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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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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

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

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Filed under: Dietary supplements

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.

Zinc: Some Facts

HPRC Fitness Arena:
Your body needs zinc for a number of essential functions, so make sure your diet includes foods that provide this nutrient.

Zinc, an essential trace element, is found in cells throughout the body and helps the immune system by fighting off bacteria and viruses. It is also involved in making proteins and DNA and helps wounds heal, among other functions. Oysters are the richest source of zinc, and other good sources include red meat, poultry, crab, lobsters, and fortified cereals. For more information, including the average daily recommended amounts, see the Office of Dietary Supplements’ Fact Sheet.

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.

Durbin raises concerns over melatonin baked goods

HPRC Fitness Arena:
Senator Dick Durbin (D-IL) has asked the FDA to clarify its regulatory position on dietary supplements and food additives on the back of widespread concerns about the marketing of melatonin-containing baked goods.

Food Safety News is reporting that Senator Dick Durbin (D-IL) has asked the FDA to clarify its regulatory position on dietary supplements and food additives on the back of widespread concerns about the marketing of melatonin-containing baked goods.  A recent HPRC Performance News  post notes that there have been questions raised on commercially available products such as Lazy Cakes and Lulla Pies that are marketed as "relaxation" brownies - which contain high doses of the sleep aid melatonin.


These products are being sold as dietary supplements to help people relax and fall asleep, rather than foods containing additives.  Senator Durbin contends that these foods are being sold as dietary supplements but are really foods containing a dietary ingredient additive, which would require FDA approval. He has asked U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to see if she has the authority  "to oversee the safety of foods containing dietary supplement additives."

What you need to know about dietary supplements

HPRC Fitness Arena:
The variety of dietary supplements available can make it difficult to assess products. The NIH has issued a pamphlet to help you understand what’s what.

The vast array of dietary supplement products come in the form of tablets, capsules, powders, drinks, and energy bars. You can learn about dietary supplement labels, effectiveness, quality standards, safety and risks, and other important information about these products from the National Institute of Health’s Office of Dietary Supplements publication “Dietary Supplements: What You Need to Know.”

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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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FDA Press Release: FDA Warns about Counterfeit ExtenZe Dietary Supplements

HPRC Fitness Arena:
The FDA is warning consumers about a counterfeit product marketed as the dietary supplement product “ExtenZe”

The Food and Drug Administration (FDA) has issued a press release to consumers warning them about a counterfeit product being represented as the dietary supplement "ExtenZe.” The counterfeit product has hidden ingredients, including tadalafil or a combination of tadalafil and sildenafil, which are active ingredients of FDA-approved drugs, making these products unapproved drugs. Taking these products with prescription medications containing nitrates could lower blood pressure to dangerous levels. More information, including the lot numbers on the counterfeit packages, is provided in the FDA Press Release.

Help or hindrance? Market for melatonin-laced brownie snacks persists

HPRC Fitness Arena:
Lazy Cakes, Kush Cakes and Lulla Pies are the names of melatonin-laced snacks that have been in the news lately as an anti-dote to the trend of energy/caffeinated powered beverages and products. But the research on whether they are safe, or that they actually work, has not been established.

Lazy Cakes, Kush Cakes, and Lulla Pies are the names of melatonin-laced snacks that have been in the news lately as an antidote to the trend of energy/caffeinated powered beverages and products. But there is no research available on whether they are safe, or whether they actually work.

The New York Times reported on the sale of these products and others that are being sold online and in convenience stores and smoke shops. Some claim melatonin has a relaxing effect and can be used to alleviate jet lag or simply help induce sleep. But the Food and Drug Administration hasn't approved melatonin as a food additive or confirmed its safety when used as a sleep aid.

The HPRC began encountering stories of melatonin-laced brownie products back in March 2011, and we posted a Healthy Tip then that focused on the emergence of Lazy Cakes.

The FTC and fake acai “news” claims

HPRC Fitness Arena:
Watch out for apparent news websites, even those displaying recognizable logos, that make weight-loss claims for acai berry supplements. The FTC is targeting these deceptive practices.

The Federal Trade Commission (FTC) is seeking to bar deceptive claims made by websites posing as reputable news sites to entice consumers to buy acai berry weight-loss products. The FTC says these companies are not “news-gathering organizations” and their claims that acai berry supplements can cause rapid weight loss are unsupported. For more information, read the FTC release: “FTC Seeks to Halt 10 Operators of Fake News Sites from Making Claims About Acai Berry Weight Loss Products.”

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