Tag: baby food

Gerber Argues FDA Preemption in Baby Food Lawsuit

  • In February 2021, the U.S. House of Representatives subcommittee on Economic and Consumer Policy released a report on the levels of heavy metals found in baby foods and the respective manufacturers. The report findings described “significant levels of toxic heavy metals” based on internal documents and test results submitted by baby food companies.  Lawsuits quickly followed, including many actions against Gerber Products Co., that allege Gerber falsely and deceptively failed to disclose the presence of unsafe levels of heavy metals in their baby foods.
  • Gerber argues in a recent motion to dismiss  that the primary jurisdiction doctrine should control. For background, the primary jurisdiction doctrine is a judicial doctrine used when courts and an agency have concurrent jurisdiction, but the court favors administrative discretion and expertise in deciding the issue.   In this case, Gerber argues that the Food and Drug Administration (FDA) is in a better position to decide “acceptable levels of heavy metals in baby foods” because of the need for expertise in issues of infant nutrition.
  • Gerber further alleges that Plaintiff’s claims are preempted by the Food, Drug, and Cosmetic Act (FDCA). Gerber argues that Plaintiff’s demand for mandatory disclosures on packaging is preempted by FDA because it is the Agency’s role to establish national policy on food safety and labeling.  Finally, Gerber says the Plaintiffs fail to plead deception, pointing to a lack of misleading statements on their packaging and no legal requirement to disclose heavy metals on a product label.
  • Keller and Heckman will continue to monitor and report on this litigation and any responsive regulatory actions or developments.

Article By Food and Drug Law Practice Group at Keller and Heckman LLP

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© 2022 Keller and Heckman LLP

Heavy Metals In Baby Food Pose Concern For Baby Food Industry

On February 4, 2021, the U.S. House of Representative’s Committee On Oversight and Reform (Subcommittee on Economic and Consumer Policy) issued a report entitled “Baby Foods Are Tainted With Dangerous Levels of Arsenic, Lead, Cadmium and Mercury“, which sent ripples of concern through the consumer ranks and the baby food industry. Heavy metals in baby food has received attention before, but never before in such a significant way from a House Subcommittee report like the one published this month. The findings and the proposed changes to regulations for the baby food industry that the subcommittee put forth will have significant compliance impacts on companies, as well as open certain baby food companies up to litigation risks that cannot be ignored.

Findings In the House Report

On November 6, 2019, the House Subcommittee requested internal documents from seven of the largest manufacturers of baby food in the United States, which included companies making both organic and conventional products. The request was prompted by reports that alleged that there are high levels of heavy metals in baby foods, specifically arsenic, lead, cadmium and mercury. The Food and Drug Administration (FDA) and World Health Organization (WHO) have both found these heavy metals to be dangerous to human health, especially infants and children. Four of the baby food manufacturers complied with the House Subcommittee’s request.

From the documents obtained from the four companies, the House Subcommittee concluded that there was evidence that “commercial baby foods are tainted with significant levels of toxic heavy metals,
including arsenic, lead, cadmium, and mercury.” The report said that internal company standards “permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.”

The FDA currently has maximum allowable limits for the heavy metals at issue in certain circumstances, including 10 parts per billion (ppb) of arsenic, 5 ppb of lead, and 5 ppb of cadmium in bottled water. The Environmental Protection Agency has also set the permissible level of mercury in drinking water at 2 ppb. However, the House Subcommittee concluded that  “the test results of baby foods and their ingredients
eclipse those levels: including results up to 91 times the arsenic level, up to 177 times the
lead level, up to 69 times the cadmium level, and up to 5 times the mercury level.”

The FDA indicated that it is reviewing the House Subcommittee’s report. It also noted that the heavy metals at issue in the report are present naturally in the environment and can enter baby food through the soil, water or air.

Recommendations From the House Report

As a result of its findings, the House Subcommittee outlined five recommendations:

(1) Mandatory testing – this would require baby food manufacturers to test finished products (not just ingredients) for heavy metals. The House Subcommittee urged the FDA to set this requirement;

(2) Labeling – the Subcommittee proposed that the FDA require baby food manufacturers to list all heavy metals in the finished product on labelling so that consumers are aware of the elements’ prsence;

(3) Phase Out – the House Subcommittee urged manufacturers to voluntarily phase out heavy metals from products entirely, or at least phase out products that have high amounts of ingredients that test high in heavy metals;

(4) FDA Standards – the Subcommittee urged the FDA to set limits for permitted heavy metals in baby foods; and

(5) Parental Vigilance – the report urges parents to avoid baby foods that contain ingredients that test high in heavy metals. The Subcommittee indicated that implementing recommendations 1 through 4 would inform parents to make determinations soundly.

Immediate Litigation Impact

The day after the House Subcommittee’s report was published, three major baby food companies were sued for selling products with elevated levels of certain heavy metals. One such lawsuit was filed in New Jersey, while the other was filed in California. While the class actions lawsuits present several legal theories for liability, the one that may have some weight with courts is the simple allegation that the products were unsafe for consumption by the very class (infants and babies) for which the products were made.

Baby food has been on California’s Proposition 65 target list for quite some time, and many companies that manufacture or sell baby food products in California have been receiving customer and retailer inquiries regarding heavy metals in baby food products. Companies have also begun testing baby food products to ensure compliance with Prop 65 regulations. Ensuring proper responses to consumer and retailer inquiries, compliance auditing of ingredients and end products, and developing risk management plans are key for any company right now in the baby food industry, especially with the potential for future FDA regulations.

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ARTICLE BY John Gardella of CMBG3 Law
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