Foods

Can Efforts to Develop an Integrated Food Safety System Advance in the Face of State Budget Crises?July 19th, 2011
By Ricardo Carvajal – The integration of federal and state food safety systems is one of the goals of the Food Safety Modernization Act. To that end, FDA recently announced the availability of grant funding to help with the “design, development, delivery, and maintenance of a …
FDA’s NDI Guidance and the 18-Year Cycle of Correcting Regulatory OverreachJuly 14th, 2011
By Wes Siegner, Ricardo Carvajal & Riëtte van Laack – Since at least the early 1960s, FDA has attempted to exercise control over the dietary supplement market, sometimes in ways that the public, industry and Congress have found unacceptable. In the 60s, FDA proposed a regulation …
Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? DoubtfulJuly 6th, 2011
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
Industry Front-of-Pack Labeling and “Bad Foods” Come Under Added ScrutinyJune 26th, 2011
By Ricardo Carvajal – The New England Journal of Medicine published two articles bound to stoke more controversy in the battle over approaches to countering obesity. A perspective piece authored by Dr. Kelly Brownell, Director of the Yale Rudd Center for Food Policy and Obesity, and …
DC Circuit Rules that FDA Inaction on Requested BPA Ban Should be Challenged in District CourtJune 21st, 2011
By Ricardo Carvajal – In October 2008, the Natural Resources Defense Council ("NRDC") submitted a citizen petition to FDA asking the agency to repeal regulations that permit food additive uses of BPA, to which FDA tentatively responded with a standard letter stating that “limited availability of …
Not an Empty Threat; Recent FDA Seizure Actions Follow Warning Letters to a Dietary Supplement Distributor and a WineryJune 12th, 2011
By Riëtte van Laack – Recent FDA enforcement actions suggest that FDA will diligently pursue companies that have received Warning Letters for certain violations – and that have allegedly failed to clean up their act. U.S. Marshals recently seized product from UAS Laboratories (“UAS”), a probiotics dietary …
Criminal Contempt for Allegedly Storing Dietary Supplements Under Insanitary ConditionsJune 7th, 2011
By Susan J. Matthees – The DOJ has announced that a New Jersey jury found two dietary supplement companies and their owner and managers guilty of criminal contempt for allegedly violating a Consent Decree that had enjoined them from engaging in certain conduct. In 2009, the government …
FDA Issues Letter of Enforcement Discretion for Qualified Health Claims for Infant FormulaMay 31st, 2011
By Ricardo Carvajal – FDA issued a letter of enforcement discretion for the use of certain qualified health claims on the labeling of an infant formula marketed by Nestle Nutrition (Gerber). The claims provided in FDA's letter are: Very little scientific evidence suggests that, for healthy infants …
Farmer Allegedly Harmed by FDA Warning on Tomatoes Sues Under the Federal Tort Claims ActMay 26th, 2011
By Ricardo Carvajal – Seaside Farm, Inc., a South Carolina tomato farmer, has sued the federal government under the Federal Tort Claims Act to recoup losses allegedly suffered as the result of the government’s misidentification of fresh tomatoes as the culprit in the outbreak of Salmonella Saintpaul …
Please Pass the Prune Juice: Must FTC Toe FDA’s Line on Health Claims?May 25th, 2011
By Riëtte van Laack & Ricardo Carvajal – As we reported on several occasions (see, e.g., here and here), recent Federal Trade Commission ("FTC") consent orders concerning health-related claims include the requirements that 1) certain claims be approved by FDA under the Nutrition Labeling and Education Act …
FDA Extends Comment Period for Proposed Rule on Menu LabelingMay 23rd, 2011
By Susan J. Matthees – FDA is extending the deadline for comments to the proposed rule on menu labeling from June 6 to July 5, 2011 (see our previous post here). FDA states in a notice to be published in the Federal Register on May 24th …
GAO Issues Critical Seafood Safety Report (and Domestic Catfish Farmers Rejoice)May 19th, 2011
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 …
Imposing Needless Burdens on Small and Large Businesses, FDA’s Proposed Regulations on Menu and Vending Machine Labeling Requirements Need More WorkMay 5th, 2011
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 …
FSMA Update: FDA Publishes Interim Final Rules to Amend its Administrative Detention and Prior Notice RegulationsMay 4th, 2011
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 …
HP&M Attorney to Present at IFT Annual Meeting and Pre-Meeting Food Labeling Short CourseMay 4th, 2011
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 …

Foods

Search FDA Law Blog

Subscribe

Latest Tweets

Awards & Honors