Sports Supplements Are Regulated

To the editor (Times Herald-Record, Hudson Valley, New York state):

Your special report, “Supplements for athletes stir serious debate” (June 29, 2010) is interesting but presents some misleading ideas.

For example, the quote that “18.8 percent of supplements are tainted with steroids or other illegal, potentially dangerous ingredients” is seriously flawed, since the percentage actually refers to 240 sports supplements tested, a tiny fraction of the tens of thousands of dietary supplements on the market. These products were actually tested 9 years ago when steroid precursors were legal; spiking them with steroids was always illegal. Today, thanks in part to the dietary supplement industry lobbying for a federal ban on steroid precursors, that product category is dead and this inflammatory quote does not reflect the present market. If any illegal drug is present in a product it is defined by law as an unapproved drug, not a dietary supplement, subject to FDA and DEA enforcement.

Regarding Senator McCain’s bill to more strictly regulate supplements: I met with him after the bill was introduced to present the inconsistencies between the actual bill and how he described it. Under the anti-bioterrorism bill of 2003 all dietary supplement manufacturers are already required to register with the FDA; as do all domestic or foreign food manufacturers selling in the US. Under several federal laws all ingredients already must be on dietary supplement labels. Failure to do so makes the products adulterated and subject to a range of FDA actions. His bill would actually have subjected each new product introduction to prior FDA approval, expanding the federal bureaucracy and amounting to a government takeover of the entire dietary supplement industry. Importing this Canadian-style regulatory scheme would duplicate that system’s failures: half as many products on the Canadian market, products considered safe in the US are effectively banned, waits of over 4 years to introduce variations of existing products, higher prices, etc.

Your series promises to disclose how the dietary supplement industry “is opposed to regulations.” That is absolute nonsense! The dietary supplement industry has long supported new laws and regulations that are reasonable, with these already in place: all vitamin companies must follow FDA-audited Good Manufacturing Practices requiring safety and identity testing, only FDA-approved ingredients can be used, steroid precursors are banned, and companies must disclose all complaints of adverse events requiring medical attention to the FDA within 15 days. The dietary supplement industry supports increased government authority to mandate product recalls in the Food Safety Bill. But the American people won’t stand for a major expansion of government power that gives bureaucrats absolute veto authority over each new consumer product, stifling innovation. That’s not only anti-capitalism, it’s un-American.

Original story
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100629/SPORTS/6290316/-1/SPORTS

This reply published:
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100709/OPINION/7090312

Reference:
http://multimedia.olympic.org/pdf/en_report_324.pdf

More about steroids and DSHEA

The fact that CNN removed the video and corrected its text report on DSHEA by substituting some of the original quotes with quotes from US regulatory agencies adequately confirms that my original criticism was both factual and confirmable. Make no mistake; it is currently illegal - under DSHEA - to put undeclared ingredients like steroids and steroid precursors in a dietary supplement. The fact that some outlaws have made supplements containing illegal drugs - without declaring them on their labels - is not a reflection on the legally operating dietary supplement industry; any more than a drug smuggler hiding contraband in a teddy bear is representative of all teddy bear manufacturers or a hollowed-out book is representative of all publishers. My contention is that steroids are often being deliberately and illegally added to “spike” certain dietary supplements, which are not "contaminated" in the sense that the substance was not accidently added. The addition of an undeclared active ingredient is "adulteration" under DSHEA, whether deliberate or accidental, and adulteration is quite clearly illegal. The FDA has full power to remove adulterated substances from the market under DSHEA and other laws; there is absolutely no legal protection for these unlawful “supplements”. It’s not a law’s fault if a government regulatory agency fails to vigorously enforce it, despite having clear authority in that area to act. Yet that’s precisely the kind of misdirected criticism that some critics of the industry propose: blaming weak enforcement on a perceived legal emasculation which simply isn’t there. This, despite the fact that the dietary supplement industry’s legislative allies have introduced bills to add funding to the FDA specifically so the agency could enforce DSHEA more strictly; which is additional proof that the industry does not avoid reasonable regulation and in fact prefers it to false claims of being “unregulated”. The Dietary Supplement and Nonprescription Drug Consumer Protection Act now requires all serious adverse events to be reported to the FDA within 15 business days. The supplement industry also supported this Act, knowing that it had to prove the safety of its products and show responsibility to the public and to lawmakers. The fact that supplement manufacturers supported the Anabolic Steroid Control Act of 2004 (HR 3886), banning androstene-type substances, should also reflect favorably on their commitment to responsible regulation and a desire to protect the public health. Even that has not quieted some critics. It is precisely an industry revulsion to outlaws posing as legitimate manufacturers that has repeatedly prompted industry support for additional government regulation. Industries do not typically request more regulation, so this stance should be more notable. Still, in my opinion it is illogical to blame a law for the actions of outlaws. Outlaws fill a perceived need at a high price, just like other drug dealers, but to consider their products to be accidentally “contaminated” is naïve, at best. Under authority granted to it by DSHEA, and after years of industry prodding, the FDA has only recently rolled out mandatory current good manufacturing practices (cGMPs), requiring safety and identity testing. There are a number of manufacturers already certified as operating under independently certified GMPs, giving consumers a high assurance against inadvertent contamination. Steroids and anabolic steroid precursors are currently regulated as prescription drugs. So no dietary supplement manufacturer has any legitimate, legal reason to use these controlled substances in any of their products, whether on or off the label, making accidental contamination quite implausible. The FDA has not claimed that DSHEA blocked its ability to regulate dietary supplements. Actually, several FDA commissioners have testified to Congress that they already had adequate enforcement powers under DSHEA; and that was before the introduction of additional regulation such as cGMPs, adverse event reporting, the anabolic steroid precursor ban, etc. It is irresponsible to continue to echo allegations that have already been disproved, taking on faith the word of cheaters who have been revealed and are trying to point the blame elsewhere. It’s ludicrous to try to shift blame on a law passed some 13 years ago, a law that specifically prohibits adulterated products. I think that the baseball player’s union leader successfully did just that, knowing that he had a receptive audience in a leading DSHEA critic. But the resulting publicity, repeating the tired old complaint of supplements being “unregulated”, does not constitute any form of real evidence, flying in the face of so many contrary facts. If you are still in doubt, don’t take my word for it. Please read the various pieces of legislation or check the websites of the regulating agencies and see for yourself. I have done both and base my writings solely on these demonstrable facts and reputable references, including official government agencies.