American Herbal Products Association (AHPA) President Michael McGuffin described how the Food and Drug Administration (FDA) could implement a low-cost enforcement strategy to remove misbranded and adulterated products labeled to contain illegal synthetic steroids during the Nov. 13 “State of the Industry” session at SupplySide West in Las Vegas. McGuffin’s suggestions were delivered in his presentation entitled, “Enforcement Overview: Adulterated and ‘Fraudulent’ Products Masquerading as Dietary Supplements.”
The presentation described and elaborated on AHPA’s Oct. 7 letter to FDA that proposed the agency adapt its current program for identifying, issuing Warning Letters, and informing the public of fraudulent 2009 H1N1 influenza products as a means to identifying and initiating and publicizing enforcement actions against illegal synthetic steroid products. AHPA noted in the letter and reiterated during the presentation that the suggestion is relevant to marketed products labeled as containing synthetic steroid products. (See the AHPA Update of Oct. 7, 2009 for more information.)
“AHPA recognizes that some other enforcement approach is needed for products that fail to disclose synthetic steroid ingredients, and that such an approach may also assist FDA in removing illegal products that contain undeclared prescription drugs,” McGuffin said. “AHPA nonetheless continues to believe that FDA can adopt elements of its successful H1N1 program to enforce against the ‘low-hanging fruit’ represented by products that claim in labels or labeling to contain synthetic steroid ingredients.”
McGuffin also suggested in his presentation that companies that market supplement products in categories that are prone to adulteration look to the dietary supplement cGMP rule for guidance in setting and meeting specifications for known contaminants. “We cannot rely solely on FDA to fix the problem of drug-spiking, which has come to be of international concern,” he noted.
McGuffin’s presentation is available online at http://www.ahpa.org/portals/0/pdfs/09_1113_MMcGuffin_SSW.pdf.
An AHPA Update on the Oct. 7 letter to FDA is available here:
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.