Anti-adulteration actions aren’t working, says FDA

The meeting, due to take place on May 1, comes after a rash of economically motivated contamination scandals, including Chinese-manufactured melamine-tainted infant formula that has sickened at least 300,000 children and killed six. Manufacturers added the chemical to watered-down formula in order to reduce costs and cheat tests for protein content last year.

The FDA said the meeting’s purpose is to stimulate discussion on how industry can better predict and prevent economically motivated adulteration (EMA) of food – including supplements and animal food – drugs, medical devices and cosmetics.

“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, economically motivated adulteration remains a public health threat,”​ it said.

Areas for comment​

For the purposes of the meeting, FDA has proposed that EMA be defined 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.”​

It goes on to clarify that this would include dilution of products with an already present substance, “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.”​

The FDA is looking for comments on this definition, as well as how ingredients are tracked and sourced, and possible inadequacies in contaminant detection processes.

Specifically in relation to food, it is asking for more information on those foods that are particularly vulnerable to EMA, based on the question: “What food products are marketed based on measured content of certain constituents, such as content of certain proteins, certain fats, or certain sugars?”​

Protein content is important in the marketing of infant formula, for instance, and adding melamine to watered-down milk increases detectable levels of nitrogen, a marker for the presence of protein.

The FDA is also looking for comments on what is already being done both within and outside of the US, and on what more could be done by regulators and industry.

Other incidents that have prompted the meeting include repeated contamination of cough syrup resulting in several mass poisonings around the world, nearly 150 deaths associated with contaminated heparin, a drug used for dialysis patients, and melamine-tainted pet food.

The FDA is inviting attendees to register for the meeting at http://www.fda.gov/oc/meetings/ema.html​ and invites comments via http://www.regulations.gov​.