By Ricardo Carvajal – FDA has approved the biological product ATryn, an anticoagulant derived from the milk of genetically engineered ("GE") goats. The approval follows on the heels of the agency’s issuance of long-awaited guidance on its regulatory approach to GE animals, which we discussed …
By Ricardo Carvajal & Susan J. Matthees – The FDA Globalization Act (“FDAGA”) of 2008 was “meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety” of products over which the agency has jurisdiction. When we commented on …
By Ricardo Carvajal – USDA has suspended, and proposes to debar, Peanut Corporation of America ("PCA") from “participating in government contracts or subcontracts, as well as federal non procurement programs,” among other activities. The suspension is for one year and is effective immediately. The proposed debarment …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by four Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “Imported Products – FDA Is Not Fooling Around,” was written by Dara Katcher Levy and John R. Fleder. It …
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 …
