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 The guidance contains no surprises as it is virtually identical to the draft guidance (based on the docket, it appears that FDA did not …
By Riëtte van Laack – On July 30, FDA announced the publication of a draft guidance titled “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels”. The draft guidance addresses an apparent conflict between FDA’s compliance guidelines and FDA’s rounding rules for nutrition …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 …
By Wes Siegner – In 2005, FDA published a Dietary Supplement Labeling Guide that, among other things, provided guidance on whether the words “Dietary Supplement” by themselves satisfied the requirement that the front panel of all dietary supplement products include a statement of identity. FDA’s answer? …
By Etan J. Yeshua – Last week, FDA announced that it will be extending by one year the compliance date for its menu labeling rule. This means that restaurants and other establishments covered by the rule, and by the menu labeling provisions of the Affordable Care …
By Ricardo Carvajal – The White House Office of Science and Technology Policy (OSTP) directed the three federal agencies charged with ensuring the safety of biotechnology products (FDA, USDA, and EPA) to undertake a review intended to “improve the transparency, predictability, coordination, and, ultimately, efficiency of …
By Ricardo Carvajal – As directed under FSMA, FDA issued draft guidance on its approach to implementation of the Voluntary Qualified Importer Program (VQIP). In exchange for voluntarily subjecting themselves to an initial round of heightened scrutiny, importers who are approved for participation in the program …
By Ricardo Carvajal, Diane B. McColl & Jenifer R. Stach – FDA issued a declaratory order revoking the GRAS status of partially hydrogenated oils (PHOs), thereby finalizing its November 2013 tentative determination that there is no longer consensus among qualified experts that PHOs are safe for use in …
By Riëtte van Laack – Where’s the beef? It’s in a recent announcement from the USDA Food Safety and Inspection Service (“FSIS”) concerning finalized labeling requirements for mechanically, blade- or needle-tenderized beef. Under the new rule, published on May 18, 2015, raw or partially cooked mechanically tenderized …
By Ricardo Carvajal - The AP reports that USDA has developed a Process Verified Program (PVP) claim for non-GMO corn and soybeans, at the request of “a leading global company.” The PVP claim was approved under a program operated by USDA’s Agricultural Marketing Service. The program provides …
