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FDA reminds baby food industry to follow the regulations for lead, other toxins

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In response to a recent congressional report about lead and other toxins in baby food, the Food and Drug Administration has posted a public notice and included a link to an industry letter sent by Susan T. Mayne, director of the Center for Food Safety and Applied Nutrition.

Mayne’s letter cites federal regulations chapter and verse and reminds industry to operate within those rules.

Here is the FDA statement, including the link to the industry letter.

The U.S. Food and Drug Administration takes exposure to toxic elements, such as arsenic, mercury, cadmium and lead, 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. That is why today, we are announcing new actions aimed at further preventing or reducing chemical hazards that may be present in foods for babies and young children.

First, today we issued a letter to industry reminding manufacturers of these types of foods of their existing responsibilities related to these efforts. Secondly, the agency is announcing that we’ll soon be putting into action a plan aimed at reducing toxic elements in foods for babies and young children to levels as low as is reasonably achievable.

As parents and caregivers ourselves, we recognize and understand concerns about toxic elements and how they could impact the health of children. We share the public’s concerns for the health of America’s children, and want to reassure parents and caregivers that at the levels we have found through our testing, children are not at an immediate health risk from exposure to toxic elements in foods. The FDA routinely monitors levels of toxic elements in food, and if we find that they pose a health risk, the FDA takes steps to remove those foods from the market. Research has shown that reducing exposure to toxic elements is important to minimizing any potential long-term effects on the developing brains of infants and children. A report released last month by the U.S. House of Representatives Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy also highlighted important questions on what more can be done to reduce toxic elements in baby food.

The FDA issued a letter to manufacturers of foods for babies and young children covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, as well as persons covered under other rules requiring a hazard analysis. The letter reminds them of their existing responsibility to consider risks from chemical hazards, including toxic elements, when conducting a hazard analysis, including for products for babies and young children. The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards requiring a control. For example, some manufacturers may conduct verification activities like testing the final product. Ultimately, we want consumers to be reassured that manufacturers of foods for babies and young children have a legal responsibility under the Federal Food, Drug, and Cosmetic Act to ensure the safety of their products.

To build on our ongoing work with regulated industry in this area, we intend to address the following areas:

    • Issuing guidance to identify action levels for contaminants in key foods, with plans to revisit those levels on a regular basis and lower them if appropriate, as well as providing guidance to industry on how to meet their obligations under current regulations;
    • Increasing inspections and, as appropriate, taking compliance and enforcement actions;
    • Boosting sampling of foods for babies and young children, including sharing results; and
    • Working with government, academia and industry to support research and development of additional safety information on toxic elements in foods for babies and young children and additional steps that industry can take to further reduce levels.

Our new activities will further efforts that the agency has continued to take in this area, including our work in 2020 to finalize an action level for inorganic arsenic in infant rice cereal. We’ll be working to develop additional action levels, finalize our draft guidanceon reducing inorganic arsenic in apple juice and publish a draft guidance that will establish action levels for lead in juices. These activities, along with an increase in sampling and reporting, will help continue to drive down levels of toxic elements in foods.

It’s important to understand that toxic elements are present in the environment, including in our air, water and soil, and therefore are unavoidable in the general food supply. This is why another part of our plan is to ramp up availability of consumer information and resources that underscore how the key to a healthy diet including for infants and young children is variety.

For example, 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 does not recommend throwing out packaged foods for babies and young children or eliminating certain foods from children’s diets. The agency recommends that parents and caregivers speak with a pediatrician about a diet that includes a variety of age-appropriate healthy food in order to get needed nutrients. While not directly related, it’s also important to remind parents and caregivers not to make their own infant formula, as this has resulted in infants that have suffered severe illness due to nutrient deficiencies and microbial foodborne illness. We’ll continue working with key stakeholders to develop messaging to provide important tips for parents and caregivers on developing varied and nutritious meal plans for babies and young children.

Engaging stakeholders and our federal partners on issues such as developing and setting standards will help to identify impactful solutions for reducing toxic elements in foods commonly

consumed by babies and young children. As such, we’ll also soon be announcing a public workshop to discuss the science surrounding levels of exposure that result in developmental impacts, and the foods that may contribute to those exposures, to identify solutions to protect our youngest consumers.

The FDA is committed to reducing exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area. We look forward to providing additional updates in the near future.

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