FDA Issues Draft Guidance to Industry on Action Levels for Lead in Juice

Constituent Update

April 27, 2022

Today the U.S. Food and Drug Administration issued draft guidance to industry providing action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends. These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods and advance our goals in the Closer to Zero action plan. We believe that by taking a whole of government approach through our collaboration with federal partners, along with engagement with other stakeholders, our regulatory actions will have a lasting impact in reducing exposure to toxic elements in babies and young children.

The draft guidance titled “Action Levels for Lead in Juice; Draft Guidance for Industry” provides an action level for lead in apple juice of 10 parts per billions (ppb), which is lower than the action level for lead in other juices of 20 ppb, because, as the most commonly consumed juice by young children, apple juice may contribute a greater share of their potential lead exposure than other juices. The FDA has prioritized reducing lead exposure because it is associated with serious health effects, including effects on the developing brain, such as impaired intellectual development.

With the Closer to Zero action plan, we committed to identifying interim reference levels (IRLs) and considering them among the key factors to inform the development of action levels. IRLs are a measure of exposure from food that the FDA may use to determine if the amount of exposure to an individual element across foods could result in a specific health effect. Our draft action levels for lead in juice represent this approach and are guided by the FDA’s IRL for lead, a measure of the contribution of lead in food to blood lead levels. We also considered exposure and risk assessments, detection and quantification capabilities, and achievability.

The FDA estimates establishing a 10 ppb action level for lead in apple juice could result in as much as a 46% reduction in exposure to lead from apple juice in children. For all other fruit and vegetable juices, establishing an action level of 20 ppb is estimated to result in a 19% reduction in exposure to lead from these juices in children.

The FDA issues action levels according to our regulations to inform industry on the levels of contamination at which FDA may regard specific foods to be adulterated. Because lead in the environment can be absorbed by plants and animals and because it, like other elements, does not disappear over time, it is not possible to remove lead entirely from the food supply. Action levels are established based on the unavoidability of the poisonous or deleterious substances and do not represent permissible levels of contamination where it is avoidable. We intend to consider action levels, in addition to other factors, when determining whether to bring an FDA enforcement action.

Historically, action levels have promoted the implementation of measures to further reduce the level of a toxic element in specific foods. Most juices have low levels of lead that are below the draft action levels. Therefore, it is reductions in the level of lead in juices with levels higher than the draft action levels that will have the largest impact in reducing lead exposure from juices.

Today’s announcement further demonstrates the FDA’s commitment to a science-driven approach. We are continuing our work to identify interim reference levels for arsenic, cadmium, and mercury and later this year we expect to provide draft guidance to industry on action levels for lead in foods intended for babies and young children. We are also continuing to work towards issuing final guidance on an action level for inorganic arsenic in apple juice.

To ensure comments regarding "Action Levels for Lead in Juice: Draft Guidance for Industry" are considered before the FDA begins work on the final guidance, please submit written or electronic comments within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Submit comments electronically on Regulations.gov to docket number FDA-2019-D-5609.

Submit written/paper submissions to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All submissions received must include the Docket No. FDA-2019-D-5609 for "Action Levels for Lead in Juice: Guidance for Industry."

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