Rules Aren’t Made to be Broken

Posted By elissa on Jul 17, 2009 | 1 comment

Which is something that certain supp manufacturers/retailers evidently don’t understand.

Earlier in the week, I clicked through an interesting presentation given at the recent International Society of Sports Nutrition conference.  Entitled “Sports Supplements, Science, and the Politics of New Washington“, it offered some explicit warnings to the supplement industry.  As authors Rick Collins, JD, CSCS and Alan Feldstein, JD put it in a section headed “Self-Regulation or More Regulation”:

If companies making unsubstantiated claims continue to be reported in the press, and lawsuits and class actions proliferate, FDA and FTC may ratchet up their scrutiny.

Indeed. 

Just out of curiosity, I ambled over to fda.gov this morning to look at the warning letters issued for 2009, and happened to notice a recurring theme:

Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus

Since H1N1 is a novel human disease agent, any company claiming its product(s) can prevent or treat H1N1 infections is making the mother of all unsubstantiated claims.

As I noted in this May 2009 post, a coalition of supplement industry trade groups took the nearly-unheard-of step of urging supplement manufacturers and retailers to “refuse to stock or sell any supplements that are presented as treating or curing swine flu” and to “refrain from promoting any dietary supplement as a cure or treatment for swine flu.”

This plea apparently fell on more than a few deaf ears, however, judging from the number of warnings sent out so far.  The FDA even has a special page, the Fraudulent 2009 H1N1 Influenza Products List, to cover all the products/companies they’ve cited… so far.  As the agency put it:

This list does not include every Web site that is marketing products related to the 2009 H1N1 Flu Virus without FDA approval, clearance, or authorization, only those Web sites to which FDA has issued a warning letter.

There are 111 items on that list (as of July 15), and a majority of them appear to be either supplements or related CAM treatments (the others are air systems or other devices, masks and kits).

Love or hate the FDA, the rules are pretty clear:

If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph (g) of this section, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.

As Collins and Feldstein asked, “Does it seem that new legislative or regulatory restrictions are based on the least responsible common denominator of conduct?”

Yep, it sure does… and if the FDA continues to find more examples like these, then I don’t doubt the noose will be tightened on everyone – for better or for worse.