By Ricardo Carvajal - The Weston A. Price Foundation sued FDA to compel a response to the Foundation’s 2008 citizen petition (Docket No. FDA-2008-P-0452) asking FDA to revoke its regulation authorizing heart health claims for soy protein, which the Foundation claims is “not soy in its natural form.” …
By Ricardo Carvajal – In tandem with its menu labeling final rule (see our prior posting here), FDA published a final rule that sets out requirements for calorie declaration for foods sold from certain vending machines. In certain respects, the final rule is broader in scope …
By Riëtte van Laack – The Affordable Care Act requires calorie and other nutrition information on menu and menu boards for consumers in chain restaurants and other “similar retail establishments” that sell restaurant-type food. In 2011, FDA issued a proposed rule (see our previous post here). …
By Ricardo Carvajal - The D.C. District Court granted FDA’s motion for summary judgment in a lawsuit alleging unreasonable delay in the agency’s response to a citizen petition asking for the inclusion of FDA/EPA’s seafood consumption advisory in seafood labeling and at point-of-sale. Although the petition was …
By Ricardo Carvajal & Riëtte van Laack – FTC filed a complaint in the district court of New Jersey alleging that certain of Gerber’s advertising claims for its hydrolyzed-whey-based infant formula constitute deceptive acts or practices and the making of false advertisements, in violation of the FTC Act. …
By Ricardo Carvajal - FDA released an online learning module intended “to help the seafood industry, retailers, and state regulators ensure the proper labeling of seafood products offered for sale in the U.S. marketplace.” The learning module consists of three videos that provide an overview of applicable …
By Ricardo Carvajal – FDA and the Center for Food Safety (CFS) entered into a consent decree that calls for FDA “to submit a final rule regarding ‘Substances Generally Recognized as Safe’ to the Federal Register for publication no later than August 31, 2016.” As we reported in …
By Ricardo Carvajal – That’s the clever title of a symposium on entomophagy being delivered at the next annual meeting of the Entomological Society of America (ESA), scheduled for the week of November 16 in Portland, Oregon. As we noted in a prior posting, the market for insect-derived …
The International Society of Regulatory Toxicology and Pharmacology (“ISRTP”) will be holding a Workshop on GRAS Determinations from October 13-14, 2014 at the ASEA Conference Center in Washington, DC. The workshop provides a forum for leading scientific experts to contribute to the ongoing debate prompted …
By Ricardo Carvajal & Diane B. McColl – In Part 1 of our effort to characterize the principal errors and mischaracterizations underpinning attacks on the GRAS exception, we focused on misrepresentations of the Food Additive Amendment’s legislative history and of the difficulties FDA allegedly faces in …
By Ricardo Carvajal & JP Ellison – The U.S. Department of Justice recently announced the convictions of former officials and a broker of the Peanut Corporation of America (“PCA”) – the company at the heart an outbreak of salmonellosis five years ago that was traced to the …
The integrity of Generally Recognized As Safe (“GRAS”) determinations, and FDA’s reliance on the voluntary GRAS notification process, has come under attack. Critics allege that, among other things, GRAS determinations employ outdated science; GRAS determinations are rife with conflicts of interest; the safety of food …
By Ricardo Carvajal – FDA has made no secret of its increasing investment in, and reliance on, databases of genetic information to investigate outbreaks of foodborne illness. In public presentations, compliance officials have lauded the utility of PFGE and PulseNet, the Whole Genome Sequencing (WGS) Program, …
In conjunction with Virginia CLE, Hyman, Phelps & McNamara, P.C. Director Ricardo Carvajal and Senior Counsel Brian Donato are presenting a 2-hour CLE telephone seminar that will provide an overview of the Food Safety Modernization Act and its anticipated impact on food businesses. The seminar is directed …
By Ricardo Carvajal & Diane B. McColl – The Grocery Manufacturers Association ("GMA") announced an initiative designed to “improve the process and increase transparency for making Generally Recognized As Safe ("GRAS") determinations of ingredients added to food.” The initiative includes the following five elements: Development by independent …
