dietary supplements: when a medication isn’t

Sunday, August 2, 2015

Elite athletes know their bodies well. They understand the signals that push them to perform and those that may cause potential damage and injury. They also know that what they put into their body for fuel is an important part of the equation. For that reason, an athlete who tests positive for a performance-enhancing drug, can reasonably presume that it was illegal. So it was not unreasonable to hear the collective sigh of disbelief, when Antonio Gates of the San Diego Chargers told reporters that he was shocked when he failed his drug test. Mr. Gates said he was not quite sure how the illegal drugs got into his body but he had not necessarily changed his routine and had never before tested positive.

Fans may roll their eyes and stare in disbelief, but Mr. Gates may be the victim of the dietary supplement and alternative medication industry that has grown without oversight and regulation. While pharmaceutical companies are held to stringent production and distribution standards by governmental agencies around the world, those companies who tout the benefits of their “nutraceuticals” can do so because of large loopholes found in the Food and Drug Administration (FDA) regulations. There is no guarantee that what is listed on the label is actually contained in the pill.

This year the New York attorney general’s office found that the majority of herbal supplements tested did not contain any of the herbs listed on their labels. These were supposedly reputable brands sold at major retailers like Walgreens, Target, Wal-Mart and GNC. This was not necessarily news, since past studies had documented similar inaccuracies. Not to be outdone, this month, the Department of Justice sued three Wisconsin manufacturers (Atrium, Nutripak and Aspen Group) for mislabeling multiple supplements and because it was a repeat offense, asked that they be continually monitored at company expense by the FDA. European researchers found that more than 10% of dietary performance supplements were contaminated, often with steroids and other stimulants (Judkins, C. Investigation into supplementation contamination levels in the UK market. HFL Sport Science 2008).

So why does this matter and why should we care what a pro athlete puts into their body? The answer is relatively simple. Dietary supplements are not innocuous. They can have significant side effects if take inappropriately and may also interact with prescription medications to cause problems.

Excessive caffeine can affect blood pressure, heart rates and rhythms. St. Johns Wort can interact with blood thinning drugs to decrease their effectiveness and lead to increased risk of stroke. Bodybuilding and weight loss supplements contain chemicals and proteins that may stimulate increased production of anabolic steroids in the body, increasing the risk of liver disease, cancer and other illnesses. Some, like androstenedione, were available for years before being banned by the World Anti Doping Agency and other pro sport organizations. Other chemical supplements are now marketed to take their place. Plus, there is the potential for contamination in the manufacturing process. A hepatitis outbreak in 2013 was related to the weight loss supplement OxyElitePro. In 2014, the probiotic, ABD Dophilus Powder, was found to be contaminated with fungus.

While all manufacturers should not be painted with the same brush, industry lobbied hard for Congress to exempt them from the tighter FDA regulations that are imposed on pharmaceutical companies. In 1994, Congress exempted supplements from the FDA approval process required of pharmaceutical companies. In 2012, an amendment to register products with the FDA and list their ingredients was defeated. Now, all the FDA can do is ask that makers of dietary supplements voluntarily adhere to good manufacturing practices and guarantee the identity, purity, strength and composition of their product.

The National Institutes of Health notes that “research studies in people to prove that a dietary supplement is safe is not required before the supplement is marketed…the manufacturer does not have to prove that it is effective.” Dietary supplements cannot be marketed to treat, prevent or cure a disease or illness. Therefore, the weight loss or male sexual enhancement claims are not meant to treat obesity or erectile dysfunction. Supplements developed to regulate acid secretion or bowel habit are not directed to peptic ulcer disease or constipation.

With the inaction by Congress and the FDA, other companies have filled the void. NSF International will certify products as safe, containing what the label says it does, and sports leagues like the NFL accept that certification. But it is a leap to say that the manufacturing standards of dietary supplements meet those of pharmaceutical companies, without the stamp of approval of a governmental agency. And while it is sometimes hard to believe the explanations that athletes give for failing a drug test, it is a distinct possibility that Mr.. Gates did nothing wrong and was the victim of circumstance beyond his control.

For Mr. Gates, the potential lack of manufacturer accountability led to a missed paycheck. For those who developed hepatitis or a fungal infection, or had a heart attack or stroke, the loss was much more tangible. Without aggressive FDA oversight and action, the self-regulation in the industry will only get better only if the risk of an expensive lawsuit outweighs the benefit of increasing their standards. And that’s asking a lot for a company to balance corporate ethics against their bottom line.

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