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Administrative/Regulatory,
Health Care & Hospital Law

Oct. 11, 2021

The US FDA must lead by example on lead exposure

Last week, the Congressional Subcommittee on Economic and Consumer Policy issued a scathing report.

Vineet Dubey

Cofounder, Custodio & Dubey LLP

445 South Figueroa Street Suite 2520
Los Angeles , CA 90071

Phone: (213) 593-9095

Email: dubey@cd-lawyers.com

UCLA SOL; Los Angeles CA

Rep. Raja Krishnamoorthi on Capitol Hill. (New York Times News Service)

"It was good enough for my generation." "Kids today are being coddled!" "Regulations gone wild!"

The critiques of California's Proposition 65 are similar to the arguments you'd hear from opponents of the removal of asbestos from building material, the removal of lead from paint, and the introduction of the modern football helmet.

Just as these positions seem rightfully absurd today, I suspect history will regard them in the same category as skeptics of the California law, requiring businesses to either remove chemicals like lead and arsenic or to provide warnings about significant exposure to the chemicals.

And the future may not be far off, if a scathing report from the Congressional Subcommittee on Economic and Consumer Policy last week is any indication. The report condemned baby food makers like Gerber and Beech-Nut for their failure to recall products containing levels of arsenic exceeding the FDA's established standard of 100 parts per billion, an already dangerously high standard that the FDA is now lowering.

"Beech-Nut only recalled two of its six products that tested over the limit. Gerber was even worse," wrote Rep. Raja Krishnamoorthi (D-IL), the subcommittee's chairman, in a statement summarizing the report's findings. "It had two products test over the 100 PPB limit and took no action to tell the public or get them off the shelves."

The report lists a number of baby food brands and varieties that according to tests conducted in 2021 contained toxic levels of carcinogenic metals like lead and arsenic, and dozens more testing between 80 and 100 PPB. By comparison, the maximum level of inorganic arsenic the FDA allows for bottled water is 10 PPB.

It's natural to wonder whether our foods -- even our baby foods -- have always contained these levels of dangerous toxic metals, and modern testing has simply made us more aware of it. It's among the most common criticisms I've seen as a consumer protection lawyer who has brought litigation under Prop. 65.

It's true testing has become more prevalent since the days when I and most of the readers of this piece grew up, but it's indisputable that the problem has gotten much, much worse, largely thanks to soil polluted by irrigated groundwaters and contamination from popular pesticides. Foods like rice, sweet potatoes, and carrots that are grown in soil often test exceptionally high for toxic metals such as lead and arsenic, and while several baby food makers have attributed these results to "naturally occurring" heavy metals in the soil, studies like the one conducted earlier this year by Portland's Center for Biological Diversity show time and again the strong link between pesticides used over the last century and the enormous degradation in soil quality.

The peer-reviewed medical journal JAMA Pediatrics released a study last month on detectable and elevated blood lead levels in U.S. children, finding that of the 1.14 million children (younger than 6 years old) tested, more than half had detectable blood lead levels. Worse, the study found the problem is particularly prevalent in children coming from low-income families -- 95% of children residing in zip codes with predominantly black populations had detectable blood lead levels.

The study notes a strong correlation between elevated blood lead levels and pre-1950 housing, showing that even in areas where we think we've "solved" the lead exposure problem by removing lead from paint, we've made pitiful amounts of progress.

And when it comes to lead, arsenic and other toxic metals in our baby foods, the FDA hasn't lifted a finger. Despite acknowledging that children exposed to high levels of lead can suffer significant neurological effects including learning disabilities, behavior difficulties and lowered IQ, the FDA hasn't set federal standards for lead in baby food, even as legislators like Krishnamoorthi demand it. Its proposed solution to this crisis has been to ask these baby food makers (who have already proven themselves bad actors) to voluntarily submit themselves to what's essentially an honor system as part of its "Closer to Zero" program. If you'd like to know how

If you'd like to see how allowing an industry to self-regulate itself tends to work out, look no further than the 2008 financial crisis.

The four-phase program remains in phase one, the "data gathering" stage, and according to the FDAs own timetable most protections would be implemented, at the earliest, in April 2024. Small comfort for parents with infant children today.

Krishnamoorthi, who is seeking legislation that would force the FDA to set strict limits for toxic metals in baby food within a year, concluded the aforementioned subcommittee report by calling on the FDA to accelerate its timeline for action.

I hope they listen, but in the meantime, litigation brought under Prop. 65 remains the only meaningful way of holding these baby food makers accountable to California consumers. Gerber isn't going to do the right thing and pull these products if they think it's going to impact their bottom line, and if they think they can keep getting away with it. It's only going to do it if the costs of failing to act outweigh the costs of acting.

Lead poisoning was an enormous problem back in the days of Ancient Rome, with some historians even crediting it as a primary cause of the empire's downfall. It's a common misconception that the greatest minds of the era were ignorant to it; the author-engineer Vitruvius proved, it was understood even then that water "conveyed in lead must be injurious," while water provided through earthen pipes was preferred among the elite as purer and tastier.

"That itself cannot be a wholesome body, concluded Vitruvius," who died in 15 BC, "water should therefore on no account be conducted in leaden pipes if we are desirous that it should be wholesome."

Unfortunately for Vitruvius, lead was a cheap and abundant sweetener, the Stevia of its time, and the costs of replacing those lead pipes were likely time consuming and cost prohibitive. Over 2,000 years later we're facing the same problems, which clearly aren't going away on their own. It's past time we act and for the sake of our kids and their future, Congress must immediately pass the Baby Food Safety Act. 

#364592


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