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 …
By Riëtte van Laack – Last week, Senator Richard Durbin (D-IL) introduced “the Dietary Supplement Labeling Act of 2011” (S. 1310). The bill proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to “improve the safety of dietary supplements.” Durbin’s bill includes a …
By Riëtte van Laack – The Food Safety Modernization Act ("FSMA") required that FDA, within 180 days of enactment of the FSMA, publish guidelines clarifying the definition of a new dietary ingredient ("NDI") and requirements for NDI notifications. FDA just made that deadline when it released …
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. …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
