FDA’s Regulation of Toxic Metals in Baby Food Would Take Years to Implement

In 2019 an independent study uncovered extensive heavy metal contamination in baby food products. Specifically, 95% of the 168 tested products showed traces of toxic contaminants.

This prompted an investigation led by the Subcommittee on Economic and Consumer Policy.

The Subcommittee’s report, released on February 4, 2021, revealed shockingly high amounts of inorganic arsenic, lead, cadmium, and mercury in baby foods from major US manufacturers. These metals are known for their pernicious effects on human health and are categorized as dangerous substances. 

Legacy Brands Sold Heavy Metal Laced Products    

The Subcommittee’s investigation focused on several US baby food companies, requesting information on testing results and safety standards for heavy metals. Beech-Nut, Nurture, Geber, and Hain Celestial provided the necessary data, but Walmart, Sprout Foods, and Plum Organics (owned by Campbell) didn’t disclose any information.

After reviewing the data provided by responsive manufacturers, the investigation found disturbingly high amounts of toxic heavy metals in both ingredients and finished products.

Compared to applicable FDA standards for bottled water, cadmium was 69 times higher, arsenic levels were 91 times increased, and lead concentrations were 177 times more elevated. Mercury levels exceeded the EPA’s standards for drinking water by a factor of 5. 

The subpar testing and safety standards employed by manufacturers allowed the contamination to proliferate. Most manufacturers rarely tested for mercury, some would bypass finished product evaluation and only analyzed ingredients for heavy metals, unsafe additives were utilized, and products containing increased heavy metal counts were sold to the public. 

Consuming tainted baby food represents a serious risk of toxic exposure for vulnerable infants who cannot adequately filter harmful heavy metals. As arsenic, cadmium, mercury, and lead from baby food gradually accumulate, they act as neurotoxins impacting the nervous system and brain.

Over time, they produce irreparable and often permanent neurologic damage that has been associated with disabilities like ADHD and autism. 

FDA’s Measures Lack Urgency and Focus

In response to the congressional report’s findings, the FDA launched its “Closer to Zero” action plan to reduce harmful metal contaminants in baby food products. The strategy follows a four-step approach to establish and implement actionable safety levels until 2024 and beyond. 

While the plan has been praised for addressing a significant public health concern, it has also been criticized for its ineffective, if not disregardful, outlook. Allowing harmful contaminants in baby food for another two years or more until adequate safety levels are finally mandated is hardly justifiable. 

Considering that appropriate safety levels for the heavy metals in question have already been established by dependable sources, the Closer to Zero plan can bypass the first two steps it has proposed.

Focusing on the final two stages would save valuable time and enable setting actionable levels earlier than the FDA’s current timeline. 

The FDA currently regulates only one toxic metal in baby foods, namely inorganic arsenic in infant rice cereal products at a disputed 100 ppb, a niche market segment that doesn’t comprehensively address the scale of contamination.

Limited institutional regulations permit manufacturers to voluntarily set their own standards and avoid inexpensive testing that would require additional capital expenditure, seemingly prioritizing profits over ethics. 

The Baby Food Safety Act Could Bring a Faster Resolution

In March 2021, Raja Krishnamoorthi proposed a bill that would bring immediate change to infant nutrition security. The Baby Food Safety Act of 2021 would enforce a drastic reduction of toxic metal contaminants, setting initial safety levels that are subject to further regulatory reviews. 

Arsenic would be limited to 10 ppb, cadmium and lead would be capped at 5 ppb, and mercury would be restricted to 2 ppb. Moreover, the FDA would perform regular inspections to ensure compliance with the new standards. Manufacturers will be required to publish testing results twice a year and phase out harmful ingredients. 

Despite overwhelming public support, the bill has been pending in the Senate since its submission. The lack of progress drew a strong reaction from a coalition of 23 Attorney Generals, including California’s Rob Bonta, who petitioned the FDA to set interim safety levels by 2022 as suggested by the bill. 

Ruling in LA Lawsuit May Establish a Precedent

Baby food manufacturers hold a privileged position in the public’s trust and are ethically compelled to provide quality products that don’t endanger vulnerable consumers.

Parents that purchased tainted products were understandably scandalized after the Subcommittee’s report revealed the high amounts of toxic metal contaminants. 

The industry’s lack of reaction and the FDA’s slow progress in adopting efficient measures determined many parents to seek legal action. The charges that manufacturers face range from fraud to negligence; however, one case filed in LA could establish a groundbreaking precedent in baby food litigation. 

In September 2021, the parents of a child diagnosed with ADHD and autism after consuming tainted products from the companies named in the Subcommittee’s report filed a personal injury lawsuit against the liable manufacturers. For the case to go to trial, Judge Amy D. Hogue moved for a Sargon hearing to establish the scientific validity of the claims.

After reviewing experts’ testimonies from both sides, Judge Hogue determined that the plaintiff’s representatives used sound logic and valid scientific proof to argue that dietary exposure to heavy metals can lead to ADHD and autism.

Consequently, the case will move to the discovery phase, where the plaintiffs can request internal documents from the defendants to support their claims. 

This is the first time that a lawsuit targeting the heavy metal content of baby food proceeds to trial in the US, with massive implications for similar cases depending on the outcome.

More importantly, Judge Hogue’s ruling in support of a potential causal link between toxic metals and autism/ADHD could pave the way to more lawsuits that may determine manufacturers to reduce contaminant levels voluntarily before the FDA enforces safety limits.

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