Two companies, DKSH Italia Srl and Polycell Technologies LLC, have filed a citizen petition with FDA asking that it expand the health claim on soluble fiber and coronary heart disease to include their product, Glucagel. The petition describes Glucagel as a “barley beta-glucan fiber that …
By Ricardo Carvajal – A federal district court rejected FDA’s proposed “target timeframes” for issuance of regulations to implement major provisions of the Food Safety Modernization Act ("FSMA"), finding them to be “an inadequate response to the request that the parties submit a proposal regarding …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
By Etan J. Yeshua – FDA has announced several key areas on which it plans to focus its food- and cosmetic-related research and regulatory efforts. The plan specifically names imported foods, nanoparticles in cosmetics, dietary supplement toxicology, and obesity, among others, as specific areas of …
By Riëtte van Laack – Last week, Health Science Funding, LLC filed what might be the first medical food lawsuit against FDA. (A copy of the Complaint is available here, and a copy of the Motion for a Preliminary Injunction is available here.) Plaintiff markets what it …
By Ricardo Carvajal – In previous postings (see here and here), we reported on the Center for Food Safety’s ("CFS’s") lawsuit seeking to compel FDA to accelerate its implementation of FSMA. In April, the presiding court ruled that FDA’s delay violated the APA and ordered …
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
By Riëtte van Laack – On Friday, May 24, 2013, the California Assembly unanimously voted (72-0) for bill AB 227, amending Proposition 65 by including a new provision allowing certain small business owners 14 days to fix an alleged violation of Proposition 65’s warning requirements. AB …
Environmental seals and certifications have received renewed attention recently. The Federal Trade Commission (“FTC”), last week, submitted comments to a private group that is in the process of revising its certification program for “sustainable” seafood. The FTC did not take a stance on the program, …
By Ricardo Carvajal – DHHS and USDA announced the inaugural meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC), scheduled for June 13-14. At the inaugural meeting, the DGAC will be provided with an orientation to the process for revising the Dietary Guidelines (revisions take place …
By JP Ellison – You may not recall our prior April 2009 blog post about the FTC’s settlement with Kellogg over its marketing campaign for Frosted Mini-Wheats. To briefly recap, Kellogg had claimed that “its cereal was “clinically shown to improve kids’ attentiveness by nearly …
By Ricardo Carvajal – A fight that started as a citizen petition asking FDA to permit the interstate sale of raw milk under limited circumstances is now being waged in federal court. In 2008, raw milk advocates and the Organic Pastures Dairy Company ("OPDC") petitioned FDA …
By Riëtte van Laack – On May 9, 2013, the U.S. Court of Appeals for the Third Circuit affirmed a District Court’s decision that a state law class action concerning claims regarding the absence of trans fat and cholesterol lowering effect was preempted. The case, Young v. …
By Ricardo Carvajal & Wes Siegner – A year ago, FDA issued a warning letter to USPlabs alleging that certain products containing dimethylamylamine ("DMAA") that were marketed as dietary supplements were adulterated because (1) DMAA is a new dietary ingredient ("NDI") for which no notification had …
By Riëtte van Laack – Senator Barbara Boxer (D-Calif.) and Representative Peter DeFazio (D-Ore.) recently introduced the Genetically Engineered Food Right-to-Know Act (S. 809 and H.R. 1699) that would direct FDA to require labeling to identify genetically engineered (“GE”) foods “so that consumers can make informed …
