Congressional Oversight Subcommittee Report – February 4th, 2021
The U.S. House of Representative’s Subcommittee on Economic and Consumer Policy gathered data on inorganic Arsenic, Lead, Cadmium, and Mercury concentrations in baby food and current assessed regulations. Several prominent baby food companies voluntarily participated by submitting historical data from their internal heavy metal testing programs, while others opted not to participate. Baby food heavy metals regulations have been proposed as a result of these recent revelations.
The subcommittee noted that the FDA had not established limits for heavy metals in baby food. Therefore, it was up to each company to develop internal action levels and testing programs designed to minimize heavy metal concentrations. However, based on the subcommittee’s research into the effects of heavy metals at low concentrations, they recommend that the FDA and baby food producers establish more stringent regulations or internal standards.
The five Congressional Subcommittee recommendations:
- Mandatory testing—FDA should require baby food manufacturers to test their finished products for toxic heavy metals, not just their ingredients.
- Labeling—The FDA should require manufacturers to report toxic heavy metals on food labels.
- Voluntary phase-out of toxic ingredients—Manufacturers should voluntarily find substitutes for high amounts of toxic heavy metals or phase-out products with high amounts of ingredients that frequently test high in toxic heavy metals, such as rice.
- FDA standards— FDA should set maximum levels of toxic heavy metals permitted in baby foods. One level for each metal should apply across all baby foods. And the level should be set to protect babies against the neurological effects of toxic heavy metals.
- Parental vigilance—Parents should avoid baby foods that contain ingredients testing high in toxic heavy metals, such as rice products. Instituting recommendations one through four will give parents the information they need to make informed decisions to protect their babies.
The full congressional subcommittee report can be found here.
The Baby Food Safety Act of 2021 – March 25th, 2021
The subcommittee report has increased public concern regarding heavy metals in baby food. As a result, parents are looking to companies, regulatory agencies, and U.S. lawmakers to take further action. Subsequently, Congress has introduced the “Baby Food Safety Act of 2021.” to address the current lack of FDA action levels in baby food. The proposed baby food heavy metal regulations would amend FDCA (Food Drug and Cosmetic Act) and establish action levels for inorganic Arsenic, Cadmium, Lead, and Mercury in baby food.
The four new limits that Congress is hoping to implement.
|Infant and Toddler Food (except cereal)||10 ppb||5 ppb||5 ppb||2 ppb|
|Infant and Toddler Food that is cereal||15 ppb||10 ppb||10 ppb||2 ppb|
- Establish action levels, effective one year after enactment
- Define toddler food as food up to 36 months of age, including infant formula
- Representative testing of final products as part of hazardous preventive efforts
- Publicly available (twice per year) product testing report and hazard preventatives
- Initiate a baby food recall if it determined to contain toxic heavy metals exceeding the newly established levels
- CDC public awareness campaign to highlight the risks posed by heavy metals in baby food
- $50 Million to the National Academy of Sciences to research agricultural methods of minimizing levels of toxic heavy metals in crops
Closer to Zero: Action Plan for Baby Foods – April 8th, 2021
The U.S. Food and Drug Administration’s (FDA) plan, “Closer to Zero,” is a blueprint for change aimed at the baby food industry. The main difference between both plans is that “Closer to Zero” is focused on consulting stakeholders on the achievability and feasibility of the proposed set action levels. A component that the baby food safety act is missing.
The FDA approach is centered around four stages known as “the cycle of continual improvement.” The plan’s goal is to evaluate (the science), propose (draft action levels), consult (with stakeholders), and finalize set action levels as close to zero trace amounts of heavy metals.
The timeline of phases is as follows:
- Phase 1 (April 2021 – April 2022)
- Propose set action levels for Lead
- Start evaluation for Arsenic
- Phase 2 (April 2022 – April 2024)
- Finalize set action levels for Lead
- Propose set action levels for Arsenic
- Start evaluation for Cadmium and Mercury
- Phase 3 (April 2024 – ∞)
- Finalize set action levels for Arsenic
- Propose set action levels for Cadmium and Mercury
- Review new research for Lead
Credit: FDA “Closer to Zero” Action Plan
How will these New Acts Affect Food Manufacturers?
One of the proposed subcommittees baby food heavy metal regulations is to phase out ingredients that tend to have high concentrations of heavy metals. Baby food manufacturers have established formulations and manufacturing processes that may not be possible to modify. Consequently, launching new limits could cause difficulties if companies must change their formula or supply chain operations to maintain compliance.
Stakeholders have the power to voice their opinion, especially on the topic of feasibility and achievability of proposed set action levels. The FDA is well known for stakeholder collaboration and reducing exposure to toxic elements in food will be a cooperative effort.
Manufacturers will have to ensure that the 3rd party labs they utilize offer limits of quantification that are compliant with the new action levels. Additionally, baby food companies should ensure the lab’s heavy metal method is ISO-17025 Accredited and experienced at analyzing baby foods.
AGQ Labs USA uses an ICP-MS to test water and food products and an ICP-OES to test soils, vegetation, and food additives for heavy metals. It allows us to detect heavy metals at low levels to help ensure clients comply with different heavy metal regulations (CA Prop 65, Korea, Taiwan, E.U., and U.S. action levels)
Click here to learn more about heavy metals food testing.