April 19, 2021

Volume XI, Number 109


April 16, 2021

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Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers

Are baby foods subject to stricter standards that adult foods?  The short answer is, not really.  The U.S. Food and Drug Administration (FDA) has specific guidelines for baby formulas, labeling requirements for baby and toddler foods, and maximum allowable levels of arsenic in baby rice cereal.  These requirements are not unlike requirements for other foods, but should baby food requirements be stricter than those for adult foods?  Recently, baby foods have come under scrutiny following reports of allegedly high levels of heavy metals in baby food.  This led to a Congressional investigation.

On February 4, 2021, the Chairman of the Subcommittee on Economic and Consumer Policy of the House Committee on Oversight and Reform released a staff report entitled “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury” (“Staff Report”).  The Staff Report recommended additional testing and FDA regulations.  The FDA responded to the Staff Report,

While the report . . . raises important questions on what more can be done to reduce toxic elements in baby foods, the FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study. Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.

The FDA further responded,

Firms and individuals who manufacture or sell food have a legal responsibility under the Federal Food, Drug, and Cosmetic Act to ensure the safety of their products. The FDA reviews information and takes action on a case-by-case basis. If the FDA finds that a product violates the law, the agency takes steps to stop the product from being imported, takes court action to stop its sale or recalls it if it is in the domestic market.

The Staff Report noted the “Subcommittee’s investigation has found that baby food manufacturers are selling baby food with higher levels of lead than what is allowed by existing standards for water, juice, and candy.”  Specifically, “the Food and Drug Administration has set the maximum allowable levels in bottled water at 10 ppb inorganic arsenic, 5 ppb lead, and 5 ppb cadmium, and the Environmental Protection Agency has capped the allowable level of mercury in drinking water at 2 ppb.”  

Not surprisingly, class action lawsuits followed.  The lawsuits noted the concerns about heavy metals and toxins in baby food and alleged false advertising and violations of state consumer protection statutes.1

But, since there are no current FDA guidelines on acceptable levels of the concerning substances (except for arsenic in rice cereal), what legal standard will be used to determine liability for baby food manufacturers?  One possible answer is internal standards set by the baby food manufacturers themselves.  The Staff Report noted that some of the baby food manufacturers sold products with parts per billion of heavy metals, etc., well over the manufacturers’ internal standards.  If a manufacturer sets an internal standard and does not meet it, could that be a basis for legal liability?  This would seem to reward manufacturers who set no standards and punish those who did.  It may also encourage manufacturers to set limits higher than what is appropriate.  Further, if manufacturers were to set the standards, how would consumers know that the standards were the correct ones that will protect a baby’s health?

The Staff Report recommended that the FDA set maximum levels of inorganic arsenic, lead, cadmium and mercury for baby foods designed to protect children from adverse neurological impacts.  The Staff Report also recommended:

  • Mandatory testing of finished baby foods (and not just the individual ingredients in the baby food)

  • Voluntary phasing out of ingredients that are high in heavy metals

  • FDA labeling requirements to report heavy metal levels on baby food labels

However, until the FDA acts and creates heavy metal levels, testing and labeling requirements, what happens to manufacturers now facing lawsuits?  It seems inevitable that manufacturers are going to be held to different standards in different jurisdictions based upon the scientific literature present by plaintiffs’ attorneys in individual cases.  One jury might determine there is liability while another may not when looking at the same parts per billion for each of the heavy metals in question.  Until the FDA sets national standards, manufacturers need to consider whether to set their own standards, how to scientifically defend any standards they may set, and how and when to test their products.  

1 Shepard et al v. Gerber Products Company, Case No. 2:21-cv-01977, USDC for the District of New Jersey; Laurie Thomas et al v. Beech-Nut Nutrition Co., Case No. 1:21cv00133, USDC for the Northern District of New York; Gulkarov et al. v. Plum, Case No. 3:21-cv-00913, USDC for the Northern District of California; Laura Peek v. Beech-Nut Nutrition Company, Case No. 1:21-cv-00167-TJM-ML, USDC for the Northern District of New York.

Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume XI, Number 63



About this Author

Jonathon A. Fligg Product Liability Attorney Womble Bond Dickinson Atlanta, GA

Jon Fligg defends companies against high-stakes product liability claims. He works closely with clients in all phases of litigation from the initial planning of the defense of the case through discovery, trial and necessary appeals. For more than 20 years, Jon has represented clients in multiple industries and primarily represents tobacco manufacturers in product liability cases across the country. He has been on more than a dozen trial teams, including at counsel’s table, and has worked with numerous experts of different specialties supporting dozens of other trial teams.

Jon is a...


Christine is an experienced product liability litigation and regulatory compliance attorney with more than 20 years of experience defending manufacturers and laboratories in complex cases in which medical and scientific facts were at issue. She focuses her practice on food and beverage regulation and litigation, as well as smoking and health litigation.

In her practice defending food product manufacturers, Christine relies on her first-hand experience as a small business owner of a company that makes snacks inspired by the dietary restrictions...