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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.

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Filed under: Safety

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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.

Tainted dietary supplements: How do you know?

Dietary supplements do not require approval by the FDA, so how can you know if the supplement you are considering is tainted? Read on for warning signs and new actions by the FDA that can help.

Tainted dietary supplements most often occur among products typically marketed for weight loss, sexual enhancement, and bodybuilding. They can have deceptive labeling as well as undeclared, harmful ingredients. The question is: How can consumers protect themselves from these products?

The Food and Drug Administration (FDA) has recently taken some steps to help consumers look out for potentially harmful dietary supplement products.  Consumers and healthcare professionals can receive notifications from the FDA by subscribing to the RSS feed. The Commissioner of Food and Drugs also sent a letter to the dietary supplement industry reminding them of their responsibility to prevent the sale of tainted products in the United States. The FDA has also made it easier to report to the FDA about tainted products.

Some of these tainted dietary supplement products contain active ingredients of FDA-approved drugs or other compounds that are not classified as dietary ingredients. These products can have serious side effects, including death. The FDA has identified roughly 300 tainted products that are not legal dietary supplements and are warning consumers about the serious side effects of these products. Consumers should be cautious of:

  • Product ads that claim to “melt your fat away,” or claim that “diet and exercise [are] not required,” or products that use the words “guaranteed,” “scientific breakthrough,” or “totally safe.”
  • Products that use numerous testimonials about “results seen” from using the product.
  • Any product that is labeled or marketed in a foreign language. Consumers should not buy or consume these products.
  • Products that are marketed as herbal alternatives to FDA-approved drugs.
  • Products marketed and sold on the Internet.

    There have been some recent voluntary recalls due to FDA investigations of dietary supplement products. Some of these have included weight-loss products that contained the prescription drug ingredient sibutramine. Sexual enhancement products have also been recalled for containing the undeclared drug ingredients sulfosildenafil and tadalafil. Other products marketed as supplements have been identified as containing various prescription drug ingredients.

    It is important that consumers be aware that, under the Dietary Supplement Health and Education Act of 1994, companies do not need FDA approval prior to marketing such products. Thus, generally speaking, the FDA does not approve dietary supplements.

    Consumers need to be savvy when they make product purchases, and when in doubt, check with a healthcare professional or registered dietitian to determine if you need a dietary supplement product and to help determine what could be a tainted product. If it looks too good to be true, chances are it is.  For more information, read the “FDA’s Beware of Fraudulent ‘Dietary Supplements’.”

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    Dietary supplements: Questions and answers

    HPRC Fitness Arena:
    The Food and Drug Administration (FDA) answers consumers' questions about dietary supplements and the regulations of dietary supplements.

    The U.S. Food and Drug Administration (FDA) has information for consumers regarding dietary supplements: Questions and answers, regulations, and safety alerts. Click here for their website.

    Beware of Fraudulent Weight-Loss "Dietary Supplements"

    HPRC Fitness Arena:
    The FDA warns against weight-loss products which don't live up to their claims and can potentially cause serious harm.

    The FDA warns against weight-loss products which don't live up to their claims and can potentially cause serious harm. Dozens of products have been found being marketed as dietary supplements which contain hidden prescription drugs or compounds that have not been adequately studied in humans.

    For more information, click here [PDF].

    Beware of Fraudulent "Dietary Supplements"

    HPRC Fitness Arena:
    Federal regulators continue to warn consumers about tainted, dangerous products that are marketed as dietary supplements.

    The Food and Drug Administration (FDA) has found nearly 300 fraudulent products–promoted mainly for weight loss, sexual enhancement, and bodybuilding–that contain hidden or deceptively labeled ingredients.

    Click here for more information [PDF].

    Relaxation beverages: Don’t believe the hype

    HPRC Fitness Arena:
    A new wave of beverage products is gaining attention, aimed at helping us relax, reducing our anxiety, and helping us sleep.

    We’ve seen all the recent news and reports about energy drinks and the concern about the amount of caffeine in these products. Now a new wave of products is gaining attention, aimed at helping us relax, reducing our anxiety, and helping us sleep. These “relaxation beverages,” or “anti-energy drinks,” contain ingredients such as melatonin, valerian root, kava, St. John’s Wort, L-theanine, rose hips, and chamomile. A great number of relaxation beverages have been introduced into the market over the last three years, with names such as “Dream Water,” “iChill,” “Vacation in a Bottle,” and “Unwind.” Consumers of any age can buy these drinks in convenience stores, college campuses, and online.

    Part of the problem with these relaxation drinks is that some of their ingredients, particularly melatonin, have not gone through the Food and Drug Administration’s (FDA) approval process required for all food ingredients to be designated as safe or GRAS (“generally recognized as safe”). Melatonin is a hormone made by the body, but it is also available as a supplement and is often used to treat sleep disorders and jet lag. The FDA sent a warning letter last year to the manufacturers of the “Drank” beverage saying, “there is no food additive regulation in effect that provides for the safe use of melatonin…Likewise, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.” The manufacturers of “Drank” want their product to be classified as a dietary supplement, not as a beverage, since the FDA scrutinizes foods and beverages much more closely than dietary supplements.

    People who have liver problems, liver disease, or are taking prescription drugs should be cautious about using the herb kava, an ingredient found in some of these relaxation drinks. Kava has been linked to severe liver injury, and the FDA issued a consumer advisory in 2002 with a warning that kava-containing dietary supplement products have been associated with liver-related injuries, including hepatitis, cirrhosis, and liver failure. Valerian root, a medicinal herb, is used to treat sleep disorders as well as anxiety. Although some research has been conducted on the effects of valerian on insomnia, the data are mixed, and no studies have tested the safety and effectiveness of the combination of ingredients found in relaxation beverages.

    The marketing of relaxation drinks is also of concern, as it is geared toward a younger crowd, with bottles resembling the look of popular energy drinks and shots. The concern is that young adults will think nothing of having more than one of these a day. Some of these beverages have warnings on their labels stating that users should not consume them before operating/driving machinery or if pregnant or nursing.

    What’s the bottom line? Buyers beware! There’s no magic pill, and there’s no magic beverage. Try to determine the causes of your stress and/or insomnia, address those issues, and then work towards establishing a healthy lifestyle overall.

    New York Times: "Serious dangers" of alcoholic energy drinks

    HPRC Fitness Arena:
    A recent New York Times article reports that scientists are worried about highly caffeinated beverages like Red Bull, Rockstar, Monster and Full Throttle, which are popular among teenagers and young adults.

    A recent New York Times article reports that scientists are worried about highly caffeinated beverages like Red Bull, Rockstar, Monster and Full Throttle, which are popular among teenagers and young adults.  According to the article, the often bizarre combination of ingredients in these drinks prompted three researchers from the University of Texas Health Science Center at Houston and the University of Queensland in Australia to examine what is known — and not known — about the contents of these beverages, which are sold alongside sodas and sport drinks in supermarkets, drugstores and highway rest stops.

    Click below to access the article.

    Scientists See Dangers in Energy Drinks

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    Prevent food poisoning

    HPRC Fitness Arena:
    Foodborne illness, commonly known as food poisoning, can make you feel as if you have the flu! Some tips will help you stay safe.

    Foodborne illness, commonly known as food poisoning, can make you feel as if you have the flu! Symptoms often include nausea, vomiting, diarrhea, or fever. It’s caused by consuming foods or beverages contaminated with bacteria, parasites, or viruses. To prevent, wash your hands and surfaces; cook foods to proper temperatures; and refrigerate cooked foods promptly. For more helpful tips, click here.

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    Save your knees with a few simple tips

    HPRC Fitness Arena:
    Prevent knee injury with these tips.

    Try these tips from the National Institute of Arthritis and Musculoskeletal and Skin Disease to prevent knee injury while you exercise:

    • Avoid bending your knees past 90 degree when doing half knee bends or squats.
    • Avoid twisting your knees by keeping your feet as flat as possible during stretching.
    • When jumping, land with your knees bent.

    Source: Handout on Health. Sports Injuries. National Institute of Arthritis and Musculoskeletal and Skin Disease.

    Exercise smart to prevent injuries

    HPRC Fitness Arena:
    Some tips to keep you from hurting yourself while exercising

    Since injuries can occur in physically active individuals, here are a few tips to help you stay injury free:

    • Warm-up and cool-down after exercise;
    • Use proper form;
    • Spread activity throughout the week, not just the weekend;
    • Wear appropriate safety gear;
    • Increase intensity and time gradually, and
    • Cross train to prevent overuse injuries.

    Click here for more information: Handout on Health. Sports Injuries. National Institute of Arthritis and Musculoskeletal and Skin Disease.

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