• where experts go to learn about FDA
  • Foods and Dietary Supplements

    • Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 WarningJanuary 20th, 2021

      On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed amendments to Proposition 65 warning regulations that would limit use of the short-form version of the safe harbor warning. Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates …

    • HP&M’s Food, Beverage & Supplement Wrap Up: December 2020January 6th, 2021

      Welcome to the final 2020 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.  Happy New Year, everyone. Food & Beverage Make Every Bite Count: USDA and HHS …

    • 2020-2025 Dietary Guidelines for AmericansJanuary 4th, 2021

      At long last, and with just two days remaining in 2020, HHS and USDA released the 2020-2025 Dietary Guidelines for Americans (Guidelines).  For those who work in and around the food industry, the Guidelines are a big deal (I could quote Joe Biden here, but …

    • Intentional Genomic Alteration Gets Approval For Food and Therapeutic UsesDecember 23rd, 2020

      FDA had approved an intentional genomic alteration in animals for food uses or therapeutic uses, but not both – until last week. With some fanfare, FDA announced just such an approval of an alteration in a line of domestic pigs. The pigs are referred to as GalSafe …

    • 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” …

    • Petition to TTB Requesting Cancer Warning on Alcoholic BeveragesNovember 5th, 2020

      The Alcoholic Beverage Labeling Act of 1988 (ABLA) directs the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) to notify Congress if science shows that the required warning statement on alcoholic beverages must be updated.  Specifically, the ABLA provides that TTB “shall promptly …

    • 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 …

    • FDA Wants to Know about Sugars That Do Not Act Like “Traditional Sugars”October 23rd, 2020

      As we previously reported, FDA was petitioned to exempt allulose, a monosaccharide, from being included as a carbohydrate, sugar, and added sugar in the Nutrition Facts box, as well as recognize that the number of calories for this monosaccharide is less than the 4 calories …

    • FDA Requests Comment on Labeling of Cell-Derived Seafood Products Except… Wait For It… CatfishOctober 9th, 2020

      FDA published a constituent update and Federal Register notice asking for comment on a number of questions pertaining to labeling of “foods comprised of or containing cultured seafood cells.” The notice discusses the basis for FDA’s jurisdiction over such products, as well as misbranding provisions that FDA considers relevant. …

    • 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 …

    • Citizen Petition Asks FDA to Enforce the FDC Act Requirement Regarding the Cumulative Effect of Food Substances as Part of Safety AssessmentOctober 6th, 2020

      On Sept. 23, 2020, a coalition of public health and consumer advocacy groups submitted a Citizen Petition to FDA, requesting that FDA start considering the cumulative health effects of substances added to food as (according to Petitioners) is required by the Federal Food, Drug, and …

    • Final Decision on Economic Analysis Report of Organic Livestock and Poultry Practices Rule and Summary of Comments on the Economic Analysis Report; The Lawsuit ContinuesSeptember 24th, 2020

      Quite some time ago, we blogged on the organic livestock and poultry practice (OLPP) rule.  The rule established minimum indoor and outdoor space requirements for chickens based on the type of production and stage of life, as well as added new provisions for livestock handling …

    • A Couple of Firsts in Food EnforcementSeptember 22nd, 2020

      Last week brought a reminder that the government can bring to bear a range of legal theories – some old, some new – in pursuing alleged violations of food safety requirements. The U.S. Department of Justice (DOJ) announced a sentence levying $17.25 million in criminal penalties …

    • FDA Law Alert – September 2020September 10th, 2020

      During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and …

    • Lawsuit Challenges USDA’s BE Labeling RuleAugust 24th, 2020

      On July 27, 2020, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety (“Plaintiffs”) filed a complaint against USDA challenging the final “BE labeling rule,” i.e., the final rule implementing …