The Draft Guidance1 (link) and proposed action levels represent a highly anticipated step in the Agency’s Closer to Zero2 action plan to reduce childhood exposure to contaminants in food. The action levels represent levels at which FDA may regard a food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Additionally, the United States Department of Agriculture Food Safety Inspection Service (FSIS) has indicated that it supports the action levels developed by FDA for meat products and “intends to consider these action levels, in addition to other factors, when considering appropriate FSIS actions in a particular case."
Background
FDA recognizes lead is widely present in the environment due to both its natural occurrence and to human activities. Lead, and certain other metals, are considered unavoidable contaminants. Therefore, FDA has developed interim reference levels (IRLs) for dietary lead intake which represent a maximum recommended daily dietary intake of lead from food. The IRLs are not regulatory limits or action levels. Rather, they are estimates used by the FDA in assessing the safety of lead exposure from food. FDA updated the IRLs for lead in 2022 and set the IRL for children at 2.2 ug/day. The agency recognizes the IRL serves as a useful benchmark in evaluating the potential for adverse effects of dietary lead. In setting the proposed action levels, FDA considered the intake of the covered foods at 90th percentile consumption levels and the maximum level of lead that could be in the food without causing the IRL to be exceeded if consumed at the 90th percentile consumption level.
FDA estimates that the proposed action levels would reduce dietary exposure to lead for babies and young children by 24-27% at the 90th percentile consumption levels for each of the covered food categories. The agency asserts that the action levels are achievable for 88% of single-ingredient root vegetable foods, 90% of dry infant cereals, and 95% of fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats.
The agency’s action levels are based on testing data collected through the agency’s Toxic Elements Program (TEP)3, Total Diet Study (TDS)4, and FDA special surveys5. The agency used these data to first identify current lead levels in foods intended for babies and children, and second evaluate the ability of industry to achieve lower lead levels. FDA’s review of the data show that different types of food exhibit different lead concentrations. For example, the agency noted root vegetables can absorb lead more readily from the soil than other crops. FDA then set the proposed action levels with several considerations in mind, including:
- the action level should minimize the likelihood that a consumer will be exposed to lead levels exceeding the IRL;
- the action levels should result in a reduction in exposure to lead; and
- for those baby foods where lead levels are already relatively low, the action levels should be established where achievability is in the 90th-95th percentile range.
Action Levels
The Draft Guidance applies only to a specific subset of foods and does not cover all foods that may be consumed by babies or young children.
The proposed action levels cover processed foods “represented or purported to be specifically for babies and young children less than two years old.” Also, according to the Draft Guidance, the following categories are not covered:
- raw agricultural commodities
- infant formals
- all beverages, including toddler drinks
- grain-based snacks (e.g., arrowroot cookies, puffs, rusks, or teething biscuits)
- homemade foods
While 100 percent juices are not covered by the draft guidance, the agency noted it had issued a separate draft guidance that would set 10 ppb as the level for apple juice and 20 ppb for all other juices. The chart, below, summarizes the draft action levels being considered by FDA.
Next Steps
The agency has acknowledged that reducing levels of toxic elements in foods is complicated and multifaceted, as well as that it is “crucial that measures taken to limit toxic elements in foods do not have unintended consequences – like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.”
The agency requests that written comments be submitted to the docket by March 27, 2023.6 In particular, FDA is seeking additional information on the grain-based snacks category of foods to inform whether an action level would be appropriate.
References
1 Draft Guidance for Industry: Action Levels for Lead in Food Intended for Babies and Young Children (Jan. 2023), available here https://www.fda.gov/media/164684/download; Constituent Update, FDA Issues Guidance for Industry on Action Levels for Lead in Baby Foods (Jan. 24, 2023), available here https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-guidance-industry-action-levels-lead-baby-foods
2 FDA Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods, available here https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods
3 FDA examined the TEP data collected between fiscal years (FY) 2008 through 2021.
4 FDA examined TDS data collected between FY 2014-20.
5 FDA examined special survey data collected in FY 2013-14 and FY 2021.
6 All comments should be identified with the docket number FDA-2022-D-0278 listed in the notice of availability that publishes in the Federal Register.
