SILVER SPRING, MD August 6, 2009 – The American Herbal Products Association (AHPA) suggests in comments filed Aug. 3 that the Food and Drug Administration (FDA) consider including language in its proposed definition of economically motivated adulteration (EMA) to clarify EMA addresses products that are marketed as dietary supplements but that contain undeclared drug ingredients.
During FDA’s May 1 public meeting on the topic of EMA, AHPA suggested FDA expand the definition to include the addition or substitution of substances intended to make an adulterated material conform to existing identity and other quality tests of the genuine article. AHPA’s Aug. 3 comments build upon this recommendation by including the addition or substitution of substances for the purpose of allowing an adulterated ingredient, component, or product to “have a physiological effect that is dependent upon the added or substituted ingredient.”
“AHPA applauds FDA’s actions against ‘spiked’ weight-loss and other products that are marketed as dietary supplements but found to contain prescription drugs,” said AHPA President Michael McGuffin, “It is obvious that enforcement action is needed against these bad actors, and it is also clear that these products are intentionally adulterated for financial gain.”
In addition to its suggestion that FDA expand the definition of EMA, AHPA, along with other comments, encourages FDA to revisit a July 2007 petition submitted by AHPA that suggests FDA require under dietary supplement Good Manufacturing Practice (GMP) that companies receiving product in manufactured form conduct examinations or tests to verify that identity and other specifications were met, as is required of dietary supplement manufacturers receiving dietary ingredients. This requirement for dietary ingredients provides significant protection against any manufacturer inadvertently including a deliberately adulterated dietary ingredient in a manufactured dietary supplement.
“Any EMA is always threat to public health because there is no assurance that adulterants used are safe,” AHPA General Counsel Tony Young noted. “The Federal Food, Drug and Cosmetic Act, as enacted, was meant to be an easily enforceable law. If you manufacture or sell an economically adulterated food or dietary supplement, that is all that needs to be proven to establish the crime, and it is strict criminal liability. Now that FDA has held its public meeting and received stakeholder comment, we should expect to see the law enforced as it was always intended to be enforced.”
AHPA’s comments are available online at http://www.ahpa.org/portals/0/pdfs/09_0803_AHPA_Comments_FDA_EMA.pdf
See also the AHPA Updates of May 6, 2009 “Expand Current Definition of Economically-Motivated Adulteration, AHPA Says to FDA” and Jan. 9, 2009 “AHPA Applauds FDA’s Recall of Tainted Dietary Supplements.”
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.