A plaintiff has filed a putative class action alleging Abbott Laboratories Inc.'s Similac Pro-Advance infant formula is advertised as the company's "closest formula to breastmilk," allegedly misleading consumers into believing that the formula can convey the same benefits as breast milk. Conner v. Abbott Labs. Inc., No. 21-1463 (S.D. Ill., Benton Div., filed November 20, 2021). "Infant formula is critical for children whose mothers are unable to breastfeed or produce enough milk," the complaint asserts. "Marketing of infant formula sometimes goes beyond meeting those limited needs, to tout itself as an equivalent to breast milk. The representations that the Product contains lutein, vitamin E, DHA, and HMO—Human Milk Oligosaccharide, and the claim, 'Our Closest Formula to Breast Milk,' imply the inclusion of these constituents can approach the benefits from breast milk." The plaintiff seeks class certification, injunctive relief, damages and fees for allegations of fraud, unjust enrichment, negligent misrepresentation and…
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The U.S. Food and Drug Administration (FDA) has released "Closer to Zero," its action plan for reducing infants' exposure to heavy metals following a Congressional report on toxic elements in baby foods. "Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time," the agency states. Under the plan, FDA will (i) "evaluate the scientific basis for action levels," (ii) "propose action levels," (iii) "consult with stakeholders on proposed action levels," and then (iv) "finalize action levels." The agency will then "establish a timeframe for assessing industry’s progress toward meeting the action levels and recommence the cycle to determine if the scientific data support efforts to further adjust…
U.S. Sens. Amy Klobuchar (D-Minn.) and Tammy Duckworth (D-Ill.) have introduced the Baby Food Safety Act of 2021, which aims to "require manufacturers of infant and toddler food to implement preventive controls to comply with performance standards under Section 104 of the FDA Food Safety Modernization Act (FSMA)." The act would establish action levels for heavy metals in infant and toddler foods at 10 parts per billion (ppb) of inorganic arsenic, 5 ppb cadmium, 5 ppb lead and 2 ppb mercury, effective one year after enactment. The act would also require the Secretary of Health and Human Services to regularly review the regulatory limits and provide reports to Congress summarizing progress on the issue.
The European Food Safety Authority (EFSA) has released several guidance documents to aid stakeholders in complying with EU regulations on food issues implemented on March 27, 2021. The publications provide guidance on: Applying for an exemption from mandatory food allergen labeling; Renewing applications for genetically modified organisms (GMOs) in food and feed; Preparing applications for genetically modified plants; Applying for authorization of a novel food; Preparing applications for substances to be used in food-contact plastics; Applying to make health claims about foods; Preparing an evaluation for infant formula manufactured from protein hydrolysates; and Submitting notifications for traditional foods from third countries.
The U.S. Food and Drug Administration (FDA) has responded to the House report on levels of heavy metals in baby food with the promise of additional action. The FDA statement notes, "First, today we issued a letter to industry reminding manufacturers of these types of foods of their existing responsibilities related to these efforts. Secondly, the agency is announcing that we’ll soon be putting into action a plan aimed at reducing toxic elements in foods for babies and young children to levels as low as is reasonably achievable." The industry letter asserts that the agency will take action to remove foods from the market "when the levels of toxic elements or other chemicals in foods do pose a health risk," citing as an example a consent decree the agency obtained in January 2021 to stop Valley Processing Inc. from selling adulterated juice. The agency's plan includes finalizing an action level…
The U.S. Food and Drug Administration (FDA) has issued a constituent update responding to the Senate's report on elevated levels of heavy metals in baby foods. "While the report released on February 4, 2021 by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy raises important questions on what more can be done to reduce toxic elements in baby foods, the FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts," the update states. "Firms and individuals who manufacture or sell food have a legal responsibility under the Federal Food, Drug, and Cosmetic Act to ensure the safety of their products. The FDA reviews information and takes action on a case-by-case basis. If the FDA finds that a product violates the law, the agency takes steps to stop the product from being imported, takes…
Three similar lawsuits were filed against Target Corp., Gerber Products Co. and Mead Johnson & Co. alleging their "transition" formulas intended for 9- to 18-month-old children are misleadingly marketed as reviewed and monitored by the U.S. Food and Drug Administration to the same extent infant formulas are. Gavilanes v. Gerber Prods. Co., No. 20-5558 (E.D.N.Y., filed November 15, 2020); Gordon v. Target Corp., No. 20-9589 (S.D.N.Y., filed November 15, 2020); Palmieri v. Mead Johnson & Co., No. 20-9591 (S.D.N.Y., filed November 15, 2020). The complaints assert that the use of the infant formula nutrition panel on the back of the packaging "gives caregivers the impression that the Product is subject to the same scrutiny and oversight as Infant Formula products," causing buyers to be "less likely to identify the added sugar in the Infant & Toddler Formula Product, in the form of corn syrup solids, absent from the Infant Formula product." The…
