FDA issued a follow-up to their earlier response on heavy metals in baby food. As you many remember, a US Senate Subcommittee released a report on compounds such as arsenic, lead, cadmium and mercury in baby food, for which FDA issued a response. This current issuance, A Letter to Industry basically reminds baby food companies "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. "
In this Letter, "FDA does not advise parents and caregivers to throw out their supply of packaged baby foods or to stop feeding their babies and children certain foods altogether. Eliminating food groups from your children’s diet in order to avoid certain toxic elements that occur in the food supply may result in deficiencies in certain nutrients and potential poor health outcomes."
It also tell parents that if they make their own food, they are unlikely to do a better job than the food companies. "For parents who choose to make their own baby foods, it is important to know that this is not likely to reduce potential exposure to toxic elements in baby foods and may instead result in higher concentrations, as food manufacturers have the capability to implement strategies that result in using ingredients with lower concentrations of toxic elements. Finally, we want to stress that it is critical that parents and caregivers not attempt to make and feed their infants homemade infant formula—as this is extremely unlikely to reduce exposure to toxic elements and has resulted in infants suffering life-threatening consequences, including severe nutritional deficiencies and microbial foodborne illness."
Are there many who are left thinking...well, tell us how bad is it? What are the real risks? Well FDA starts the letter with this "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. "
In an announcement issued the same day, FDA stated some of their planned actions.
- 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.
Constituent Updates
https://www.fda.gov/food/cfsan-constituent-updates/fda-letter-industry-chemical-hazards-including-toxic-elements-food-and-update-fda-efforts-increase
Center for Food Safety and Applied Nutrition
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FDA Letter to Industry on Chemical Hazards, including Toxic Elements, in Food and Update on FDA Efforts to Increase the Safety of Foods for Babies and Young Children
March 5, 2021
The U.S. Food and Drug Administration (FDA) is providing an update on our work to further reduce toxic elements in foods for babies and young children. Toxic elements are in the environment, and therefore in the food supply. The levels of arsenic, lead, mercury, and cadmium in certain foods depends on many factors, including: growing conditions; manufacturing and agricultural processes; past or current environmental contamination; and the genetic capacity of food crops to take up elements. 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. As such, this issue is among FDA’s highest priorities and we are actively working to make progress on identifying and implementing impactful solutions to make foods commonly consumed by infants and young children safer.
Letter to Industry:
As the FDA advances its work in this area, so too must industry. Today, the FDA issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. 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.
Advice for Parents and Caregivers:
The FDA recommends that parents and caregivers speak with their child’s pediatrician about a diet that includes a variety of age-appropriate, healthy foods in order to get needed nutrients. For proper growth and development, parents and caregivers should ensure they are feeding iron-fortified grain cereals or other iron-containing foods to babies over six months of age. The American Academy of Pediatrics has detailed advice for feeding infants and young children.
The Key to a Well-Balanced Diet is Eating a Variety of Healthy Foods
The FDA does not advise parents and caregivers to throw out their supply of packaged baby foods or to stop feeding their babies and children certain foods altogether. Eliminating food groups from your children’s diet in order to avoid certain toxic elements that occur in the food supply may result in deficiencies in certain nutrients and potential poor health outcomes.
For parents who choose to make their own baby foods, it is important to know that this is not likely to reduce potential exposure to toxic elements in baby foods and may instead result in higher concentrations, as food manufacturers have the capability to implement strategies that result in using ingredients with lower concentrations of toxic elements. Finally, we want to stress that it is critical that parents and caregivers not attempt to make and feed their infants homemade infant formula—as this is extremely unlikely to reduce exposure to toxic elements and has resulted in infants suffering life-threatening consequences, including severe nutritional deficiencies and microbial foodborne illness.
Update on FDA Activities:
The FDA is finalizing a comprehensive plan to further reduce levels of toxic elements in foods for babies and young children.
In the near term, the FDA is committed to:
• Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
• Focused compliance and enforcement activities, including inspections.
• Providing guidance to industry on how to meet their obligations under current regulations.
The FDA will also continue our ongoing surveillance sampling assignment targeting these products.
We are eager to work with federal partners, academia, and other stakeholders to inform the development of action levels of lead, cadmium, mercury, and arsenic in foods for babies and young children. We will be looking to additional sources of data, as well as increasing our testing for these elements, to better understand their prevalence in foods commonly eaten by babies and young children. We will also continue to build our understanding of the variability of toxic element levels in different foods and the potential impacts, if any, of low exposures on childhood development. In addition, in the coming year, the FDA will host a workshop to bring together our stakeholders to share knowledge on these issues and discuss potential mitigation strategies.
As our work to establish an action level for inorganic arsenic in infant rice cereal demonstrates, the process of reducing levels of toxic elements in foods is complicated and multifaceted. It is crucial to ensure that measures to limit toxic elements in foods do not have unintended consequences—like eliminating foods with significant nutritional benefits or reducing the presence of one toxic element while increasing another. For this reason, the FDA’s process must be deliberative and inclusive, and in the coming weeks we will share our plan and provide more information on FDA’s future work on this important issue.
Additional Information for Consumers:
• FDA Infographic: The Key to a Well-Balanced Diet is Eating a Variety of Healthy Foods
• What You Can Do to Limit Exposure to Arsenic
• For Consumers: Seven Things Pregnant Women and Parents Need to Know About Arsenic in Rice and Rice Cereal
• Metals and Your Food
https://content.govdelivery.com/accounts/USFDA/bulletins/2c55cf0
US Food and Drug Administration
FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies, Young Children
The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D. and Susan Mayne, Ph.D., Director, FDA’s Center for Food Safety and Applied Nutrition
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.
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.
Food Business News
https://www.foodbusinessnews.net/articles/18141-new-urgency-in-addressing-toxic-heavy-metals-in-baby-food
New urgency in addressing toxic heavy metals in baby food
03.10.2021By Jay Sjerven
WASHINGTON — Prodded by a scathing House subcommittee report issued Feb. 4 charging baby food manufacturers were marketing products they knew contained “dangerous levels of toxic heavy metals” and a subsequent request from lawmakers for technical guidance on legislation they have drafted on this issue, the Food and Drug Administration on March 5 announced new and more aggressive actions aimed at further reducing toxic elements in foods for babies and young children.
The FDA statement was issued jointly by Janet Woodcock, MD, the FDA’s acting commissioner of food and drugs, and Susan T. Mayne, PhD, director of the Center for Food Safety and Applied Nutrition.
........(rest of article - https://www.foodbusinessnews.net/articles/18141-new-urgency-in-addressing-toxic-heavy-metals-in-baby-food)
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