By Ricardo Carvajal – In the latest major rulemaking initiative under the Food Safety Modernization Act ("FSMA"), FDA issued a proposed rule to implement provisions of FSMA that address intentional adulteration. Further below we summarize major provisions of the proposed rule. However, we note at the outset …
By JP Ellison – In early 2014, the Supreme Court will meet in conference to decide whether to hear a case concerning whether, and to what extent, a private party can pursue a Lanham Act claim based on labeling regulated under the FDC Act. The Court will …
By Ricardo Carvajal – A California district court granted Defendants’ motion to dismiss in a putative class action brought by Plaintiffs who alleged that certain plant-based beverages, including soymilk, almond milk, and coconut milk, were misbranded because FDA defines “milk” as being derived from lactating cows. …
By Riëtte van Laack & Wes Siegner – Hyman, Phelps & McNamara, P.C. has filed comments to FDA’s Draft Guidance on Frequently Asked Questions about Medical Foods – Second Edition. As discussed in a prior post, FDA’s Draft Guidance seeks to establish a policy with respect …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 …
