SILVER SPRING, Md.—The American Herbal Products Association (AHPA) sent a letter to FDA urging the agency to adapt its current and successful enforcement program against fraudulent 2009 H1N1 products and apply it to illegal synthetic steroid products. The association addressed its suggestion to Michael Levy, Esq., director of the Division of New Drugs and Labeling Compliance at FDA’s Center for Drug Evaluation and Research (CDER) and to Roberta Wagner, director of the Office of Compliance at the Center for Food Safety and Applied Nutrition (CFSAN). Levy provided FDA’s testimony at a Senate subcommittee hearing last week concerning illegal steroid products, where he noted the agency “struggles” in enforcing current regulations against adulterated dietary supplements.
“AHPA is concerned that the net impression left by FDA’s testimony before the Senate is that the agency cannot presently take effective enforcement action with respect to synthetic steroids that are illegally marketed as dietary supplements,” stated Michael McGuffin, AHPA’s president. “AHPA disagrees, and believes that FDA has all of the authority it needs to shut down the marketers of any such product. We are today suggesting that the agency can do so efficiently by adapting its successful program for enforcing against fraudulent H1N1 products.”
AHPA’s letter cited FDA’s current program for addressing fraudulent 2009 H1N1 influenza products, which includes direct enforcement action, in the form of Warning Letters, and a prominently displayed Web site list of marketers to whom FDA has sent these Warning Letters. AHPA added FDA records show the identified fraudulent claims have now been removed from 120 of the 136 products listed.
The AHPA letter also noted FDA’s testimony identified “several possible enforcement outcomes” against any product that contains a synthetic steroid, and FDA did not need to identify in its testimony “a category of marketed synthetic steroids for which there is no possible enforcement outcome, because under current law, except with respect to approved new drugs, all such marketing is unlawful.”
