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 …
By Ricardo Carvajal – FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Safety of Nanomaterials in Cosmetic Products, and Assessing the Effects of Significant …
By Ricardo Carvajal – As widely reported in the press, several food industry trade associations sued the state of Vermont to overturn its recently enacted law requiring that a food “entirely or partially produced with genetic engineering” be labeled with the “clear and conspicuous words ‘produced …
By Ricardo Carvajal – In a prior posting, we reported on a lawsuit brought by Jensen Farms (Jensen) against its auditor Primus Labs (Primus) alleging that Primus had been negligent in the conduct of its audit – negligence that allegedly contributed to the 2011 outbreak of …
By Jennifer M. Thomas – In another confirmation of the Lanham Act’s reach following on the heels of the Lexmark decision, the U.S. Supreme Court ruled today that POM Wonderful LLC’s (“POM’s”) Lanham Act suit against Coca-Cola Co. (“Coke”) over juice product labeling is not precluded …
By Riëtte van Laack – In Quesada v. Herb Thyme Farms, Inc., Plaintiff Quesada alleged that Herb Thyme Farms, Inc. (Herb Thyme) lied about the nature of its “Fresh Organic” line of herbs. According to Plaintiff, Herb Thyme misrepresented its “Fresh Organic” products as 100% percent …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Ricardo Carvajal – FDA filed a motion to dismiss the lawsuit brought by the Center for Food Safety challenging the legality of FDA’s GRAS notification program (for background information on the lawsuit, see our prior posting here). In its supporting memorandum, FDA argues that plaintiff …
By Riëtte van Laack – FDA’s proposed rule regarding nutrition labeling (see our previous post here) will have far-reaching consequences that may not be obvious. For example, FDA intends to make major changes in its approach to defining and measuring dietary fiber – changes that could …
