BlogFood Safety Bill Needed To Protect Kids From Heavy Metals: Law360 Column

March 12, 20240

On Jan. 26, the Centers for Disease Control and Prevention announced that 404 children in 43 states may have been exposed to lead poisoning through their consumption of cinnamon applesauce.[1]

The applesauce, marketed under the brands WanaBana, Schnucks and Weis, was recalled in November 2023, but the damage had already been done.[2] Investigation of the manufacturing process revealed that the products were not tested for heavy metals at the plant.

An inspection of the Austrofood facility in Ecuador found “numerous rough edges, chipped, and pitted areas” on a stainless steel conveyor belt, with metal pieces breaking off and ending up in the final product.[3] It’s every parent’s worst nightmare — and it should never have happened.

Almost three years ago — on March 25, 2021 — Sens. Amy Klobuchar, D-Minn., and Tammy Duckworth, D.-Ill., introduced S. 1019, the Baby Food Safety Act.[4] They were joined by several other members of Congress who proclaimed themselves tired of waiting for the U.S. Food and Drug Administration to set limits on lead and other heavy metals that are endemic in baby food.

To great national fanfare, these lawmakers pledged to enact the Baby Food Safety Act, and to quickly set limits on the amount of lead, arsenic, cadmium and mercury in the foods that babies and young children regularly consume.

Theirs was an important mission. Lead has been shown to cause serious harm to both brains and nervous systems. Even low levels can cause learning and behavior problems in young children, as well as serious problems with their hearing and speech.[5]

More importantly, lead and other toxic elements have been shown to significantly slow growth and development in infants and children. On top of this, children absorb the lead they ingest at a rate that is four to five times greater than the rate for adults. And nearly 80% of brain development occurs within the first 1,000 days of life.[6]

Babies who are fed baby food containing lead, cadmium, arsenic or mercury are thus being compromised at the earliest, most vulnerable stage of their lives. And there is no way to undo the damage once it occurs.

Unacceptable levels of toxic elements have been found in a roster of foods from well-known brands, including Gerber Products Co., Beech-Nut Nutrition Co. and Hain Celestial Group Inc.’s Earth’s Best Organic.[7] These companies rely on suppliers located in developing countries with high water and air pollution, which makes its way into baby foods such as rice cereal, juice and purees.

While baby food producers might credibly argue that completely eliminating lead — even from baby food products — is impossible, it is not only possible but vitally necessary to limit the amount of toxic substances in all of these food products.

Over the past few years, the FDA has actually set limits for certain heavy metals in specific foods, including inorganic arsenic in infant rice cereals. But the agency missed its April 2022 target for setting lead limits in all kinds of processed baby food — and even if it had met its deadline, the limit it established would not have been enforced until 2025.

In January 2023, the FDA issued draft guidance under its “Closer To Zero” effort, suggesting allowable limits of up to 10 parts per billion of lead for processed baby foods including fruits, nonroot vegetables, yogurts, puddings and single-ingredient meats.[8] For root vegetables, the proposed level was set at 20 ppb.

Any potential enforcement of the FDA’s limits, however, remains years away. Think of what’s at stake: Some 3.8 million children are born in the U.S. every year, and all of them risk being exposed to toxic substances as soon as they switch to solid foods.
Consider a baby’s fussy eating habits, which may include preferring one food over all others for days. Then take into account certain manufacturers’ subscription programs, which automatically send busy new parents multiple days’ worth of that favorite food. It is not hard to see how an otherwise healthy baby can be dosed with high levels of lead every day for much of their first year of life.

The Baby Food Safety Act would impose limits almost immediately. And those limits would be lower than those the FDA pitched, with lead levels set at 5 ppb. The act would both set limits and create a mechanism for testing and enforcing those limits.
The act would amend Section 418(c) of the Federal Food, Drug, and Cosmetic Act to require manufacturers to minimize or prevent “the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means, including representative testing by manufacturers of infant and toddler foods that are finished products.”

The act would also amend Section 104(b) of the FDA Food Safety Modernization Act to add “neurological impairment” to the definition of “serious illness” whose risk is to be avoided. Lawmakers appreciated the urgency of the matter in 2021, and pledged to enact the legislation quickly. But almost three years later, hundreds of young children were exposed to lead poisoning.

Their parents, who probably thought they were giving their children healthy snacks, unknowingly and inadvertently sickened them with applesauce that increased their lead levels by more than eight times the amount of lead found in the blood of most American children.[9]

How is this possible? Look no further than the deadlock that pervades today’s Congress. Only three days after announcing the creation of a new federal law that would finally protect vulnerable children from consuming toxic heavy metals, the Baby Food Safety Act was bundled off into a subcommittee, and has not been heard of since.[10]

Now, those same politicians whose inability or unwillingness to champion the 2021 bill into law are making the same promises, vowing to reintroduce the Baby Food Safety Act in Congress. Seeing it through remains another matter. This time the bill’s sponsors need to do whatever it takes to persuade both sides of the aisle that baby food manufacturers need more oversight to ensure they do what’s best for children’s health.

The task is simple: Set the lowest limits possible for lead and other heavy metals, and arm the FDA with the financial resources needed to enforce those limits. When testing shows that a single jar, tub or portion of a product given to a child contains more lead than is allowed for adult consumption in a day, it is well past time to make changes.
The limits set forth in the 2021 legislation were as follows:

• Inorganic arsenic at 10 ppb for infant and toddler food except cereal, and 15 ppb for infant and toddler food that is cereal;
• Cadmium at 5 ppb for infant and toddler food except cereal, and 10 ppb for infant and toddler food that is cereal;
• Lead at 5 ppb for infant and toddler food except cereal, and 10 ppb for infant and toddler food that is cereal; and
• Mercury at 2 ppb.

These limits are still too high, but they are, at least, a start. If lawmakers really want to take meaningful action, they should enact a rewritten Baby Food Safety Act that sets a maximum lead level of 3 ppb in any baby food sold in the U.S. And all new legislation regarding tainted baby food should include sufficient funding to allow the FDA to enforce these standards with random testing.

Until then, consider the tainted baby food train a slow-moving catastrophe. It could take years for parents or doctors to realize that a child has developmental problems. By then, the baby food the child consumed will be a thing of the distant past.
Such outcomes are tragic but avoidable. If lawmakers fail to act, they will have only themselves to blame.


Vineet Dubey is a co-founding partner of Custodio & Dubey LLP.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of their employer, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.