By Ricardo Carvajal – FDA has issued a proposed rule that would amend the standard of identity for yogurt and revoke the regulations on standards of identity for lowfat and nonfat yogurt. Under § 401 of the FDC Act, FDA has the authority to establish a …
By Riëtte van Laack – On January 16, 2009, FDA announced the availability of its final guidance for industry, titled “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (“2009 guidance”). At the same time, the Agency withdrew the 2003 “Guidance for Industry and …
By Ricardo Carvajal – The Center for Science in the Public Interest ("CSPI") and a New York firm have filed a class action lawsuit against Coca-Cola and Energy Brands, Inc. over allegedly fraudulent marketing of Glaceau VitaminWater. The complaint contends that defendants “deceptively promote VitaminWater …
By Riëtte van Laack – The United States Department of Agriculture (“USDA”) finalized its rulemaking concerning Country of Origin Labeling (“COOL”) mandated by the 2002 and 2008 Farm Bills. The final rule requires that retailers notify customers of the country of origin of covered commodities (meat …
By Ricardo Carvajal – The Supreme Court has denied certiorari in the case of Albertson’s, Inc. v. Kanter (No. 07-1327). As we previously reported, the California Supreme Court ruled against federal preemption of plaintiffs’ lawsuit alleging false advertising and unfair and deceptive trade practices in …
By Ricardo Carvajal & Colleen M. Brown – Purified water is at the heart of a recently decided case in which the Federal Food, Drug, and Cosmetic Act ("FDC Act") was found to expressly preempt state law claims alleging unfair and deceptive trade practices in violation …
By Ricardo Carvajal – On December 10, 2008, FDA issued a warning letter contending that the Coca-Cola Company’s Diet Coke Plus product violates FDC Act section 403(r)(1)(A) because it fails to comply with regulations that govern the use of the nutrient content claim “plus.” Nutrient …
By Ricardo Carvajal – FDA has issued a final rule that requires declaration of the color additives cochineal extract and carmine in the ingredient statement on the label of all food and cosmetic products that contain those additives. FDA has made no changes to the …
By Diane B. McColl & Ricardo Carvajal – FDA has issued “no questions” response letters to the GRAS notices submitted by Cargill and Whole Earth Sweeter Company for rebaudioside A, described as “a highly purified component of the stevia plant.” The letters (available here and here) …
By Riëtte van Laack – On October 21, 2008, the National Resource Defense Council (“NRDC”) petitioned FDA to issue a regulation to prohibit the use of Bisphenol A (“BPA”) as a food additive. Currently, BPA is approved as a chemical for use in the production of …
By Diane B. McColl & Ricardo Carvajal – On December 15, Cargill issued a press release in which it announced a “broad-based national integrated marketing campaign” to promote its sweetener Truvia™ (Truvia™ is Cargill’s preparation of rebiana, or rebaudioside A, one of the sweetening components …
By Ricardo Carvajal & John R. Fleder – At the invitation of the U.S. Supreme Court, the federal government has recently filed a brief as amicus curiae in the case of Albertson’s, Inc. v. Kanter (No. 07-1327) in which the government argues against preemption of California …
By Ricardo Carvajal – According to a recently-issued Letter to Manufacturers, FDA “feels it is imperative to remind its constituents that front-of-package symbols can at times constitute nutrient content claims” that are subject to FDA’s regulatory requirements at 21 C.F.R. 101.13 and Subpart D of …
By Kurt R. Karst – Earlier today, by a five-to-four vote, the U.S. Supreme Court ruled against preemption in Altria Group, Inc. Good, the so-called “light cigarette” case. Background on the case is available via the SCOTUS Wiki. The respondents in the case (i.e., Good …
By Ricardo Carvajal & Diane B. McColl – FDA has announced a pretest of a survey instrument designed to gather information about five issues relevant to modernization of the food CGMP regulations at 21 C.F.R. Part 110. The food CGMP regulations are essentially unchanged since …
