Anyone who has recently (on Tuesdays and Thursdays at least) tried – and we mean tried – to wander on to www.regulations.gov to do a little FDA docket research has likely been redirected to a new URL: https://outage.regulations.gov/beta-redirect/. And the first thing you see on …
The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The virtual conference is scheduled to take place on June 23-24, 2020. This “must-attend” event for legal, regulatory, and compliance stakeholders in …
Last week, FDA announced availability of a guidance that would temporarily provide flexibility regarding certain labeling requirements during (and possibly after) the COVID-19 pandemic. This is the fifth time since the start of the pandemic that FDA announced flexibility regarding labeling regulations for foods. The temporary …
The U.S. Government Accountability Office (GAO) released a report titled “Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat.” This report was requested by Rep. Rosa DeLauro (D-Conn.), and concerns the federal oversight of cell-cultured (or cell-based) meat, …
Given the broad deference afforded to federal agencies, it is rare when a court overturns an agency action challenged under the Administrative Procedure Act (APA). In a recent decision, however, a court found that a regulation issued by the U.S. Department of Agriculture (USDA) violated …
In some news that is not about Emergency Use Authorizations, how to make a DIY face mask, or even about COVID-19, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published a final rule amending its regulations governing the labeling and advertising of wine, distilled …
As readers of this blog may recall, the Food Safety Inspection Service of the USDA (FSIS) received two Petitions regarding the Product of USA Labeling for Meat Products. (See here and here for our blog posts). In 2018, the Organization for Competitive Markets and the American …
The recent opinion in FTC v. Quincy Bioscience Holding Co., 2020 U.S. Dist. LEXIS 36424*(S.D.N.Y. Mar. 2, 2020) (background here) is a primer on affirmative defenses in an FTC Act case alleging deceptive advertising of a dietary supplement. The FTC and State of New York …
On February 27, the U.S. Department of Agriculture (USDA) announced the delay of enforcement of certain requirements under the interim final rule (IFR) for the U.S. Domestic Hemp Production Program. As we previously reported, on Nov. 7, 2019, USDA published its much-anticipated rule establishing the requirements …
On February 13, the FDA released the final installment of guidance to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA …
On January 24, 2020, the Food Safety Inspection Service (FSIS) announced that it had received a Petition by Marler Clark LLP, on behalf of several individuals (victims of food poisoning from Salmonella containing meat or poultry products) and three consumer advocacy organizations (Food & Water …
Yesterday’s announcement by the U.S. Federal Trade Commission (“FTC”) that it was issuing so-called “6(b) Orders” to heavyweights in the tech industry at first glance, might not seem relevant to most readers of the blog, but it is. As the announcement reminds us, “Section 6(b) …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Karin Moore has become its newest Director. Drawing on her years of experience as a former general counsel to leading trade associations, Karin is an industry expert and thought leader in the areas of …
Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
In a letter dated January 9, 2020, the Center for Science in the Public Interest (CSPI) asked FDA to take immediate enforcement action to prevent what CSPI argues are misleading and unauthorized implied “low sugar” and “reduced sugar” claims, such as “lightly sweetened” and “less …
