We want to inform you of a new law in Maryland, effective January 1, 2025, that mandates baby food manufacturers to test for toxic heavy metals, excluding infant formula. Known as Rudy’s Law, this legislation was inspired by the case of young Rudy Callahan, who suffered lead poisoning from contaminated applesauce.

Rudy’s Law Key Requirements

Testing

Starting in 2025, manufacturers must test a “representative sample” of each production aggregate of their final baby food product for arsenic, cadmium, lead, and mercury (which the state defines as toxic heavy metals).  Testing must be conducted monthly by a “proficient laboratory.”

Disclosure and Labeling Requirements

Beginning January 1, 2026, manufacturers also are subject to certain disclosure and labeling requirements.  Regarding disclosure, they must make publicly available on their website for each baby food product sold, manufactured, delivered, held, or offered for sale in the State of Maryland:

1. the name and level of each toxic heavy metal present in the final baby food product;
2. sufficient information, such as the product name, universal product code, or lot or batch number, to enable consumers to identify their baby food products; and
3. a link to the U.S. Food and Drug Administration’s (FDA) website that includes the most recent guidance and information about the health effects of toxic heavy metals on children.

If the baby food is tested for a toxic heavy metal subject to an action level, regulatory limit, or tolerance established by FDA, the manufacturer must include on its baby food product label:

1. the following statement: “FOR INFORMATION ABOUT TOXIC HEAVY METAL TESTING ON THIS PRODUCT, SCAN THE QUICK RESPONSE (QR) CODE”; and
2. a QR Code or other machine-readable code that allows consumers to access on its website the test results and the link to FDA’s website referenced above.

Currently, FDA has a draft guidance regarding a proposed “action level” (a level of concentration that when exceeded may be viewed by FDA as injurious to health) for lead in processed food intended for babies and young children less than two years old. FDA has stated on its website that the target date to issue the final guidance is December 2024.  The Agency is also working on proposing action levels for arsenic, cadmium, and mercury in foods that babies and young children commonly eat, as part of its Closer to Zero action plan.

Sale Prohibition

Except for baby food manufactured before January 1, 2026, a person may not sell, distribute, or offer for sale baby food in Maryland that contains toxic heavy metals that exceed the limits established by the FDA.

Consumer Complaints

If a consumer believes, based on information gathered by using the QR Code, that baby food is being sold in Maryland with toxic heavy metals that exceed the limits established by FDA, the consumer must report the baby food product to the Maryland Department of Health.

Other States and Proposed Federal Legislation

Maryland is currently the second state in the nation to require baby food manufacturers to test their products for toxic heavy metals, following California.  Pennsylvania is considering similar legislation, and we anticipate that other states may follow suit.  Furthermore, federal legislation, the Baby Food Safety Act of 2024, is under consideration to enforce limits on toxic heavy metals in baby food nationwide. If enacted, this legislation would give FDA the authority to enforce scientifically established limits on heavy metals in commercially produced infant and toddler food (defined as food that purports to be, or is represented as being, specifically for infants or children up to the age of 24 months). The bill would also set requirements on food manufacturer sampling, testing, and recordkeeping for contaminants in imported and domestic processed food and call for a report on FDA’s domestic and foreign facility inspections that includes aggregate inspection findings. 

What Else to Expect and What to Do About It

We predict that both consumers (thus the plaintiffs’ bar) and regulators will continue to be focused on heavy metals in infant and toddler foods for the near future. Considering FDA’s target date for finalizing its guidance on lead and the future actions it plans to take, you may wish to consider reviewing your company’s standards and policies regarding heavy metal testing.  In addition, you may wish to review your ingredients to determine if finding substitutes would be appropriate.