On January 24, 2023, as part of its Closer to Zero action plan, FDA issued a draft guidance on action levels for lead in food intended for babies and young children. The draft guidance establishes the following action levels for when FDA may consider a product adulterated:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats;
- 20 ppb for root vegetables (single ingredient); and
- 20 ppb for dry cereals.
Background
In 2021, FDA established Closer to Zero as an action plan to reduce dietary exposure to contaminants to as low as possible while maintaining access to nutritious foods. FDA acknowledges that heavy metals occur naturally in the environment and cannot be completely avoided in fruits, vegetables or grains that are often the basis for baby foods, juices, and infant cereals. As part of Closer to Zero, FDA is establishing action levels for lead, arsenic, cadmium, and mercury in various food categories, through an iterative process over a few years, on a timeline set forth on the agency’s website. Last year, FDA issued a draft guidance on action levels for lead in juice. According to FDA’s updated timeline, action levels for arsenic and cadmium in foods intended for babies and young children will be developed in 2024 for interagency review (target dates for issuance have not been provided).
FDA defines action levels as concentration levels for poisonous or deleterious substances at which the agency may deem a food to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA). See 21 CFR 109.6(d). While action levels are not binding, FDA will consider them, among other factors, when deciding whether to bring enforcement action in a particular case. Over the past few decades, even before Closer to Zero, FDA has issued action levels in various food categories under this authority through guidance, though some stakeholders have argued that action levels should be established through rulemaking and not guidance.
Lead Action Levels
While no safe level of lead exposure has been identified, FDA developed interim reference levels (IRLs) of 2.2 μg/day for children and 8.8 μg/day for women of child-bearing age. The IRLs are tied to blood lead levels and represent the dietary lead needed to achieve a blood lead level 10 times lower than that associated with the Centers for Disease Control and Prevention’s blood level reference value. The IRLs represent the maximum daily dietary intake of lead from food.
In developing the action levels for foods intended for babies and young children, FDA considered the population’s intake of the food (exposure) and the maximum level of lead that could be in the food without causing the IRLs to be exceeded. As part of the evaluation, FDA reviewed data collected from its Toxic Elements Program (TEP), special FDA surveys, and the Total Diet Study (TDS). Based on the data, the average and 90th and 95th percentiles of lead levels in various food categories varied. For example, fruits and vegetables had lower levels of lead compared to dry infant cereals based on the TEP sampling. FDA also considered achievability, i.e., manufacturers’ ability to achieve the lead action levels. Achievability is based on percentiles of lead concentrations in individual samples surveyed.
The agency explained that it took into account the following considerations in evaluating possible action levels:
- the action level should minimize the likelihood that a consumer will be exposed to lead levels exceeding the IRL;
- as appropriate, there should be a limited number of unique action levels for simplicity;
- 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.
Based on these considerations, FDA identified the following action levels for lead in processed food intended for babies and young children:
- 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats (FSIS supports this action level);
- 20 ppb for root vegetables (single ingredient); and
- 20 ppb for dry infant cereals.
The agency set these action levels based on both the levels of lead found in these food categories and the exposure of babies and young children to these foods. FDA found fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats to have low lead levels and therefore, a lower action level was established. Single-ingredient root vegetables, on the other hand, have higher lead levels for which FDA found the achievability rate at 10 ppb to be difficult leading to a 20 ppb action level. FDA also considered the fact that root vegetables are a source of several nutrients important in the growth and development for babies and young children. These factors warranted a separate action level for root vegetables. In setting the action level for dry infant cereals, FDA took into account dry infant cereals being the only solid food consumed for an extended period of time for many infants. FDA encourages manufacturers to maintain these action levels to reduce risks associated with dietary lead exposures. As noted above, while action levels are not binding, the agency will consider them in determining whether to bring enforcement action against a product as adulterated.
Interested stakeholders should consider submitting comments on the draft guidance by March 27, 2023.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
Back
