We have reported on FDA’s guidance document, “Inorganic Arsenic in Rice Cereals for Infants: Action Level Guidance for Industry,” which was finalized in August 2020 and sets an action level of 100 parts per billion (ppb) as the threshold for considering whether infant rice cereal may be “adulterated” and enforcement action is warranted. A February 4, 2021 Congressional report on the finding of heavy metals in baby foods in the U.S. raised questions regarding compliance with FDA’s action level and, among other things, recommended the possibility of “phasing out” ingredients such as rice, that are high in toxic heavy metals. As discussed here, the “Baby Food Safety Act of 2021,” was later introduced, on March 25, 2021, and would impose a lower action level of 15 ppb for inorganic arsenic in infant and toddler cereal.
In an April 29, 2021 press release, New York Attorney General Letitia James announced a new investigation into whether infant rice cereal products that are sold in New York contain arsenic at levels exceeding the legal maximum under the law and whether the advertising and promotion of the products complies with New York’s consumer protection laws. Gerber Products Co., Beech-Nut Nutrition Co., Nurture Inc., and Hain Celestial Group Inc. were identified as targets of the probe. This action follows Attorney General James’ February 9 2021 request urging FDA to set federal standards for toxic metals in all baby food categories and require all baby food manufacturers to test their finished products for toxic metals rather than testing just individual ingredients.
The recently announced NY investigation and U.S. congressional activity, as well as recent litigation (discussed here), involve complicated and multifaceted issues. As discussed in Closer to Zero, the new FDA action plan released on April 8, 2021 for reducing exposure to toxic elements from foods eaten by babies and young children to as low as possible, FDA is simultaneously focused on avoiding unintended consequences, such as eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.
© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 123