By Wes Siegner & Ricardo Carvajal – Last August, FDA published data that the Agency had gathered on the content of lead in 324 vitamin products labeled for use by women or children. FDA made clear that its estimates of lead exposures for all of …
By Diane B. McColl & Ricardo Carvajal – In an attempt to improve import safety and further implement its Food Protection Plan, FDA has issued a Guidance for Industry titled “Voluntary Third-Party Certification Programs for Foods and Feeds.” The guidance recognizes that independent certification of …
By Kurt R. Karst – Those following the subject of preemption of conflicting state laws have speculated for months whether the Obama Administration might undo the position FDA has advanced in Federal Register announcements and in court filings in which the Agency has generally staked …
By Diane B. McColl & Ricardo Carvajal – In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and …
By Riëtte van Laack & Ricardo Carvajal – On January 15, the Center for Veterinary Medicine ("CVM") published its final guidance on “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs.” The final guidance describes CVM’s application of the FDC Act’s new animal drug provisions …
Ricardo Carvajal of Hyman, Phelps & McNamara, P.C. will be moderating panels or speaking in two upcoming conferences that address dietary supplement and food regulatory issues. The first is a Food and Drug Law Institute conference titled “What you Need to Know Now about Emerging …
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) …
