By Riëtte van Laack – In a strongly worded letter to FDA Commissioner Hamburg dated December 22, 2011, the principal authors of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), requested that FDA immediately withdraw the …
By Riëtte van Laack – On January 3, 2012, the U.S. Pharmacopeial Convention (“USP”), a scientific organization that publishes the Food Chemical Codex (“FCC”), an international compendium of quality specifications for food ingredients, announced proposed standards for probiotic food ingredients. The proposed standards will be included …
The Food and Drug Law Institute’s (“FLDI”) annual Food Week Conference is being held in Washington, DC on January 23-26, 2012. FDLI Food Week features a two-day introduction to food law and regulation, as well as three days of advanced programming on advertising and labeling, …
By Ricardo Carvajal – Earlier this month, the HHS Office of Inspector General ("OIG") issued a report that identifies a number of “significant weaknesses” in FDA’s oversight of food facility inspections conducted by state agencies under contract with FDA. OIG found that FDA: “failed to ensure that …
By Riëtte van Laack – In a December 12, 2011 decision, Judge R. Leon of the District Court for the District of Columbia granted Defendants’ Motion to Dismiss an action by Physicians Committee for Responsible Medicine (Plaintiff) requiring that Defendants FDA and USDA withdraw the “MyPyramid” …
By Ricardo Carvajal – On November 18, the United States District Court for New Jersey granted FTC’s motion for a finding that Lane Labs violated an order agreed to by the parties in 2000. In part, that order requires Lane Labs’ health-related marketing claims to be …
By Riëtte van Laack – On December 5, 2011, the Food Safety Inspection Service (“FSIS”) of the USDA proposed to amend its regulations concerning label approval of meat and poultry products. The proposed rule would further expand the types of labels that do not require pre-market …
On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011. We have a keen interest in the draft guidance and have previously posted on it …
By Ricardo Carvajal - Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril. For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and …
By Ricardo Carvajal – FDA issued a warning letter to a food manufacturer for labeling as “all natural” a product that contains disodium dihydrogen pyrophosphate, purportedly a synthetic chemical preservative. The letter cites an alleged violation of FDC Act § 403(a)(1), under which a food is …
By Ricardo Carvajal – Late last month, a district court issued a ruling of interest in a Lanham Act case brought by sugar producers and trade associations against corn refiners and the Corn Refiners Association ("CRA") over their marketing of high fructose corn syrup ("HFCS"). The …
By Riëtte van Laack – On November 8, 2011, Senator Durbin and Representative Waxman requested that the U.S. Government Accountability Office ("GAO") determine how the adverse event reporting ("AER") for dietary supplements system is working. Since December 22, 2007, pursuant to the Dietary Supplement and Nonprescription …
By Riëtte van Laack – Last week, Rep. Dan Burton (R-IN) introduced the “Dietary Supplement Protection Act of 2011.” Referencing the exemplary safety record of dietary supplements, the bill proposes to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to significantly …
By Susan J. Matthees – The American Council of Independent Laboratories (“ACIL”), the Association of Food Industries, and the Cheese Importers Association of America, Inc. recently petitioned FDA to revoke or partially revoke its Federal Register notice announcing Food Safety Modernization Act (“FSMA”) user fees amounts …
By Cassandra A. Soltis – The Institute of Medicine (“IOM”) recently issued its Phase II report on consumer use and understanding of front-of-package (“FOP”) labeling systems for foods, recommending that both the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) “consider …
