Regulatory Information
As a parent or caregiver, you have a right to be concerned about the food you provide to your family. In the absence of strong federal regulations, a patchwork of state legislation has emerged to address this concern. However, this approach creates challenges. Inconsistency in regulations across regions can confuse consumers and make it difficult for manufacturers to comply. Additionally, limited monitoring resources at the local, regional, and even national level raise concerns about the effectiveness of current efforts to ensure safe levels of heavy metals in baby food. This section will explore existing regulations and proposed legislation at the state, federal, and international levels, highlighting the ongoing efforts to decrease contaminants in the foods marketing for the youngest among us.
The United States Food and Drug Administration (FDA) launched the Closer to Zero (CTZ) initiative in 2021. The program aims to minimize dietary exposure to contaminants including arsenic, lead, cadmium, and mercury in foods commonly consumed by infants and young children. CTZ looks to achieve lowering contaminant levels through a multi-pronged approach. First, Federal researchers are looking to establish “action levels” – recommended limits for contaminants that can be realistically achieved by the industry and progressively lowered over time. Second, the initiative strengthens compliance by increasing monitoring and enforcement activities to ensure adherence to these regulations. Finally, Closer to Zero emphasizes continuous monitoring of contaminant levels in baby food. This data will be crucial for informing potential adjustments to action levels in the future. As of this writing, efforts within CTZ have moved slowly and various pieces of proposed legislation at state and national levels in the United States have been introduced and in some cases passed in the absence of enforceable contaminant limits meant to result from CTZ.
In October of 2023 California took a proactive stance on heavy metals in baby food with Assembly Bill 899 prioritizing transparency and increased testing. Starting January 2024, manufacturers selling baby food in California must test their products monthly at a “proficient laboratory” for arsenic, cadmium, lead, and mercury. By January 2025, these test results must be readily available on the manufacturer’s website for consumers. The bill also states If a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the United States Food and Drug Administration, manufacturers are required to include a quick response (QR) code on the product label that links to a page on the manufacturer’s internet website containing, among other information, test results for the toxic element and a link to related FDA education. Given the lack of federal regulations in the area and the size of California’s market, AB 899 has effectively become the national benchmark for baby food safety regulation in the United States.
Maryland passed “Rudy’s Law” (SB 0723/HB0097) in May 2024 which prioritizes the goals of increased testing and transparency for baby food manufacturers, mirroring many of the regulations in California’s AB 899. The law requires manufacturers to perform monthly tests on their final products for arsenic, lead, cadmium, and mercury using an accredited lab. Test results, including the name and level of each heavy metal detected, must be published on the manufacturer’s website with a link to FDA guidance on these contaminants. Alternatively, a QR code on the product label can link directly to this webpage. “Rudy’s Law” follows CA AB 899 in empowering consumers through informed choice, however the slight differences between the two have begun to make compliance with the growing patchwork of regulation difficult for brands that choose to sell products in both states.
For decades the European Union has set limits on contaminants substances including heavy metals through Commission Regulation (EU) 2023/915.1 “Since many contaminants are naturally occurring, it would be impossible to impose a total ban on these substances. Instead, the best course of action to protect public health is to ensure that these substances are kept at levels which are as low as possible.”
The regulation stipulates that food containing a level of contaminant that is unacceptable cannot be put on the market. The regulation sets maximum levels for lead, cadmium, mercury, arsenic, as well as other contaminants in various food categories to safeguard public health. The levels are set on the basis of scientific advice provided by the European Food Safety Authority (EFSA) and Member State authorities are responsible for sampling food products, to ensure that they comply with the legislation. The regulation also includes provisions for specific food groups like baby food, often with lower maximum levels compared to general foodstuffs.1 This provides additional protection for vulnerable populations.
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