FDA Economic Adulteration Meeting

ASTA recently attended a one-day meeting at the FDA on economically motivated adulteration.  The purpose of the meeting was to "stimulate and focus a decission about ways in which the food, drug, medical device and cosmetic industries, regulatory agencies and other parties can better predict and prevent economically motivated adulteration, with a focus on situations that pose the greatest public health risk."  there is a Federal Register notice on this issue with a request for comments due August 1st, 2009.  FDA proposed a working definition of economically motivated adulteration (EMA), "as the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increaing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.  EMA includes dilution of products with increased quantities of an already-present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product, or watering down of juice) to the extent that suchdilution poses a known or possible health risk to consumers, as well as the addition or substitutionof substances in order to mask dilution.

Meeting speakers included FDA officials, academics, pharmacy industry representatives, and representatives from the Grocery Manufacturers Association (GMA), American Feed Industry Association, National Fisheries Institute, Pet Food Institute, American Herbal Products, and consumer groups.  Many of the groups, including GMA, urged greater regulatory oversight and vigilance from the FDA on the identification and prosecution of individuals committing economic adulteration.  For more information, Click Here.