By Riëtte van Laack & Wes Siegner – Hyman, Phelps & McNamara, P.C. has filed comments to FDA’s Draft Guidance on Frequently Asked Questions about Medical Foods – Second Edition. As discussed in a prior post, FDA’s Draft Guidance seeks to establish a policy with respect …
By Riëtte van Laack – In addition to the many (more than 20,000) comments to FDA on the draft rules regarding Produce and Preventive Controls implementing the Food Safety Modernization Act (“FSMA”) (Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921), FDA has received a flurry of letters from Congress …
Next Wednesday, December 12th, the ABA Section of Litigation, Products Liability Committee is sponsoring a live audio program titled “Understanding criminal prosecution of food and supplement companies (and their corporate officers) under the Food Drug and Cosmetic Act: Best practices to avoid becoming the next …
By Ricardo Carvajal – The National Nanotechnology Initiative ("NNI") released its draft 2014 Strategic Plan for comment. The draft plan lays out the NNI’s goals and objectives, which remain largely unchanged from 2011 (see here). As with the 2011 Plan, the draft 2014 Plan includes a …
By Riëtte van Laack – On November 7, 2013, the Food Safety and Inspection Service (FSIS) amended its prior label approval system regulations to expand the circumstances in which certain types of labels and labeling are generically approved and do not need specific FSIS approval. Under the …
On November 20th, the Food and Drug Law Institute ("FDLI") will present a webinar on the regulatory requirements that apply to health-related claims for foods. Hyman, Phelps & McNamara, P.C.'s Ricardo Carvajal will discuss requirements applicable in the U.S. Vicente Rodriguez, current president of the …
By Etan J. Yeshua – The Food and Drug Administration last week initiated a process that could prohibit the sale of partially hydrogenated oils (PHOs), as well as food products containing industrially manufactured PHOs, such as certain baked goods, microwave popcorn, frozen pizzas, frostings, and …
The New York Academy of Sciences will present a conference on scientific and regulatory issues pertaining to nanomedicine on November 21. The conference will feature speakers from the U.S. and abroad so as to provide domestic and international perspectives. Hyman, Phelps & McNamara’s Ricardo Carvajal …
By Ricardo Carvajal – Colorado’s Department of Revenue recently published retail marijuana rules to implement that state’s Retail Marijuana Code (“RMC”). C.R.S. 12-43.4-101 et seq. The rules took effect on October 15, and are the culmination of a change in Colorado law that began with an …
Postponed due to the partial government shutdown, this conference will address numerous compliance and enforcement issues of interest to dietary supplement manufacturers and distributors, and will feature discussion of the anticipated impacts of FSMA implementation. Senior FDA and state officials will provide their perspectives, …
By Ricardo Carvajal – We previously reported on a case – Wilson v. Frito-Lay North America, Inc. – in which a federal district court held that statements on a food company’s website do not constitute labeling even though the labels of some products include a reference …
The Grocery Manufacturers Association ("GMA") is presenting a webinar on GRAS self-determinations for food ingredients next Tuesday, October 29 from 1:30 to 3:00 p.m. EST. The webinar is intended to help food businesses understand applicable requirements and avoid missteps in ingredient safety assessments, and will …
By Ricardo Carvajal – This past Monday, the European Food Law Association held its third conference on developments in food law in the EU and US. The conference was devoted entirely to the subject of food recalls and related public alerts, and the significant impact that …
By Riëtte van Laack – Jensen Farms, (the Jensens), the growers facing criminal charges related to the deadly 2011 listeria outbreak linked to their cantaloupes, are suing Primus Group, Inc. d/b/a/ Primus Labs (Primus) alleging that the food safety consultants who audited the Jensens’ facilities shortly …
By Riëtte van Laack – As previously reported, the American Meat Institute (“AMI”) and several international meat industry organizations filed a lawsuit in an effort to stop the Agricultural Marketing Service ("AMS") of the USDA from implementing the Country of Origin Labeling ("COOL") rule. On …
