- New requirements will apply to baby food in California starting in 2025.
- Manufacturers must publicly disclose test results and must include information on product labels regarding heavy metal content.
- FDA draft guidance on heavy metals in baby food expected in 2024.
New requirements for baby food in California
It has been a busy month for California Governor Gavin Newsom, who has signed several bills impacting food manufacturers. The latest is AB 899, which will require baby food manufacturers to test their products for heavy metal content, publicly release those test results, and include new label language regarding the metal content. The law specifically applies to both in-state and out-of-state manufacturers of infant formula and baby food for sale or distribution in California. No person or entity will be permitted to sell in the state or manufacture, deliver, hold, or offer for sale in the state any baby food or infant formula that does not comply with the new requirements.
For purposes of compliance, starting January 1, 2024, manufacturers can begin the mandated testing of their products for toxic heavy metals, which must include lead, mercury, cadmium, and arsenic. By January 1, 2025, manufacturers will be required to make the results of their testing publicly available on their websites and must disclose that a sample of the product has been tested for heavy metals. If the product does not exceed an action level, regulatory limit, or tolerance established by the FDA for any of the heavy metals listed above, the product label must include that the product meets FDA guidance for that toxic heavy metal.
Interestingly, the label requires only a statement that the product meets FDA guidance if tested levels are below those thresholds, but products that exceed the thresholds are not required to provide a specified warning or any language indicating that is the case. Further complicating things, the FDA is in the process of releasing draft guidance on action levels for arsenic and cadmium in baby food, and there is yet to be a set date for guidance from the FDA regarding mercury levels. The only metal with current limits from the FDA is lead. Until the FDA establishes other levels, companies will have to comply with the testing provisions but may struggle with accurately conveying to their consumers what level is considered safe, particularly since companies generally need some lead time to print their product labels prior to product manufacture.
Manufacturers should be diligent in monitoring the FDA guidance released in the coming year regarding heavy metal content and should begin making plans for testing their products so that they comply with the new California law. As always, Reed Smith will continue to monitor the developments around this new law and is prepared to help clients best navigate the complexities of the changing regulatory landscape.