Last week, members of both chambers of Congress announced the introduction of new legislation – the Baby Food Safety Act of 2021 – that would establish limitations on the levels of certain heavy metals in infant and toddler foods. The proposed legislation would establish a framework that progressively lowers the action levels for inorganic arsenic, cadmium, lead, and mercury in infant and toddler foods, as well as provide additional authority to the U.S. Food and Drug Administration (FDA) to regulate levels of other substances.
Interim action levels for inorganic arsenic, cadmium, lead, and mercury
The bill would establish initial action levels for infant and toddler foods (defined as a food intended for sale to children up to 36 months of age, including infant formula) as follows:
10 parts per billion (PPB) for infant and toddler food (except cereal) and 15 PPB for infant and toddler food that is cereal
5 PPB for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal
5 PPB for infant and toddler food (except cereal) and 10 PPB for infant and toddler food that is cereal
Under the proposal, one year after enactment, infant and toddler foods in excess of an action level would be deemed adulterated. Within two years of enactment, the legislation would require the Secretary of Health and Human Services to review all relevant health and dietary data and lower the initial action levels to further minimize exposure and reduce potential clinical or population-level health effects as based on the Secretary’s review of relevant data. Within three years of enactment, regulations must be issued establishing even lower regulatory limits for inorganic arsenic, cadmium, lead, and mercury to levels “protective of infant and toddler neurological development, taking into account the most sensitive testing available” and review the levels established every five years thereafter.
In addition to establishing initial action levels for inorganic arsenic, cadmium, lead, and mercury, the proposed legislation contains a catch-all provision granting authority to the Secretary to establish, via guidance or regulation, interim action levels and regulatory limits for toxic elements in infant and toddler food if determined appropriate upon review of relevant health and dietary data.
Implications under FSMA
The proposed bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) statutory provisions governing hazard analysis and preventive controls to require the owner, operator, or agent in charge of a facility to identify and implement preventive controls to ensure infant and toddler foods manufactured, processed, packed, or held a facility will comply with performance standards and action levels for toxic elements in infant and toddler foods under Section 104 of the Food Safety Modernization Act (FSMA). Additionally, the proposed legislation would require verification of any preventive controls related to compliance of infant and toddler foods with performance standards and action levels for toxic substances. The owner, operator, or agent in charge of a facility that manufactures infant or toddler foods would be required to make publicly available on a webpage a biannual report summarizing the results of monitoring and verification results for these foods.
The mandatory recall provision in Section 423(a) of the FFDCA would also be amended to explicitly provide that an infant or toddler food can be subject to mandatory recall for exceeding an applicable action level.
We will continue to monitor legislative, regulatory, and litigation developments related to heavy metal content of infant and toddler foods.