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'Tainted,' 'unregulated' supplements

The issue of “tainted” and “unregulated” supplements came to the fore for me the other day via a posting on the website by editor Charles Pelkey.

The issue of the unintended ingestion of banned substances by athletes is in focus for Velonews and other cycling news outlets because of the allegations of doping by Spanish superstar and three-time Tour de France winner Alberto Contador, who claims he tested positive for the drug clenbuterol as a result of eating tainted meat. In answering a reader’s question about why a cyclist might want to dope with clenbuterol in the first place, Pelkey added this by way of rhetorical flourish: “Of course, that opens up another one of my big pet peeves, the complete lack of regulation of the supplement industry. (We can generally thank Utah Senator Orrin Hatch for blocking those efforts, but alas, I digress.)”

Lest you rush to light your torches, let me state that Pelkey is more entitled to his opinion than most who make such statements. In addition to being a cycling journalist and a former bicycle racer, Pelkey is a lawyer and was a senior staffer for Wyoming Sen. Alan Simpson at the time DSHEA was passed.

I called Pelkey to talk about his posting. He was very open to discussing the posting and was very generous with his time.  I asked whether he disagreed with the view that the dietary supplement industry already operated within a regulatory framework.

“I haven’t seen any evidence to suggest that it has real teeth,” he said. “But I would have to concede that I have not followed the regulatory battle within that industry as I did when I was in the Senate.”

So if someone as well-educated and well-connected as Pelkey can hold such opinions, the industry has a long way to go to get across the point that our operations ARE  regulated.  The long period of FDA inaction after DSHEA’s passage has had its effect and has created a public perception that the dietary supplement industry is still operating in the regulatory equivalent of the Wild West.

The efforts by industry groups such as the American Herbal Products Association to publicize FDA enforcement actions are a start.  But more needs to be done.  How about prominently mentioning the results of safety studies in the press release for every new product and ingredient, and include the name of the relevant part of law?

The costs of complying with regulations now coming up to full speed, such as GMPs, are real and undeniable.  And the question of how the upcoming NDI guidance from FDA might be worded is vexing, too.  But rather than chafing and complaining, it seems to me that companies in this business should be rejoicing.  If it can’t be demonstrated to the satisfaction of people outside the industry’s immediate circle that the regulatory framework of DSHEA is vigorously functioning, it makes it that much more likely that regulations both more onerous and less carefully crafted could come online. The recent, brief sortie by Sen. John McCain might be just a warning shot.

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