FDA Announces Increased Inspections and Enforcement Actions, Additional Guidance to Reduce Toxic Elements in Food for Babies and Young Children

On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the risk heavy metals pose to infant and young children’s neurological development. The Agency indicated that it would take the following actions:

• Issue guidance to develop action levels for contaminants such as heavy metals.
• Increase inspections of facilities to ensure compliance.
• Increase testing of foods for babies and young children.
• Collaborate with academia, industry and government to support research of additional safety information on toxic elements in food for babies and young children and additional steps that industry can take to further reduce levels.

Background

In 2017, FDA established the Toxic Elements Working Group to reduce exposure to toxic elements (i.e., chemical hazards including heavy metals, mycotoxins and pesticides) in food, cosmetics and dietary supplements. Since that time, FDA has established a limited number of action levels for certain heavy metals listed in the table below.

A February 4, 2020, report issued by U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy examined heavy metal levels in baby food products (the Report). The Report found high levels of heavy metals (inorganic arsenic, lead, cadmium and mercury) in the final products. The Report concluded baby foods are “tainted” with toxic heavy metals and criticized FDA’s lack of regulatory action on ensuring the safety of baby food.

The Report recommended FDA adopt the following actions: 

• Mandatory testing of finished products
• Labeling: Require disclosure of heavy metal levels on food labels
• Guidance: Establish maximum heavy metal levels across all baby food products to protect against neurological effects

In addition, the Report also recommended that the industry voluntarily find substitute ingredients or phase out products that contain ingredients that frequently test high in toxic heavy metals, such as rice.

In conjunction with FDA’s public statement, FDA issued a letter to industry on March 5, 2021, reminding baby and toddler food manufacturers and processors of the legal requirement to evaluate chemical hazards under FSMA’s Hazard Analysis and Preventive Control Rule (HARPC) and other hazard analyses as required by 21 CFR Parts 120 and 123 where applicable. To emphasize this enforcement priority, the letter cited a January 15, 2021, consent decree issued by the U.S. District Court for the Eastern District of Washington to Valley Processing, Inc. This order required the company to stop distributing adulterated juice products that contained inorganic arsenic and patulin toxins at levels that can pose health risks to consumers.

Implications for Industry: Toxic Elements Such as Heavy Metals are Potential Adulterants

FDA’s public statement and letter to industry clearly show that toxic elements in foods for babies and young children are an enforcement priority. Manufacturers and processors of these products should evaluate their supply chain and require Certificates of Analysis from ingredient suppliers demonstrating an absence of heavy metals and other chemicals of concern. In addition, it is advisable to reexamine HARPC and other hazard analyses to identify steps to reduce chemical hazards as well as conduct periodic final product testing.