As 2023 ended, an investigation into the cause of the elevated lead levels in pouches of cinnamon applesauce was continuing, with FDA’s current thinking being that the lead was intentionally added to the cinnamon and was economically motivated. Though the investigation is still ongoing, FDA Deputy Commissioner for Human Foods Jim Jones said, “so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain.” With the source of the cinnamon having been identified as from a facility in Ecuador, the FDA and CDC are continuing to work with Ecuadorian authorities on tracking down the potential perpetrator.
Intentional adulteration (IA) and economically motivated adulteration (EMA) of food differ in both definition and applicable regulation, but EMA is always intentional while IA is not always economically motivated. Additionally, IA more frequently causes a food safety issue while EMA more often impacts quality. It is that which makes the cinnamon applesauce outbreak distinctive – the suspected EMA which extensively impacted food safety, resulting, thus far, in more than 250 suspected cases of lead poisoning, including 73 confirmed, across 34 states. To explain, let’s delve further into the IA and EMA differences, and the current situation.
As defined by FDA:
- Intentional adulteration is the deliberate contamination of food with a biological, chemical, radiological, or physical agent by an individual or group of individuals. It includes acts intended to cause wide-scale public health harm (e.g., terrorism focused on the food supply); acts of disgruntled employees, consumers, or competitors; as well as EMA (though it is addressed in the PC Rule rather than the IA Rule, discussed below). Because attacks intended to cause wide-scale public health harm to humans are ranked as the highest risk, FSMA’s Intentional Adulteration rule is focused on addressing those acts.
The FSMA IA Rule: Intentional adulteration covers non-economically motivated intentional adulteration intended to cause illness or death on a wide scale, requiring that covered facilities develop and implement a written food defense plan. To comply with the IA rule, facilities must conduct a vulnerability assessment; implement mitigation, or preventive, strategies to address those vulnerabilities; apply food defense monitoring, corrective action, and verification; maintain records; and train personnel and supervisors working at the most vulnerable points in a facility – all of which must be overseen by a food defense qualified individual.
- Economically motivated adulteration occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food; or when someone adds a substance to a food to make it appear better or of greater value. EMA is often referred to as food fraud.
The FSMA Preventive Controls Rule governs the control of EMA, in that facilities must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether there are any hazards requiring a preventive control. Relevant to EMA, this must consider hazards that have historically been intentionally introduced for purposes of economic gain, particularly those for which a pattern has been seen (e.g., the repeated EMA of spices with toxic colorants). However, hazards are defined to only include those agents that have the potential to cause illness or injury. EMA that does not affect food safety (e.g., affecting product integrity or quality) is out of the scope of this rule; hazards that may be intentionally introduced to cause wide-scale public health harm, such as acts of terrorism, are regulated by the IA rule.
The cinnamon applesauce lead situation is suspected to be EMA due to the commonality of using dyes (some of which are lead based) to enhance or provide the reddish coloring of certain spices (such as chili powder, turmeric, cumin, and cinnamon), which makes the spice more appealing and thus more profitable. Lead chromate also has been added to foods to increase the weight, which would, again, increase its profitability. As with all heavy metals, lead may be present in food from the environment where a food is grown, raised, or processed. However, by law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed. Earlier this year, FDA also published draft guidance on action levels for lead in processed foods that are intended for babies and children under two years of age. (See TAG’s Insights article on the Guidance here.)
The cinnamon applesauce recall also falls at a time when FDA is expanding its focus on both heavy metals and intentional adulteration. Given that, along with the FDA’s plan to roll out IA Comprehensive inspections this year, California’s heavy metal testing requirement for baby foods, and the fact that 2024 is an election year with candidates seeking platforms that appeal to voters, TAG would expect the incident to further increase the general attention on both heavy metals and IA. Are you prepared for an IA inspection? Do you know where and how your ingredients are grown and processed; are all your suppliers vetted?
With its many-leveled supply chain and extensive regulation, the food industry can be quite complex, but TAG can help simplify your food safety and regulator compliance. Give us a call!
