• where experts go to learn about FDA
  • Ricardo Carvajal

    • MAHA, Nutrition, and the FDANovember 14th, 2024

      Among the more interesting developments in the recent election was the emergence of Robert Kennedy as a prominent figure in the MAGA movement – and the collateral emergence of the MAHA movement (Make America Healthy Again). As crisply laid out in short YouTube video, MAHA …

    • By the Thinnest of Margins, State-Based Animal Welfare Requirements Move ForwardMay 22nd, 2023

      In a dense, multi-part opinion, the Supreme Court affirmed 5-4 the lower courts’ dismissal of a challenge to California’s Proposition 12. That law bans the knowing sale of eggs, uncooked pork, or veal derived from farm animals that are housed under conditions that do not …

    • A Holiday Surprise; FTC Published Its Health Products Compliance GuidanceJanuary 11th, 2023

      On Dec. 20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). FTC staff  prepared the new Guidance to update and replace Dietary Supplements:  An Advertising Guide for Industry, issued in 1998 (“1998 Guidance”).  The new Guidance provides the first update …

    • FDA Completes First Consultation for an Animal Cell-Cultured FoodNovember 17th, 2022

      FDA announced that it has completed the first pre-market consultation for an animal cell-cultured food, based on a safety assessment submitted by UPSIDE Foods. In an indication of the significance of this development, FDA Commissioner Robert Califf and CFSAN Director Susan Mayne issued a statement …

    • When Refusing a Picture During a Food Inspection Could Prove CostlyOctober 27th, 2022

      The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number …

    • 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 …

    • 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 …

    • 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 …

    • 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 …

    • 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 …

    • 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” …

    • 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 …