Shook Partner Connor Sears has authored "Food, Drug, Cosmetic Cos. Should Expect More Additive Suits" for Law360. In the article, Sears explores the recent spate of litigation alleging that additives approved for use by the U.S. Food and Drug Administration (FDA) are causing harm to consumers because the same additives are not approved for use in certain other countries. Challenged additives are used in a wide variety of foods, including fish, cereal, dairy, meat, candy and more. "Considering the wide scope of products that may face future lawsuits, manufacturers and distributors may be curious about how courts have treated similar lawsuits," Sears notes. He suggests that courts may approach additives lawsuits similarly to how lawsuits alleging harm from partially hydrogenated oils (PHOs) were decided between 2015, when FDA determined PHOs to be unsafe for food, and 2018, when a ban on their use took effect. Read the full article >>
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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 –…
Several advocacy groups, including the Environmental Defense Fund, American Academy of Pediatrics, Center for Food Safety and Consumer Reports, have submitted a citizen petition urging the U.S. Food and Drug Administration (FDA) to "define key terms essential to consider the cumulative effect of a food additive, food contact substance, generally recognized as safe substance, or color additive, taking into account any chemically- or pharmacologically-related substances in the diet, when assessing safety as required by law." The petition asserts that "FDA and food manufacturers have not taken into account the many chemicals we consume in our daily diet that are similar in structure or affect similar function(s) of organs in the body when making safety determinations for new additives, despite the Congressional mandate and the agency’s own regulations." The organizations argue that "one of almost 900 safety determinations conducted by food manufacturers and submitted to FDA for review as Generally Recognized…
Following the French Agency for Food, Environmental and Occupational Health and Safety's opinion suspending the sale of food products containing titanium dioxide—a food additive appearing in chewing gum, sauces and baked goods—the European Food Safety Authority (EFSA) has issued a statement asserting that no further research has been published that would cause the agency to amend its previous opinion that the substance "did not raise concern with respect to genotoxicity and that it was not carcinogenic after oral administration." EFSA notes that its earlier opinion "identified data gaps and uncertainties that required follow-up by the European Commission by means of a subsequent call for additional data" but that the French opinion did not fill those gaps. The statement also follows the submission of a letter to the European Commission from several civil society organizations based in France, Italy and other member countries calling on the entity to "put forward a…
A Pew Research Center poll has reportedly found that Americans are "of two minds about food additives" because about half "say the average person faces a serious health risk from food additives over their lifetime (51%) while the other half believes the average person is exposed to potentially threatening additives in such small amounts that there is no serious risk (48%)." The poll also found that 49 percent of respondents believed genetically modified (GM) foods to be "worse for one's health than non-GM foods, while 44% say such foods are neither better nor worse and 5% say they are better for one's health." Pew reports that it found "an inverse relationship between how much people know about science generally, based on a nine-item index of factual knowledge, and their beliefs about the health risk of foods with additives as well as GM foods. People with low science knowledge tend to…
Seven advocacy groups, including the Center for Science in the Public Interest, Natural Resources Defense Council and Center for Food Safety, have filed a petition for a writ of mandamus seeking to compel the U.S. Food and Drug Administration (FDA) to issue a decision on a 2015 petition asking FDA to withdraw its approval of seven food additives purportedly shown to cause or linked to cancer. In re Breast Cancer Prevention Partners v. FDA, No. 18-71260 (9th Cir., filed May 2, 2018). According to the petition, the additives—including benzophenone, ethyl acrylate and pyridine—add flavoring to food, such as mango, butterscotch, “floral, cinnamon and mint notes." The petition alleges that “food labels do not indicate whether a product contains any of the seven flavors here at issue. And the degree of risk associated with consumption is impossible to predict. ... [C]oncentrations of the flavors—and, therefore, the health consequences of ingestion—may vary significantly between brands.”
The European Food Safety Authority (EFSA) has issued a scientific opinion reevaluating the safety of silicon dioxide used as a food additive, concluding that the available information is insufficient to confirm the current acceptable daily intake. The panel reportedly found no indication of adverse effects or genotoxicity, but it questioned a long-term study indicating silicon dioxide is not carcinogenic because the description of the primary particle size was not reported. The panel recommended that the European Commission consider lowering the current limits for arsenic, lead, mercury and cadmium in the current specifications for silicon dioxide to ensure it will not be a source of exposure to those elements.
The makers of vodka infused with chemicals that purportedly reduce the risk of alcohol-related damage to DNA have filed a lawsuit against the Treasury Department and the Alcohol and Tobacco Tax and Trade Bureau (TTB) seeking to include health-related claims in product labeling and advertising. Bellion Spirits, LLC, v. United States, No. 17-2538 (D.D.C., filed November 27, 2017). Bellion Spirits asserts that it develops alcohol beverages that protect against the adverse effects of alcohol with “safe additives.” The company petitioned TTB for permission to use health-related claims for vodka containing the additive NTX, according to the complaint, but TTB referred the petition to the U.S. Food and Drug Administration (FDA). Adopting FDA’s finding that the health claims were not adequately substantiated and that the protective effects of NTX were not established, TTB denied the petition. The plaintiffs allege that TTB violated federal law by deferring to FDA, which used evaluative…
Five public advocacy groups have filed suit against the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) seeking to vacate FDA’s “Substances Generally Recognized as Safe” (GRAS) rule, which allegedly allows “potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the Federal Food, Drug and Cosmetic Act (FDCA).” Ctr. for Food Safety v. Price, No. 173833 (S.D.N.Y., filed May 22, 2017). The plaintiffs argue that the GRAS rule allows manufacturers to certify that a substance is GRAS without notice to FDA or the public, although the rule gives them the option to notify the agency about certification. However, they allege, the Food Additives Amendment to the FDCA requires food additives to go through an FDA approval process. FDA allowed manufacturers to begin using the proposed rule’s optional notification…
The U.S. Food and Drug Administration (FDA) denied a citizen petition to ban the use of perchlorates in dry food packaging while revoking regulations permitting the use of potassium perchlorate in food-container seals, saying industry makers no longer use the chemical. FDA said it will amend food additive regulations allowing the use of potassium perchlorate as a component in sealing gaskets for food containers. Trade groups petitioned for the change, arguing that plastics manufacturers have stopped using the compound. The following day, FDA rejected a petition from public interest groups seeking to ban use of potassium perchlorate and sodium perchlorate monohydrate in dry food packaging and requesting that the agency issue new regulations prohibiting use of perchlorates in packaging. Neither request was “the proper subject of a food additive petition,” the agency stated, but the groups could petition to revoke or reevaluate the Threshold of Regulation exemption. Issue 633
