By Etan J. Yeshua – Last week, FDA issued for the dietary supplement industry a draft guidance document that largely doubles-down on controversial positions the Agency has previously taken. The draft guidance – “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” – replaces the draft …
By Riëtte van Laack – Yesterday, FDA announced the availability of a webpage providing information to industry regarding the requirements of the recently finalized Nutrition Facts and serving size regulations. FDA clarifies that until the compliance date of July 26, 2018 (or July 26, 2019 for companies …
By Riette van Laack and Ricardo Carvajal – On Thursday July 14, the House approved legislation authorizing USDA to establish and administer a National Bioengineered Food Disclosure Standard. The bill, S.764, was previously approved by the Senate. The bill had been promoted as an urgent and necessary compromise by …
By Ricardo Carvajal – In an unusual “Early Alert,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) publicly took FDA to task for allegedly lacking “an efficient and effective food recall initiation process that helps ensure the safety of …
By Riëtte van Laack – On May 31, 2016, the Food Safety Coalition submitted a Petition to the Food Safety Inspection Service (FSIS) to amend regulations requiring safe food handling instructions (SHI) on certain meat and poultry products. The Federal Meat Inspection Act (FMIA) and the Poultry …
By Riëtte van Laack – On May 27, 2016, FDA published the final rule, required under FSMA, regarding “the Mitigation Strategies to Protect Food against Intentional Adulteration.” Food defense has been on the agenda ever since the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 …
By Riëtte van Laack – On Friday the 20th of May, FDA announced the availability of the final regulations for nutrition labeling and serving sizes (in prepublication format). The final regulations will be published in the Federal Register on May 27, 2016. That date will be used …
By Riëtte van Laack – FDA announced the availability of the Final Guidance for Medical Foods: “Frequently Asked Questions About Medical Foods; Second Edition.” As we previously reported, in August 2013, FDA issued a draft guidance, updating the 2007 guidance for medical foods. In the 2013 draft …
The American Conference Institute’s 4th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements will be presented in collaboration with the Council for Responsible Nutrition, and is scheduled for June 27-28 in New York. The Forum will feature presentations on policy initiatives, federal and state …
By Etan J. Yeshua – Today, FDA officially announced the availability of a final guidance document that answers questions about the Agency’s menu labeling rule. In doing so, FDA also set May 5, 2017 as the rule’s enforcement date. Although there are only a few differences …
By Riëtte van Laack – Last year (October 2015), POM Wonderful LLC (POM) petitioned the U.S. Supreme Court for review of the decision of the U.S. Court of Appeals for the District of Columbia (see our previous post here). As we discussed, POM’s arguments in its …
By Ricardo Carvajal – The would-be marketer of a probiotic suppository submitted a citizen petition (Docket No. FDA-2016-P-1133) to FDA asking the agency to “amend the definition of dietary supplement under the present statutory authority [of DSHEA] and to treat probiotic suppositories the same as oral probiotic …
By Riëtte van Laack – As we have reported on several occasions, “natural claims,” particularly when used in the advertising of food and dietary supplements, are frequently challenged by competitors and consumers. Neither the Federal Food, Drug, and Cosmetic Act (FDC Act), nor FDA regulations, nor …
By Riëtte van Laack – Last week, FDA issued the sixth of the seven major rules expected to issue under the authority of the Food Safety Modernization Act (FSMA), namely the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to …
By Jay W. Cormier – Just a little more than four months after FDA approved AquAdvantage Salmon (AAS) – the first genetically engineered (GE) animal intended for food use – several organizations filed suit against FDA and the U.S. Fish and Wildlife Service (FWS) challenging that approval. Plaintiffs …
