Part of the Food Policy Snapshot Series
Policy name: Action Levels for Lead in Juice: Guidance for Industry
Overview: The Food and Drug Administration (FDA) has released draft guidance for reducing lead levels in apple juice and other single-strength (ready-to-drink) juices.
Location: United States
Population: 334.6 million
Food policy category: Food safety
Program goals: To reduce lead exposure from juice
How it works: The draft guidance identifies an action level (the concentration that, when exceeded, may result in regulatory action) of 10 parts per billion (ppb) of lead in apple juice, and 20 ppb for other single-strength juices and juice blends, compared to a level of 50 ppb set in 2004. Apple juice is the most commonly consumed type among young children, which is why its action level is lower than for other juices.
The draft guidance is not binding, but rather an encouragement to manufacturers to reduce lead levels in their products to protect children’s health. It supports the FDA’s Closer to Zero plan, which outlines actions the FDA will take to reduce babies’ and young children’s exposure to arsenic, lead, cadmium, and mercury from foods.
Progress to date: Closer to Zero was released in April 2021. The draft guidance for reducing lead in juice was released on April 27, 2022, and is open to public comment until June 28, 2022.
Why it is important: Lead exposure affects children more severely than adults, with limited exposures resulting in inattentiveness, hyperactivity, and irritability, and higher exposures leading to learning difficulties, delayed growth, hearing loss, and even brain damage and death.
The FDA estimates that an action level of 10 ppb in apple juice will reduce children’s lead exposure by up to 46 percent, and an action level of 20 ppb in other juices may reduce exposure by up to 19 percent.
Program/Policy initiated: The draft guidance was issued on April 27, 2022.
Point of contact:
Eileen Abt, Chemist, Center for Food Safety and Applied Nutrition, FDA
Phone: 240-402-1700
Email: Eileen.Abt@fda.hhs.gov
Jessica Larkin, Regulatory Counsel, Center for Food Safety and Applied Nutrition, FDA
Email: jessica.larkin@fda.hhs.gov
Similar practices: Closer to Zero is a broad action plan with the goal of reducing babies’ and young children’s exposure to arsenic, lead, cadmium, and mercury from foods.
Evaluation: Evaluation has not yet been conducted.
Learn more:
- The Deadly Biology of Lead Exposure (Harvard University)
- FDA Announces Steps to Limit Lead in Juice (Food Safety News)
- FDA Sets Plan to Lower the Acceptable Amount of Lead in Fruit Juices (Food and Wine)
- FDA Takes Steps to Limit Lead in Apple Juice, Other Juice Blends (ABC 7 Chicago)
- Half of US Population Exposed to Adverse Lead Levels in Early Childhood (Proceedings of the National Academy of Sciences of the United States of America)
- U.S. Food and Drug Administration’s Interim Reference Levels for Dietary Lead Exposure in Children and Women of Childbearing Age (Regulatory Toxicology and Pharmacology)
References:
- Action Levels for Lead in Juice; Draft Guidance for Industry; Availability (Federal Register)
- Action Levels for Lead in Juice: Guidance for Industry (US Food and Drug Administration)
- Closer to Zero: Action Plan for Baby Foods (US Food and Drug Administration)
- FDA Issues Draft Guidance to Industry on Action Levels for Lead in Juice (US Food and Drug Administration)
- Lead (Centers for Disease Control and Prevention)
- Lead Exposure In Children Affects Brain And Behavior (American Academy of Child and Adolescent Psychiatry)
- Lead in Food, Foodwares, and Dietary Supplements (US Food and Drug Administration)
