By Ricardo Carvajal – FDA previously announced that the Reportable Food Registry that the agency is required to establish by section 417 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") would become operational on September 8, 2009, and that responsible parties would be …
By Susan J. Matthees – FDA has published a new draft guidance titled Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration. Last month we reported that the Alcohol and Tobacco Tax and Trade Bureau ("TTB") issued a …
By Ricardo Carvajal – Last year, a New Jersey district court held in favor of federal preemption of a state law consumer fraud claim against the manufacturer of a beverage that contains high fructose corn syrup (HFCS) and is labeled as “all natural” (see Holk …
By Ricardo Carvajal – In conjunction with other plaintiffs, the Alliance for Natural Health has filed suit in the D.C. district court challenging FDA’s denial of plaintiffs’ petition for the use of four qualified health claims for selenium and certain forms of cancer, and FDA’s …
By Jamie K. Wolszon & Ricardo Carvajal – FDA has published three draft guidances that instruct growers, packers, processors, transporters, retailers and others on the prevention of microbial hazards in tomatoes, melons, and leafy greens. According to FDA’s press release, Dr. Hamburg stated that the …
By Ricardo Carvajal – The U.S. House of Representatives has passed the Food Safety Enhancement Act of 2009, which would substantially strengthen FDA’s regulatory authority over foods. The bill would grant FDA mandatory recall authority, expanded access to records, stronger seizure and administrative detention authorities, …
By Cassandra A. Soltis – In Pom Wonderful LLC v. Ocean Spray Cranberries, Inc., 2009 WL 2151355 (C.D. Cal. 2009), the U.S. District Court for the Central District of California determined that Pom Wonderful LLC’s (Pom’s) false advertising claim against Ocean Spray Cranberries, Inc. (Ocean …
By Ricardo Carvajal – On July 23, FDA held the first of three public workshops to explain the Reportable Food Registry requirements that will take effect on September 8, 2009. One thing was made clear: the agency has no plans to offer a definition of …
By Ricardo Carvajal – The Institute of Food Technologists (“IFT”) has published an expert report that addresses the challenge of responding to food contamination events in the face of limited scientific information. The report describes the U.S. legal framework that governs substances intentionally or inadvertently …
By Ricardo Carvajal – The Council to Improve Foodborne Outbreak Response (“CIFOR”) has published guidelines intended to help local, state and federal agencies improve their response to foodborne disease outbreaks. The guidelines address planning and preparation, surveillance and outbreak detection, investigation of clusters and outbreaks, …
By Ricardo Carvajal – In a complaint filed on July 1, the government is asking a federal district court to enjoin certain manufacturers of protein powder mixes and dietary supplements from further marketing of products alleged to be adulterated under FDC Act section 402(a)(4) due to the …
By Diane B. McColl & Riëtte van Laack – On June 25, 2009, Ovos Natural Health Inc. ("Ovos") filed a citizen petition asking FDA to promulgate a regulation allowing use of homotaurine, a new dietary ingredient, in dietary supplements under sections 201(ff)(3)(B)(ii) and 301(ll)(2) of …
By Ricardo Carvajal – FDA has announced public workshops on the Reportable Food Registry intended to “explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the …
JP Ellison – The U.S. Attorney's Office for the Western District of Missouri announced three guilty pleas to misdemeanor violations of the FDC Act in connection with the "nationwide recall of pet food and the death and serious illness of countless pets across the United States …
By Riëtte van Laack – The FDA Amendments Act (“FDAAA”) amended the Food, Drug, and Cosmetic Act (“FDC Act”) to create section 417, which directs FDA to establish a Reportable Food Registry (“Registry”). The purpose of the Registry is to provide a “reliable mechanism to …
