By Ricardo Carvajal – In a report titled “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” GAO found fault with many aspects of FDA’s imported seafood safety program. GAO set the stage for its review by noting that more …
By Wes Siegner & Susan J. Matthees – On April 6, only 2 weeks behind schedule, FDA issued proposed rules (here and here) implementing section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose …
By Ricardo Carvajal – As directed by the Food Safety Modernization Act (“FSMA”), FDA published interim final rules amending its administrative detention and prior notice regulations. Both rules (here and here) take effect July 3, 2011. Under the administrative detention regulations as amended, an FDA officer or …
Hyman, Phelps & McNamara's Ricardo Carvajal will speak on the legal aspects of food allergen labeling and control at the Institute of Food Technologists’ 2011 Annual Meeting and Food Expo, taking place in New Orleans from June 11-14. He will also serve as co-instructor for …
By Cassandra A. Soltis – The Interagency Working Group charged with drafting standards for marketing food to children has released draft nutrition principles, available here. The proposed principles are intended to help food companies determine which foods should be marketed to children as a way to …
By John R. Fleder – In 2004, the Federal Trade Commission (“FTC”) brought a civil action against the marketers of products sold as “Coral Calcium Daily” and “Supreme Greens with MSM.” The FTC challenged a number of claims, including that the products allegedly made express or …
By Riëtte van Laack – On Friday April 22, 2011, a customer slapped Bayer HealthCare LLC (“Bayer”) with a class action suit in California federal court accusing Bayer of falsely and deceptively advertising the benefits of its Phillips Probiotics Colon Health (“PPCH”) supplements. The complaint alleges …
By Ricardo Carvajal - The Atlantic’s second annual Food Summit in Washington, DC brought together speakers and attendees with divergent views on questions of how to ensure sustainability of the food supply, improve the availability and affordability of foods, and address the problem of obesity. On one …
By Ricardo Carvajal – The Senate has adopted legislation that would strengthen criminal penalties "for any individual or corporation that knowingly endangers American lives by contaminating the food supply by distributing misbranded or tainted food products" (see Sen. Leahy's press release here). The legislation provides for …
By Wes Siegner & Cassandra A. Soltis – There has been a buzz in the trade press and industry over when a company is required under the Federal Food, Drug, and Cosmetic Act ("FDC Act") to submit to the Food and Drug Administration ("FDA") a 75-day …
By Jennifer D. Newberger – After more than fifteen years of related cases in the larger matter of The First Amendment v. Dietary Supplement Health Claims, FDA mostly won one. And its winning card? Knowing that the courts will not, and cannot, independently assess whether the …
By Cassandra A. Soltis – In an opinion dated April 6, 2011, Judge Beryl Howell of the U.S. District Court for the District of Columbia granted summary judgment for the FDA in a case challenging the dietary supplement good manufacturing practice (“GMP”) regulations. Alliance for Natural …
Hyman, Phelps & McNamara's Ricardo Carvajal will be speaking on the Reportable Food Registry at the American Conference Institute’s 2nd Advanced Summit on Food Safety Regulatory Compliance, taking place in Chicago from June 15-16, 2011. See here for a copy of the brochure and to register …
By Ricardo Carvajal – FDA has a web page devoted to the Food Safety Modernization Act (“FSMA”) that provides ready access to useful information on the new law and on FDA’s implementation activities, including: the text of the law; Q&A’s; descriptions of the work groups charged with implementation; the text …
By Ricardo Carvajal – At FDA’s public meeting on the food import safety provisions of the Food Safety Modernization Act ("FSMA") (see our prior blog posting here), the challenges posed by implementation of those provisions started to take shape. Presentations by agency personnel, industry representatives, and …
