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Lead In Applesauce Pouches, Reasonably Foreseeable Hazards, & Re-emphasizing an All-Hazards Approach to FSMA

Recently, based on great detective work conducted by health officials in the State of North Carolina, the nation has become aware of number of children nationwide intoxicated with lead poisoning linked to applesauce pouches made by Wana Bana and targeted specifically towards children.  According the CDC, there have been over 200 cases now reported across 33 states.

While this tragic incident remains an evolving story, I thought I’d offer some of my perspective.

First and clearly, this tragic incident was foreseeable, preventable, and is unacceptable.  The potential for alarmingly high levels of lead to occur in spices should not come as a complete surprise, and certainly not to a food manufacturer.  Elevated levels of lead in applesauce pouches (flavored with cinnamon spice) should have been a “reasonably foreseeable hazard” to the manufacturer, and they had a duty to be aware of the potential risk and a duty to manage it. 

In fact, the potential for high levels of lead to be in various spices, if sourced from unscrupulous suppliers, is well documented in the literature.  For example, in a long term study conducted in the State of New York titled, a Spoonful of Lead: A 10-Year Look at Spices as a Potential of Lead Exposure, investigators tested nearly 1,500 samples of spices and found 31% of them had lead levels higher than 2 ppm.  The study also found alarming levels (comparable to and even higher than the levels detected in this incident) in various spices.  For example, levels of lead were as high as 21,000 ppm in curry, 2,700 ppm in turmeric, and 1,200 ppm.  Moreover, concern over lead in infant and children’s products has been well publicized over the past few years, even by political leaders in Congress. 

Secondly, we need to redouble our efforts on re-emphasizing an all-hazards approach to food safety.  When the Food Safety Modernization Act (FSMA) was passed by Congress in 2011, the initial approach and framework was based on the HACCP model of managing food safety risks.  And fundamental to HACCP is an all-hazards approach to food safety, be they microbiological, chemical, or physical.  Unfortunately, I believe some in the profession have contributed to a narrower mindset that separates, compartmentalizes, and creates silos of hazards and risks (microbiological vs chemical), thereby, all potential hazards are no longer thought of as being part of FSMA.  This less holistic view of food safety can result in food manufacturers conducting less than adequate risk assessments.  In fact, this was a point of debate for me with colleagues while in federal service, as I didn’t want the agency to contribute to such siloed thinking. 

In my mind, FSMA, like HACCP, was always about an all-hazards approach to food safety.  We need to a) shape thinking among manufacturers and regulators and b) insist they conduct proper risk assessments of all of the hazards that could potentially be in or contaminate foods, which could cause harm to consumers. 

It’s time to redouble our efforts and re-emphasize an all-hazards approach to food safety and FSMA.  Allowing manufacturers to think that they have to comply with FSMA, and a separate chemical contamination plan is misguided.  It’s all food safety.

Clearly, this manufacturer (and potentially a separate importer) failed to manage a “reasonably foreseeable hazard” and they should be held to account.  And we should review how the efforts of other stakeholders involved in the food safety net in this instance, ranging from buyer standards, 3rd party audit providers, and regulators, failed to build sufficient hurdles to prevent something like this from happening.


Again, a big shout out to officials in the State of North Carolina.  Had it not been for them, this incident, as tragic as it is, could have gotten much worse.

We CAN and MUST do better.  Until next time, thanks for reading.


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