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 …
The Institute of Food Technologists (“IFT”) is requesting proposals for its March 28-29, 2012 annual Wellness Conference, which will explore new trends and examine recent scientific, technological, and business information in the health and wellness sector of the food industry. The conference will cover a …
By Ricardo Carvajal – FDA announced fee rates for reinspections of domestic and foreign facilities, importer reinspections, and noncompliance with a recall order – all authorized by the Food Safety Modernization Act ("FSMA"). The fees kick in on October 1, 2011. The hourly fee rate is …
By Ricardo Carvajal – A federal district court dismissed with prejudice a claim that Bayer’s labeling of gummy vitamins violated the Arkansas Deceptive Trade Practices Act. Plaintiff alleged that the brand name “ONE A DAY” is misleading because the daily serving size for the vitamins is …
On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient ("NDI") notifications that FDA issued earlier this month. Our …
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 …
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 …
