Address economically-motivated adulteration of ingredients: USP to FDA

The United States Pharmacopeial Convention (USP) submitted a public comment letter to the United States Food and Drug Administration (FDA), urging it to reconsider its strategy to address economically-modified adulteration (EMA) of food ingredients. The letter highlighted the specific risks posed by the intentional and fraudulent adulteration of food ingredients for economic gain.

“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, chief executive officer, USP. He suggested that EMA be addressed as its own unique category of food adulteration. 

USP recommended that FDA consider a framework tailored to the specific nature of EMA. While the former agreed that it was not ideal to handle EMA under a typical food-defence/vulnerability approach, it stated that EMA would be equally misplaced under preventive controls.

The suggested approach would include a vulnerability assessment, mostly focussed 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,” said Piervincenzi

“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,” he added. 

USP highlighted the wide array of concerns related to EMA of food adulteration. These include:

Dilution: Examples include the dilution of olive oil with potentially toxic tea-tree oil or products watered down using non-potable water

Substitution: Examples include the partial substitution of sunflower oil with mineral oil or hydrolysed leather protein in milk

Concealment: An example is the application of harmful food colouring to fresh fruit to cover defects

Mislabelling: Examples include the labelling of toxic Japanese star anise as Chinese star anise or the mislabelling of recycled cooking oil 

USP offers free public resources, including a food fraud database and plans to develop additional tools.