By Ricardo Carvajal – FDA released an ambitious Draft Strategic Plan for 2012-2016 to guide the activities of its Foods and Veterinary Medicine ("FVM") Program (meaning the activities of CFSAN and CVM, as well as ORA’s food-related activities). The Plan articulates priorities organized around the following …
By Cassandra A. Soltis – There is yet another lawsuit to add to the growing list of class actions against companies marketing foods bearing “natural” claims. On September 21, 2011, a class action complaint was filed in California against Bear Naked, Inc. (“Bear Naked” or “the …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be presenting at the following upcoming conferences on food law and policy. The ASQ Food, Drug, and Cosmetic Division's 22nd West Coast Conference on Dietary Supplement Challenges will address cGMPs, analytical issues, the FSMA, and FDA’s draft guidance …
By Wes Siegner, John R. Fleder & Ricardo Carvajal – In U.S. v. Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues. Although nominally a veterinary drug case, …
By Ricardo Carvajal – FDA and FSIS have published a notice seeking information on issues related to reduction of dietary sodium. Last year, the CDC determined that the government’s recommendation to limit sodium to no more than 1,500 mg/day applied to nearly 70% of adults (those …
By Riëtte van Laack – As we previously reported, on December 29, 2010, the Food Safety Inspection Service ("FSIS") published its final rule on nutrition labeling of single ingredient meat and poultry products and ground or chopped meat and poultry products. The new rule requires nutrition …
By Ricardo Carvajal – That question is presented in class actions recently filed against ConAgra Foods, Inc. in California and New York. The complaint in the California case alleges that ConAgra’s labeling and advertising of Wesson Oils as “100% natural” violates California law because the oils …
On September 9, 2011, FDA will publish in the Federal Register a notice granting a 60-day extension, until December 2, 2011, to file comments on the draft guidance on New Dietary Ingredient (“NDI”) notifications that the Agency issued on July 5, 2011 (see our previous …
By Riëtte van Laack – On August 24, 2011, another class action suit regarding “natural” food labeling claims was filed in the Southern District of California. The defendants include Kashi Co. (“Kashi”) and its general manager, as well as Kashi’s parent Kellogg Co. and its President …
By Ricardo Carvajal – In June, we reported that the DC Circuit Court of Appeals decided it lacked exclusive jurisdiction over a Natural Resources Defense Council (“NRDC”) citizen petition seeking FDA action against BPA. Undeterred, NRDC has now filed its complaint in district court. The complaint …
By Riëtte van Laack – Under the law, a manufacturer of a new dietary ingredient ("NDI") or a dietary supplement containing an NDI must notify FDA of the basis for the manufacturer’s conclusion that its product “will reasonably be expected to be safe.” FDA’s regulation, 21 …
By Ricardo Carvajal – Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") sued to invalidate an FDA import alert on cantaloupe from Productos Agricolas de Oriente, S.A. ("PAO"), a Guatemalan producer that is one of Del Monte Fresh’s principal suppliers. FDA imposed the import alert …
By Cassandra A. Soltis – In response to the Food and Drug Administration’s (“FDA’s”) proposed rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments, members of the U.S. Senate and House of Representatives have requested that FDA exclude grocery stores …
By Riëtte van Laack – FDA is reopening the comment period on the proposed rule it published on December 8, 2010, to amend the regulations on plant sterol/stanol esters and risk of coronary heart disease. (See our previous post on the proposed rule.) One of FDA’s proposed …
By Cassandra A. Soltis – The Food and Drug Administration (“FDA”) has reopened the comment period for its proposed rule on “gluten-free” labeling of food to announce the availability of, and seek comments on, its report titled “Health Hazard Assessment for Gluten Exposure in Individuals with …
