The American Herbal Products Association (AHPA) today suggested that the Food & Drug Administration (FDA) adapt its current and successful enforcement program against fraudulent 2009 H1N1 products and apply it to illegal synthetic steroid products.
AHPA’s letter is addressed to Michael Levy, Esq., Director of the Division of New Drugs and Labeling Compliance at FDA’s Center for Drug Evaluation and Research and to Roberta Wagner, Director of the Office of Compliance at the Center for Food Safety and Applied Nutrition. Mr. Levy provided FDA’s testimony at a hearing last week before the U.S. Senate Committee on the Judiciary, Subcommittee on Crime and Drugs, at which illegal steroid products were discussed (see the AHPA Update of Sept. 29, 2009).
“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.”
The AHPA letter notes that FDA’s current program for addressing fraudulent 2009 H1N1 influenza products includes direct enforcement action, in the form of Warning Letters, and a prominently displayed Web site list of marketers – of fraudulent air system products, shampoos, supplements, and other product forms – to whom FDA has sent these Warning Letters. AHPA also notes that FDA records that the identified fraudulent claims have now been removed from 120 of the 136 products listed.
“AHPA’s proposal is that FDA apply this same efficient and successful enforcement approach to illegal steroid products masquerading as dietary supplements,” added McGuffin.
The AHPA letter also notes that FDA’s testimony identified “several possible enforcement outcomes” against any product that contains a synthetic steroid, and that 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.”
“At the same time,” commented McGuffin, “it is important to note, as did FDA in its testimony, that naturally-occurring steroids, such as phytosterols and vitamin D, do not present significant regulatory issues, so the mere presence of steroidal saponins in an herb, for example, is not of concern.”
AHPA’s Oct. 7 letter to FDA is available here: http://www.ahpa.org/portals/0/pdfs/09_1007_AHPA_to_FDA_re_Illegal_synthetic_steroids.pdf
The Sept. 29 AHPA Update on the hearing before the U.S. Senate Committee on the Judiciary, Subcommittee on Crime and Drugs is also online: http://www.ahpa.org/Default.aspx?tabid=69&aId=555&zId=1
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers and marketers of herbs and herbal products, including foods, dietary supplements, cosmetics, and nonprescription drugs. Founded in 1982, AHPA’s mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org.