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 …
By Kurt R. Karst – Earlier today, by a five-to-four vote, the U.S. Supreme Court ruled against preemption in Altria Group, Inc. Good, the so-called “light cigarette” case. Background on the case is available via the SCOTUS Wiki. The respondents in the case (i.e., Good …
By Kurt R. Karst – We previously reported on concerns as to whether a company submitting an ANDA (or a 505(b)(2) application) containing the results of an in vivo bioequivalence study must certify on Form FDA 3674 that new Public Health Service Act (“PHS Act”) …
By Anne Marie Murphy – We have previously reported on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) (here, here, and here), which makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). Section 102(a)(1) of the CPSIA …
By Jeffrey N. Wasserstein, Alan M. Kirschenbaum & Bryon F. Powell – On December 10, 2008, the Massachusetts Department of Public Health (Department) issued proposed regulations pursuant to Mass. Gen. L. § 111N, which requires the Department to promulgate regulations that adopt a standard marketing code …
By Cassandra A. Soltis – FDA has posted on its web site two revised draft guidance documents (here and here) concerning the labeling requirements of dietary supplements and over-the-counter (OTC) drugs under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. That Act …
By Susan J. Matthees— FDA and the Department of Health and Human Services Office for Human Research Protections (OHRP) recently announced the availability of two guidance documents intended to help investigators, researchers, sponsors, and IRBs understand how data already collected may be used after a …
By Susan J. Matthees – FDA recently announced the availability of a new draft guidance document on the types of information FDA recommends be included in a complete submission for the evaluation of proprietary names for prescription drug products, biologics, and nonprescription drug products that …
By Bryon F. Powell – On November 26, 2008, the Massachusetts Department of Public Health delayed plans to propose emergency regulations that would implement the state’s recently enacted pharmaceutical and device marketing law at a December 10 meeting of the Public Health Council. A pair …
By Kurt R. Karst – Late last week while those of us in the U.S. were still digesting our turkey dinners, FDA issued a draft guidance document describing the Agency’s current thinking on the implementation of § 4(b)(1) of the Q1 Program Supplemental Funding Act …
By Kurt R. Karst - On November 25, 2008, FDA granted in full a citizen petition (petition supplements are available here and here) submitted by Osmotica Pharmaceutical Corp. earlier this year requesting that FDA determine that any company with a pending Abbreviated New Drug Application ("ANDA") …
