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FDA Action Plan Seeks To Address Concerns Over Toxic Metals In Baby Food

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Amid growing concerns over the health risks of toxic metals in baby food products sold by several major manufacturers in recent years, federal health regulators have developed an action plan, which will start by evaluating and setting limits for the amounts of arsenic and lead acceptable in baby food.

The FDA issued a press release on April 8, announcing a new action plan called “Closer to Zero”, which seeks to address concerns over the levels of arsenic, cadmium, lead and mercury in baby food. However, the agency cautions it does not believe it is feasible to eliminate toxic metals from baby food products entirely.

In February, a report by the U.S. House Oversight Committee ignited a firestorm of concerns over the various heavy metals found in baby foods, including arsenic, cadmium, lead and mercury. Exposure to these heavy metals by infants has been linked to a risk of autism, ADHD and other developmental disorders, placing this vulnerable population of Americans at a serious risk, according to the report.

House staffers conducted the review using data turned over by Beech-Nut, Gerber, Hain and Nurture, Inc. about the levels of toxic heavy metals present in their baby food products and the ingredients used to create them.

On March 5, the FDA announced it was investigating new initiatives aimed at reducing the presence of the metals in baby food products. The new action plan is the culmination of those efforts.

“We recognize that Americans want zero toxic elements in the foods eaten by their babies and young children. In reality, because these elements occur in our air, water and soil, there are limits to how low these levels can be,” the FDA said in its latest announcement. “The FDA’s goal, therefore, is to reduce the levels of arsenic, lead, cadmium and mercury in these foods to the greatest extent possible.”

The agency said it must also be mindful of the impact of new regulations on the supply of these products, to ensure there is enough nutritious food for the nation’s children.

The plan will occur in stages, the first of which is evaluating the scientific basis for action levels. That will involve collecting and interpreting the existing science to determine what levels are both safe and achievable. After evaluating the science, the FDA will propose recommended limits, or action levels, for arsenic, cadmium, lead and mercury. The agency will then consult with stakeholders, such as manufacturers and consumer protection groups, on those proposed action levels before finalizing them.

The first two substances to be targeted by the action plan will be arsenic and lead, because the FDA has the most existing science on their potential health effects.

The FDA hopes to propose action levels for lead within the next year.

In the meantime, the agency said its own testing has shown children are not at an immediate health risk from the exposure levels which have been found in baby food products by recent investigations.

Toxic Metal Baby Food Lawsuits

Since the congressional subcommittee report was released in February, manufacturers have faced a growing number of baby food lawsuits filed in federal courts nationwide.

Given common questions of fact and law raised in lawsuits pending throughout the federal court system, a group of plaintiffs filed a motion to centralize the baby food cases earlier this month, asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the cases before one judge in the Eastern District of New York, where the majority of cases are currently pending.

Such consolidation is common in complex product liability litigation, where a large number of product liability lawsuits have been filed over similar injuries caused by the same products. Centralizing the cases before one judge is intended to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings from different courts and serve the convenience of common witnesses, parties and the judicial system.

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