Apr 8, 2010

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At Your Peril: Quality Control Failures can Lead to Disaster

No reputable sports dietary supplement company wants to be associated with reports of a contaminated product. In some cases, tainted supplements can lead to arrest and criminal prosecution; in others, the bad press alone can have a devastating effect upon consumer confidence and a company’s bottom line-sometimes even before the alleged contamination is confirmed. Even if the reports of supposed contamination are ultimately found to be unsupported in whole or in part, the damage done may be disastrous. If the contamination involves a substance banned in competitive sports, a lawsuit may be filed if an athlete fails a doping test after using the product.

How prevalent are tainted supplements? Research conducted at an Olympicaccredited testing lab in 2002 found 94 of 634 supplement samples contained substances not listed on the label that would trigger positive drug tests, and a 2007 report found that about 25% of supplement samples contained low levels of steroid and/or stimulant contamination. U.S. bobsledder Pavle Jovanovic and NFL running back Mike Cloud blamed doping positives on tainted protein powders. World-class swimmer Kicker Vencill and Austrian skier Hans Knauss got big bucks when they sued supplement manufacturers for their flunked doping tests.

Why would banned substances be present in supplement products, even when quality control safeguards are in place? First, there’s the possibility that somebody at the manufacturing facility is intentionally spiking the product with an illegal drug to enhance the effects. That was the case not too long ago when the unapproved drug clenbuterol showed up in a supplement product, and it might be the case regarding an energy and fat loss supplement recently reported to contain undeclared sibutramine, a controlled substance appetite suppressant. The FDA issued a public warning that unsuspecting consumers could be injured because sibutramine can substantially increase blood pressure and heart rate-quite risky for anyone with heart problems. According to the FDA, the manufacturer claimed on its Web site that only “trace amounts” were found but FDA lab tests showed that the product contained “a significant amount of sibutramine per dosage unit.”

Second, some manufacturers, in a misguided effort to keep their proprietary ingredients a secret, may be unclear or indifferent as to their labeling obligations under the law. Some manufacturers of sexual enhancement dietary supplements have come under heavy fire for the undeclared presence of “analogs” of prescription erectile dysfunction drugs. While the legal definition of an analog may be debatable, the requirements about listing a product’s ingredients are not. The FDA has issued health alerts that these products threaten public health especially “because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.”

Third, and the most common explanation for tainted supplements, is accidental “cross-contamination” at the raw materials stage. Supplement raw ingredients, like many pharmaceutical ingredients today, often originate in China, where quality control may be hit-or-miss. Some bad apples among U.S. supplement. manufacturers have not scrutinized the raw ingredients to the extent that they should; it’s time for them to upgrade their quality control protocols immediately. But even companies committed to high quality can inadvertently market tainted products when trace impurities-including banned substances-escape detection during standard quality control review. The result can be products with too little contamination to have any physiological effect-either good or bad-but just enough to cause a flunked drug test. Recognizing that “certificates of analysis” accompanying foreign raw ingredients may not be reliable guarantees of purity, some supplement companies have begun using explicit warning labels to stop drug-tested individuals, including athletes, from using certain products at all. It’s hard to have sympathy for a drug-tested athlete who cries foul if he uses a product with a label that explicitly warns tested athletes like him not to use it.

At Collins, McDonald & Gann, we’ve personally witnessed all three scenarios in our years as legal counsel within the sports nutrition industry. We’ve seen federal criminal prosecutions for intentional spiking and, sometimes, for mislabeling. As for inadvertent contamination, critics of the supplement industry, including Major League Baseball, are calling for stricter federal regulation of dietary supplements. It could happen. But it’s important to remember that most supplements are not contaminated, and that those that are often only have trace amounts. Besides, stricter quality control and labeling is already on the way as the FDA-issued new Rule for “good manufacturing practices” is phased in requiring industry to test the purity, strength and composition of their supplements. The rule, with limited exceptions, applies to all domestic and foreign companies that manufacture, package, or hold dietary supplements intended for sale in U.S. commerce, including those involved with the activities of testing, quality control, packaging, labeling, and distributing (all companies must comply by June, 2010). We are working hard to help our clients meet the new standards. Hopefully, reports of tainted supplements will become fewer and farther between, to the great benefit of both industry and consumers.

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