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 Critics allege that, among other things, GRAS determinations employ outdated science; GRAS determinations are rife with conflicts of interest; the safety of food …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 …
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 …
By Riëtte van Laack – As previously discussed, since at least 2006, the U.S. honey bee industry has been trying to get FDA to adopt a standard of identity for honey. In 2006, the American Beekeeping Federation and honey industry groups petitioned FDA for a standard …
The Food and Drug Law Institute is sponsoring a conference titled "Food Safety: Latest FSMA Developments & Enforcement Actions in a Changing Business Climate," scheduled for September 9. The conference will feature a regulatory update by Michael Landa (Director of FDA/CFSAN), an exploration of the …
By Ricardo Carvajal & JP Ellison – The Vermont Public Interest Research Group ("VPIRG") and Center for Food Safety ("CFS") filed a motion to intervene in the lawsuit challenging Vermont’s new law requiring labeling for foods produced with genetic engineering (see our prior posting here). VPIRG …
By Ricardo Carvajal – FDA released data for its Total Diet Study (TDS) covering the period from 2006 to 2011. Under the TDS, FDA collects data on levels of pesticide residues, industrial chemicals, toxins, and nutrients present in foods to monitor changes in the levels of …
By Wes Siegner – Just in time for the windup to ad campaigns for the fall/winter cold/flu season, FDA has sent Zarbee’s, Inc. a Warning Letter alerting the company that its dietary supplement products are in fact illegal drugs, some prescription drugs, given the claims that the …
