FDA to Hold Public Meeting on "Economically Motivated Adulteration" (Suspected Incidents Include Pet Food, Heparin, Baby Formula, Etc.)

(For purposes of the meeting, FDA proposes 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.

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 such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution.)

Meeting to Find Ways Industry, Others Can Better Predict and Prevent EMA

The purpose of the meeting is 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 EMA with a focus on situations that pose the greatest public health risk. (See notice for list of questions to help prepare for the meeting or submit comments.)

Suspected Incidents of EMA Include Pet Food, Heparin, Baby Formula, DEG

According to FDA, several recent incidents involving FDA-regulated products are suspected to be examples of EMA. As the following examples illustrate, despite longstanding FDA requirements to assure the safety of regulated products, such as requirements for the use of ingredients of known identity and quality in drugs, EMA remains a public health threat:

Pet food. In March 2007, FDA received reports of kidney failure among cats and dogs and a report that cats died during taste tests of certain brands of pet food. Consumers and veterinarians since reported many more animal illnesses and deaths potentially associated with pet foods made with melamine and melamine-related compounds. Over 150 brands of pet food and 1,000 products were voluntarily recalled by a number of companies. In the subsequent investigation, melamine and melamine-related compounds were found in products labeled as wheat gluten and rice protein concentrate that had been imported from China. It appears that these contaminants were added to the products handled by Chinese suppliers to increase the apparent protein content in those products.

Heparin. In January 2008, FDA received reports of adverse reactions in pediatric dialysis patients in the U.S., with initial investigations implicating heparin manufactured by Baxter Healthcare Corp. In January and February 2008, Baxter voluntarily recalled all of its heparin products. FDA's investigation ultimately identified almost 150 U.S. deaths occurring between January 1, 2007, and May 31, 2008, that appeared to be associated with the use of these heparin products. During the investigation, scientists identified a contaminant in the heparin active pharmaceutical ingredient (API) obtained from suppliers in China. Contaminated heparin API has been found in 11 countries.

Baby Formula. In September 2008, FDA issued a Health Information Advisory in response to reports of melamine contaminated milk-based infant formula manufactured in China. Melamine was apparently added to diluted milk in order to increase measured nitrogen levels (indicators of protein content) and thereby inflate the apparent protein content found in the product. While there have been no confirmed illnesses or deaths in the U.S. attributed to melamine in products containing milk or milk-derived ingredients, nearly 300,000 Chinese infants were sickened by the contaminated infant formula, six Chinese infant deaths were likely due to the contamination, and some contaminated products were found at ethnic markets selling imported products in the U.S.

DEG. Adulteration of glycerin, an ingredient in cough syrup and other drugs, with diethylene glycol (DEG) has resulted in several mass poisonings around the world in the past two decades. In 2007, foreign-made toothpaste contaminated with DEG was reported in the U.S. resulting in recalls and restriction on imports of suspect toothpastes.

(See ITT's Online Archives or 03/06/09 news, 09030615, for most recent BP summary of FDA melamine-related detentions, including for pet food and milk products.

See ITT's Online Archives or 11/10/08 and 08/14/09 news, 081110995 and (Ref:080814994, for most recent BP summaries of FDA heparin-related seizures.

See ITT's Online Archives or 09/10/07 news, (Ref:07091025), for BP summary of September 2007 FDA update on its import alerts for Chinese vegetable protein, farm-raised seafood, and toothpaste.)

FDA contact - Juanita Yates (301) 436-1731

FDA notice (D/N FDA-2009-N-0166, FR Pub 04/06/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-7843.pdf