Baby food fda
Closer to Zero: Action Plan for Baby Foods
About | Approach | Action Items & Proposed Timeline | On-Going Work | Announcements
Featured
FDA and Federal Partners Launch Study on the Role of Seafood Consumption in Child Growth and Development
Learn more about the National Academies of Sciences, Engineering, and Medicine study that is designed to provide the most up-to-date understanding of the science of seafood consumption and child growth and development that supports the goals of our Closer to Zero Action Plan. It will also help inform whether updates are needed for the current Advice about Eating Fish for children and those who might become or are pregnant or breastfeeding.
FDA Updates Interim Reference Level for Lead
To help ensure that FDA’s guidance to industry on lead in food is based on the latest science, FDA researchers have lowered the Interim Reference Level. Learn More.
Stakeholder Webinar on Lead in Juice
Watch the stakeholder webinar held on Tuesday, June 14, 2022 where the agency's draft guidance on action levels for lead in juice was discussed.
Guidance
The FDA has issued draft guidance to industry on action levels for lead in single-strength juices and juice blends. To learn more about the action levels and how to submit public comments, please see FDA Issues Draft Guidance to Industry on Action Levels for Lead in Juice.
About the Action Plan
The U.S. Food and Drug Administration’s (FDA) plan, Closer to Zero, identifies actions the agency will take to reduce exposure to arsenic, lead, cadmium, and mercury from foods eaten by babies and young children—to as low as possible. We have prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants.
Exposure to arsenic, lead, cadmium, and mercury, from foods depends on the levels of the elements in the food and the amount consumed. The levels of these elements in foods depend on many factors, including:
- the levels of these elements in the air, water, and soil used to grow the crops, which vary depending on factors such as natural geographical differences and past or current contamination,
- the type of food crop and how much “uptake” there is of specific elements from the environment, and
- industrial, manufacturing, and agricultural processes.
Our work, combined with that of our stakeholders, has led to meaningful reductions in exposure to toxic elements. The FDA’s action plan builds on this progress and outlines a science-based, iterative approach for achieving continual improvements over time. Further reductions in the levels of arsenic, lead, cadmium, and mercury in foods will be made by:
- advancing the FDA’s research on and evaluating changes in dietary exposures to these elements,
- setting action levels, with input from stakeholders,
- encouraging adoption of best practices by industry to lower levels of toxic elements in agricultural commodities and products,
- increasing targeted compliance and enforcement activities, and
- monitoring progress of levels over time.
Action levels are a level of contamination at which a food may be regarded as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. The FDA considers action levels, in addition to other factors and scientific evidence, when considering whether to bring enforcement action in a particular case.
Reducing levels of toxic elements in foods is complicated and multifaceted. It is crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods does not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.
The FDA is committed to a science-driven, transparent, and inclusive process that will include active stakeholder engagement and public sharing of data and information. This iterative plan will be updated as new data, information, and resources become available.
Understanding the FDA’s Approach
To make continual improvements, the FDA’s action plan follows a four-stage iterative approach that includes research, regulatory, and outreach efforts.
The Four Stages of the FDA’s Approach:
Evaluate the scientific basis for action levels. The cycle of continual improvement starts with the FDA evaluating existing data from routine testing of the food supply, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.
Through a process that may include engagement with stakeholders, advisory committees, public workshops, and consultation with scientific experts, federal agency partners and other stakeholders, the agency will establish interim reference levels (IRLs) for certain toxic elements as appropriate. An IRL is a measure of exposure from food that the FDA may use to determine if the amount of exposure to an individual element across foods could result in a specific health impact.
Propose action levels. The IRLs may be among the key factors that inform the development of the FDA’s proposed action levels for certain toxic elements in categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables) and other foods commonly eaten by babies and young children.
Consult with stakeholders on proposed action levels, including the achievability and feasibility of action levels. For each individual element in every identified category of food, the FDA will gather data and other information through a process of consultation which could include workshops, scientific meetings, and collaboration with federal partners to assess, among other things, the achievability and feasibility of the proposed action levels and the timeframes for reaching them.
Finalize action levels. The FDA will use the information gathered from stakeholders, updated scientific research, and routine monitoring of data to make any needed adjustments and finalize action levels.
The FDA's Approach in Action
Once the FDA has published final action levels, the agency will establish a timeframe for assessing industry’s progress toward meeting the action levels and recommence the cycle to determine if the scientific data support efforts to further adjust the action levels.
The availability of data and additional research needs for arsenic, lead, cadmium, and mercury are different. Therefore, because of currently available data, we will start with proposing action levels for lead while we evaluate data for the other toxic elements. We will then progress through the cycle for each element as we gather more data and information across various categories of food consumed by babies and young children.
The FDA will support the cycle of continual improvement with ongoing activities related to monitoring levels in foods; research on chemical methods, toxicological impacts, exposures, and risk communication; and routine compliance and enforcement efforts.
The FDA will evaluate information as it becomes available to determine whether any foods are adulterated or otherwise violative and take action as appropriate. The FDA intends to make information about our monitoring, research, and enforcement actions publicly available. The timeline and deliverables included in the plan will be updated periodically as new data, information, and resources become available.
Action Items and Proposed Timeline
Phase 1: April 2021 – April 2022
| Stage in the Cycle of Improvement | Toxic Element | Action |
|---|---|---|
| Evaluate | Arsenic | Gather data through a process of consultation, which could include workshops, scientific meetings, and collaboration with federal partners to work toward establishing an interim reference level |
| Propose | Lead | Draft action levels for categories of foods consumed by babies and young children |
| Consult | Lead | Engage with stakeholders to assess, among other things, feasibility and best practices |
| Ongoing Monitoring, Research, and Compliance | All | Provide resources to industry on best practices for reducing or preventing lead contamination Complete sampling assignment for baby foods |
| Key Accomplishments | All | Provided draft action levels for lead in juice. Made significant progress in evaluating the science for arsenic and the dose-response of cadmium to establish interim reference levels. Sampled baby foods for research, monitoring, and compliance purposes. Collaborated with USDA, USDA-WIC, NIH, consumer safety stakeholders, and industry, including:
|
Phase 2: April 2022 – April 2024
| Stage in the Cycle of Improvement | Toxic Element | Action |
|---|---|---|
| Evaluate | Cadmium Mercury | Gather data through a process of consultation which could include workshops, scientific meetings, and collaboration with federal partners to work toward establishing an interim reference level |
| Propose | Arsenic | Draft action levels for categories of foods consumed by babies and young children |
| Consult | Arsenic | Engage with stakeholders to assess, among other things, feasibility and best practices |
| Finalize | Lead | Finalize action levels for lead in categories of foods consumed by babies and young children |
| Ongoing Monitoring, Research, and Compliance | All | Issue guidance chapter on chemical hazards in the Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food Publish results from sampling assignment for baby foods Publish Total Diet Study results (to occur biennially) Publish exposure assessments for children to toxic elements (to occur biennially) |
Phase 3: April 2024 – beyond
| Stage in the Cycle of Improvement | Toxic Element | Action |
|---|---|---|
| Evaluate | Lead | Review new scientific data, assess progress on reducing lead in foods consumed by babies and young children and feasibility of attaining even lower levels |
| Propose | Cadmium Mercury | Draft action levels for categories of foods consumed by babies and young children |
| Consult | Cadmium Mercury | Engage with stakeholders to assess, among other things, feasibility and best practices |
| Finalize | Arsenic | Finalize action levels for arsenic in categories of foods consumed by babies and young children |
| Ongoing Monitoring, Research, and Compliance | All | Complete additional baby food sampling assignments Publish results from sampling assignment for baby foods Publish Total Diet Study results (to occur biennially) Publish exposure assessments for children to toxic elements (to occur biennially) |
As action levels are finalized, we will continue the cycle of continual improvement, addressing arsenic, lead, cadmium, and mercury in its turn, to evaluate whether downward adjustments of interim reference levels should be made; proposing new action levels, as appropriate; consulting with stakeholders on feasibility, achievability, and other issues; and adjusting (as needed) and finalizing action levels.
Ongoing Work on Toxic Elements
Trends in Exposure to Toxic Elements from Foods for Babies and Young Children (PDF: 1.7MB)
The FDA’s testing of toxic elements in foods has shown that over time there have been significant reductions in the levels of these elements in foods and the Closer to Zero action plan will help further advance progress in this area.
In addition to the actions in the proposed timeline, we will continue:
- Developing and validating analytical methods.
- Toxicological research on impacts of toxic elements on development in children.
- Developing new dose-response models to consider the probability of other adverse health effects in different sub-populations, including infants and young children.
- Collaborating with the U.S. Department of Agriculture on research on agronomic techniques that may mitigate uptake of toxic elements in agricultural commodities.
- Collaborating with the National Institutes of Health and the Centers for Disease Control and Prevention to better understand impacts of toxic elements on development and the role of nutrition for mitigating those impacts.
- Evaluating potential impact of new technologies, interventions, or mitigation controls to reduce exposure and resulting risk to consumer health.
- Reevaluating risk assessments based on declining levels of toxic elements in foods.
The FDA’s regulatory actions, along with research and collaboration with all of our stakeholders – industry, advocacy, policy makers, academia, and consumers – will result in significant reductions in exposures to arsenic, lead, mercury, and cadmium, among children and the general population and have lasting public health impact.
Announcements
FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice (June 20, 2022)
FDA Issues Draft Guidance to Industry on Action Levels for Lead in Juice (April 27, 2022)
FDA Announces First Closer to Zero Action Plan Public Meeting (October 8, 2021)
FDA Statement: FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children (April 8, 2021)
FDA Shares Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies and Young Children (April 8, 2021)
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)
FDA Statement: FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies, Young Children (March 5, 2021)
FDA Response to Questions About Levels of Toxic Elements in Baby Food, Following Congressional Report (February 16, 2021)
Food Safety for Infants & Toddlers
Spotlight
July 2022
The FDA is taking additional steps to increase infant formula supplies.
The FDA issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula.
Companies Receiving Enforcement Discretion for Infant Formula
These Infants & Toddlers web pages contain information about infant formula that may be helpful to industry, consumers, government agencies, and other interested parties. They include the following:
- Information about FDA's regulation of commercial infant formulas
- Commonly asked questions about infant formulas
- Links to other relevant resources
- How to report problems
Requirements for infant formula are found in the Federal Food, Drug, and Cosmetic Act. All manufacturers of infant formula must begin with safe food ingredients, which are either generally recognized as safe (GRAS) or approved as food additives for use in infant formula.
Once an infant formula product is formulated, current laws require that the manufacturer must provide FDA assurance of the nutritional quality of that particular formulation before marketing the infant formula.
FDA has provisions that include requirements for certain labeling, nutrient content, manufacturers quality control procedures (to assure the nutrient content of infant formulas), as well as company records and reports. FDA is also working to finalize a proposed rule for good manufacturing practice, quality control procedures, quality factors, notification requirements, and reports and records, for the production of infant formulas.
Imported Infant Formula and Infant Formula Supplies
- Ongoing FDA Efforts to Increase Supply
- Resources for Parents and Caregivers on Imported Infant Formula
- Imported Infant Formula Names to Know
- Tips for Preparing Imported Infant Formula (Consejos para preparar la fórmula infantil importada)
- Infant Formula Supply Consumer Update
- Find Formula During the Infant Formula Shortage (HHS)
- Enforcement Discretion for Infant Formula
Food Safety & Nutrition from FDA
- Questions & Answers for Consumers Concerning Infant Formula
- Do's and Don'ts with Infant Formula
- What You Need to Know aout the Risk of Cronobacter in Powdered Infant Formula
- Help Prevent Cronobacter Illness: Prepare and Store Powdered Infant Formula Safely
- FDA Advises Parents and Caregivers to Not Make or Feed Homemade Infant Formula to Infants
- Food Safety Booklet for Pregnant Women, Their Unborn Babies, and Children Under Five
- Food Safety for Moms-To-Be - See Once Baby Arrives (Cuando llega el bebé)
Alerts
- FDA Advises Parents and Caregivers Not to Buy or Give Mother’s Touch Formula to Infants (2022)
- FDA Investigation of Cronobacter Infections: Powdered Infant Formula (2022) (For additional information, see Powdered Infant Formula Recall: What to Know)
- Additional Safety Alerts
Industry Resources
- Infant Formula Guidance Documents & Regulatory Information
- Exempt Infant Formulas Marketed in the United States by Manufacturer and Category
- Enforcement Discretion for Infant Formula
Additional Resources
- Breastfeeding | NIH
- Children's Health | MEDLINEplus
- Choking | MEDLINEplus, (Atragantamiento)
- Women, Infants, and Children (WIC) | USDA - WIC provides Federal grants to States for supplemental foods, health care referrals, and nutrition education for low-income pregnant, breastfeeding, and non-breastfeeding postpartum women, and to infants and children up to age five who are found to be at nutritional risk.
- Infant Formula: Evaluating the Safety of New Ingredients - Report from the Committee on the Evaluation of the Addition of Ingredients New to Infant Formula
Shortage of infant formula in the United States: why a state of emergency is introduced in cities and whether it threatens Russia
In the United States, there is an acute shortage of infant formula milk. According to the Datasembly agency, in early May, the deficit in warehouses across the country was 43%. The crisis is so serious that dry food is delivered to certain regions on military aircraft from Europe. What happened and does the same thing happen to Russia?
What's happening to baby food in the US
In late 2021, four parents contacted the US Food and Drug Administration (FDA) to complain that their children had contracted a rare and dangerous bacterial infection after taking infant formula.
infection with Cronobacter sakazakii, which resulted in death in two cases. Another application was filed by the parents of an infant who was hospitalized with Salmonella Newport.
On January 31, 2022, FDA inspectors came to inspect Abbott Nutrition, the largest manufacturer of infant formula in the United States, and found serious food safety violations, and found five different strains of Cronobacter there (although not Cronobacter was among them sakazakii). In mid-February, at the end of the review, Abbott Nutrition recalled batches of products from stores and suspended the production line until the problem was fixed. So the country was left without the largest plant for the production of infant formula for several months - a supplier of about 20% of all mixtures in the country.
Empty shelves in the infant formula department. USA. State of Georgia. Photo: Erik S. Lesser / EPA / TASS According to Datasembly, the states of Iowa, Missouri, South Dakota, Tennessee and Texas were the first to experience shortages, but now in 25 states infant formula is out of stock in 40-50% of stores, and in five states - in more than half of the outlets.
In this regard, on May 18, US President Joe Biden applied the Defense Production Act and allowed the use of Department of Defense aircraft to deliver products from abroad. He also required suppliers to send ingredients to infant formula manufacturers before any other companies. And on May 22, the mayor of New York declared a state of emergency in the city due to the lack of milk formula for children - it prohibits retailers from raising prices for scarce goods.
The British Daily Mail reports that the remaining two monopolists, Walgreens and CVS, have imposed a ban on the sale of more than three units of baby food in one hand, and the popular online store Target.com - more than four. The FDA cites data that baby food manufacturers Gerber (USA) and Reckitt (UK) have increased the production of infant formula since the beginning of the year - by 50% and 30%, respectively.
How to solve this problem
However, the problem is that the manufacturers that remain on the market do not make enough formula for children with metabolic diseases, allergies and other conditions that require a special diet.
Parents are sounding the alarm: Minnesota Public Radio news portal reports that there are already cases of hospitalization of children in Tennessee, Georgia, Wisconsin and other states due to nutritional problems.
On May 23, USA Today reported that a military cargo plane arrived in Indianapolis carrying the first batch of Nestle hypoallergenic infant formula from Germany. In total, there were 35 tons of baby food on board. Agriculture Secretary Tom Vilsack, in an interview with NBC News, said that this amount would be enough for 9,000 babies and 18,000 toddlers within one week.
Military aircraft loaded with infant formula. USA. Indianapolis. Photo: Michael Conroy / AP / TASSAccording to The Washington Post, Abbott CEO Robert Ford apologized for the deficit and promised to set up a $5 million fund to help affected families cover medical and living expenses until until the supply crisis is resolved.
When Abbot Laboratories returns to the market
Robert Ford told The Washington Post that Abbott Nutrition has retooled its adult food lines at its Ohio plant to produce pre-packaged liquid infant formula and shipped millions of cans of its most sought-after dry formula from its Irish facility .
In March, the company reported that it did not detect Cronobacter sakazakii in any sample of the mixture at the Michigan plant (signs of bacteria were detected in the non-contact area with the product) and regularly conducts tests, hoping to eliminate all violations by the summer.
On May 16, the Court for the Western District of Michigan granted a reopening of proceedings after all violations were resolved. According to the head of the company, if the plant passes the test, new mixtures will appear on store shelves in 6-8 weeks.
Abbott will face $30,000 in damages for each day of violation if it fails to comply.
And what about in Russia
After the closure of the plant in the USA, the company's branch in Israel, Abbott Israel, announced the withdrawal of mixtures of Similac Alimentum and Similac HMF (Human Milk Fortifier), produced at the same Michigan plant. There are also representative offices of Abbott in Russia. In particular, the Russian Veropharm factories in the Vladimir region, Belgorod and Voronezh produce Dufalac, Duspatalin, Duphaston drugs - but these are medicines, not baby food.
The main brands of Abbott baby food in Russia are Similak, Similak Premium for healthy babies, Similak Hypoallergenic for children with a high risk of allergies, Similak Low Lactose for children with lactose intolerance, Similak Antireflux, formulas for premature babies "Similak Special Care" and "Similak NeoSure", as well as a comprehensive and balanced diet "PediaSure", intended for children aged 1 to 10 years. They, according to the information on the packages, are produced in Spain, Denmark, the Netherlands and Ireland.
According to Rosstat, from April 30 to May 6, prices for powdered milk formulas for baby food in Russia increased by 1.1%. Thus, since the beginning of the year, the price of mixtures has already increased by 7.02%. This was caused by fluctuations in the ruble exchange rate and problems with logistics. Against this background, Abbott Labs, Danone (Tyoma, Malyutka, Rastishka, Nutrilon) and Nestle (sells NAN, Gerber, Nestle, Nestogen) announced the termination of investments in the Russian Federation and the reduction of the range.
However, there is no information that the supply of products may stop.
Cover image: Liderina / Shutterstock / Fotodom
Endemic nature of Russian traceability — Alexander Androsov's blog on vc.ru
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Last spring, domestic TV channels regularly reported on the shortage of baby food in the United States. The real reason why this happened , remained unknown to the Russians.The reason for this is the recall (with an emphasis on N) of Abbott Nutrition products, which account for up to 50% of the US infant formula market.
The recall is the withdrawal of potentially unsafe products from the market.
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A topic that is familiar in Russia mainly to car owners. Abbott products were recalled due to the discovery of cronobacteria in them, which caused the death of two babies. By order of the Food and Drug Administration (FDA), the plant was closed. After carrying out all sorts of reconfiguration measures at the enterprise, checking suppliers, etc. production was restarted in early June.
The volume and number of product recalls in different countries has grown steadily in recent years. Increased due to increasingly complex global supply chains amid ever-tightening regulation. During the pandemic, when global logistics began to crumble, the numbers on reviews began to grow more rapidly. For example, the number of recalls registered in the European Food and Feed Rapid Alert System (RASFF) in 2021 increased by 25% (to 4,676 cases) compared to 3,737 cases in 2020. At the same time, in the first quarter of 2022, food and beverage recall rates in Europe decreased by 10.
3%. This is not due to the sagging of the food industry, but to the restoration of global food logistics. But this is in Europe.
Russia's logistical ties with the outside world are not becoming easier with the retreat of Covid, rather the opposite. As a result, our "food workers" are forced to look for new suppliers of raw materials, to experiment with the recipe. The consumer has every reason to think about the quality and safety of food products more than ever, and before there were a lot of idle talk about how and with what we are being "poisoned". However, the Russians still do not hear about product reviews. By the way, there have been recall campaigns in the food market in our country. Probably, the first of them was initiated 20 years ago by Nestle, which returned instant coffee from the market because of the threat of broken glass getting into it.
It is a memorable story in 2013 when IKEA suspended the sale of hot dogs due to a violation of the recipe for sausages purchased from a third-party manufacturer.
In April of this year, Ferrero (it happened, however, in Europe) announced the recall of some of its products due to possible contamination with salmonella. European supervisory authorities promptly notified Rospotrebnadzor. In Europe, Kinder Surprise was in short supply. Whether there were interruptions with chocolate eggs in Russia I can’t say, because during this period I didn’t buy them.
In all these recall campaigns, it is noteworthy that they were all initiated by the manufacturers themselves, who are accustomed to the rules of the game by which they live abroad. Not always, of course, the recall initiative comes from the manufacturer. Supervisory authorities are also vigilant. Our problem is the lack of a recall system. And it is impossible without the introduction of a traceability system. With regard to food products, this is their authentically documented history, based on tracking the origin, movement, storage of raw materials, as well as details, production conditions, delivery and storage of finished products.
In Russia, the concept of traceability has become widespread in connection with the “Honest Sign” system that has been introduced in recent years. But within the framework of this system, counterfeiting was fought. It is gratifying that the penetration of the concept of traceability into legislative acts and initiatives continues. And the concept began to change. For example, in the summer of 2021, changes were made to the Law “On Grain”. It contained an article on the creation of the Federal State Information System for the traceability of grain and grain processing products. The website of the Federal State Budgetary Institution Center for Agroanalytics, a subordinate agency of the Ministry of Agriculture, says in this regard that the introduction of the federal grain traceability system “allows Russian business to work effectively in conditions of grain market transparency, and the state to track the contribution of regions to ensuring the country’s food security.”
My company is in the business of building traceable food businesses that can create consistent quality, safe products.
