The U.S. Food and Drug Administration has announced that it has "made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring." The agency determined that the product does not raise any safety concerns and that the product developer is not expected to pursue FDA approval before marketing the product, which is produced from cattle with an intentional genomic alteration (IGA) ensuring a short-hair coat. "To date, the FDA has made low-risk determinations for enforcement discretion for many other IGAs in animals for non-food uses and also has approved applications for five IGAs: in groups of goat, chicken, salmon, rabbit and, most recently, in a line of pigs," the announcement notes. “Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat…
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U.S. Representative Rosa DeLauro (D-Conn.) has written a letter to the Office of the Inspector General seeking "assistance in investigating whether the Food and Drug Administration (FDA) took prompt, appropriate, and effective action leading up to the recent recall involving powdered infant formula produced by Abbott Nutrition's Sturgis, Michigan plant." DeLauro indicates she is "concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illnesses and death." The letter notes that FDA alerted the public to a potential link between formula produced at the Sturgis location and Cronobacter sakazakii four months after the agency learned of the possible link. "The delay between the September inspection and the recall raises serious questions about the FDA's ability to adequately regulate the infant formula industry," the letter asserts. "It seems evident that the FDA could have acted sooner to prevent additional illnesses and deaths…
A consumer has filed a projected class action alleging Mondelez International Inc.'s Green & Black's chocolate packaging misleads as to the product's cacao content. Lee v. Mondelez Int'l Inc., No. 22-1127 (S.D.N.Y., filed February 9, 2022). The labels indicate that the products are 60%, 70% or 85% cacao, but "the back labels uniformly reveal that the principal chocolate ingredient is not cacao but cocoa, which [] is an inferior, highly processed derivative of the cacao bean that has been stripped of the nutritional qualities that make dark chocolate appealing to its consumers." The complaint explains that the ingredient list—"organic bittersweet chocolate (organic chocolate liquor, organic cane sugar, organic cocoa butter, organic vanilla extract)—makes no "mention of cacao butter, but only of cocoa butter." Further, the front labeling also states that the product is "made from 'the finest Trinitario cacao beans,'" the plaintiff argues, which allegedly implies that the products "retain…
A plaintiff has filed a putative class action alleging that Mead Johnson & Co. markets its Enfamil infant formula products as "milk-based" despite containing corn-syrup solids as the primary ingredient. Martinez v. Mead Johnson & Co. LLC, No. 22-0213 (C.D. Cal., E. Div., filed February 2, 2022). The front-label packaging indicates that the product is a "milk-based powder," the complaint asserts, but "corn syrup solids" is listed as first on the ingredient list on the back of the packaging. The plaintiff argues that added sugars are banned in infant formulas sold in Europe in favor of carbohydrates that come from lactose. "[C]onsumers are being deceived into believing they are receiving a milk-based, healthier formula for their infant when, in reality, they are feeding their baby a product where the primary ingredient is unhealthy corn syrup." The plaintiff seeks damages, restitution, class certification, injunctive relief and attorney's fees for alleged violations of…
The Center for Food Safety and International Center for Technology Assessment have filed a rulemaking petition urging the U.S. Food and Drug Administration to regulate the use of nanotechnology in infant formula. "These new materials can have fundamentally different properties from their bulk material counterparts—properties that also create unique human health and environmental risks—which create new oversight challenges for the regulatory agencies charged with protecting public health and the environment," the petition states. "Of unique concern is the use of engineered nanomaterials in infant formulas sold throughout the United States." The actions the groups request include "rigorous screening or safety testing" of infant formula for "nanomaterials or other potentially toxic synthetic ingredients," a required delineation of all nanoparticle ingredients on the label of an infant formula product, and a declaration that any infant formula currently available that contains nanomaterials is adulterated and misbranded.
Following the Environmental Protection Agency's 2021 final rule revoking tolerances for residues of the pesticide chlorpyrifos in food, the U.S. Food and Drug Administration's (FDA's) Center for Food Safety and Applied Nutrition has issued guidance for industry on how the agency will enforce the rule, which sets the expiration date for the tolerances as February 28, 2022. The guidance document is issued in the form of questions and answers; questions include "After the tolerances expire, is food containing residues of chlorpyrifos considered adulterated under the [federal Food, Drug and Cosmetic Act]?," "As an example, how would FDA respond to rutabagas with chlorpyrifos residues before and after the showing date?" and "As an example, how would FDA respond to canned rutabagas with chlorpyrifos residues before and after the showing date?" "There are two stages to our enforcement approach after February 27, 2022: (1) in Stage 1, we generally intend to exercise…
The U.K. Advertising Standards Authority (ASA) has upheld several complaints against Oatly UK Ltd. arguing that the company's advertisements misled consumers into believing the product is more environmentally friendly than the production processes actually are. The ads cited several statistics on the greenhouse gases generated by the dairy and livestock industries and asserted Oatly's production generated fewer emissions. ASA found that the statistics were presented in ways that consumers would be likely to misunderstand, such as the assertion that "Oatly generates 73% less CO2e vs. milk," which applied specifically to whole milk and not the broader milk category. The one complaint that was not upheld was the assertion that “If everyone in the world adopted a vegan diet, it would reduce food’s annual greenhouse emissions by 6.6bn metric tons (a 49% reduction)” because ASA found sufficient evidence to support the statement.
The U.S. Food and Drug Administration (FDA) has released a list of the draft and final guidance topics that the agency is prioritizing for 2022. The list includes guidance on allergens, cell-cultured foods, heavy metals in juice and labeling of plant-based alternatives to milk and animal-derived foods. According to a caveat in the constituent update, "Although the FDA's intent is to publish all draft and final guidance topics on the list, modifications in plans may be needed to support emerging issues and Administration priorities."
The U.S. Department of Agriculture's Agricultural Marketing Service (AMS) has proposed its regular update to the National List of Allowed and Prohibited Substances, which lists the synthetic substances allowed in the cultivation of organic products. The proposed additions are (i) low-acyl gellan gum, which is used as a thickener, and (ii) paper-based crop planting aids, which can transplant closely spaced crops. The proposal also includes a spelling change from "wood resin" to "wood rosin" because the latter term is more specific. Comments on the proposed changes will be accepted until April 4, 2022.
Several advocacy groups, including the Environmental Defense Fund, Consumer Reports and Environmental Working Group, have filed a petition with the U.S. Food and Drug Administration (FDA) "requesting that the agency remove its approvals of the use of bisphenol A [BPA] . . . because recently published scientific studies show that the exposure from those food additive uses is not safe." The groups cite a reevaluation of BPA effects conducted by the European Food Safety Authority (EFSA) and published in December 2021 that "unanimously concluded that 'there is a health concern from dietary BPA exposure for all age groups.'" "Given the magnitude of the overexposure, we request an expedited review by FDA of the food additive petition because the proposed amendments to the agency’s rule are intended to significantly increase the safety of the food supply," the petition asserts. "Not only will it dramatically decrease exposure to a toxin – BPA –…
