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 …
The Weston A. Price Foundation has submitted a citizen petition asking FDA to revoke its regulation approving a health claim for soy protein and coronary heart disease. According to the petition, in light of studies published since the regulation was issued in 1999, “[t]he totality …
When Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 to require source declaration for ingredients derived from major food allergens, Congress chose not to include any requirements with respect to so-called advisory labeling (e.g., “may contain peanuts,” or “processed in a …
As we previously reported, Section 912 of the FDA Amendments Act (“FDAAA”) added a new prohibition to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The new prohibition, found at FDCA § 301(ll) (21 U.S.C. § 331(ll)), prohibits the introduction into commerce of any food …
