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 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 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 On Friday, September 11, FDA issued the promised draft guidance. The draft guidance is …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 …
By Jenifer R. Stach* & Ricardo Carvajal – On July 24, 2015, FDA issued a proposed rule amending the Agency’s previously issue proposed rule on Accreditation of Third-Party Auditors/Certification Bodies (see our prior posts here and here) and establishing user fees for the Agency’s proposed accreditation …
By Jenifer R. Stach* – After Stewart Parnell’s conviction for selling salmonella-tainted peanut products, causing many deaths and illnesses, he could be facing life in prison. Attorneys on both sides called the recommendation for a life sentence “unprecedented” for a food-poisoning case. We wrote about the convictions …
By Riëtte van Laack – On August 5, 2015, FDA announced the availability of a guidance document regarding nanomaterials in food for animals. The guidance contains no surprises as it is virtually identical to the draft guidance (based on the docket, it appears that FDA did not …
By Riëtte van Laack – On July 30, FDA announced the publication of a draft guidance titled “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels”. The draft guidance addresses an apparent conflict between FDA’s compliance guidelines and FDA’s rounding rules for nutrition …
By Riëtte van Laack – Last week, FDA announced a supplemental proposal to amend the nutrition labeling regulation for food and dietary supplements, and the availability of consumer studies related to FDA’s proposed changes to the format of the Nutrition Facts box. Undoubtedly, the proprosal to establish …
By Ricardo Carvajal - The distinction between the claims “natural” and “made with natural ingredients” is among the issues addressed in a recent NAD decision involving advertising for ASPIRE, a brand of sports drinks promoted as “all natural” and “natural sports drinks.” The drinks include vitamins and citric …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
By Riëtte van Laack – On July 14, the House Agriculture Committee approved The Safe and Accurate Food Labeling Act (H.R. 1599), advancing the legislation another step in the long legislative process. The Act is an amended version of legislation introduced in March by Representative Mike Pompeo (R-KS). (a copy …
