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Alerts

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: Safety

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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: 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.

Herbal products: Important information to know

HPRC Fitness Arena: Dietary Supplements
Herbal products are advertised as “natural," but are they safe? The American Academy of Family Physicians has some answers to important questions.

There are many herbal products available to consumers, yet it is difficult to determine if they are safe. The American Academy of Family Physicians provides answers to questions about herbal product use, potential dangers with specific health problems, and possible drug interactions. A helpful chart about interactions between herbal products and supplements is also available.

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.

The lure of Jack3d

HPRC Fitness Arena: Dietary Supplements
This relatively recent supplement targeting the exercise performance market has been growing in popularity, but the limited information about its “recipe” and the severe warnings on its label and website should make potential users think twice.

Jack3d (sometimes known as “Jacked”) is, according to the bottle, a “powerful pre-workout supplement that increases your capacity to perform.” HPRC did an extensive search for evidence-based information on Jack3d and found that all the apparently scientific literature on the product led to its promotional website, where they offer their own reviews. Anyone taking supplements should know that there have been reports about “tainted” dietary supplements containing active ingredients of FDA-approved drugs or other compounds that are not classified as dietary supplements. But there are still testimonials, blog entries, and bodybuilding forums touting the effects of Jack3d. It’s important to know exactly what is in Jack3d and that there isn’t any information on how much of each individual ingredient is in a serving.

The label of Jack3d says that it contains 4145 mg of a “Proprietary Blend” in one scoop, with 45 servings per container. In that blend are the ingredients:

  • arginine alpha-ketoglutarate,
  • creatine monohydrate,
  • beta alanine,
  • caffeine,
  • 1,3-dimethylamylamine (geranium [stem]), and
  • schizandrol A,
  • as well as some flavoring and color additives.

So, what does this all mean to a consumer? There have been individual studies conducted on each of the ingredients in Jack3d. Some are more effective than others for potentially enhancing athletic performance and building muscle mass. For example, creatine may increase muscle mass and enhance exercise performance during short, high-intensity repeated exercise bouts. For more information about creatine, see HPRC’s research brief. We know that 1,3-dimethylamylamine (DMAA), a chemical from the geranium plant and also synthetically made, is used in supplements promoted for weight loss, bodybuilding, and enhanced athletic performance. According to the Natural Medicines Comprehensive Database, it’s thought to have stimulant effects. Its chemical structure is similar to that of amphetamine, and it is on the World Anti-Doping Agency’s banned substance list. No scientific literature exists on the effectiveness of DMAA for weight loss, bodybuilding, or enhanced athletic performance. Caution is advised on the use of DMAA with caffeine, since both have stimulant effects and could increase the chance of increased heart rate and blood pressure.

The amount of caffeine per scoop of Jack3d has not been released, although it has been estimated that there is less than 150 mg of caffeine/scoop. Caffeine is included on the FDA’s list as a substance “generally recognized as safe.” However, the FDA has established a maximum concentration for caffeine in cola beverages: 32.4 mg per 6 oz or 71 mg per 12 oz. Other than colas, the caffeine content of food and beverages is not regulated. The label of Jack3d states: “Do not use in combination with caffeine or any stimulants from other sources whatsoever, including but not limited to, coffee, tea, soda and other dietary supplements or medications.” Caffeine seems to increase physical endurance, but it does not seem to affect activities that require high exertion over a short period of time, such as lifting.

The main issue with Jack3d is the same one that exists with many bodybuilding products on the market. There is no way to judge the interaction between the ingredients, especially when the consumer is unable to determine how much of each ingredient is in the product. This product contains multiple ingredients and, potentially, additional and potent ingredients not listed. It also could be contaminated, as has been seen with many other supplements. The FDA has put together information on tainted products promoted for bodybuilding.

It is important to mention that Jack3d comes with serious warnings on its label. As with any supplement, be educated, be advised, and consider all the unknowns before you decide whether the possible benefits are worth risking your health.

The FDA cracks down on a Minnesota company making unproven claims

HPRC Fitness Arena:
The FDA seizes probiotic products from Minnesota company that makes unproven disease claims.

Probiotic products were seized by U.S. Marshals after the Food and Drug Administration (FDA) complained that the products were marketed as drugs. The company who sells the probiotic products claims that the products will prevent or treat disease, which is in violation of the Federal Food, Drug, and Cosmetic Act. More information is provided in the FDA News Release.

Herbs at a glance

HPRC Fitness Arena:
Visit the website of the National Center for Complementary and Alternative Medicine for information on many of the herbs used as and in dietary supplements.

The National Center for Complementary and Alternative Medicine (NCCAM) has produced a series of fact sheets on specific herbs and botanicals. Find information on common names, uses, potential side effects, and other information by choosing any of the 45 herbs or botanical fact sheets.

New cooking temperature for pork

HPRC Fitness Arena:
The USDA recommendations for cooking various types of meet offer important and useful guidelines, including some changes from previous directions.

The United States Department of Agriculture’s (USDA) new cooking guidelines for meats include a reduced “safe” cooking temperature for whole cuts of pork to 145ºF (down from 160ºF). They recommend using a food thermometer and allowing a three-minute rest time before serving. For whole cuts of beef, veal, and lamb, the safe temperature is the same—145ºF—but the new guidelines add a three-minute rest time after these meats, too, are removed from a heat source.  For additional information, including the recommendations for cooking ground meats and poultry, read the new cooking guidelines.

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FDA Press Release: Don’t use products marketed as antimicrobial dietary supplements

HPRC Fitness Arena:
The FDA is warning consumers not to buy or use products claiming to antimicrobial and marketed as dietary supplements.

 

The Food and Drug Administration (FDA) is warning consumers to stop using dietary supplement products that claim to be antimicrobial (antibiotic, antifungal, or antiviral) drugs. These products are falsely promoted to treat upper respiratory infections, sinusitis, pneumonia, bronchitis, and colds, and they look like antimicrobial products sold in Mexico.  More information, including product names, is provided in the FDA Press Release.

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