By Ricardo Carvajal – The Food and Nutrition Board of the Institute of Medicine and the Board on Agriculture and Natural Resources of the National Research Council have established an ad hoc committee to examine FDA’s oversight of food safety and make recommendations to fill “gaps …
By David B. Clissold – It seems likely that the answer will be “yes.” The Family Smoking Prevention and Tobacco Control Act (H.R. 1256) is on a fast-track under the new administration. The bill passed the House Energy and Commerce Committee by an overwhelming margin …
When Hyman, Phelps & McNamara, P.C. launched the FDA Law Blog 2 years ago today – Is that 14 in “blog years”? It certainly seems like it, if not more! – we could hardly imagine how successful it would become and how our subscribers (and the …
By Cassandra A. Soltis – The Indiana Senate is currently reviewing House Bill No. 1207, passed by the House on February 25, 2009, which would require food establishments having 20 or more locations in Indiana to post both calorie and carbohydrate information “in a manner that …
By William T. Koustas – As we have previously reported, Title IX of the Food and Drug Administration Amendments Act of 2007 (“FDAAA” or “the Act”) provides a new statutory framework and authority for FDA (or “the Agency”) to require Risk Evaluation and Mitigation Strategy …
By Kurt R. Karst – Last week, we reported on the third citizen petition submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of an old antibiotic drug, …
By Kurt R. Karst – Earlier today, the U.S. Supreme Court issued its highly anticipated opinion in Wyeth v. Levine. By a 6-3 vote (Justice Alito, Chief Justice Roberts, and Justice Scalia dissenting), the Court ruled that FDA labeling approval does not preempt state laws. …
By Wes Siegner – In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.” Chapter II of this guidance contains FDA’s views on how to fulfill the statement of identity requirement for dietary supplements contained in 21 C.F.R. § …
By Cassandra A. Soltis & Wes Siegner – Previously we have commented on FDA’s draft guidance originally issued on January 2, 2008 and recently reissued again in draft form on December 11, 2008 (here and here). Both draft guidance documents assert that, in the Dietary …
By Riëtte van Laack – The Eastern District Court of California enjoined California from enforcing California's Penal Code Section 599f against federally inspected swine slaughterhouses on the ground that section 599f is expressly preempted by the Federal Meat Inspection Act (“FMIA”). Section 599f prohibits a slaughterhouse …
By Cassandra A. Soltis – A settlement agreement reached between numerous state attorneys general and Coke, Nestle, and Beverage Partnership Worldwide makes clear that it is not just the Federal Trade Commission that is scrutinizing weight loss claims. The target of the attorneys general action …
By Susan Matthees and Jeff Wasserstein – Although the stimulus bill that President Obama recently signed into law received significant attention for its economic implications, less noticed was Title XIII of the stimulus bill, entitled the "Health Information Technology for Economic and Clinical Health Act" or …
By Douglas B. Farquhar – More than nine years after passage of federal legislation that would permit individuals to legally import prescription drugs from Canada, the Obama Administration appears ready to open the door to importation. Prior administrations, including President Clinton’s, prevented individuals from legally …
By Kurt R. Karst – Actavis Elizabeth LLC (“Actavis”) has sued FDA after the Agency refused to accept the company’s ANDA for a generic version of the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules earlier this year. FDA’s Orange Book shows that VYVANSE is a Type …
By Alan M. Kirschenbaum – Last week we reported on the Obama Administration’s 10-year budget proposal, focusing on the Department of Health and Human Services budget. As noted, the budget establishes a reserve fund of over $630 billion over 10 years to finance health care reform. …
