By Ricardo Carvajal & John R. Fleder – At the invitation of the U.S. Supreme Court, the federal government has recently filed a brief as amicus curiae in the case of Albertson’s, Inc. v. Kanter (No. 07-1327) in which the government argues against preemption of California …
By Ricardo Carvajal – According to a recently-issued Letter to Manufacturers, FDA “feels it is imperative to remind its constituents that front-of-package symbols can at times constitute nutrient content claims” that are subject to FDA’s regulatory requirements at 21 C.F.R. 101.13 and Subpart D of …
By Kurt R. Karst – Earlier today, by a five-to-four vote, the U.S. Supreme Court ruled against preemption in Altria Group, Inc. Good, the so-called “light cigarette” case. Background on the case is available via the SCOTUS Wiki. The respondents in the case (i.e., Good …
By Ricardo Carvajal & Diane B. McColl – FDA has announced a pretest of a survey instrument designed to gather information about five issues relevant to modernization of the food CGMP regulations at 21 C.F.R. Part 110. The food CGMP regulations are essentially unchanged since …
By Dara Katcher Levy & Ricardo Carvajal – On November 12, 2008, FDA issued an Import Alert on all food containing milk products from China. The Import Alert was issued because of concerns over melamine contamination of China’s milk products, including Chinese infant formula, which …
By Ricardo Carvajal – According to a web site set up by GAO to aid the 2009 congressional and presidential transition, the need to revamp oversight of food safety is one of several pressing issues that demand urgent attention. Since the early-1990’s, GAO has issued …
By Ricardo Carvajal – FDA recently published a notice of a proposed collection of information that solicits comments on the use of its new electronic system, called MedWatchPlus Portal, for the collection, submission, and processing of adverse event reports and other safety information for all …
By Diane B. McColl & Ricardo Carvajal – FDA has published a final rule and a draft Compliance Policy Guide (“CPG”) on prior notice of imported food shipments under the Bioterrorism Act of 2002 (“BT Act”). The final rule and draft CPG are available here. …
By Ricardo Carvajal – In its most recent response letters to New Dietary Ingredient ("NDI") notifications submitted pursuant to FDC Act § 413(a)(2), FDA included the following paragraph: Based on the information in your submission, it is possible that a recently enacted law may affect the legal status of …
A citizen petition has been submitted to FDA asking the agency to take regulatory action under § 301(ll) against any foods to which sweetening compounds present in the botanical Stevia rebaudiana have been added, on the ground that those compounds (known as steviol glycosides) are …
FDA recently published a final rule to expand and streamline authorized health claims related to osteoporosis risk reduction. Effective January 1, 2010, companies may use the newly simplified health claims for calcium and vitamin D products, and calcium products in relation to osteoporosis risk reduction. …
More than one might guess. On September 26, 2008, the Government Accountability Office (“GAO”) released a report, titled "Food Safety: Improvements Needed in FDA Oversight of Fresh Produce." As the title suggests, the report is somewhat critical in tone, although it does acknowledge FDA’s efforts …
In response to an urgent request of the European Commission, Health and Consumers Directorate, the European Food Safety Authority ("EFSA") conducted an exposure assessment for biscuits and confectionery contaminated with melamine. Although milk and milk products originating from China currently are prohibited from importation into …
FDA has denied a petition for administrative reconsideration of its June 2005 decision on qualified health claims for green tea and certain cancers. In that decision, FDA stated its intent to consider the exercise of enforcement discretion for two weakly worded qualified health claims for …
In recent years, FDA has studiously avoided taking any broad regulatory action on the issue of whether, and under what circumstances, the presence of methylmercury in fish renders that fish adulterated. FDA recognized that the scientific evidence that addresses the potential risks posed by methylmercury …
