• where experts go to learn about FDA
  • Riëtte van Laack

    • 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 …

    • FDA Issues Warning Letters for CBD-containing OTC Analgesic DrugsMarch 29th, 2021

      For more than five years now, FDA has pursued action regarding cannabidiol (CBD) products.  FDA has taken the position that CBD is not a lawful food or dietary ingredient.   But despite the agency’s strong statement about CBD, FDA has acted, primarily through Warning Letters (WLs), …

    • 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 …

    • HP&M’s Food, Beverage & Supplement Wrap Up: January 2021February 8th, 2021

      Welcome to the latest edition of HPM’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. It’s been quite a January, hasn’t it? Food & Beverage Transition: As of this writing, Janet Woodcock is Acting …

    • 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 …

    • OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the TableJanuary 11th, 2021

      That did not take long.  As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees.  Then on Jan. 6, 2021, HHS announced that the fees are off the table. What happened?  Well, …

    • 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 …

    • FDA Announces OTC Monograph Drug User Fees for Manufacturers for FY2021December 30th, 2020

      As we previously reported, in March, as part of the CARES Act, OTC monograph reform was signed into law.  This law amended the FDC Act to include, among other things, an OTC monograph drug user fee program, under which FDA is authorized to assess and …

    • 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 …

    • 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 …