daily diet, the FDA is requiring a succinct statement that says, “2,000 calories a day is used for general nutrition advice, but calorie needs vary” to be included on menus and menu boards. The menu labeling final rule also requires covered establishments to provide, upon consumer request, written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein.

Restaurants and similar retail food establishments that are covered, including those that voluntarily register with FDA to comply with the menu labeling requirements, will have one year from the date of publication of the menu labeling final rule to comply with the requirements.

The vending machine final rule requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exceptions. Vending machine operators that are covered, including those that voluntarily register with FDA to comply with the vending machine labeling requirements, will have two years from the date of publication of the vending machine labeling final rule to comply with the requirements.

For More Info:

Menu and Vending Machines Labeling Requirements

Federal Register Notice - Final Rule: Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (PDF)

Federal Register Notice - Final Rule: Food Labeling; Calorie Labeling of Articles of Food in Vending Machines (PDF)



FDA Issues Warning: V26 Slimming Coffee Contains Controlled Substance


The FDA has advised consumers not to purchase or use V26 Slimming Coffee. Their lab anaylsis found the product contains the controlled substance, sibutramine. The FDA issues the release show below and notice their “note”. The note mentioned “a growing trend of dietary supplements or conventional food with hidden drugs and chemicals.” A bit of foreshadowing on what’s the come for the supplement industry and the FDA? Only time will tell but for the FDA to specifically note it’s a “growing trend” is a bit unsettling.

V26 Slimming Coffee Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use V26 Slimming Coffee, a product promoted and sold for weight loss on various websites and possibly in some retail stores.

FDA laboratory analysis confirmed that V26 Slimming Coffee contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online: MedWatch Online Voluntary Reporting Form

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.

Contact FDA
Toll Free
(855) 543-3784, or
(301) 796-3400
druginfo@fda.hhs.gov

Human Drug Information
Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993

News via www.fda.gov



Diet Trends Through The Years – Infographic


A quick look at a few diet trends throughout the years courtesy of medifastcalifornia.com.

diet trends

Diet Trends Through the Years [Infographic]
Written by Cara Walsh

Sometimes it seems easier to keep track of Hollywood gossip than it is all of the diet trends—and that’s saying something! From prep time to cost, diet limitations to inclusions, this infographic has everything you need to know about the trending diets. Whether you just want to be well informed or you are looking for your next weight loss strategy, it is important to know what each diet entails. Being fit and in-shape is something that most people strive for, but you won’t believe what extreme diets people have tried to get there.

While they all have their own pros and cons, it can be difficult to determine whether or not a diet works, and which one is right for you. Furthermore, 95% of people who followed a diet re-gained all the weight lost within 1-5 years! It is a challenge to successfully lose weight and keep it off. Enjoy reading about the Diet Trends infographic, and if you feel as though you need that extra help to reach or maintain your weight loss goals, Medifast California is here to help!

diet trends

Infographic Courtesy: medifastcalifornia.com



Going Far With Agar in Your Diet


Going Far With Agar in Your Diet
Registered Dietitian Discusses the Benefits of Agar

Agar, the dietary supplement originally derived from seaweed, is the latest craze in the health and wellness community. Although it is virtually flavorless and odorless, agar offers a plethora of health benefits. According to Keren Gilbert MS, RD, a registered dietitian and certified nutritionist, everyone could benefit from adding more of this Asian supplement into their daily diet.

“In addition to being high in fiber, loaded with minerals, and low in calories, agar acts as an appetite suppressant by expanding and absorbing water in the stomach, leaving you with a greater feeling of fullness,” notes Gilbert, Founder and President of Decision Nutrition™, a nutrition consulting firm. “A diet rich in agar certainly provides the body with the tools it needs for healthy weight loss, or maintaining optimal health.”

When cooking with agar, it is important to note that it exists in several forms, including powder, flakes, and blocks. “The substance is commonly used as a gelatinous thickener for soups, jelly and ice cream, to create a more wholesome and filling option,” Gilbert continues.

“Being that agar is free from nearly all allergens (soy, gluten, corn, lactose, starch, eggs, etc.) it makes for an incredible culinary ingredient. In the near future, I believe we will see it as a staple element for healthy diets.”

About Keren Gilbert MS, RD:
Keren Gilbert is a nutritionist and the Founder and President of Decision Nutritionâ„¢, a nutrition consultant firm in Great Neck, NY and Roslyn, NY. Keren has years of experience in both clinical and private settings and has counseled patients with a variety of nutrition related issues including obesity, high cholesterol, diabetes, high blood pressure, pre natal, pregnancy and digestive issues. Keren is a registered dietitian and certified nutritionist in the state of New York. Keren completed her Masters degree in nutrition and food studies from New York University (NYU) and completed her dietetic residency at Mount Sinai Hospital in New York City. She is an accredited member of the American Diabetic Association and the Greater New York Dietetic Association. She is a member of Nutrition Entrepreneurs, Dietitians in Business, The Diabetes Care and Education Diabetic Practice Group and Sports, Cardiovascular, and Wellness Nutrition (SCAN). For more information visit www.decisionnutrition.com or visit Keren on Facebook at Decision Nutrition.



Hormel Foods to Acquire CytoSport, Makers of Muscle Milk


cytosport sold

CytoSport® To Be Acquired By Hormel Foods Corporation
BENICIA, Calif., June 30, 2014 /PRNewswire/ –-CytoSport®, one of the largest sports nutrition companies in the United States and the makers of Muscle Milk®, announced today that it will be acquired by Hormel Foods Corporation (NYSE: HRL), creating one of the foremost protein and sports nutrition brand platforms with extensive domestic and international reach. As a leading provider of premium protein products in the sports nutrition category, CytoSport’s brands align with Hormel Food’s focus on protein while further diversifying its portfolio and broadening the appeal to younger consumers. The acquisition also enhances the resourcesand capabilities for CytoSport to further develop as an industry leader in innovation, consumer experience, marketing, sales, retailer relationships and distribution on a multinational scale. The transaction is subject to customary closing conditions, including the receipt of regulatory approvals in the United States, and is expected to close within 30 days.

CytoSport was founded in 1998 by father-son duo Greg and Mike Pickett, and has remained a family-operated business from its inception. The company produces a complete line of sports nutrition products, including powders, shakes and bars under the Muscle Milk® brand. The Pickett family will remain committed to the company’s growth and will continue to be involved in day-to-day operations.

“We are excited for the future of the company and are fully confident that aligning our team’s knowledge and experience in the sports nutrition world with the incredibly robust global strategies of Hormel Foods, will help the company establish an even stronger portfolio of brands and products,” said CytoSport Chairman and Founder Greg Pickett. “Over the last 15 years we’ve developed one of the strongest brands in the industry and built an entirely new protein beverage category with Muscle Milk. This next step in the company’s growth story will enable CytoSport to continue its leadership role in the industry and be a part of a global company with greater resources. My family is extremely proud of where the company sits today and grateful to the passionate people who have been a part of this extraordinary adventure.”

TSG Consumer Partners, CytoSport’s strategic equity partner, is also selling its stake in the company. “We are fortunate to have partnered with the Pickett family and the management team to help drive the company’s success over the last seven years,” said Brian Krumrei, Managing Director at TSG Consumer Partners. “During this period, Muscle Milk has established a leading position in the protein beverage category and sales have more than quadrupled. This transaction represents an exceptional outcome for CytoSport, TSG Consumer Partners and Hormel Foods. We look forward to watching the company’s continued success under new ownership.”

CytoSport and Hormel Foods share strong corporate values and are passionate about making a difference in the lives of consumers and active lifestyle enthusiasts in local communities throughout the United States and the world. The acquisition will allow for further community investment and growth through the sports nutrition and food industries.

“We view this new opportunity as a tremendous way to expand the CytoSport brand presence on the global scale and align with a company that shares our commitment to employees and consumers,” said CytoSport Co-Founder Mike Pickett. “With the support from a multinational company like Hormel Foods, the entire CytoSport team is confident in the direction of the brands and look forward to continuing to share the brands’ experiences with consumers around the country and the world.”

Credit Suisse is serving as the exclusive financial advisor to CytoSport in connection with this transaction while Dean Bradley Osborne Partners has represented the Pickett family.

About CytoSport®
CytoSport®, Inc. is one of the largest sports nutrition companies in the United States and provides high quality nutritional products to help athletes and active lifestyle individuals achieve their peak performance potential. The company was founded in 1998 by father and son duo Greg and Mike Pickett, and operates its NSF International GMP for Sport’ registered facility at its headquarters in Benicia, Calif.The CytoSport team is dedicated to working with sports scientists, coaches and trainers to redefine protein-enhanced products to promote workout recovery, lean muscle growth and sustained energy. CytoSport helps in building athletes from the inside out’ with a complete line of powders, shakes and bars, including the Muscle Milk® brand, an award-winning protein line used by professional athletes, collegiate athletic departments and fitness enthusiasts everywhere. CytoSport was named 2009 Small Company of the Year at the annual Beverage Forum presented by Beverage Magazine and Beverage Marketing Corporation and was named one of CircleUp25’s 2013 most innovative companies according to Forbes. In 2014, Fast Company listed CytoSport as one of the world’s top 10 most innovative companies in fitness.

About Hormel Foods
Hormel Foods Corporation, based in Austin, Minn., is a multinational manufacturer and marketer of consumer-branded food and meat products, many of which are among the best known and trusted in the food industry. The company leverages its extensive expertise, innovation and high competencies in pork and turkey processing and marketing to bring branded, value-added products to the global marketplace. The company is a member of the Standard & Poor’s (S&P) 500 Index, S&P Dividend Aristocrats for 2013, was named the 2013 Sustainable Supply Chain of the Year by Refrigerated & Frozen Foods magazine, and was again named one of “The 100 Best Corporate Citizens” by Corporate Responsibility Magazine for the sixth year in a row. Hormel Foods was recognized on the G.I. Jobs magazine list of America’s Top 100 Military Friendly Employers in 2012 and 2013, and named one of the 2014 40 Best Companies for Leaders by Chief Executive magazine. The company enjoys a strong reputation among consumers, retail grocers, foodservice and industrial customers for products highly regarded for quality, taste, nutrition, convenience and value. For more information, visit http://www.hormelfoods.com.

About TSG Consumer Partners LLC
TSG Consumer Partners LLC is a leading investment firm with over $2.9 billion in equity capital under management, focused exclusively on the branded consumer sector. Since its founding in 1987, TSG has been an active investor in the food, beverage, restaurant, beauty, personal care, household and apparel & accessories sectors. Representative past and present partner companies include vitaminwater, Smart Balance, popchips, Yard House, Smashbox Cosmetics, Pureology, e.l.f. cosmetics, Planet Fitness and Revolve. For more information please visit www.tsgconsumer.com.

SOURCE CytoSport

Hormel Foods to Acquire Maker of Muscle Milk Sports Nutrition Products
No. 1 Ready-to-Drink Protein Beverage Brand Expands Specialty Foods Portfolio

AUSTIN, MINN. — Hormel Foods Corporation (NYSE: HRL) today announced that it has entered into a definitive agreement to acquire CytoSport Holdings, Inc., maker of Muscle Milk® products. The transaction is subject to customary closing conditions, including the receipt of regulatory approvals in the United States, and is expected to close within 30 days.

As a leading provider of premium protein products in the sports nutrition category, CytoSport’s brands align with the company’s focus on protein while further diversifying the Hormel Foods portfolio.

Based in Benicia, Calif., CytoSport was founded in 1998 by the Pickett family, and produces Muscle Milk® products, the No. 1 brand in the ready-to-drink protein beverage category.

Total 2014 annual sales are expected to be approximately $370 million. The purchase price is approximately $450 million. Hormel Foods expects this acquisition to provide about 5 cents per share accretion in fiscal 2015, with a neutral impact to fiscal 2014 earnings, including transaction costs.

“Muscle Milk® products will serve as a growth catalyst for our Specialty Foods segment, providing this division with a leading brand in the high-growth sports nutrition category,” said Jeffrey M. Ettinger, chairman of the board, president and chief executive officer at Hormel Foods. “The acquisition of CytoSport expands our offerings of portable, immediate, protein-rich foods, and broadens our appeal with younger consumers. Muscle Milk® premium protein products further enhance our balanced business model.”

BofA Merrill Lynch is serving as exclusive financial advisor to Hormel Foods in connection with this transaction.

CONFERENCE CALL
A conference call will be webcast at 8:30 a.m. CT on Tuesday, July 1, 2014. Access is available at http://www.hormelfoods.com. If you do not have Internet access and want to listen to the call over the phone, the dial-in number is 888-587-0615 and the conference access code is 7709925. The audio replay is available by calling 888-203-1112 and entering access code 7709925. The audio replay will be available beginning at 11:30 a.m. CT on Tuesday, July 1, 2014, through 11:30 a.m. CT on Tuesday, July 8, 2014. The Webcast replay will be available at 11:30 a.m. CT, Tuesday, July 1, 2014, and archived for one year.

About Hormel Foods
Hormel Foods Corporation, based in Austin, Minn., is a multinational manufacturer and marketer of consumer-branded food and meat products, many of which are among the best known and trusted in the food industry. The company leverages its extensive expertise, innovation and high competencies in pork and turkey processing and marketing to bring branded, value-added products to the global marketplace. The company is a member of the Standard & Poor’s (S&P) 500 Index, S&P Dividend Aristocrats for 2013, was named the 2013 Sustainable Supply Chain of the Year by Refrigerated & Frozen Foods magazine, and was again named one of “The 100 Best Corporate Citizens” by Corporate Responsibility Magazine for the sixth year in a row. Hormel Foods was recognized on the G.I. Jobs magazine list of America’s Top 100 Military Friendly Employers in 2012 and 2013, and named one of the 2014 40 Best Companies for Leaders by Chief Executive magazine. The company enjoys a strong reputation among consumers, retail grocers, foodservice and industrial customers for products highly regarded for quality, taste, nutrition, convenience and value. For more information, visit http://www.hormelfoods.com.

Forward-Looking Statements
This news release contains forward-looking information based on management’s current views and assumptions. Actual events may differ materially. Factors that may affect actual results include, but are not limited to: whether and when the required regulatory approvals will be obtained, whether and when the closing conditions will be satisfied and whether and when the transaction will close, whether and when the Company will be able to realize the expected financial results and accretive effect of the transaction, and how customers, competitors, suppliers and employees will react to the transaction. Please refer to the cautionary comments regarding Forward-Looking Statements and Risk Factors that appear on pages 32-38 in the company’s Form 10-Q for the quarter ended April 27, 2014, which can be accessed at http://www.hormelfoods.com under “Investors-SEC Filings” for other factors that could affect our business.

Source Business Wire.



FDA Guide to “Gluten-Free” Food Labeling


FDA Announces Guide to Help Small Businesses Comply with Gluten-Free Labeling Requirements
June 25, 2014 – The U.S. Food and Drug Administration has issued a guide for small food businesses to help them comply with new federal requirements for the voluntary use of the term “gluten-free” on food products. The Small Entity Compliance Guide provides a plain-language question and answer overview of FDA’s regulatory requirements for use of the term “gluten-free” on food labels.

FDA published the final rule on “gluten-free” labeling in August 2013 so that consumers, particularly those with celiac disease, can depend on the accuracy and reliability of the claim. Celiac disease is an autoimmune digestive disorder that can be managed effectively only by eating a gluten-free diet.

Starting August 5, 2014, the compliance date of the rule, all FDA-regulated food products labeled on or after that date and bearing the gluten-free claim must comply with the rule’s requirements.

FDA is issuing the Small Entity Compliance Guide as required by the Small Business Regulatory Enforcement Fairness Act of 1996. The guide covers the key requirements of the regulation, including food products subject to the rule; the definitions of the terms “gluten” and “gluten-free”; and when FDA considers a food labeled “gluten-free” to be misbranded.

FDA encourages the public to submit comments on the guide. The comment period opens June 26, 2014. Electronic comments should be submitted to http://www.regulations.gov. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2005-N-0404

 

Guidance for Industry¹ Gluten-Free Labeling of Foods Small Entity Compliance Guide

The following information can be found on www.fda.gov (PDF).

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction
On August 5, 2013, FDA (or we) published in the Federal Register a final rule that established a regulatory definition of the term “gluten-free” for voluntary use in the labeling of foods (see 78 FR 47154). The rule implements part of the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, enacted on August 2, 2004, which directed the Secretary of Health and Human Services to issue a regulation to define and permit use of the food labeling term “gluten-free.” Firms are not required to label their foods “gluten-free,” but if firms whose foods are regulated by FDA voluntarily choose to make this labeling claim, those products must conform to our definition for a “gluten-free” food. This final rule is intended to provide a uniform definition of the term “gluten-free” so that consumers, particularly those who have celiac disease, will know what it means when they see it on the labeling of food.

The final rule became effective on September 4, 2013, but August 5, 2014 is the date when FDA-regulated foods labeled “gluten-free” must comply with all requirements established by the final rule. However, we encourage manufacturers that wish to make a “gluten-free” claim for their foods to comply voluntarily before this date.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the requirements set forth in the regulation at 21 CFR 101.91 concerning use of the term “gluten-free” in the labeling of foods. The “gluten-free” regulation is binding and has the full force and effect of law.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required.

¹ In the remainder of this guidance, “you” refers to entities that choose to make a “gluten-free” claim on their food labels. We have organized this guidance in a question/answer format and also identify the relevant regulation in parentheses after each answer.

II. Background
Celiac disease is a hereditary, chronic inflammatory disorder of the small intestines triggered by the ingestion of certain storage proteins, referred to as gluten, occurring in wheat, rye, barley, and crossbreeds of these grains. In such individuals, the consumption of gluten stimulates the production of antibodies and inflammatory cells, resulting in an abnormal immune response which damages the tiny, fingerlike protrusions called “villi,” that line the small intestine and function to absorb nutrients from food. Over time, continued dietary exposure to gluten can destroy the intestinal villi of individuals with celiac disease, leading to a lack of absorption of nutrients and a wide variety of other health problems.

The symptoms and clinical manifestations of celiac disease are highly variable among affected individuals and differ in severity. Symptoms of celiac disease may be: (1) “Classical,” affecting the digestive tract (e.g., abdominal bloating; cramping and pain; chronic diarrhea; vomiting; constipation) and resulting in gastrointestinal malabsorption; or (2) “atypical,” affecting mainly other parts of the body (e.g., fatigue; irritability; behavior changes; bone or joint pain; tingling numbness in the legs; ulcers in the mouth; tooth discoloration or loss of enamel; itchy skin rash with blisters called dermatitis herpetiformis). A large portion of the subpopulation that has celiac disease may not experience any symptoms at all, and these individuals are classified as having either the “silent” or “latent” form of celiac disease. Persons who have the silent form of celiac disease have most of the diagnostic features commonly seen in individuals with classical or atypical celiac disease, such as specific serum antibodies and evidence of damaged intestinal villi. Those who have the latent form of celiac disease have specific serum antibodies, but no evidence of damaged intestinal villi. In addition to the aforementioned clinical symptoms and ailments, celiac disease is associated with a number of significant health problems and disorders, including iron-deficiency anemia, vitamin deficiencies, protein-calorie malnutrition, weight loss, short stature, growth retardation in children, delayed puberty, infertility, miscarriage, and osteoporosis. Individuals with unmanaged celiac disease are at an increased risk of developing other serious medical conditions, such as Type I diabetes mellitus, intestinal cancers, and both intestinal and extraintestinal non-Hodgkin’s lymphomas.

Celiac disease has no cure, but individuals who have this disease are advised to avoid all sources of gluten in their diet. Over time, strictly avoiding consumption of gluten can resolve the symptoms, mitigate and possibly reverse the damage, and reduce the associated health risks of celiac disease.
III. Questions and Answers

1. Who is subject to the rule?
The rule does not require anyone to use the term “gluten-free” on a food label. However, if you choose to label your food as “gluten-free,” the rule defines what we mean by “gluten-free” and also establishes requirements regarding the use of the claim.

2. What does the term “gluten-containing grain” mean?
The term “gluten-containing grain” means wheat, rye, barley, and other grains produced by breeding wheat, rye, or barley with each other or breeding them with different grains. For example, triticale is produced by breeding wheat with rye, and so triticale also is considered to be a gluten-containing grain under the rule.

Specifically, the rule defines “gluten-containing grain” as:
any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye):

• Wheat, including any species belonging to the genus Triticum;
• Rye, including any species belonging to the genus Secale; or
• Barley, including any species belonging to the genus Hordeum.

(21 CFR 101.91(a)(1))

3. What does the term “gluten” mean?
The term “gluten” means the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease. Examples of such proteins are called “prolamins” and “glutelins.”
(21 CFR 101.91(a)(2))

4. What does the food labeling claim “gluten-free” mean?
The labeling claim that a food is “gluten-free” means that the food bearing the claim in its labeling does not contain any of the following ingredients:

• An ingredient that is a gluten-containing grain; or

• An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten. For example, “wheat flour” is an ingredient made from wheat that has not been processed to remove the naturally occurring gluten in wheat. Therefore, wheat flour cannot be used as an ingredient to make a food labeled “gluten-free;” or
Contains Nonbinding Recommendations 6

• An ingredient that is made from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten. For example, wheat starch is an ingredient made from wheat that has been processed to remove gluten. However, the use of this ingredient must result in under 20 parts per million gluten in the finished food for the food to be labeled “gluten-free.”

A “gluten-free” claim also can appear on the labels of foods that inherently do not contain gluten (e.g. raw carrots and grapefruit juice).|

Additionally, any unavoidable presence of gluten in a food bearing a “gluten-free” claim, whether manufactured to be gluten-free or inherently free of gluten, must be below 20 ppm gluten. This means that foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten-containing grains or other gluten-containing ingredients.

Twenty ppm gluten is a concentration level rather than an absolute quantity of gluten in a food. It is equivalent to 20 milligrams of gluten per 1 kilogram (or 1000 grams (g)) of food.
(21 CFR 101.91(a)(3))

5. Does the rule require a “gluten-free” claim to appear in a particular size or color?
No. The rule does not require the claim to be in any particular size or color.

6. Does the gluten-free label claim have to appear in a particular place on the food label?
No. The rule does not limit where you place the “gluten-free” claim on the product.

7. How can I determine the gluten content of my food?
The rule does not require you to use any specific method to determine a food’s gluten content. However, there are scientifically valid methods²  that can reliably detect the presence of 20 ppm gluten in a variety of foods, including both raw and cooked or baked products. For example, certain enzyme-linked immunosorbent assay (ELISA) based methods can be used reliably and consistently to detect gluten at 20 ppm levels. These test methods are used by testing laboratories.

We will use scientifically valid test methods to determine compliance with the gluten-free labeling requirements.

²For purposes of this guidance, a “scientifically valid” method for purposes of substantiating a “gluten-free” claim for foods matrices where formally validated methods (e.g., that underwent a multi-laboratory performance evaluation) do not exist is one that is accurate, precise, and specific for its intended purpose and where the results of the method evaluation are published in the peer-reviewed scientific literature. In other words, a scientifically valid test is one that consistently and reliably does what it is intended to do.

8. Am I required to test my food for gluten to make a gluten-free claim on my food labels?
The rule does not require you to test for the presence of gluten in your starting ingredients or finished foods labeled “gluten-free.” However, you are responsible for ensuring that foods bearing a gluten-free claim meet our requirements, including that any unavoidable gluten present in a food labeled gluten-free is less than 20 ppm. We encourage you to use effective measures to ensure that any foods labeled as “gluten-free” comply with our requirements; such measures may include:

• testing the ingredients to determine their gluten content;
• requesting certificates of gluten analysis from ingredient suppliers; or
• participating in a third-party gluten-free certification program.

If you choose to have someone, such as a laboratory, test ingredients for their gluten content, we suggest that you consider whether the laboratory is capable of testing food ingredients for gluten and ask what type of test it uses. For example, we are aware that the R5-Mendez Method (sometimes referred to as the ELISA R5 Mendez Method) and another test method known as the “Morinaga method” can be used to detect gluten in a variety of food matrices.
9. When will FDA consider a food labeled “gluten-free” to be misbranded?
We will consider a food labeled “gluten-free” to be misbranded if its labeling:

• States “gluten-free,” but the food does not meet all of our requirements for a “gluten-free” claim;

• States “no gluten,” “free of gluten,” or “without gluten,” but the food does not meet all of our requirements for a “gluten-free” claim; or

• States both “gluten-free” and either the term “wheat” appears in the ingredient list (e.g., wheat starch) or in a separate “Contains wheat” statement to meet our food allergen labeling requirements, but additional wording is absent that would clarify that the food still meets our requirements for a “gluten-free” claim. In such cases when both the terms “wheat” and “gluten-free” are declared on the same food label, the word “wheat” must be followed immediately by an asterisk or other symbol that refers to this same asterisk or other symbol with the words, “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”

(21 CFR 101.91(b))

10. Can I make a different claim, such as “low gluten” or “very low gluten?”
The rule does not define terms such as “low gluten” or “very low gluten.” If you use such claims, we will evaluate them, on a case-by-case basis, to determine if the claim is truthful and not misleading. We discourage the use of claims other than “gluten-free” and will evaluate any such statements under sections 403(a)(1) and 201(n) of the Federal Food, Drug, and Cosmetic Act (which require labels to be truthful and not misleading).

11. What type of method will FDA use if it decides to analyze a food labeled “gluten-free” to determine if it complies with the agency’s definition of gluten-free”?
We will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food substances, including both raw and cooked or baked products. We will also issue a separate proposed rule regarding the way that we intend to determine compliance for hydrolyzed and fermented foods wishing to make a “gluten-free” claim.

(21 CFR 101.91(c))

12. What happens if I label my food as “gluten-free” and the food is not in compliance with the “gluten-free” regulation, such as it has a gluten level above 20 ppm?
If you label your food as “gluten-free,” but it is not in compliance with the “gluten-free” regulation, such as its gluten content level is above 20 ppm, then it would be “misbranded” under the Federal Food, Drug, and Cosmetic Act, and FDA could take regulatory action.

Information provided by fda.gov. 

 

 



Nikki Haskell “Diet Queen to the Stars” fined $60,000


(Reuters) – A socialite who billed herself as “Diet Queen to the Stars” was fined $60,000 on Friday by a U.S. magistrate judge for drug misbranding of a weight-loss supplement that was linked to suspensions of several NFL players in 2008.

Nikki Haskell and her defunct company, Balanced Health Products Inc, were sentenced by a federal magistrate judge in Manhattan after pleading guilty to a misdemeanor charge related to the sale of a pill called StarCaps. [ID:nL1N0MN1TP]

Prosecutors had sought a $100,000 fine. Haskell, 73, also faced up to six months in prison under a plea agreement announced in March.

“I am so remorseful for this,” she told the judge. “It was never my intent to do anything inappropriate my entire life.”

A onetime television show host, Haskell has occasionally appeared in the New York Post’s Page Six gossip column. Billing herself the “Diet Queen to the Stars,” she was the chief executive of Balanced Health, which marketed StarCaps as an “all natural diet supplement” containing papaya and garlic.

But in 2008, the company voluntarily recalled StarCaps citing the presence of bumetanide, which is used to treat heart failure, renal failure and high blood pressure and that also carries health risks including fluid and electrolyte loss.

Bumetanide is also banned by several sports organizations including the National Football League as a potential steroid-masking agent.

Haskell during the hearing said she was “completely unaware” StarCaps, which was manufactured in Peru, had bumetanide it, adding she had “never even heard of the product until I heard these football players were using it.”

“I’m still to this day shocked anything was in it,” she said.

The NFL cited StarCaps in 2008 in announcing four-game suspensions to six players on the New Orleans Saints, Houston Texans and Minnesota Vikings who tested positive for banned substances.

That year, two other players, Jamar Nesbit of the Atlanta Falcons and Grady Jackson of the Saints, sued Haskell and her company after receiving four-game suspensions because they tested positive for bumetanide.

Haskell subsequently filed for Chapter 7 bankruptcy in 2010, listing potential multimillion-dollar claims by the NFL, players and teams including the Saints, Vikings, Falcons and Texans.

Ahead of Friday’s hearing, Nesbit sent a letter to U.S. Magistrate Judge Netburn seeking as part of the sentence what Chris Manicini, Haskell’s lawyer, described as a “shocking amount of money.” A lawyer for Nesbit did not respond to a request for comment.

Assistant U.S. Attorney Robin Morey said the NFL, meanwhile, had been aware since 2006 that StarCaps contained bumetanide, but did not tell anyone.

Morey called the NFL’s lack of legal obligation to inform the U.S. Food and Drug Administration “unfortunate,” though she said the government found no evidence anyone was injured taking StarCaps.

Brian McCarthy, a spokesman for the NFL, declined comment.

(Reporting by Nate Raymond in New York; Editing by David Gregorio)

Via reuters.com



Jenn Brown Guest Appearance on Cooking Clean with Quest


TV Host and Sportscaster Jenn Brown made an appearance on “Cooking Clean with Quest” and we’re loving the looks of this recipe! Find out how to make a Berry Bliss Parfait with just a few simple ingredients. This is just one of many recipes Quest has on their popular Youtube Channel.

jenn brown cooking

With spring in the air, and summer right around the corner, this yummy #CheatClean treat is perfect for those warm weather afternoons. Host Cassey Ho and special guest Jenn Brown show you how to make a Berry Bliss Parfait that will have your taste buds celebrating.

Macros (makes one parfait):
160 calories
17g protein
13g fat
10g net carbs

Recipe by Yessi Covarrubias of the Quest R&D Team.

You can find Cassey at https://www.youtube.com/user/blogilates.
You can find Jenn at http://jennbrown.com/. Use code ‘Quest’ for 20% off any jewelry purchase!

Cassey Ho, aka Blogilates on YouTube, is a certified fitness instructor, creator of POP Pilates, and a lover of all things healthy.

Jenn Brown is two-time Emmy Award winning sports broadcaster. Currently she works as a host for NFL Network, NBC, UFC and Direct TV.

Follow Quest Nutrition:
Facebook - http://on.fb.me/1l6nfSQ
Twitter - http://bit.ly/1jxyt5v
Instagram - http://bit.ly/1pae2uC

All info via Youtube.



FDA Proposes Updates to Nutrition Facts Labels


The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.

nutrition facts

“Our guiding principle here is very simple: that you as a parent and a consumer should be able to walk into your local grocery store, pick up an item off the shelf, and be able to tell whether it’s good for your family,” said First Lady Michelle Obama. “So this is a big deal, and it’s going to make a big difference for families all across this country.”

“For 20 years consumers have come to rely on the iconic nutrition label to help them make healthier food choices,” said FDA Commissioner Margaret A. Hamburg, M.D. “To remain relevant, the FDA’s newly proposed Nutrition Facts label incorporates the latest in nutrition science as more has been learned about the connection between what we eat and the development of serious chronic diseases impacting millions of Americans.”

Some of the changes to the label the FDA proposed today would:

Require information about the amount of “added sugars” in a food product. The 2010 Dietary Guidelines for Americans states that intake of added sugar is too high in the U.S. population and should be reduced. The FDA proposes to include “added sugars” on the label to help consumers know how much sugar has been added to the product.

Update serving size requirements to reflect the amounts people currently eat. What and how much people eat and drink has changed since the serving sizes were first put in place in 1994. By law, serving sizes must be based on what people actually eat, not on what people “should” be eating. Present calorie and nutrition information for the whole package of certain food products that could be consumed in one sitting.

Present “dual column” labels to indicate both “per serving” and “per package” calorie and nutrition information for larger packages that could be consumed in one sitting or multiple sittings.

Require the declaration of potassium and vitamin D, nutrients that some in the U.S. population are not getting enough of, which puts them at higher risk for chronic disease. Vitamin D is important for its role in bone health. Potassium is beneficial in lowering blood pressure. Vitamins A and C would no longer be required on the label, though manufacturers could declare them voluntarily.

Revise the Daily Values for a variety of nutrients such as sodium, dietary fiber and Vitamin D. Daily Values are used to calculate the Percent Daily Value on the label, which helps consumers understand the nutrition information in the context of a total daily diet.

While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” would be removed because research shows the type of fat is more important than the amount.

Refresh the format to emphasize certain elements, such as calories, serving sizes and Percent Daily Value, which are important in addressing current public health problems like obesity and heart disease.

labels

The proposed updates reflect new dietary recommendations, consensus reports, and national survey data, such as the 2010 Dietary Guidelines for Americans, nutrient intake recommendations from the Institute of Medicine, and intake data from the National Health and Nutrition Examination Survey (NHANES). The FDA also considered extensive input and comments from a wide range of stakeholders.

“By revamping the Nutrition Facts label, FDA wants to make it easier than ever for consumers to make better informed food choices that will support a healthy diet.” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “To help address obesity, one of the most important public health problems facing our country, the proposed label would drive attention to calories and serving sizes.”

The Nutrition Facts label has been required on food packages for 20 years, helping consumers better understand the nutritional value of foods so they can make healthy choices for themselves and their families. The label has not changed significantly since 2006 when information on trans fat had to be declared on the label, prompting manufacturers to reduce partially hydrogenated oils, the main source of trans fat, in many of their products.

The changes proposed today affect all packaged foods except certain meat, poultry and processed egg products, which are regulated by the U.S. Department of Agriculture’s Food Safety and Inspection Service.

The FDA is also proposing to make corresponding updates to the Supplement Facts label on dietary supplements where applicable.

The agency is accepting public comment on the proposed changes for 90 days.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For more info visit: fda.gov



Jess & Blair’s “Green Drink” Recipe


Cover Model and top pro bikini competitor Jessica Mone and her husband Blair have a daily “green drink”. Jessica shared in her recent Road to The Arnold Blog that she makes it because it’s “an anti inflammatory, alkalizing,  immune system boosting, toxic removing, disease fighting, energy cranking, skin glowing, internal deodorant, bowel cleaning DREAM!!!”

green drink recipe

Jessica shares, “I notice a definite increase in energy, less sickness, my skin has never looked better.”

Jess & Blair’s “Green Drink”
1 tablespoon wheat grass
1 tablespoon turmeric or curcumin
1 scoop super green foods
1 shot mint chlorophyll
1 shot Apple cider vinegar
2 shots aloe
1 tablespoon olive leaf
1 serving (Optimum Nutrition) glutamine
4 grams ginger
1 cup kale
1 cup spinach
1 whole lemon
Passion fruit tea to help with taste

Read more here.



Quest Nutrition to Release New Flavored Bar


Question Nutrition has quickly become one of the favorite protein bars in and out of the fitness industry. The company has done what few are able to do… generate buzz. They’ve embraced social media and uses professional, enticing images to help market the products. Their latest tactic is teasing fans with new flavors and it’s working.

new quest bar

The secret to Quest Nutrition‘s success is a combination of things but ultimately it comes down to the taste of the product and it’s supplemental value. You can hype a company and/or product but if you don’t deliver on flavor, it was all for not. The days of chalky tasting protein bars are gone. Quest has come under scrutiny over some of their ingredients and labeling but they’ve openly discussed the topic related to the seemingly frivolous lawsuit.

So what’s the next big flavor they’ve been teasing? While we can’t say for certain what it will be, we can say if we were to bet on it… we’d put our money on Cookies & Cream. Rumor has it there could be samples of this new flavor at THE FIT EXPO, this weekend in in Los Angeles, CA.  If the new flavor is officially released and available, you can be sure we’ll give it a try and let you know how it tastes.

UPDATE:


Image via Quest



SHOCKING! Hershey’s New Line of Spreads Loaded with Sugar


In not so shocking news, The Hershey Company has found another way to peddle sugar to consumers with a new line of products. Coming from a candy company we really shouldn’t expect anything less than a product loaded with sugar, right? The disturbing part of this new product line is how they are marketing it and the pitch of it being a “snack enhancer”.

hershey's spreads

A spokesperson for the company says, “The average American snacks more than two times a day and what better way to transform everyday snacks into delicious treats, than with the genuine chocolate flavor that only Hershey can deliver.” Images on their web site show the spreads paired with healthy snacks like carrots, nuts, fruit and celery. If you’re goal is healthy eating it doesn’t make much sense to add these sugary spreads. It’s like going McDonald’s and ordering a Big Mac, Large Fry but oh I’ll just have a Diet Coke to drink. That’s not eating healthy.

carrots with hersheys spread

Take one look at their “nutritional facts” and you’re faced with nearly the same amount of sugar as a candy bar. Chances are you’ll end up eating more than one serving, which means you’re better off having a Hershey’s bar to start with, at least in terms of sugar consumed. It may look delicious and maybe it is but don’t fall into this sugary trap by thinking it is a healthy choice.

 

NEWS RELEASE:
Hershey Makes Everything More Delicious With New Line Of Sweet, Creamy Hershey’s Spreads
Hershey’s Spreads Offer Endless Possibilities

HERSHEY, Pa., Jan. 15, 2014 /PRNewswire/ — Today The Hershey Company (NYSE: HSY) announced it is launching Hershey’sâ„¢ Spreads, a new line of chocolate spreads. Inspired by Hershey’s® pure chocolate flavor, the creamy, rich spreads will be available in three varieties: Chocolate, Chocolate with Almond and Chocolate with Hazelnut.

Dating back to 1894, The Hershey Company has a legacy of creating chocolate experiences, from the iconic Hershey’s® Milk Chocolate Bar to Hershey’s® Syrup and Hershey’s® Cocoa. Hershey’s Spreads will continue this legacy with the introduction of chocolate spreads that can turn any food into a unique chocolate snacking experience. Hershey’s Spreads deliver genuine Hershey’s® chocolate flavor to any food, anytime, anywhere.

“The average American snacks more than two times a day and what better way to transform everyday snacks into delicious treats, than with the genuine chocolate flavor that only Hershey can deliver,” said Anna Lingeris, spokesperson, The Hershey Company. “We have been delivering genuine chocolate experiences in a variety of forms for 120 years and our legacy as the leader in chocolate continues with Hershey’s Spreads.”

Hershey’s Spreads will make everything delicious through seemingly endless pairing possibilities. Whether pairing with traditional selections such as graham crackers, strawberries or bananas, or more adventurous pairings like celery, pineapple or pickles, Hershey’s Spreads is the ultimate snack enhancer.

Hershey’s Spreads are now available nationwide at food, mass, drug and convenience stores and will be offered in 13oz jars that retail for $3.79. The new product will be supported by a robust integrated marketing campaign that began in the fourth quarter of 2013 and will continue through 2014.

For more information, including pairing ideas and recipes, please visit http://www.hersheys.com/Spreads. and join the conversation using #SpreadPossibilities.

About The Hershey Company
The Hershey Company (NYSE: HSY) is the largest producer of quality chocolate in North America and a global leader in chocolate and sugar confectionery. Headquartered in Hershey, Pa., The Hershey Company has operations throughout the world and approximately 14,000 employees.

With revenues of more than $6.6 billion, Hershey offers confectionery products under more than 80 brand names, including such iconic brands as Hershey’s, Reese’s, Hershey’s Kisses, Hershey’s Bliss, Hershey’s Special Dark, Kit Kat, Twizzlers, Jolly Rancher and Ice Breakers. The company is focused on growing its presence in key international markets such as China, Mexico and Brazil while continuing to build its competitive advantage in the United States and Canada.

For more than 100 years, The Hershey Company has been a leader in making a positive difference in the communities where its employees live, work and do business. Corporate Social Responsibility is an integral part of the company’s global business strategy, which includes goals and priorities focused on fair and ethical business dealings, environmental stewardship, fostering a desirable workplace for employees, and positively impacting society and local communities. Milton Hershey School, established in 1909 by the company’s founder and funded by a trust administered by Hershey Trust Company, provides a quality education, housing, and medical care at no cost to children in social and financial need. Students of Milton Hershey School are direct beneficiaries of The Hershey Company’s success.

SOURCEThe Hershey Company.



Cyber Monday – Save Big on Supplements


Today only you can get a 20% discount! There’s no coupon code or extra step needed to get 20% a number of supplement brands. This is a great time to stock up on your favorite brands and integrate into your workouts and fitness goals. Bodybuilding.com has you covered for all your sports nutrition needs!

 

cyber monday deals
What Bodybuilding.com has to say about CYBRO MONDAY
Whether you’re ending the year as the top scorer in your gym, planning for a 2014 reboot, or giving someone the gift of the next level of fitness, check out our biggest Cybro Monday sale ever. More than 50 of the biggest names in sports nutrition are offering amazing ways to power up for less. These deals are good today only, so start shopping before it’s Game Over.



U.S. Marshals Seize More than $2 million Dietary Supplements from Hi-Tech Pharmaceuticals, Inc.


FDA NEWS RELEASE

U.S. Marshals seize more than $2 million in adulterated dietary supplements from Georgia company
FDA acts to prevent distribution of products containing unapproved food additive

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent. The retail value of the seized products is more than $2 million.

A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.

The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.

On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals, Inc. facility.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

During the FDA’s inspection of Hi-Tech Pharmaceuticals, Inc., which began in October, investigators identified eleven products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES, and YELLOW SCORPION. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.

To date, the FDA has received numerous reports of illnesses and death associated with supplements containing DMAA, including heart problems and nervous system or psychiatric disorders. Consumers can report an adverse event or illness they believe to be related to the use of a dietary supplement by calling 1-800-FDA-1088 or online. Your health care provider may also report this by calling the FDA’s MedWatch hotline at 1-800-FDA-1088.

Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.

For more information:
FDA: DMMA in Dietary Supplements

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The FDA also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
via FDA.gov



USPlabs Dietary Supplement Recall Expands


Update: USPlabs LLC Announces a Recall of OxyELITE Pro Dietary Supplements Due to Possible Health Risk
Recall expanded to include: Raspberry Lemonade OxyELITE Pro Super Thermo Powder

FOR IMMEDIATE RELEASE – November 19, 2013 – USPlabs LLC, Dallas, TX is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products listed below.

These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.

Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii. Investigations are ongoing into a potential causal relationship. The Company agrees with FDA that a national recall is appropriate as a precautionary measure.

Product was distributed nationwide through retail stores, mail orders and direct delivery.

OxyElite Pro Super Thermo capsules

  • 2 count capsules UPC #094922417275
  • 10 count capsules UPC #094922417251
  • 10 count capsules UPC #094922417268
  • 21 count capsules UPC #094922426604
  • 90 count capsules UPC #094922395573
  • 90 count capsules “Pink label” UPC #094922447906
  • 180 count capsules UPC #094922447852

OxyElite Pro Ultra-Intense Thermo capsules

  • 3 count capsules UPC #094922447883
  • 3 count capsules UPC #094922447876
  • 90 count capsules UPC #094922395627
  • 180 count capsules UPC #094922447869

OxyElite Pro Super Thermo Powder

  • Fruit Punch 0.15 oz UPC #094922417237
  • Fruit Punch 0.15 oz UPC #094922447517
  • Fruit Punch 4.6 oz UPC #094922426369
  • Fruit Punch 5 oz. UPC #094922447487
  • Blue Raspberry 4.6 oz UPC #094922426376
  • Grape Bubblegum 4.6 oz UPC #094922447500
  • Green Apple 4.6 oz. UPC #094922426499
  • Raspberry Lemonade 4.6 oz. UPC #094922447494

No other products produced by USPlabs are subject to recall. Consumers who have purchased the products should immediately discontinue use of the product and return it to where they purchased it for a refund. Contact your health care professional if you have experienced any adverse effects.

Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 am – 5 pm EST) or info@usplabsdirect.com. Adverse reactions may be reported to the FDA MedWatch Adverse Event Reporting program online athttp://www.fda.gov/medwatch/getforms.htm, by regular mail, or by FDA’s MedWatch Hotline 1-800-FDA-1088.
Via FDA.gov

 



USPlabs Recalls OxyElite Pro


FOR IMMEDIATE RELEASE — November 9, 2013 – USPlabs LLC, Dallas, TX is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products listed below. These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.

Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii. Investigations are ongoing into a potential causal relationship. The Company agrees with FDA that a national recall is appropriate as a precautionary measure. Product was distributed nationwide through retail stores, mail orders and direct delivery.

OxyElite Pro Super Thermo capsules
2 count capsules UPC #094922417275
10 count capsules UPC #094922417251
10 count capsules UPC #094922417268
21 count capsules UPC #094922426604
90 count capsules UPC #094922395573
90 count capsules “Pink label” UPC #094922447906
180 count capsules UPC #094922447852

OxyElite Pro Ultra-Intense Thermo capsules
3 count capsules UPC #094922447883
3 count capsules UPC #094922447876
90 count capsules UPC #094922395627
180 count capsules UPC #094922447869

OxyElite Pro Super Thermo Powder
Fruit Punch 0.15 oz UPC #094922417237
Fruit Punch 0.15 oz UPC #094922447517
Fruit Punch 4.6 oz UPC #094922426369
Fruit Punch 5 oz. UPC #094922447487
Blue Raspberry 4.6 oz UPC #094922426376
Grape Bubblegum 4.6 oz UPC #094922447500
Green Apple 4.6 oz. UPC #094922426499

No other products produced by USPlabs are subject to recall. Consumers who have purchased the products should immediately discontinue use of the product and return it to where they purchased it for a refund. Contact your health care professional if you have experienced any adverse effects.

Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 am – 5 pm EST) or info@usplabsdirect.com. Adverse reactions may be reported to the FDA MedWatch Adverse Event Reporting program online at http://www.fda.gov/medwatch/getforms.htm, by regular mail, or by FDA’s MedWatch Hotline 1-800-FDA-1088.



Why Muscle Milk is Worth Mega Millions


Cytosport Inc. is a sports nutrition company founded by the father son team of Greg and Michael Pickett. The company created the popular protein drink Muscle Milk in 2000 and has become one of the leading supplement brands in the world. Last week the Wall Street Journal reported that the owners of Muscle Milk were looking to sell off the popular brand for an astonishing $500 million. The story by the WSJ has not been confirmed and there’s no indications that it will come to fruition. If it does, it will be one of the biggest deals in sports nutrition history. There are many things going for Muscle Milk and why they’re worth the reported millions.

muscle-milk
It started as a powder in 2000 and has extended into bars, oatmeal and ready-to-drinks. There’s a variety of lines within each of these categories… Muscle Milk Light, Monster Milk, Pro Series and even a collegiate brand. When brands extend into other categories they often lose their voice and miss the mark. They’ve managed to keep the same flavor and brand integrity with each product. Having tried a number of products I can attest to their flavor but the oatmeal didn’t tickle my tastebuds.

Muscle Milk has reached “main stream” appeal… a goal most companies strive to achieve. Reality TV stars like JWOWW from the Jersey Shore have been seen drinking Muscle Milk and Lady Gaga requests it on her tour rider. Muscle Milk has attracted people who simply want a healthier lifestyle. Hosting events like events the Muscle Milk Fitness Retreat and creating Evolveâ„¢ has helped them build an audience beyond athletes. Their partnerships with colleges across the country help build their brand with student athletes. It’s easy to understand why Forbes named them one of the 25 Most Innovative Consumer and Retail Brands. They’re also not afraid to have fun with the brand as evident in this Thanksgiving spot.

Occasionally, supplement companies get a bad rap for their ingredients and “tainted” products. Cytosport prides itself on being free of banned substances and in 2007 received NSF certification. That plays into why Muscle Milk is one of the largest brands in the protein category and has outlasted many “cool” brands. They manufacture their own powder products at the company headquarters in Benicia, California and the facility is inspected and regulated by the FDA. That’s not to say they’re immune from litigation. The faced a lawsuit allegedly certain products contained lead, cadmium, and/or arsenic. CytoSport denied these claims and responded with independent testing. As stated on cytosportclassactionsettlement.com, “The Court did not rule in favor of plaintiffs or CytoSport. Instead, the parties agreed to a settlement to avoid the expense and risks of continuing the lawsuits.”

The company had success with athlete endorsements over the years but also know what it’s like to have athletes that don’t live up to company standards. They were early endorsers of NFL stars like Clay Matthews and Adrian Peterson. Basketball’s lovable Shaquille O’neal helped them launch Mighty Milk and they’ve been a player in the motorsports world with their own team. On the flip side, they wisely cut ties with New England Patriots Aaron Hernandez when he was arrested on murder charges. They had an endorsement deal with baseball’s Ryan Braun, winner of the won the 2011 National League’s most valuable player award, until he had a positive drug test. Muscle Milk’s current athlete roster is an impressive mix of men and women. It includes baseball’s three-time All-Star Clayton Kershaw, snowboarding pioneer, Olympic silver medalist and four-time X Games gold medalist Gretchen Bleiler, Chicago Bears running back Matt Forte and many others.

No company is flawless however when the people behind it are passionate about it, you can count on it being successful. Only time will tell if Muscle Milk will be sold to another company but regardless of who owns it you can count on the brand being found at convenient stores, Costco, Walmart, gyms and online for years to come.



FDA Advisory – Acute Hepatitis Illness Cases Linked To OxyElite Pro


The U.S. Food and Drug Administration (FDA) shared an advisory warning linked to popular fat burner OxyElite Pro.The supplement has been under scrutiny this year which prompted the manufacturers (USPLabs LLC) to reformulate their blend.

oxy pro supplements
What is the Problem and What is Being Done About It?
The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) are investigating a growing number of reports of acute non-viral hepatitis in Hawaii. There have been 29 cases of acute non-viral hepatitis with an unknown cause identified in the state. The Hawaii DOH has reported that 24 of these cases share a common link to a dietary supplement product labeled as OxyElite Pro. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. CDC is also looking at other cases of liver injury nationwide that may be related.

The FDA advises consumers to stop using any dietary supplement products labeled as OxyElite Pro while the investigation continues. OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nation-wide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. USPlabs LLC has informed the FDA that it will voluntarily cease distributing OxyElite Pro as the company cooperates with the investigation.

The epidemiological investigation is being conducted by the Hawaii DOH and the CDC. As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients. Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.

In the interest of protecting public health, we are moving quickly to learn as much as possible. We recognize that people will be concerned about these illnesses, and we will provide updates as the investigation develops.

What are the symptoms of acute hepatitis?
Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.

What do Consumers Need to Do?
The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nation-wide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements.

Who should be Contacted?
Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

If you think you have suffered a serious harmful effect or illness from a dietary supplement, your health care provider can report this by calling FDA’s MedWatch hotline at 1-800-FDA-1088 or report online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential..

Consumers may also report an adverse event or illness they believe to be related to the use of a dietary supplement by calling FDA at 1-800-FDA-1088 or online. FDA would like to know when a product may be related to a medical problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic.

The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.

OxyElite Pro: Health Advisory – Acute Hepatitis Illness Cases Linked To Product Use

AUDIENCE: Health Professional, Consumer

ISSUE: The FDA, along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH), are investigating a growing number of reports of acute non-viral hepatitis in Hawaii. The Hawaii DOH has reported that 24 of these cases share a common link to a dietary supplement product labeled as OxyElite Pro.

BACKGROUND: OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nation-wide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. There have been 29 cases of acute non-viral hepatitis with an unknown cause identified in the state of Hawaii. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. CDC is also looking at other cases of liver injury nationwide that may be related. Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.

The epidemiological investigation is being conducted by the Hawaii DOH and the CDC. As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients. Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.

RECOMMENDATION: The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Info from: www.fda.gov



Perky Jerky October Special


Bodybuilding.com and Perky Jerky are making a difference together – now through the end of October, Bodybuilding.com and Perky Jerky will donate .50 for every bag of Perky Jerky sold. The funds raised from sales will be donated directly to the Muscular Dystrophy Association, specifically for the Halo Trial – a groundbreaking new drug trial which could potentially lead to finding a cure for muscular dystrophy! Whether you prefer sweet & spicy or hot & bothered, or you just want to keep it original – your purchase can help make a difference.

perky-jerky
Muscular Dystrophy Association is the nation’s largest voluntary health agency dedicated to funding neuromuscular disease research, health care services and education. MDA supports cutting-edge neuromuscular disease research; ensures that all Americans affected by these diseases receive treatment and critical care; and serves as a voice for families with neuromuscular disease.



Flo Rida Partners with MusclePharm


Denver based supplement company, MusclePharm has announced their latest partnership and this time it’s with global recording artist Flo Rida. Flo Rida is the guy is responsible for songs that get stuck in your head like “Good Feeling” and “Wild Ones”. MusclePharm is hoping their supplements resonate with his audience as much as his music. They continue to use not only athletes but also celebrities and fitness enthusiasts to promote their products. The company utilized social media to market and promote the easily identifiable MusclePharm green.

PRESS RELEASE
Global Superstar Flo Rida Now Partnering With MusclePharm®.

DENVER, June 20, 2013 — /PRNewswire/ — MusclePharm Corporation (OTCQB: MSLP), a nutritional supplement company focused on active lifestyles, has signed a deal with international recording artist Flo Rida. Activating a social media network of over 16 million followers, Flo Rida will promote MusclePharm products and develop exclusive viral exercise videos for the brand. He also will represent MusclePharm at events and star in a series of radio and online ads.

Flo Rida has built a fervent fan base by mixing hip-hop harmonies with slick dance beats, selling over 75 million singles worldwide. The innovative Florida-born rapper became a chart-topping artist fixture with blockbuster singles such as “Right Round” and “Wild Ones (feat. Sia).” Flo Rida is committed to imparting the importance of education to children and empowering student athletes to become leaders both on and off the field through his non-profit organizations, Big Dreams for Kids and the Florida Youth Football League (FYFL).

“Ever since I was growing up, health, nutrition and fitness have been very important aspects of my life,” said Flo Rida. “I started using MusclePharm supplements because of the company’s commitment to developing safe, scientifically backed products. Right away I noticed a positive improvement with my energy and fitness levels. I’m very excited to join the MusclePharm family and look forward to promoting the brand to my fans.”

“As one of today’s most popular musicians, Flo Rida is a global force who is at the top of his field because he is dedicated not only to his music but also to his physical well-being,” said Brad Pyatt, founder and CEO, MusclePharm. “Flo Rida’s international influence coupled with his amazing physique make him an ideal ambassador. We’re thrilled to have him represent the MusclePharm brand.”

As part of their agreement, MusclePharm will make a donation to Flo Rida’s charity, the FYFL, and gift new sports equipment to the league. MusclePharm and Flo Rida will celebrate the partnership at the customer appreciation day next month which will be taking place at Flo Rida’s new South Florida gym, Flo Fit (12425 Taft Street, Pembroke Pines, FL 33028). The musician and philanthropist joins fellow MusclePharm brand ambassador, quarterback Colin Kaepernick of the NFL® San Francisco 49ers, who partnered with the company earlier this year. Additionally, MusclePharm is the official Nutritional Supplement provider of the Ultimate Fighting Championship®.

ABOUT MUSCLEPHARM CORPORATION:

Founded in 2008 by former NFL player Brad Pyatt, MusclePharm is a healthy lifestyle company that develops and manufactures nutritional supplements to address active lifestyles like muscle building, weight loss and maintaining general fitness through a daily nutritional supplement regimen. The products are formulated through a six-stage research process using the expertise of leading nutritional scientists at MusclePharm Sports Science Center & Research Center in Denver, Colorado. MusclePharm’s products are sold to consumers in more than 110 countries and available in over 10,500 U.S. retail outlets, including Dick’s Sporting Goods, 24 Hour Fitness, Bally’s, GNC, Vitamin Shoppe and Vitamin World. MusclePharm products also are sold through more than 100 online channels globally, including bodybuilding.com, amazon.com and vitacost.com. For more information, please visit www.musclepharm.com. You can also follow MusclePharm online at www.facebook.com/MusclePharm and www.twitter.com/MusclePharm.

Forward Looking Statements The information contained herein includes forward-looking statements. These statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

MusclePharm PR Contact: Ivy Mollenkamp/Wendy Zaas Rogers & Cowan 310-854-8131/310-854-8148 imollenkamp@rogersandcowan.com wzaas@rogersandcowan.com

MusclePharm Investor Relations Contact: The Del Mar Consulting Group, Inc. Robert B. Prag President Telephone: 858-794-9500 Email: Email Contact

Or

John H. Bluher Executive Vice President MusclePharm Corporation 303-396-6149 John@musclepharm.com

Flo Rida Contact: Elora Mason Strong Arm Management 305-828-3228 305-851-5699 (mobile)

SOURCE MusclePharm Corporation



Five Tips for Juicing


Thinking about Juicing? What You Should Know Before You Start
It’s no longer just celebrities, world-class athletes and alternative-lifestyle hippies turning to green smoothies and freshly juiced vegetable and fruits for improved health, says nutritionist and juicing pioneer Cherie Calbom, MS. (“The Juice Lady”).

juicing

“People from all walks of life are looking for proven ways to lose weight, energize, sleep better, strengthen their immune systems, and have brighter skin and a younger appearance. They’re also juicing to help their bodies heal from a variety of ailments,” says Calbom, author of a new book full of juicing tips, tricks and recipes, “The Juice Lady’s Big Book of Juices and Green Smoothies,” (www.juiceladycherie.com).

“No matter your diet, juicing offers a shot of goodness – nutrition, minerals, phytonutrients and more – that you might not otherwise get,” Calbom says.

Whether you’re just getting started or you’ve been juicing awhile and want to optimize the experience, Calbom shares some important pointers that will help.

• Fruits & veggies happiness studies: Plenty of new research shows that adding more produce to your daily diet can benefit your mental health and sense of well-being. In one analysis of the eating habits and moods of 80,000 British adults, researchers at Dartmouth and the University of Warwick found that those who consumed the most fruit and vegetables every day rated themselves as significantly happier and more satisfied with their lives than those who ate lesser amounts. Research shows that the well-being score for people who ate seven to eight servings of vegetables and fruits per day was consistently three points higher than for those who ate little or none.

• More studies … Researchers at the Harvard School of Public Health concluded from a study of 982 Americans that those who exhibited the most optimistic outlooks on life also had the highest blood levels of carotene, a key antioxidant that’s delivered by a colorful array of produce: dark green spinach and kale, carrots, and sweet potatoes, and vibrant yellow or orange fruits like peaches, papayas and cantaloupe, among others. And “juicers” should consider starting at a young age. A study of 281 adults with a mean age of 20, conducted at the University of Otago, New Zealand, showed that those who reported the highest daily intake of fruits and veggies also declared they were happier, calmer and more energetic than those who ate less.

• “Do I need to juice; can’t I just eat produce?”: This is a common response, but the reality is that most people in today’s society – especially those who are booked from morning to evening with a busy lifestyle – rarely get an optimal amount of produce throughout the day. A half-cup of veggies is a serving and ¾ of a cup of juice equals one serving; chewing seven to eight servings of produce every day requires much more effort and time than drinking fresh juice for some of the servings. That makes people much more likely to benefit from juice, she says.

• Flavor diversification: Some people soon fall into creative ruts because they stick to the same basic ingredients, and that can be a disincentive for sticking with juicing. Diversify! Try gourmet and exotic juice blends, or even plant-based ingredients you simply haven’t yet considered, some of which may include: butternut squash, one-inch ginger chunks, beets with leaves and stems, Brussels sprouts, and fennel bulbs with fronds. “Juicing is not about just using common fruit ingredients – spice it up and experiment with healthy vegetables; it works!” Calbom says.

• An exotic example: A fennel-watercress-cucumber blend juice is an excellent way to mix up your typical cocktail. It includes: 1 handful of watercress; 1 dark green lettuce leaf; 1 cucumber, peeled if not organic; ½ fennel bulb and fronds; 1 lemon, peeled if not organic. Cut produce to fit your juicer’s feed tube. Wrap watercress in lettuce leaf and push through the juicer slowly. Juice all remaining ingredients. Drink immediately; this portion serves one.

About Cherie Calbom, MS
Cherie Calbom, MS is the author of 21 books, including the best-seller “Juicing for Life,” with 2 million copies sold in the United States and published in 23 countries. Known as “The Juice Lady” for her work with juicing and health, her juice therapy and cleansing programs have been popular for more than a decade. She holds a Master of Science degree in nutrition from Bastyr University. She has practiced as a clinical nutritionist at St. Luke Medical Center, Bellevue, Wash., and as a celebrity nutritionist for George Foreman and Richard Simmons.



Disclaimer: Reader discretion advised, please consult your physician before beginning any exercise or diet program.