An American Herbal Products Association letter and a Harvard medical professor's op-ed piece represent the opposing views in the escalating battle over whether dietary supplements are regulated adequately in the U.S.
In an Oct. 7 letter to FDA, AHPA suggests FDA's approach to identifying and informing the public about bogus 2009 H1N1 products (compiled here) could help stop firms from marketing steroid-containing supplements.
FDA should model a hidden steroid initiative on the H1N1 initiative with a three-part program: searching the Internet for products labeled as containing synthetic steroid ingredients; sending warning letters to companies marketing those products; and "prominently" placing on FDA’s Web site a page with lists of products the agency has identified as containing synthetic steroids and that have been the subject of warning letters, according to AHPA President Michael McGuffin's letter.
Meanwhile, physician Pieter A. Cohen, of Harvard Medical School and the Cambridge Health Alliance in Somerville, Mass., adds his opinion to the growing criticism of the effectiveness of the Dietary Supplement Health and Education Act. In a same-day New England Journal of Medicine online article, Cohen says most doctors and consumers do not understand that vitamins and supplements available in the U.S. do not require pre-market regulatory approval.
"Lenient regulatory oversight" of supplements, he says, "combined with the FDA’s lack of resources, has created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity."
AHPA's suggestion and Cohen's opinion follow a Senate hearing in which Sen. Arlen Specter criticized the Drug Enforcement Administration for a delay in classifying anabolic steroids as schedule III controlled substances. Once scheduled, the substances would be subject to strict production and recordkeeping requirements that would help prevent their use in so-called supplements sold to consumers, as "The Tan Sheet" reported here.
McGuffin says that testimony in the hearing by Michael Levy, director of the Division of New Drugs and Labeling Compliance in FDA's drug center, may have left "the net impression" that the agency "cannot presently take effective enforcement action" on synthetic steroids illegally marketed as supplements. But FDA "has all of the authority" it needs to keep supplements with undeclared steroid ingredients off the market, or to remove the products from the market, McGuffin adds.
Additionally, "The Tan Sheet" reported here that the consumer protection team FDA formed in the wake of the H1N1 outbreak is sending warnings about allegedly fraudulent products, giving companies 48 hours to reply and comply before the agency resorts to enforcement actions -- including product seizures or injunctions -- or possible referral to the Office of Criminal Investigations.
(Look for more on the possibilities for changes to DSHEA and on FDA's enforcement against firms making unapproved H1N1 claims in "The Tan Sheet," your source for the latest insight on the OTC drug and dietary supplement industries. Not a subscriber to "The Tan Sheet"? Click here for a free trial.)
- Malcolm Spicer (m.spicer@elsevier.com)
