• where experts go to learn about FDA
  • Cannabis

    • HP&M’s Larry Houck A Panelist at FDLI’s Cannabis Regulation ConferenceMarch 10th, 2024

      Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.  By doing so, FDA/HHS believe that cannabis no longer meets schedule …

    • Marijuana: Top Ten Reasons for Descheduling, Rescheduling or NotFebruary 12th, 2024

      With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) …

    • HP&M’s Larry Houck Presenting “HHS’ Cannabis Rescheduling Recommendation: A Long Strange Trip with Potholes”December 21st, 2023

      In October 2022 President Joseph Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing expeditiously how cannabis is scheduled under federal law.  HHS recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from …

    • HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises QuestionsSeptember 6th, 2023

      Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; and • Lack of accepted safety for use under medical supervision.  21 U.S.C. § 812(b)(1). Schedule III: • Potential for abuse less than drugs or …

    • When the Attorney General Talks (Cannabis), People ListenMarch 15th, 2023

      Like EF Hutton television commercials of the 1970s and ‘80s, when Attorney General Merrick Garland talks, people listen.  With Hutton it was about investing, for the Attorney General it is cannabis.  AG Garland most recently talked cannabis during a Senate Judiciary Committee hearing last week …

    • Two Steps Forward, One Step…? FDA Addresses Cannabidiol in the Existing Regulatory Frameworks for Foods and SupplementsFebruary 22nd, 2023

      Last October, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing current marijuana scheduling under federal law.  Then, Congress passed and the President signed the Medical Marijuana and Cannabidiol Research Expansion …

    • Biden Administration Facing Renewed Pressure to Legalize CannabisAugust 2nd, 2022

      At least one public interest group and several members of Congress remain frustrated with the Biden Administration’s failure to take action to legalize cannabis.  Within the last month, the Cannabis Regulators of Color Coalition (“CRCC”) and handful of Democratic Senators have separately reached out to …

    • 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), …

    • If You Want It Done . . . Bill to Facilitate Marijuana and CBD Research Re-Introduced in the SenateMarch 16th, 2021

      The Senate recently reintroduced legislation that would promote research into medical use of marijuana.  The legislation would also importantly correct a deficiency in prior law and the Drug Enforcement Administration’s (“DEA’s”) recent rulemaking related to synthetically derived CBD. Marijuana remains classified as a schedule I controlled …

    • 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 …

    • The Long and Winding Road: DEA Issues Final Marijuana Registration RuleJanuary 8th, 2021

      More than four years ago the Drug Enforcement Administration (“DEA”) started down a path by issuing a policy statement asserting that the agency “fully supports expanding research into the potential medical utility of marijuana and its chemical constituents.”  Applications to Become Registered Under the Controlled …

    • 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 …

    • Muddy Waters: Cannabis Trying to Find its GrooveDecember 18th, 2020

      Apropos for the name of the great blues musician, Muddy Waters, the various federal, state and international classifications of cannabis and cannabis-derived substances is a complex scheme in search of the right rhythm.  Cannabis and cannabis-derived substances are controlled within different schedules under the federal …

    • House Approves Amendment Shielding State-Authorized Cannabis ActivitiesAugust 6th, 2020

      Last week, in what has become an annual ritual, the House of Representatives voted 254-163 (222 of 228 Democrats, 31 of 188 Republicans) to approve an amendment prohibiting the Department of Justice (“DOJ”) from using appropriated funds to enforce federal laws against authorized marijuana activities …

    • USDA Approves, Continues to Review, Additional Hemp Production PlansJune 3rd, 2020

      The U.S. Department of Agriculture (“USDA”) continues to consider and approve state and tribal hemp production plans, announcing the approval of plans for the U.S. Virgin Islands, Cheyenne River Sioux Tribe, Chippewa Cree Tribe, Lac Courte Oreilles Band of Superior Chippewa Indians, and Red Lake …