In letters to Gerber/Nestlé, Beech-Nut, Nurture Inc (HappyBaby) and Hain Celestial (Earth’s Best), Attorney General James asks for information on communications with the FDA, practices, policies, and standards regarding testing for inorganic arsenic in infant rice cereal products and ingredients sold in New York, coupled with advertising materials “to assess their compliance with New York’s consumer protection laws.”
The letters add that James' office has reason to believe the firms have distributed products "that may be adulterated within the meaning of New York State Agriculture & Markets Law §§ 199-a, 200(1) and 202, because of the amount of inorganic arsenic" and that their ads and other promotional materials "may have violated New York General Business Law §§ 349 and 350."
According to a press release, James will “examine whether the infant rice cereal products that are sold in New York contain arsenic at levels exceeding the legal maximum under the law.”
Her office did not clarify what this means given that FDA guidance issued in August 2020 which recommends action levels of 100ppb for inorganic arsenic in infant rice cereal – like all FDA guidance documents - is not legally binding.
Attorney: 'This really doesn't make sense'
As for the state laws referenced by AG James, Section 202 of New York State Agriculture & Markets Law states: "When [a 'poisonous or deleterious'] substance cannot be so avoided, the commissioner shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for protection of public health." Section 200, meanwhile, says products may be considered adulterated if they contain poisonous or deleterious substances that may be "injurious to health."
However, her office did not point to any regulations that have been set to date on inorganic arsenic in baby foods, or state on what basis it might determine if such products are injurious to health.
Bob Durkin, formerly deputy director at the office of dietary supplement programs at the FDA, and now of counsel at Arnall Golden Gregory, told FoodNavigator-USA he was confused by the reference in the AG's press release to "exceeding the legal maximum under the law."
"This really doesn't make sense. What did they determine is the ‘legal maximum allowed by law’ for a toxin that was not added? Just because you have an amount of arsenic or an amount of a toxin, doesn't mean it's adulterated. I'm not sure where they're going with this."
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities
According to the FDA guidance, “Though not binding, the action level for inorganic arsenic in infant rice cereals is intended to encourage manufacturers to reduce levels of inorganic arsenic in their products, thus reducing the possible risk for infants fed rice cereal.”
But it added: “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities."
69 lawsuits ... and counting
According to the Feb 4 Congressional Subcommittee report, several of the firms' ingredients and/or final products exceeded 100ppb for inorganic arsenic.
"Over 25% of the products Nurture tested before sale contained over 100 ppb inorganic arsenic," while "Hain (Earth’s Best Organic) sold finished baby food products containing as much as 129 ppb inorganic arsenic; Beech-Nut used ingredients after they tested as high as 913.4 ppb arsenic;" and "Gerber used high-arsenic ingredients, using 67 batches of rice flour that had tested over 90 ppb inorganic arsenic."
At least 69 consumer lawsuits have now been filed against firms named in the report, prompting a legal wrangle over how best to handle the cases.
Given that all of the companies named in the report have been sued, with plaintiff's attorneys citing data provided by the companies themselves, it's not clear whether it's in their best interests to respond to further requests for information unless they are legally obligated, said Durkin at Arnall Golden Gregory.
"Essentially the firms that responded have had their names dragged through the mud by Congress. And there may not be a basis for it."
Nurture Inc: Will fully co-operate; Gerber: Industry-leading safety and quality standards
Nurture Inc told FoodNavigator-USA that it "welcome [s] additional guidelines from the FDA, and intend[s] to fully cooperate with the Attorney General’s request for information," while Gerber said that it has "set safety and quality standards that are industry-leading and among the strictest in not just the U.S., but the world."
It added: "Gerber takes many steps to reduce the levels of heavy metals in our foods including selecting growing locations based on soil composition, testing soil and water before growing, planting and harvesting at the right times of the year, testing ingredients before they are made into foods, and regularly testing finished products to ensure we are delivering on our promise to deliver high-quality and safe baby food."
Beech-Nut Nutrition told us: "Beech-Nut is in compliance with FDA action level guidance setting limits for inorganic arsenic in rice cereal for infants at 100ppb. That said, we would not specifically comment on the Attorney General’s request."
Under pressure to act, the FDA has accelerated plans to set action levels for key contaminants in baby and toddler foods. Simultaneously, lawmakers have introduced The Baby Food Safety Act, which proposes action levels for four heavy metals in baby foods, although the FDA has yet to evaluate the scientific basis for such thresholds.
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