Baby being spoon-fed in highchair

Baum Hedlund Public Comment to FDA on Heavy Metals in Baby Foods

Baum Hedlund Aristei & Goldman attorney Pedram Esfandiary submitted a public comment to the U.S. Food and Drug Administration (FDA) this week concerning the agency’s “Closer to Zero” action plan for heavy metals in baby foods.

Esfandiary and his firm represent hundreds of children diagnosed with autism spectrum disorder (ASD) and attention-deficit/hyperactivity-disorder (ADHD) after being exposed to heavy metals – specifically lead, mercury, arsenic and cadmium – in baby food products from the following manufacturers:

If your child consumed baby foods from the brands listed above and developed ASD or ADHD, you may be eligible to pursue a baby food lawsuit. Contact us today at (855) 948-5098 or fill out our case evaluation form to see if you qualify.

In February of 2021, a U.S. government report found baby foods from the companies listed above are “tainted with dangerous levels of arsenic, lead, cadmium, and mercury.” Chillingly, the baby food report further noted that the companies “knowingly sell these products to unsuspecting parents, in spite of internal company standards and test results, and without any warning labeling whatsoever.”

In response to the report and subsequent outcry, FDA initiated an action plan called “Closer to Zero” aimed at reducing children’s exposure to arsenic, lead, cadmium, and mercury to levels that are “as low as possible.” In November, the agency held a meeting with stakeholders to discuss the scope of the Closer to Zero plan as it relates to the impacts of heavy metals exposure and nutrition at different crucial developmental stages of children’s growth and development. FDA also initiated a public comment period where people can offer “real world” concerns, suggestions, and other discourse on the impact and effects of the plan.

FDA Public Comment on Heavy Metals in Baby Foods

Baum Hedlund Aristei & Goldman attorney Pedram Esfandiary submitted the following public comment to FDA concerning the “Closer to Zero” action plan and the issue of heavy metals in baby foods:

December 20, 2021

Re: Public Comment in Connection with the FDA “Closer to Zero” Program

Dear Madam/Sir,

We are attorneys who represent hundreds of children suffering from neurodevelopmental disorders as a result of being exposed to toxic heavy metals – specifically lead, mercury, arsenic and cadmium – in baby foods sold by a slew of U.S. manufacturers of such products.

As the Agency is aware, these metals have no business existing in food products (much less at the exorbitant levels identified in the documents recently submitted by baby food manufacturers to Congress) consumed by our most vulnerable population at critical stages of growth and development. Accordingly, while we applaud the Agency for initiating the “Closer to Zero” action plan in an effort to reduce children’s exposure to metals from food consumption to levels that are “as low as possible”, it is imperative that the Agency endeavor to eliminate the presence of such poisons in infants’ foods.

Contrary to the Agency’s implications, and the assertions of industry, it is possible to eliminate metals from baby foods, as explicitly demonstrated by the fact that many manufacturers produce baby food products untainted by heavy metals. Moreover, we respectfully disagree with the Agency’s characterization that children are not currently being exposed to levels of heavy metals anticipated to pose any risks to their health. This is simply at odds with science or sound public health policy, as most recently illustrated by the comments of eminent experts from a variety of disciplines during the Agency’s November 18 public meeting, and available data by baby food manufacturers regarding the alarming levels of heavy metals in their foods. If the Closer to Zero initiative is to stand a chance of meeting its stated objectives and purpose, the Agency must urgently recognize the ongoing threat to children’s health from heavy metals in baby foods that they consume on a daily basis.

No regulatory, research agency, or professional organization currently recognizes a “safe” level of exposure to children from the heavy metals lead, mercury, arsenic and cadmium. Indeed, the state of the available science clearly demonstrates that all four metals pose a veritable smorgasbord of adverse health effects at exceedingly low levels, particularly when ingested. For example, lead is a potent neurotoxin, capable of causing “[d]ecreased cognitive function including full scale IQ (FSIQ)”; “[a]ltered mood and behaviors that may contribute to learning deficits, including attention deficits, hyperactivity, autistic behaviors, conduct disorders, and delinquency”; and “[a]ltered neuromotor and neurosensory function, including gross and fine motor skills, visual-motor integration, and hearing threshold” at levels as low as “<10 μg/dL”. ATSDR, Toxicological Profile for Lead (2020) at 133-134 (emphasis added). Similarly, “chronic oral exposure of humans to inorganic arsenic at doses of 0.05–0.1 mg/kg/day is frequently associated with neurological…or hematological signs of arsenic toxicity[.]” ATSDR, Toxicological Profile for Arsenic (2007) at 44. Furthermore, the low oral reference doses for these metals further underscore that exposure to amounts anywhere near the levels that manufacturers have admitted to Congress is present in their foods poses a devastating public health crisis.*

A variety of observational human studies conducted in numerous child cohorts around the U.S. and throughout the world have time and again confirmed that low exposures to these non-essential metals are consistently associated with a variety of adverse health effects. We urge the Agency to carefully consider the findings and implications of this body of data, particularly the work spearheaded by Dr. Margaret Karagas, Dr. Xiaobin Wang, and Dr. Katarzyna Kordas, all of whom served as panelists during the Agency’s November 18 public hearing.

The Agency has an opportunity, and a wealth of data and resources at its disposal, to protect the health of future generations from the disastrous effects of heavy metals. Although such metals are present in our environment – primarily at ambient levels – children’s nutrition represents the most direct and chronic route of exposure, entailing disastrous results. The well-being of future generations should not be predicated on the levels that industry deems economically acceptable to achieve for the foods that companies manufacture. The Agency’s goal must be the eradication of such metals from baby foods. However, even if the Agency is to ensure that metal levels in foods are “as low as possible”, that goal can only be met if the Agency acknowledges the very real risk to the health of children posed by these metals today. Please do not hesitate to contact us should we be of further assistance with this matter.

Sincerely, BAUM HEDLUND, ARISTEI, & GOLDMAN, P.C.

Pedram Esfandiary, Esq.

10940 Wilshire Blvd., Ste. 1600 Los Angeles, CA 90024

Telephone: (855) 948-5098

Facsimile: (310) 820-7444

*As an example, for inorganic arsenic, the RfD is 0.0003 milligram per kilogram of body weight per day. ATSDR, Toxicological Profile for Arsenic (2007) at 30. The RfD for methylmercury (form of organic mercury found in food) is 0.0001 mg/kg/day based on developmental neurologic abnormalities in infants. See EPA, Integrated Risk Information System (IRIS) for Mercury (1997).

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