FDA Gets an Earful on Economically Motivated Adulteration

By Ricardo Carvajal –      

At its public meeting on economically motivated adulteration ("EMA"), FDA got no shortage of suggestions on how to better prevent, detect, and address instances of EMA.  FDA called the meeting “to stimulate and focus discussion about ways in which the food (including dietary supplements and animal food), drug, medical device, and cosmetics industries, regulatory agencies, and other parties can better predict and prevent [EMA] with a focus on situations that pose the greatest public health risk.”  For now, FDA has adopted a working definition of EMA as “the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.”

A number of speakers during the panel discussions and Q&A sessions that followed suggested that work remains to be done in both the public and private sectors if a reprisal of recent crises (e.g., heparin, melamine) is to be averted. Suggestions as to how FDA should tackle EMA included increased educational outreach, improved enforcement at the borders, more prosecutions, and establishing a greater presence abroad.  For their part, regulated industries appeared to acknowledge a need to improve supply chain management.  Among the many issues discussed during the meeting, one that received repeated mention was the need for FDA to step up its enforcement activity.  A number of industry representatives also expressed the view that FDA should broaden its working definition of EMA to address situations that do not necessarily pose a public a health risk, but that nonetheless threaten to undermine product integrity in certain industries.  The deadline for submission of comments to the docket is August 1, 2009.