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 …
By Ricardo Carvajal – A report issued by Project on Emerging Nanotechnologies ("PEN"), a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts, concludes that FDA is not prepared to effectively regulate dietary supplements that use “engineered nanomaterials” due to …
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 Anne Marie Murphy – As we have reported previously, Title VIII of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Public Health Service Act (“PHS Act”) by adding new section 402(j), 42 U.S.C. § 282(j), which greatly expands the types …
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By Kurt R. Karst - FDA has issued a draft guidance document, titled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act," explaining the Agency's interpretation of this new statutory provision. FDC Act § …
By Carrie S. Martin & Anne Marie Murphy – As we have previously reported, the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). Among those changes are new limits on …
By James P. Ellison – The Department of Justice announced a $1.415 billion settlement with Eli Lily and Company (“Lilly”) to resolve allegations of off-label promotion of the antipsychotic drug Zyprexa (olanzapine). The criminal component of this global settlement is a $515 million fine and …
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 – Several federal agencies, including FDA, have jointly issued a draft guidance for comment purposes only that recommends a wide range of practices intended to help ensure that imported products comply with applicable federal laws. The action was taken pursuant to a …
By Alan M. Kirschenbaum – Today’s Federal Register announces FDA’s issuance of a final “Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical …
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 …
