By John A. Gilbert & Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a final rule on December 29, 2008 setting annual self-certification fees at $21 for “regulated sellers.” “Regulated sellers,” persons and entities who sell scheduled listed chemical products at retail locations, …
By Ricardo Carvajal – On December 10, 2008, FDA issued a warning letter contending that the Coca-Cola Company’s Diet Coke Plus product violates FDC Act section 403(r)(1)(A) because it fails to comply with regulations that govern the use of the nutrient content claim “plus.” Nutrient …
By Ricardo Carvajal – FDA has announced the availability of a guidance for industry titled “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.” Under certain conditions, section 403(r)(6) permits manufacturers of dietary supplements to make nutritional …
By Kurt R. Karst – FDA’s recent approval of Antisoma Research Limited’s orphan drug, oral fludarabine phosphate, with 7 years of orphan drug exclusivity for the treatment of certain adult patients with B-cell chronic lymphocytic leukemia got us thinking about the unusual case of the …
By Ricardo Carvajal – FDA has issued a final rule that requires declaration of the color additives cochineal extract and carmine in the ingredient statement on the label of all food and cosmetic products that contain those additives. FDA has made no changes to the …
By Kurt R. Karst – We previously reported on the Patent and Trademark Office’s (“PTO’s”) determination that U.S. Patent #5,817,338 (“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a Patent term Extension (“PTE”) because the PRILOSEC OTC New …
Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at two upcoming conferences on various Hatch-Waxman Act product lifecycle management issues. The first conference is the Center for Business Intelligence’s Premier Bio/Pharmaceutical Summit on Legal & Regulatory …
By Jeffrey N. Wasserstein, Michelle L. Butler, and Jamie K. Wolszon – On December 18, 2008, the Advanced Medical Technology Association (“AdvaMed”) announced the release of a newly revised version of the “Code on Ethics on Interactions with Healthcare Professionals,” which is a voluntary code focusing …
By Kurt R. Karst – Last week, ViroPharma Inc. announced that the company filed a complaint in the U.S. District Court for the District of Columbia alleging that FDA has “wrongfully withheld agency records requested by [ViroPharma] by failing to comply with the statutory time limit for …
By Jamie K. Wolszon – FDA’s recent decision to require a Risk Evaluation and Mitigation Strategy (“REMS”) for two prescription oral sodium phosphate (“OSP”) products raises questions regarding the impact the agency’s evolving application of its new REMS authority will have in instances where both …
By Diane B. McColl & Ricardo Carvajal – FDA has issued “no questions” response letters to the GRAS notices submitted by Cargill and Whole Earth Sweeter Company for rebaudioside A, described as “a highly purified component of the stevia plant.” The letters (available here and here) …
By Riëtte van Laack – On October 21, 2008, the National Resource Defense Council (“NRDC”) petitioned FDA to issue a regulation to prohibit the use of Bisphenol A (“BPA”) as a food additive. Currently, BPA is approved as a chemical for use in the production of …
By Diane B. McColl & Ricardo Carvajal – On December 15, Cargill issued a press release in which it announced a “broad-based national integrated marketing campaign” to promote its sweetener Truvia™ (Truvia™ is Cargill’s preparation of rebiana, or rebaudioside A, one of the sweetening components …
The accolades keep rolling on in . . . . USPharmD has named the FDA Law Blog one of the “Top 50 Medical Ethics Blogs.” According to them, we will help you “[s]tay on top of current legal issues in the medical field.” And all …
By Ricardo Carvajal – According to a recently-issued Letter to Manufacturers, FDA “feels it is imperative to remind its constituents that front-of-package symbols can at times constitute nutrient content claims” that are subject to FDA’s regulatory requirements at 21 C.F.R. 101.13 and Subpart D of …
