A California couple has filed two putative class actions alleging that the makers of Lay’s® and Pringles® salt-and-vinegar flavored chips mislabel and deceptively advertise their products, leading customers to believe the chips are naturally flavored when they actually contain artificial chemical flavorings. Allred v. Kellogg, No.17-1354 (S.D. Cal., removed to federal court July 5, 2017); Allred v. Frito-Lay N. Am., No. 17-1345 (S.D. Cal., removed to federal court July 3, 2017). In both suits, the plaintiffs claim the manufacturers label and advertise the potato snacks “as if [they] were flavored only with natural ingredients” and as containing “no artificial flavors.” The plaintiffs allege that although both products contain “actual vinegar—but in an amount too small to flavor the product,” the chips’ vinegar flavors are artificial. The Lay’s® complaint alleges that the label states the product contains malic acid; although l-malic acid can be found naturally in fruits and vegetables, the plaintiffs…
Tag Archives GRAS
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) has published a July 31, 2015, warning letter targeting the use of whole stevia leaf in food and beverages. Issued to Ten Ren Tea Co. of San Francisco, Ltd., the letter claims that tea products containing “Stevia leaf, tea bag cut” are adulterated under the Federal Food, Drug, and Cosmetic Act “because they bear or contain an unsafe food additive.” “Any substance added to a conventional food, such as your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)],” notes the agency, which has only permitted highly-refined stevia preparations in specific applications. “[W]e are not aware of any basis to conclude that Stevia leaf is GRAS…
The Grocery Manufacturers Association (GMA) has petitioned the U.S. Food and Drug Administration (FDA) “to approve specific low-level uses of partially hydrogenated oil (PHOs) in food products.” According to an August 5, 2015, press release, the petition seeks approval to use PHOs for color, flavor and texture when “important for the production of safe food products.” Because FDA revoked the generally recognized as safe (GRAS) status of trans fats on July 16, 2015, food manufacturers must now ask the agency to approve the ingredient for specific purposes. “Our food additive petition shows that the presence of trans fat from the proposed low-level uses of PHOs is as safe as the naturally occurring trans fat present in the normal diet,” said GMA Chief Science Officer Leon Bruner. “It’s important to know that food and beverage companies have already voluntarily lowered the amount of trans fat added to food products by more…
The U.S. Food and Drug Administration (FDA) has issued a determination revoking the generally recognized as safe (GRAS) status of partially hydrogenated oils (PHOs), “the primary dietary source of industrially-produced trans fatty acids.” To comply with the declaratory order, food and beverage companies must remove PHOs from products by June 18, 2018, or request food additive approval for specific uses of PHOs. Concluding that there is no longer expert consensus as to the safe use of artificial trans fat in human food, FDA argues that the action is “expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.” In the wake of its November 2013 tentative decision, the agency apparently received more than 6,000 comments from individuals, industry and trade associations, consumer groups, and government officials, the majority of which purportedly supported the reduction of trans fat in the food supply. “Studies show that diet…
A June 10, 2015, petition filed by consumer and environmental groups asks the Food and Drug Administration (FDA) to ban the following synthetic substances widely used in baked goods, ice cream and beverages: (i) benzophenone (also known as diphenylketone); (ii) ethyl acrylate; (iii) eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol); (iv) myrcene (also known as 7-methyl-3-methylene- 1,6-octadiene); (v) pulegone (also known as p-menth-4(8)-en-3-one); (vi) pyridine; (vii) styrene; and (viii) trans,trans-2,4-hexadienal. Signed by the Center for Science in the Public Interest, National Resources Defense Council, Center for Environmental Health, Environmental Working Group, Center for Food Safety, Consumers Union, and Improving Kids’. Environment, the petition claims that the flavorings are not safe for use in human food under the Delaney Clause of the Food Additives Amendment Act (21 U.S.C. § 348 (c)(3)(A)) because the National Toxicology Program and other agencies have linked them to animal or human cancers. The…
The Center for Science in the Public Interest (CSPI) and other organizations have filed a regulatory comment challenging the approval process for substances generally recognized as safe (GRAS) for use in food products, arguing that the U.S. Food and Drug Administration (FDA) has weakened the GRAS standards to the point that they violate the Food Additives Amendment of 1958. According to the comment, “[T]he American public would likely find it both disturbing and surprising that thousands of chemicals added to food today are not approved or even reviewed by FDA. Instead, of the roughly 10,000 additives currently used in food, more than 3,000 have never been substantively reviewed by FDA. For an estimated 1,000 of these substances, safety decisions were made by the food industry without any notice at all to FDA.” The comment further alleges that the agency has weakened food-safety laws with its 1997 proposal to change the GRAS…
An Environmental Working Group (EWG) investigation has reportedly concluded that 49 processed snack foods contain propylparaben, a preservative commonly found in cosmetic products. In light of its findings and various studies allegedly linking exposure to the chemical to decreased fertility and other hormone-related issues, EWG is urging the U.S. Food and Drug Administration to reconsider the preservative’s current “Generally Recognized as Safe” status as a food additive. “It is of great concern to us that the use of an endocrine-disrupting chemical in our food is considered safe by our own government,” Johanna Congleton, an EWG senior scientist was quoted as saying. “European Union regulators do not permit propyl paraben in food. So why do we?” EWG is soliciting concerned consumers to sign an online petition to food companies that states: “Your company uses the endocrine-disrupting chemical propylparaben in your products! Parabens are being taken out of some cosmetics and food products,…
Sazerac Co. has recalled its Fireball Cinnamon Whiskey from Sweden, Norway and Finland because some batches contain levels of flavoring chemical propylene glycol that exceed European limits. The company says that it mistakenly shipped batches to Europe that were intended for the United States, where the U.S. Food and Drug Administration (FDA) allows higher levels for the Generally Recognized As Safe ingredient. The recall drew media attention to the regulation discrepancy, with many noting that industrial-grade propylene glycol is used in antifreeze. The company clarified October 29, 2014, that it uses food-grade propylene glycol, which it says is also used in many other consumable products, including salad dressing, beer, ice cream, and cake. Sazerac called the ingredient “ideal for use in a large variety of flavors to give most of today’s food and beverages their distinctive taste. Flavor companies use it to carry flavor ingredients through to the final product,…
According to a proposed consent decree filed in a D.C. district court, the U.S. Food and Drug Administration (FDA) will “submit a final rule regarding ‘Substances Generally Recognized as Safe’ [GRAS] to the Federal Register for publication no later than August 31, 2016.” Ctr. for Food Safety v. Burwell, No. 14-0267 (U.S. Dist. Ct., D.D.C., consent decree filed October 20, 2014). The Center for Food Safety apparently brought the action over concerns that food makers have been able to use an interim GRAS process and secure agency approval for allegedly unsafe ingredients, such as volatile oil of mustard, “olestra” and “quorn,” based on self-assessments. According to the Center’s complaint against the agency, FDA has unlawfully exempted GRAS substances from regulation as food additives under a rule proposed, but never finalized, some 15 years ago. That proposed rule purportedly eliminated a petition process requiring food companies to demonstrate that a substance satisfies…
