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  1. CFSAN Constituent Updates

FDA Response to Questions About Levels of Toxic Elements in Baby Food, Following Congressional Report

Constituent Update

February 16, 2021

The FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water or air. Because these elements occur in the environment, currently they cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals made by companies or by consumers who make their own foods. They also cannot be completely avoided by using organic farming practices. Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.

FDA regulations and monitoring help to ensure the safety of baby foods sold or manufactured in the United States.

While the report released on February 4, 2021 by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy raises important questions on what more can be done to reduce toxic elements in baby foods, the FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study. Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.

When toxic elements in food present a potential health concern, the FDA takes steps to reduce levels, such as using science to set action levels, making data public, and working with industry on identifying effective mitigation strategies.

For example, FDA sampling of infant rice cereal since 2011 has shown that manufacturers have made significant progress in reducing arsenic in infant rice cereal products through selective sourcing and testing of rice and rice-derived ingredients (e.g., rice flour). This progress has been advanced by the FDA through final guidance to industry on action levels. Because of these efforts, infant rice cereal on the market now is safer than it was a decade ago and we expect that by using emerging science and good manufacturing practices companies will continue to reduce levels of arsenic in infant rice cereal.

Firms and individuals who manufacture or sell food have a legal responsibility under the Federal Food, Drug, and Cosmetic Act to ensure the safety of their products. The FDA reviews information and takes action on a case-by-case basis. If the FDA finds that a product violates the law, the agency takes steps to stop the product from being imported, takes court action to stop its sale or recalls it if it is in the domestic market.

For example, on January 15, 2021 the FDA ordered a U.S. company that had been put under court order for distributing adulterated food to stop distributing adulterated juice products containing potentially harmful levels of the toxic element inorganic arsenic and the mycotoxin patulin, until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements in the court order. The FDA has also worked with several manufacturers whose products contained elevated levels of toxic elements, to remove them from the market. In addition, between 2019-2020, approximately 65 import actions kept products with potentially elevated levels of toxic elements from entering the U.S.

The FDA currently has multiple ongoing Import Alerts for toxic elements in food, including for arsenic in fruit juice, bottled water and dietary supplement products and for lead in candy, dried fruits, spices, dietary supplements, and other foods.

The FDA is continuing to work to ensure both domestic and imported foods meet the same standards for toxic elements.

For example, FDA scientists help ensure there are internationally-recognized standards to reduce the levels of toxic elements in foods by participating in Codex Alimentarius, an international food standard setting body of the Food and Agriculture Organization and World Health Organization. As part of FDA’s work at Codex, our scientists have been instrumental in setting maximum levels and establishing codes of practices for toxic elements including lead, arsenic, cadmium, and mercury. Levels set by Codex, although not binding, can inform our regulatory decisions.

FDA provides consumers with actionable advice to limit exposure to toxic elements from food.

For example, consistent with the Congressional report’s recommendations, the FDA has communicated advice about the importance of feeding infants a variety of grain-based infant cereals. Rice cereal fortified with iron is a good source of nutrients for infants, but it shouldn’t be the only source and does not need to be the first one.

The FDA will continue working with our federal partners, industry and consumer and health advocates on our shared goal of reducing consumer exposure to toxic elements from food.

Additional Information:

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