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 …
In a case brought by POM Wonderful under the Lanham Act and California state statutes governing false advertising and unfair competition, the U.S. District Court for the Central District of California held Purely Juice and its president liable to the tune of nearly $1.5 million. …
In previous postings (here and here), we have observed that § 912 of the 2007 FDA Amendments Act (“FDAAA”), which added the new § 301(ll) prohibition to the FDC Act, could represent a fundamental shift in the dividing line between foods and drugs, and has …
Under the terms of a 1987 Memorandum of Understanding, the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) exercises jurisdiction over labeling of distilled spirits, wines, and malt beverages subject to the Federal Alcohol Administration Act (“FAA Act”), and FDA exercises jurisdiction over other alcohol …
On June 5, 2008, a citizen petition was submitted to FDA requesting that the Agency “initiate rulemaking proceedings addressing the authoritative statement nutrient content claim provisions” of the Federal Food, Drug, and Cosmetic Act (“FDC Act”). The petition takes issue with FDA’s November 27, 2007 …
The German Federal Institute for Risk Assessment (“BfR”) has issued a report that discusses recent human data on potential health risks arising from consumption of energy drinks. According to the report, the safety concerns expressed by BfR in a prior expert opinion are “substantiated by …
FDA has filed an amicus curiae brief with the Second Circuit Court of Appeals that supports a New York City (“NYC”) law requiring all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear calorie content information for each menu …
