By Ricardo Carvajal – FDA’s Food Advisory Committee (FAC) will meet on December 7-8 to discuss a number of issues related to Listeria monocytogenes (L. mono) in ready-to-eat (RTE) foods. As summarized in the supporting background document, the public health and regulatory challenges posed by L. mono have bedeviled FDA and …
By Ricardo Carvajal – In tandem with its approval of genetically engineered (GE) salmon (see our previous post here), FDA issued two guidance documents on labeling of GE foods – a final guidance document applicable to foods derived from GE plants, and a draft guidance document specific to GE …
By Riëtte van Laack – In 2013, FDA issued a final rule defining criteria for the term gluten-free for purposes of food labeling. The rule was “incomplete” because it did not address how to test fermented, hydrolyzed and distilled foods for compliance with the rule. In 2013, …
By Ricardo Carvajal - FDA released pre-publication versions of the three final rules on foreign supplier verification program (FSVP), accredited third-party certification, and produce safety. As with the recently issued rules on CGMPs and preventive controls for human and animal food (see our previous post here), FDA …
By Ricardo Carvajal – FDA is publishing a Federal Register notice asking for information and comments on the use of the term “natural” in human food labeling, “including when, if ever, the use of the term is false or misleading.” The notice purports to be based partly on …
By Riëtte van Laack – As we previously reported, POM Wonderful (“POM”) petitioned the U.S. Court of Appeals for the D.C. Circuit for en banc review of that Court’s earlier decision which had largely upheld the FTC’s cease and desist order issued against POM. That petition was …
By Wes Siegner – Effective October 30, 2015, FDA issued a stay on certain food provisions of the final guidance, “Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an IND” (IND Guidance). FDA announced the stay in the Federal Register notice, 80 …
FDA recently announced that it has submitted the FSMA final rules on produce safety, foreign supplier verification, and third party accreditation to the Federal Register – just in time for the third and fourth installments in the Food and Drug Law Institute’s (FDLI’s) FDA Food Safety …
By Diane B. McColl – On October 28, 2015, FDA announced that a food additive petition (FAP) submitted by the Grocery Manufacturers Association (GMA) for minor uses of partially hydrogenated vegetable oils (PHOs) was accepted for filing on October 1, 2015 (Docket No. FDA-2015-F-3663). GMA’s FAP …
By James R. Phelps & Wes Siegner – “Bad reactions to dietary supplements are sending thousands of Americans to the ER every year, a new study shows.” That’s the attention-getting lead in a CBS News story dated October 15. It was based on a study report …
By Ricardo Carvajal – The Center for Science in the Public Interested (CSPI) filed suit in the D.C. District Court to compel FDA to respond to CSPI’s 2005 citizen petition (Docket No. FDA-2005-P-0196) asking FDA to revoke the GRAS status of salt, require reduced levels of salt …
By Jennifer M. Thomas – On October 1, 2015, the U.S. District Court for the District of New Jersey unsealed its opinion in United States v. Bayer Corp., No. 07-cv-00001 (D.N.J. Sept. 24, 2015), confirming a significant defeat for the government, and a clear victory for …
By Riëtte van Laack & Etan J. Yeshua – As we previously reported, when FDA announced a new compliance date for the menu labeling rule, it also announced that it would issue guidance. On Friday, September 11, FDA issued the promised draft guidance. The draft guidance is …
By Ricardo Carvajal & Riëtte van Laack – FDA released pre-publication versions of the two final rules on current good manufacturing practice and preventive controls requirements – one governing human food (here), and the other animal food (here). The pre-publication versions total over 1,500 pages, so will …
By Ricardo Carvajal – FDA issued a warning letter to Hampton Creek alleging that its Just Mayo products are misbranded, in part because they purport to be a food governed by a standard of identity – namely, mayonnaise – that the products fail to meet. This alleged …
