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  • Foods and Dietary Supplements

    • ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)August 5th, 2022

      The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022.  The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. The approval process, pre-approval concerns, product labeling, clinical trials, …

    • A New Bill Would Take the F Out of FDAJuly 27th, 2022

      A couple of weeks ago, Senator Durbin and Representative DeLauro introduced the Food Safety Administration Act.  The legislation would create the Food Safety Administration (FSA), a food safety agency that would incorporate FDA’s food safety and veterinary medicine centers and the Office of Regulatory Affairs’ …

    • PETA Petition to FSIS to Remove Animal Raising Claims from Label Approval ProcessJuly 19th, 2022

      Last month, the People for Ethical Treatment of Animals (PETA) submitted a petition to the Food Safety and Inspection Service of the U.S. Department of Agriculture (FSIS) requesting that FSIS initiate rulemaking to remove animal raising claims from the label approval process because, according to …

    • 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days AwayJune 24th, 2022

      The American Conference Institute and Council for Responsible Nutrition are hosting the 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements live in New York next week, June 29-30. The conference will feature speakers from government and industry who will provide updates on the …

    • The FDLI Annual Conference is Back Live!June 1st, 2022

      On June 14-15 in Washington, DC, the Food and Drug Law Institute (FDLI) will hold its first in-person Annual Conference since 2019.  The conference brings together leading regulators and a wide range of stakeholders to discuss current issues and trends of importance to FDA-regulated industries.  …

    • Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production ActMay 19th, 2022

      As one of several means to alleviate the ongoing shortage of infant formula in the U.S., earlier this week FDA issued a guidance document that outlines the factors FDA will consider in deciding whether to allow the distribution of an infant formula that does not …

    • NPA Files Complaint Seeking to Prevent FDA from Applying the Exclusionary Clause RetroactivelyDecember 20th, 2021

      On December 7, 2021, the Natural Products Association (NPA) filed a complaint seeking an injunction based on FDA’s actions excluding N-acetyl-L-cysteine (NAC) from the definition of dietary supplement.  At issue is FDA’s interpretation of the “exclusionary clause,” section 201(ff)(3)(B)(ii) of the FDC Act, which among …

    • FDA Proposes Substantial Changes to Agricultural Water RequirementsDecember 14th, 2021

      On December 6, 2021, FDA published a proposed rule to reorganize and amend the highly criticized agricultural water provisions of the Produce Safety Rule (PSR). This marks the Agency’s latest effort to balance public health protections with covered farms’ persistent concerns that the current provisions …

    • ABA publishes Food Law: A Practical GuideOctober 7th, 2021

      The American Bar Association has published a guide to food law that was co-authored by a number of practitioners in this growing field. The book is billed as having been “written by practicing lawyers for practicing lawyers, with a focus on information that is both …

    • FSIS Begins the Process of Rule Making for Labeling of Cultured or Cell-Based Meat and PoultrySeptember 9th, 2021

      As readers of our blog know, FDA and the Food Safety Inspection Service of the USDA (FSIS) agreed to jointly oversee the production of human food products using animal cell culture technology.  Under the Memorandum of Understanding signed in March 2019, FDA will oversee cell …

    • It’s Groundhog Day for Food Labeling, Again: The Food Labeling Modernization Act is BackAugust 20th, 2021

      In a repeat of 2013, 2015 and 2018, Rep. Frank Pallone (D-N.J.) has yet again introduced the Food Labeling Modernization Act (FLMA).  As in the past, there are a few new things of note, and a few other things have been removed (e.g., requirements for …

    • Time is (Not) on Your Side: January 1, 2022 Bioengineered Food Disclosure Deadline is Fast ApproachingJuly 13th, 2021

      While some of us are just starting to recover from graduations, ends of fiscal years, or just looking forward to a summer vacation and listening to the Rolling Stones, time is decidedly not on your side if you have not yet determined if your food …

    • In Seventeen Years will the Cicadas Around FDA’s White Oak Campus Find Complete Culinary Acceptance? Stay TunedJune 3rd, 2021

      As has been widely covered in local and national press in and around the Washington, DC area, this month marks the once every seventeen year emergence of the Brood X cicadas.  These insects are so plentiful in local areas with trees, including FDA’s aptly named …

    • FASTER Law Adds Sesame as Major Food AllergenApril 27th, 2021

      On Friday April 23, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act that designates sesame as the ninth major food allergen.  The first eight major allergens – peanuts, tree nuts, fish, Crustacean shellfish, soy, milk, eggs, and wheat …

    • HP&M’s Food, Beverage & Supplement Wrap Up: February 2021March 4th, 2021

      Welcome to the latest edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Food & Beverage Transition: As of this writing, Janet Woodcock is Acting Commissioner of Food …