USP Urges FDA to Address Economically-Motivated Food Adulteration as a Unique Issue

12 May 2014 --- Emphasizing the specific risks posed by the intentional and fraudulent adulteration of food ingredients for economic gain, the United States Pharmacopeial Convention (USP) has submitted a public comment letter to the U.S. Food and Drug Administration (FDA) urging the FDA to reconsider its strategy to address Economically-Motivated Adulteration (EMA) of food ingredients.

“Economically-motivated adulteration of food ingredients is a significant concern, with its own challenges, posing a threat to public safety, eroding consumer confidence in the integrity of food and disrupting markets by placing control of the supply chain in the hands of criminals,” said Ronald Piervincenzi, Ph.D., chief executive officer at USP. “EMA should be addressed as its own unique category of food adulteration.”

USP recommends that FDA considers a framework tailored to the specific nature of EMA. While USP agrees that it is not ideal to handle EMA under a typical food-defense/vulnerability approach, the organization says EMA would be equally misplaced under preventive controls. The suggested approach would include a vulnerability assessment mostly focused on determining the likelihood of EMA occurring, but also including a component of public health risk assessment; a second component would be a vulnerability control plan to mitigate these risks.

“Any food ingredient can be adulterated, and the list of potential adulterants is equally unlimited. The best way to protect consumers and safeguard industry is to focus on determining where EMA is most likely to occur.  Publicly available standards can also help safeguard against adulteration of food ingredients by helping assure food integrity and excluding ingredients that have been substituted, diluted or replaced, through fraud or other means,” said Piervincenzi.

USP highlighted the wide array of concerns related to economically-motivated food adulteration:
• Dilution – such as olive oil diluted with potentially toxic tea tree oil or products watered down using non-potable water.
• Substitution – including sunflower oil partially substituted with mineral oil or hydrolyzed leather protein in milk.
• Concealment – such as harmful food coloring applied to fresh fruit to cover defects.
• Mislabeling – including toxic Japanese star anise labeled as Chinese star anise or mislabeled/recycled cooking oil.