By Jamie K. Wolszon – On August 31, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted comments to FDA’s June 1 Draft Guidance regarding research use only (“RUO”) products (see our previous posts here and here). Although HPM supports many parts of the Draft Guidance, in its comments, …
By Susan J. Matthees – The Center for Inquiry, a non-profit organization with a mission to “promote scientific inquiry,” recently submitted a Citizen Petition to FDA requesting that the Agency initiate rulemaking for a proposed rule that would require all homeopathic drugs to be tested for …
The Practising Law Institute ("PLI") has released a new Medical Devices Law and Regulation Answer Book 2011–12, edited by Suzan Onel (K&L Gates LLP) and Karen M. Becker (Becker & Associates Consultants). This Q&A guide is intended to orient and guide those new to the …
By Ricardo Carvajal – FDA and FSIS have published a notice seeking information on issues related to reduction of dietary sodium. Last year, the CDC determined that the government’s recommendation to limit sodium to no more than 1,500 mg/day applied to nearly 70% of adults (those …
By Carmelina G. Allis - Below is a summary of some of the key issues discussed during FDA’s September 12 and 13, 2011, public meeting on the recently issued draft guidance document for mobile med apps. During the meeting, FDA also requested input on how to …
By Kurt R. Karst – September 12th marked the beginning of the eighth round of Trans-Pacific Partnership (“TPP”) negotiations, which are taking place in Chicago, Illinois. The TPP is an Asia-Pacific regional trade agreement being hammered out among the United States and eight other partners. The …
By Riëtte van Laack – As we previously reported, on December 29, 2010, the Food Safety Inspection Service ("FSIS") published its final rule on nutrition labeling of single ingredient meat and poultry products and ground or chopped meat and poultry products. The new rule requires nutrition …
By Carmelina G. Allis – If you thought you’ve had enough trying to figure out whether FDA regulates your mobile app, watch out for the FTC. The FTC has brought its first case targeting health claims related to mobile medical apps. The mobile apps, sold in Apple’s …
By Ricardo Carvajal – That question is presented in class actions recently filed against ConAgra Foods, Inc. in California and New York. The complaint in the California case alleges that ConAgra’s labeling and advertising of Wesson Oils as “100% natural” violates California law because the oils …
By Nisha P. Shah – The U.S. Department of Health and Human Services recently revised conflict of interest rules for Public Health Service ("PHS") related grants and research (i.e., the National Institutes of Health (“NIH”)) in response to congressional and public concerns over potential conflicts between …
By Karla L. Palmer & John A. Gilbert – On September 8, 2011, the Drug Enforcement Administration (“DEA”) published a Notice of Intent to temporarily place into Schedule I of the Federal Controlled Substances Act (“CSA”) three synthetic cathinones. 75 Fed. Reg. 55616 (Sept. 8, 2011). …
By Kurt R. Karst – On September 8th, the U.S. Senate passed, by an 89-9 vote, H.R. 1249, the Leahy-Smith America Invents Act. Final passage of the bill, which will make significant changes to the U.S. patent system, was preceded by a contentious vote on, you …
On September 9, 2011, FDA will publish in the Federal Register a notice granting a 60-day extension, until December 2, 2011, to file comments on the draft guidance on New Dietary Ingredient (“NDI”) notifications that the Agency issued on July 5, 2011 (see our previous …
By Kurt R. Karst – The National Organization for Rare Disorders (“NORD”) announced the submission of a Citizen Petition to FDA requesting “that a documented policy be established regarding the review of potential treatments for people with rare diseases.” The petition comes on the heels of …
By Riëtte van Laack – On August 24, 2011, another class action suit regarding “natural” food labeling claims was filed in the Southern District of California. The defendants include Kashi Co. (“Kashi”) and its general manager, as well as Kashi’s parent Kellogg Co. and its President …
