• where experts go to learn about FDA
  • Karin F.R. Moore

    • HP&M’s Food, Beverage & Supplement Wrap Up: November 2020December 7th, 2020

      Welcome to the latest edition of Hyman, Phelps & McNamara, P.C.’s (“HP&M”) monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Tooting our own Horn:  HP&M has been named the “Law Firm of the Year” …

    • Festivus for the Rest of Us: How Competitors Can Air Grievances with the New AdministrationNovember 20th, 2020

      A new administration always brings with it the excitement of new political appointees, briefing books and never-ending speculation about forthcoming changes in the direction of various agencies.  It also brings the opportunity for meetings with incoming government officials for an airing of the grievances.  While …

    • HP&M’s Food, Beverage & Supplement Wrap Up: October 2020November 4th, 2020

      Welcome to the latest edition of HP&M’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Food & Beverage Are your cows happy? Check out Karin’s blog post on corporate social responsibility claims. Is it a …

    • Navigating Corporate Social Responsibility ClaimsOctober 26th, 2020

      Companies are embracing corporate social responsibility (CSR) more and more; it is a way for companies and brands to incorporate the company’s values into their business model, and engage with customers and employees on a different level. It is not without risk, however, and our …

    • HPM’s Food, Beverage & Supplement Wrap Up: September 2020October 8th, 2020

      Welcome to the inaugural 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.  (Yes, we know that beverages and dietary supplements are “food” within the meaning of …

    • Restitution and Disgorgement Authority Under FTC Act Section 13(b) Rejected – AgainOctober 5th, 2020

      The Third Circuit handed down a precedential decision this week in the case of Federal Trade Commission v. AbbVie Inc., et al., No. 18-2621 (3d Cir. Sept. 30, 2020), ruling that the District Court for the Eastern District of Pennsylvania erred in requiring AbbVie and …

    • FDA Releases Blueprint For “Smarter Food Safety”July 16th, 2020

      After a few months’ delay caused by the COVID-19 pandemic, FDA released its blueprint for adapting to ongoing and anticipated changes in the food system, titled New Era of Smarter Food Safety: FDA’s Blueprint for the Future.  The blueprint is the result of discussions that …

    • D.C. Circuit Strikes Down FDA’s Cigar WarningsJuly 9th, 2020

      On July 7, 2020, a unanimous panel of the D.C. Circuit held that FDA violated the Tobacco Control Act (TCA) and the Administrative Procedure Act by failing to study whether the extensive health warnings required on cigars would actually lower the number of smokers in …

    • Court Permanently Enjoins California’s Proposition 65 Warning Requirement for GlyphosateJuly 8th, 2020

      On June 22, 2020, the Eastern District of California entered a permanent injunction barring enforcement of the Proposition 65 (Prop 65) cancer warning requirements for glyphosate.  Those familiar with Prop. 65 know that a win for industry battling Prop 65 is a rare event. California Proposition …

    • DGAC Draft Report: Like Mom Said, “Eat Your Vegetables!”July 1st, 2020

      The U.S. Departments of Agriculture (USDA) and Health and Human Services (HHS) work together to update and release the Dietary Guidelines for Americans (Dietary Guidelines) every five years. (See our post about the 2015 Dietary Guidelines here.)  Each edition of the Dietary Guidelines is intended …

    • Pricing in the Time of Price Gouging: Trying to Find a Safe HarborMay 5th, 2020

      As unfortunately happens during every national disaster or emergency, unscrupulous individuals and companies see an opportunity to make money.  A lot of it.  When that happens, there are always immediate calls to prosecute individuals and companies for “price gouging” certain products and taking advantage of …

    • Court Vacates USDA Rule Citing APA ViolationsApril 20th, 2020

      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 …

    • Welcoming Citrus Wines into the Fruit Wines Family: TTB Begins Modernizing Beverage Alcohol Labeling and AdvertisingApril 15th, 2020

      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 …

    • Affirmative Defenses: What’s Going to Stick to the Wall?March 11th, 2020

      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 …

    • HP&M’s Own Prevails in a Battle of the ExpertsMarch 6th, 2020

      In a recent decision out of the Seventh Circuit, Antrim Pharms. Llc. v. Bio-Pharm, Inc., 2020 U.S. App. LEXIS 4772* (7th Cir. 2020), the court decided a battle of the experts: Bio-Pharm prevailed after Antrim unsuccessfully argued the court should preclude testimony by Bio-Pharm’s expert, HP&M’s …