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Alerts

RegenESlim Appetite Control Capsules voluntarily recalled due to the presence of DMAA.

FDA warns consumers about caffeine powder. 

FDA advises consumers to stop using any supplement products labeled as OxyElite Pro or VERSA-1. Please see the following advisories: FDA -10/08/13, FDA - 10/11/13 and CDC - 10/08/13.

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Announcements

New article on reporting side effects of supplements
Just published in The New England Journal of Medicine: A recent article brings up dietary supplement issues you need to be aware of and discusses how dietary supplement side effects could be monitored better. A PDF of the April 3rd article is available free online.

3rd International Congress on Soldiers’ Physical Performance
August 18-21, 2014
The ICSPP delivers innovative scientific programming on soldiers’ physical performance with experts from around the world.

DMAA list updated for April 2014

Fueling Performance Photo Campaign
Share photos of how you fuel your performance and be featured on our Facebook page!

Dietary supplement module
Earn continuing education credits (if eligible) for this two-hour online module.

Operation LiveWell

Performance Triad

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Filed under: FDA

Reporting adverse events associated with dietary supplement use

Reporting adverse events from dietary supplement use is essential for determining the safety of available products and ingredients.

Many adverse events associated with dietary supplement use go unreported. HPRC has developed one page information resources on how to report adverse events. Warfighters and their families can follow the directions for reporting adverse events to MedWatch (FDA) and Natural Medicines Watch. In addition to these sites, Health care providers can follow step by step directions for reporting via AHLTA.

Food contamination with Listeria monocytogenes

HPRC Fitness Arena: Nutrition, Total Force Fitness
Food contaminated with Listeria can cause a deadly infection.

Recently there has been a multistate outbreak of listeriosis from cantaloupes. The Centers for Disease Control and Prevention (CDC) has an informative report about listeriosis, including symptoms, food contamination, and how to take steps to avoid this serious infection.

Arsenic and apple juice: some answers

HPRC Fitness Arena: Family & Relationships, Nutrition
Recent news have reported arsenic found in apple juice but the FDA says it is safe to drink

Apple juice containing arsenic has been a topic in the news recently. The Food and Drug Administration (FDA) has put together questions and answers to assist the public in sorting through the information. The FDA’s conclusion is that apple juice is safe to drink. More information is available in FDA: Apple Juice Safe To Drink.

FDA seeks to remove Lazy Cakes from shelves

HPRC Fitness Arena: Nutrition, Total Force Fitness
Lazy Cakes, the melatonin-laced brownies that have caused some controversy in the past several months, have been deemed unsafe by the Food and Drug Administration.

According to an Associated Press article from August 2, 2011, the Food and Drug Administration (FDA) has warned the manufacturer of the melatonin-laced brownies known as "Lazy Cakes" that the government considers them unsafe and could seize them from store shelves. The brownies were originally sold under the name Lazy Cakes, but the manufacturer of the product has changed the product name to Lazy Larry.

The FDA said that melatonin has not been found to be safe for use in conventional foods. “On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin,” said the letter, sent last Thursday by the agency’s acting director for the Office of Compliance. Melatonin is not approved for use in any food, the FDA said.

HBB, LCC, the Memphis-based company that makes Lazy Cakes/Lazy Larry, was given 15 days to respond to the FDA with details on specific steps it would take to correct its violation of the ban against melatonin use in food.

It should be noted that the HPRC has been covering Lazy Cakes since they first became available.

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Papayas may contain Salmonella

Filed under: Alert, FDA, Safety
Papayas have been recalled due to potential contamination with Salmonella Agona.

Agromod Produce, Inc., is recalling all papayas distributed nationwide and to Canada due to potential contamination with Salmonella Agona. For more information, read the Food and Drug Administration Press Release.

FDA warning to Muscle Milk manufacturer

HPRC Fitness Arena: Dietary Supplements, Nutrition
FDA sent a warning letter to the makers of Muscle Milk products, Cytosport, Inc., for making claims that are in violation of federal law.

Cytosport, Inc. was cited for having false or misleading label and website claims in violation of several points of federal law for several products, including “Chocolate Muscle Milk Protein Nutrition Shake,” “Vanilla Crème Muscle Milk Light Nutritional Shake,” and “Chocolate Peanut Caramel Muscle Milk.”  The company is in violation of the Federal Food, Drug, and Cosmetic Act and is required to take specific actions to correct the violations. More information is provided in the FDA Warning Letter.

FDA News Release: Illegal drug claims banned for chelation products

HPRC Fitness Arena: Dietary Supplements, Nutrition
New York dietary supplement manufacturer agrees to remove drug claims from his website.

New York dietary supplement manufacturer Howard Sousa, of Artery Health Institute LLC and DeSousa LLC, has agreed to remove drug claims on his company’s website. Sousa’s Advanced EDTA Oral Chelation capsules were promoted on the website as drugs since the marketing language made disease treatment claims. More information is provided in the FDA News Release.

FDA News Release: Drug residues in veal calves

HPRC Fitness Arena: Dietary Supplements, Nutrition
Veal calves sold as food contain illegal drug residues.

Virtue Calves was cited for selling veal calves that contain illegal drug residues, which is in violation of the Federal Food, Drug, and Cosmetic Act. The company is now required to keep careful records of which animals have been medicated so that illegal drug residues do not enter the food supply. More information is provided in the FDA News Release.

Not all sunscreens are created equal

HPRC Fitness Arena: Environment, Total Force Fitness
The FDA is taking steps to protect and educate consumers about sun exposure and sunscreen products. Choose "broad spectrum" products for greatest protection.

Warfighters are deployed to all kinds of environments, including hot and dry conditions where sun exposure is a concern. Choosing a "broad-spectrum" product that protects against sunburn, skin cancer, and premature skin aging is important, but product labeling can be confusing. Now, however, the Food and Drug Administration (FDA) is taking steps to regulate the labeling of sunscreen products in order to help consumers choose a product that will protect them from sun damage to the skin.

The new measures include a regulation, effective one year from now, that requires sunscreens to undergo a standard test if they want to be labeled as a “broad spectrum” product. Those that pass the test will be allowed to use “broad spectrum” on their packaging, which indicates a product that provides protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). UVB rays are primarily responsible for sunburn, but both UVA and UVB rays are harmful and can cause sunburn, skin cancer, and premature skin aging.

Other provisions in the FDA regulation include:

  • A warning about the risk of skin cancer and early skin aging on the labels of sunscreen products that are not broad spectrum.
  • The amount of time the consumer can expect protection from a product with water resistance claims must be stated on the front label. The FDA, based on standard testing, will allow either a 40-minute or 80-minute timeframe on labels.
  • Products will no longer be allowed make a claim of “waterproof” or “sweatproof” or use the term “sunblock,” nor can they make the claim of immediate or instant protection or protection for more than two hours without reapplication.

Additional measures regarding the labeling of sunscreen products have been proposed. To learn more, view the FDA’s full article.

Food and Color Additives: What are they?

HPRC Fitness Arena:
If you read product labels, you know there are numerous “mystery” ingredients in many foods. This FDA brochure takes some of the mystery away.

Food and color additives exist in many of the foods that we eat. They are used to improve safety and freshness, maintain the nutritional value of foods, and improve texture and appearance. The Food and Drug Administration (FDA) has put together a helpful brochure reviewing how additives are approved for foods, types of food ingredients, and a description of food and color additives.

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