By Alan M. Kirschenbaum & Kurt R. Karst – Last Thursday we reported on the release by the House of H.R. 3962, the health care reform bill that will soon be considered on the House floor. As we have done with other health care reform …
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- HPM Posts Summary of H.R. 3962 Provisions Directly Affecting Drug and Device ManufacturersNovember 2nd, 2009
- From Various Quarters, Pleas to Tone Down Food Marketing ClaimsNovember 1st, 2009
By Ricardo Carvajal – We’re used to seeing the Center for Science in the Public Interest ("CSPI") take a stick to food marketers. It seems that CSPI now has plenty of friends. First, Connecticut’s Attorney General trumpeted his success in gaining agreement from food companies …
- Smart Choices Put on IceOctober 23rd, 2009
By Ricardo Carvajal – The Smart Choices ProgramTM has announced “that it will voluntarily postpone active operations and not encourage wider use of the logo at this time by either new or currently enrolled companies.” The announcement cites FDA’s recent letter to industry announcing the …
- FDA Toughens Stance on Front-of-Package Food LabelingOctober 21st, 2009
By Ricardo Carvajal – FDA has issued a letter to industry stating that the agency intends to take enforcement action against front-of-package ("FOP") or shelf labeling that provides false or misleading information (including implied nutrient claims that don't comply with regulatory requirements). Further, the letter states …
- HP&M Attorney to Participate in Webinar on Sustainable FoodsOctober 15th, 2009
Beginning on October 20, Stoel Rives LLP will present a three-part webinar on “business and legal issues related to the development of environmentally sustainable food products.” The titles and dates for the sessions are: Session 1: Where to Start? Developing and Financing Sustainable Food Products (Tuesday, …
- HP&M Attorney to Present at First EFLA Conference Devoted to International Relations in the Food Law SectorOctober 12th, 2009
On October 27, 2009, the European Food Law Association (“EFLA”) will hold its first international EU-US Food Law Conference at the Brussels Sofitel, Place Jourdan 1 – 1000, Brussels. EFLA is an international scientific association whose primary goal is to study and to promote Food …
- FSIS Has Second Thoughts On Issuing a Proposed Rule to Define “Natural”September 13th, 2009
By Ricardo Carvajal – USDA’s Food Safety and Inspection Service (“FSIS”) has released a prepublication version of an Advanced Notice of Proposed Rulemaking (“ANPRM”) that seeks additional public input on the conditions under which FSIS should permit use of the claim “natural” in the labeling …
- FDA Announces Conditional Exercise of Enforcement Discretion With Respect to Reportable Food Registry RequirementsSeptember 8th, 2009
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 …
- FDA Announces Availability of Draft Guidance on Beer LabelingAugust 18th, 2009
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 …
- Third Circuit: State Law Claims Challenging Labeling of High Fructose Corn Syrup as “Natural” Are Not PreemptedAugust 17th, 2009
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 …
- Alliance for Natural Health Takes A Swing at FDA’s Regulation of Qualified Health ClaimsAugust 13th, 2009
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 …
- With or Without FSEA, FDA Will Establish Standards to Prevent Microbial Hazards in Fresh ProduceAugust 11th, 2009
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 …
- House Passes Food Safety Enhancement Act of 2009July 30th, 2009
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, …
- False Advertising Claim under Lanham Act Not Precluded or Barred by the FDC ActJuly 28th, 2009
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 …
- So What Does “Reasonable Probability of Serious Adverse Health Consequences or Death” Really Mean?July 24th, 2009
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 …