April 27, 2022: “The U.S. FDA issued draft action levels for lead in single-strength (ready to drink) apple juice and other single-strength juices and juice blends.
This action is intended to reduce the potential for negative health effects from dietary exposure to lead, and supports the agency’s Closer to Zero action plan that sets forth the FDA’s science-based approach to reducing exposure to toxic elements in foods.
“Exposure of our most vulnerable populations, especially children, to elevated levels of toxic elements from foods is unacceptable,” said FDA Commissioner Robert M. Califf, M.D.
“This action to limit lead in juice represents an important step forward in advancing FDA’s Closer to Zero action plan, which we are confident will have a lasting public health impact on current and future generations.”
Today’s draft guidance outlines action levels, which are recommended limits of lead in juice that can be achieved by industry and progressively lowered as appropriate.
In particular, Action Levels for Lead in Juice: Draft Guidance for Industry, provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice.
As part of its commitment in the Closer to Zero action plan to consider the biological effects from exposure to harmful elements in food, the draft action levels for lead in juice were guided by the FDA’s interim reference level (IRL) for lead, a measure of the contribution of lead in food to blood lead levels.
The FDA estimates that establishing a 10 ppb action level 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, establishment of an action level of 20 ppb is estimated to result in a reduction of 19% in exposure to lead from all other juices in children.
The FDA issued a lower draft action level for apple juice because it is the most commonly consumed juice that young children drink.
“As we outlined in the Closer to Zero action plan, the agency is increasing targeted compliance activities as part of our efforts to monitor levels of these elements in foods through the FDA’s Total Diet Study, Toxic Elements in Food and Foodware program and sampling assignments,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition.
“In addition, our work in this important area of food safety will progress with advancements in science.
For example, action levels may be progressively lowered over time, as appropriate, to make continual improvements in reducing the levels of lead, arsenic, cadmium and mercury in foods eaten by babies and young children.”
The FDA is accepting comments on the draft guidance. A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final. The FDA will work with manufacturers of these products to encourage the adoption of best practices to lower levels of lead in juice.
The FDA routinely monitors levels of toxic elements in food and considers on a case-by-case basis whether a food that contains a contaminant is adulterated under the Federal Food, Drug, and Cosmetic Act and subject to enforcement action.
Because lead is in the environment as a naturally occurring element and from consumer and industrial products and processes, it is not possible to remove it entirely from the food supply. However, the action levels recommended in the draft guidance document will help limit consumer exposure.
The FDA recommends that for good nutrition, parents follow the Dietary Guidelines for Americans, which recommends limits on juice intake for children.
Decreasing juice consumption would also reduce potential exposure to lead from juice.
The Dietary Guidelines recommends that children should get at least half of their fruit needs each day from whole fruit rather than juice and that children under 12 months of age should not consume juice.
Issuing the draft guidance for lead in juice is part of the FDA’s broader efforts to reduce exposure to lead, arsenic, mercury and cadmium from foods and to advance the goals laid out in the Closer to Zero action plan, initiated in April 2021.
As it enters the second year of the Closer to Zero action plan, the FDA is working to identify reference levels for arsenic, cadmium and mercury, and to issue draft guidance to industry on action levels for lead in foods commonly eaten by babies and young children.
We’re also continuing to work towards issuing final guidance on an action level for inorganic arsenic in apple juice.”
