If you are like me and you watch the news obsessively, you’ve probably heard about heavy metals. The latest issue surrounding heavy metals is with lead found in apple sauce. As of March 2024, the Food and Drug administration (FDA) is investigating the product and more specifically, the cinnamon in the cinnamon applesauce pouches which were recalled in October, 2023. So far, they have identified six ground cinnamon products which contain elevated levels of lead ranging from 2.03 to 3.4 parts per million (ppm) and are recommending that all consumers stop using and dispose of the products. Food meant for babies and children have been plagued by a string of issues, and this recall is the latest. While these stories keep hitting the newsstands, the FDA has been working to create new allowable levels for heavy metals.
What is the FDA Draft Guidance on Lead in Food Intended for Babies and Young Children
As part of the Closer to Zero action plan, the FDA published a draft guidance in January 2023 on new allowable levels of lead in food products, focused on foods meant for children and babies. The program aims to further reduce lead levels in food products, striving to achieve this goal without adversely affecting the food supply.
According to a study conducted by HBBF, 94% of food samples tested contained detectable amounts of toxic heavy metals. This included both store-bought and homemade baby food. The ten foods consumed by babies with the highest amounts of heavy metals were: rice cakes, crisped rice cereal, rice-based puffs, brown rice, teething biscuits and rice-based rusks, white rice, raisins, teething crackers (non-rice), granola bar with raisins, and oat-ring cereal. This new guidance aims to reduce lead levels by 24-27%.
“For more than 30 years, the FDA has been working to reduce exposure to lead, and other environmental contaminants, from foods. This work has resulted in a dramatic decline in lead exposure from foods since the mid-1980s.The proposed action levels announced today, along with our continued work with our state and federal partners, and with industry and growers to identify mitigation strategies, will result in long-term, meaningful and sustainable reductions in the exposure to this contaminant from foods,” said FDA Commissioner Robert M. Califf, M.D.
To create the levels in the draft guidance, the FDA utilized data from the Toxic Elements in Food and Foodware and Radionuclides in Food – Import and Domestic Compliance Program (TEP), FDA surveys, and the Total Diet Study.
Draft action levels for lead in processed food intended for babies and young children:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats
- 20 ppb for root vegetables (single ingredient),
- 20 ppb for dry infant cereals
Timeline
April 29, 2022 – The FDA issues the draft guidance “Action Levels for Lead in Juice: Guidance for Industry”
January 24, 2023 – The FDA issues the draft guidance “Action Levels for Lead in Food Intended for Babies and Young Children”
April 6, 2023 – The FDA reopens the comment period on the draft guidance for “Action Levels for Lead in Food Intended for Babies and Young Children”
March 6, 2024 – Alert published by FDA concerning certain cinnamon products due to presence of elevated levels of lead
What is the Closer to Zero Program?
The Closer to Zero Program is an FDA program aimed at reducing dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods. This program prioritizes foods commonly eaten by babies and small children, who are more at risk for food borne illnesses. Arsenic, lead, cadmium, and mercury are the big four heavy metals prioritized in this program which is why the new draft guidance falls under its purview.
Below is a chart published by the FDA for the action levels for each of the four heavy metals in the program.
As food safety professionals, we know that the rules are always changing. The FDA has made it clear that these draft guidance documents should only be taken as exactly that – a guidance. And that they are not legally enforceable. Of course, we have customer requirements which tend to be much more strict than the government guidelines. Either way, it’s important to remain up to date on upcoming regulations. The target for the final guidance is December 2024. We will update you all when the announcement on the final guidance is released.
Next Steps
Safeguarding the integrity and safety of our food supply chain, particularly for vulnerable groups, demands proactive measures and continuous education. Safe Food Alliance offers laboratory testing and a suite of comprehensive food safety training courses to empower food safety professionals with the knowledge and skills necessary to minimize the risk of contaminations, including those associated with heavy metals.
From HACCP and GMP training to environmental monitoring, our courses cover the spectrum of best practices in food safety. By investing in our training programs, you not only bolster your compliance with regulatory standards but also foster a culture of vigilance and excellence in food safety practices. When you partner with Safe Food Alliance, you gain access to the tools necessary to champion food safety excellence and promote continual improvement within your organization. Together, we can construct a safer and more resilient food supply chain.
