The Food and Drug Administration (FDA) has proposed two new information collections related to voluntary registration, recordkeeping and mandatory third-party disclosure under section 4205 of the Patient Protection and Affordable Care Act of 2010. Section 4205 requires chain restaurants with 20 or more locations, as well as operators of 20 or more vending machines, to disclose “certain nutritional information on certain food items offered for sale so that consumers can make more informed choices about the food they purchase.” In addition, it provides for restaurants or operators with fewer than 20 locations to biannually opt in to the federal requirements. The first proposed information collection pertains to FDA’s program for voluntary registration under section 4205. FDA anticipates that chains with 10 to 19 outlets “may choose to register, either because they are growing quickly, or because they are concerned about possible regulation.” According to FDA, “[t]he primary source of potential registrants will…
Tag Archives labeling
The Grocery Manufacturers Association (GMA) and Food Marketing Institute (FMI) have unveiled plans to create a front-of-package (FOP) labeling system that aims to “inform consumers and combat obesity.” According to an October 27, 2010, joint press release, the FOP system will display “important information on calories and other nutrients to limit . . . in a fact-based, simple and easy-to-use format.” The two industry groups have also pledged to consult stakeholders as they work to finalize the system and “provide consumers with information on nutrients needed to build a ‘nutrient-dense’ diet and on ‘shortfall nutrients’ that are under-consumed in the diets of most Americans.” The announcement followed the release of an Institute of Medicine report calling for FOP labels that highlight the nutrients of greatest concern to consumers—calories, saturated fats, trans fat, and sodium—as well as serving size. Co-sponsored by the Food and Drug Administration (FDA), the Phase 1 report…
A California resident has filed a putative class action against the company that owns the Breyers ice cream brand, alleging violations of consumer protection laws because its 23 chocolate-flavored products are labeled “All Natural” but also contain cocoa processed with alkali. Denmon-Clark v. Conopco, Inc., No. 10-7898 (C.D. Cal., filed October 20, 2010). According to the complaint, “Breyers Ice Cream products containing alkalized cocoa are processed with potassium carbonate which is a recognized synthetic substance.” While acknowledging that the Food and Drug Administration (FDA) does not directly regulate the use of the term “natural,” the plaintiff alleges that the agency has a policy that defines “the outer boundaries of the use of that term” and clarifies that “a product is not natural if it contains color, artificial flavors, or synthetic substances.” The plaintiff alleges that FDA requires products made with an “alkalization” process to include the statement “Processed with alkali.” Breyers’ website…
The Institute of Medicine (IOM) has released the first phase of its report on front-of-package (FOP) rating systems and symbols for food products and recommends that the nutrients of greatest concern to consumers—calories, saturated fats, trans fat, and sodium—as well as serving size, should be highlighted, with calorie-count and serving-size information displayed prominently. According to IOM, “The inclusion of total calories is one way to emphasize the importance of calories in the diet and may help consumers identify lower calorie foods and track the number of calories consumed, . . . [while] serving size information may help consumers better visualize realistic serving sizes and put that portion into context with the other foods and beverages they are consuming.” Sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration (FDA), the report, titled “Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase 1 Report,” examines and compares…
The Food and Drug Administration (FDA) has issued a warning letter to Chiquita Brands International, Inc. indicating that the company is violating the Federal Food, Drug, and Cosmetic Act by misbranding several of its pineapple products. According to FDA, because Pineapple Bites with Coconut® is made with a coconut-flavored spray, the product’s statement of identity and ingredient statement are false and misleading and should instead be identified as containing “coconut flavor.” The labeling also apparently states that the product contains antioxidants but does not include the names of the nutrients that are the subject of the claim. FDA further contends that the products include the claim “Plus Phytonutrients.” Because no recommended daily intake or daily recommended value has been established for phytonutrients, such nutrient content claims are not authorized, according to the agency. The products also apparently include the statement “Only 40 calories,” which FDA says implies that the products…
U.S. Representative Rosa DeLauro (D-Conn.) has introduced a bill (H.R. 6325) that would require labeling for food that contains genetically engineered (GE) animal products. The Consumer Right to Know Food Labeling Act of 2010 would amend the Food, Drug, and Cosmetic Act and Meat Inspection Act to compel the disclosure of product ingredients derived from cloned animals or their progeny. It would also mandate labeling for food products that contain GE salmon. In addition to providing for civil penalties and citizen suits in the event of misbranded food, the bill would direct the U.S. Department of Agriculture and Food and Drug Administration (FDA) to develop and implement a recordkeeping audit trail applicable to “any person that prepares, stores, handles, or distributes a cloned product for retail sale.” “A recent Food & Water Watch survey revealed that 78 percent of Americans do not want genetically-engineered salmon to be approved and made available…
The Sixth Circuit Court of Appeals has determined that parts of an Ohio law regulating the use of labeling on dairy products from cows not treated with growth hormones violate the First Amendment. Int’l Dairy Foods Ass’n v. Boggs, Nos. 09-3515/3526 (6th Cir., decided September 30, 2010). The court also upheld other provisions and remanded parts of the rule relating to antibiotics and pesticides for further proceedings. Thus, the court overturned, in part, a district court determination that upheld most of the rule’s provisions. The Ohio Director of Agriculture adopted a rule in May 2008 that (i) prohibited dairy producers from claiming their milk was hormone-free (a composition claim) and (ii) placed stringent restrictions on the use of the claim “this milk is from cows not supplemented with rbST [recombinant bovine somatotropin or recombinant bovine growth hormone (rbGH)]” (a production claim). Among other matters, the latter require verification, and contiguous…
POM Wonderful LLC has filed a complaint for declaratory relief in a D.C. federal court against the Federal Trade Commission (FTC), alleging that it (i) exceeded its authority in requiring Food and Drug Administration (FDA) preapproval of health-related claims on food products, that is, those claims stating that a product treats, mitigates or prevents disease, and substantiation of non-disease-related claims with two “well-controlled” clinical studies; (ii) violated advertisers’ First and Fifth Amendment rights by requiring compliance with these new standards; and (iii) failed to comply with notice and comment rulemaking procedures in establishing the standards. POM Wonderful LLC v. FTC, No. 10-1539 (D.D.C., filed September 13, 2010). According to the complaint, FTC has advised POM Wonderful that it must comply with standards recently announced in consent orders against other companies and now apparently applicable to the food and dietary supplement industry as a whole. Additional information about one of those orders…
A federal court in Illinois has dismissed claims that companies failing to disclose that the fiber in their snack-bar and yogurt products is “non-natural” chicory root-based inulin, which allegedly lacks the same health benefits as “natural” fiber, have violated state consumer fraud laws. Turek v. General Mills, Inc., No. 09-7038 (N.D. Ill., decided September 1, 2010). According to the court, the plaintiff’s claims are expressly preempted by the federal Nutritional Labeling and Education Act (NLEA) because they would impose requirements under state law that are not identical to federal law requirements. The products at issue are labeled with statements about the percent of daily fiber they contain or grams of fiber provided per serving. Discussing the application of preemption provisions in various federal laws, the court also sets out all of the federal regulations pertaining to fiber in foods. The court concludes, “plaintiff wants to change the labeling on defendants’…
The American Bar Association Tort Trial & Insurance Practice Section’s Animal Law Committee will convene a teleconference on September 28, 2010, to discuss farmed animal welfare and related labeling issues. Temple Grandin, a Colorado State University professor well-known for her work in animal science, will be among the panel of experts to discuss (i) “commercial speech and the role of liability for false advertising under federal and state law in the labeling of food products”; (ii) “the movement to promote more detailed labeling regarding animal welfare and to create verifiable compliance”; (iii) “what, if any, legal meanings are ascribed to terms such as ‘humane,’ ‘cage-free,’ ‘free-range,’ ‘natural’ and ‘organic’ and how are they used in practice vis a vis animal welfare”; and (iv) “the rapidly shifting world of scientific awareness and consumer perceptions regarding what constitutes satisfactory animal welfare, and its impact on producers’ ability to provide accurate labeling.”
