USP’s letter (read the full text here) came in response to the FDA’s proposal to address EMA in one of two ways: under a food defense framework within the Food Safety and Modernization Act’s (FSMA) rule on intentional adulteration, or voluntarily under the framework for preventive controls. USP counters that neither approach would help lower the risk of EMA, given that its chief motivator is monetary gain.
“EMA does not fit into food defense (that framework focuses on food terrorism, for example, where the intent is primarily to put public health at risk) or preventive controls (a framework that assumes the risks are relatively well-known and predictable, such as pesticides or microbiological contamination),” Markus Lipp, Ph.D., senior director of food ingredients quality standards, told FoodNavigator-USA. “EMA’s primary motivator is economical gain, and to achieve that goal, adulterers don’t necessarily aim at putting public health at risk. Because EMA is unpredictable for the most part, it doesn’t fit the preventive controls framework. Hence, USP recommended that FDA considers a framework tailored specifically to the nature of EMA, and which is based on scientifically sound work on EMA.”
USP suggests instating a hybrid approach, comprising a vulnerability assessment focused on determining the likelihood of EMA along with a public health risk assessment and vulnerability control plan to mitigate these risks. Publicly available standards would 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.
Ingredient adulteration usually driven by supply/demand
Past EMA incidents have involved dilution (e.g.,olive oil diluted with potentially toxic tea tree oil or products watered down using non-drinkable water); substitution (e.g., sunflower oil partially substituted with mineral oil or hydrolyzed leather protein in milk); concealment (e.g., harmful food coloring applied to fresh fruit to cover defects; and mislabeling (e.g., toxic Japanese star anise labeled as Chinese star anise or mislabeled/recycled cooking oil).
Although any food ingredient can potentially be adulterated, EMA typically works under a market-driven, supply/demand concept, Dr. Lipp noted.
“The targets change as a new opportunities appear,” he said. “One could predict that high-profile ingredients, with high cost and limited inflexible supply are more attractive to adulterers, such as extra virgin olive oil, Manuka honey or pomegranate juice. However, ingredients’ demand drives their cost and even supposedly cheap ingredients may be targeted for adulteration if a new use is found for them, driving cost up.”
In one example, guar gum has been used in the food industry in many products and was considered a low-cost ingredient, therefore unattractive as a target for adulteration. But that changed abruptly when the natural gas industry began using guar gum in fracking, inciting an exponential increase in demand and making it a target for adulteration, “until the point where lower demands resulted in a substantially reduced price again.”
"Food fraud/EMA destroys markets, disrupts trade, erodes consumer confidence and poses threat of unspecified harm to consumers because it puts control of the supply chain in the hands of criminals," USP wrote in its letter. "Given the unique nature and risk of EMA, it should be handled separately from food defense and preventive controls...and standards can also help."