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 Riëtte van Laack – On Nov. 13, 2014, DOJ announced another Consent Decree of permanent injunction regarding the manufacture and distribution of dietary supplements. Under the Consent Decree, contract manufacturer SciLabs, Inc. and its CEO Paul Edalat are prohibited from the manufacture and distribution of dietary …
By Wes Siegner – In the October 30 Federal Register, FDA announced that it will hold a public meeting on December 9 to consider significant changes to its guidance titled “Toxicological Principles for the Safety Assessment of Food Ingredients,” or “Redbook”. FDA also invited comment to …
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 Jennifer M. Thomas – For the past few days, industry has reacted with anxiety to the government’s decision to pursue an order to show cause why Bayer, Corp. should not be held in contempt of that company’s 2007 consent decree with FTC due to its …
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 …
