06.01.09
In comments submitted to FDA in the beginning of May, the American Herbal Products Association (AHPA), Silver Spring, MD, suggested the agency consider expanding the current definition of economically motivated adulteration (EMA) 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 chief science officer, Steven Dentali, PhD, presented the association’s comments and highlighted its work on identification methods for botanicals during a May 1 meeting convened by the agency “to stimulate and focus a discussion about ways in which the food, (including dietary supplements and animal food), drug, medical device and cosmetic industries, regulatory agencies, and other parties can better predict and prevent economically motivated adulteration.” AHPA addresses EMA in several ways, including guidance policies on known adulterants, guidance documents on topics such as the standardization of botanical extracts and marker compounds, and the development of identification methods for botanical ingredients such as bilberry fruit extract and Hoodia gordonii stem. (For more information on adulteration, see this month’s article on the realities of “spiking” on page 57.)