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    • 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 …

    • FDA Law Alert – May 2020May 7th, 2020

      These are unsettling times as COVID-19 impacts our personal and professional lives, as well as those that we love.  During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of the FDA Law Alert.  This is the fifth …

    • State COVID-19 Response: Medical Marijuana and TelemedicineApril 7th, 2020

      State regulators across the healthcare professions continue to issue a number of guidances and waivers as part of the larger COVID-19 response.  We have previously blogged on a number of waivers issued by state pharmacy regulators in connection with COVID-19 response related to pharmacy staffing …

    • Open for Business: DEA’s Proposed Rule Would Make the Agency an Active Buyer and Seller of MarijuanaMarch 26th, 2020

      In 2009, Levon Helm, formerly of The Band, wrote and recorded “Growin’ Trade,” a song about a weary, disillusioned American farmer reluctantly staves off bankruptcy by growing illegal cannabis.  Helm nor anyone else could have known that in the ensuing years, a majority of states …

    • CBD Gets the Slow-WalkMarch 13th, 2020

      Last week, FDA submitted to Congress the report on CBD (“CBD Report”) that the agency was directed to prepare by the Further Consolidated Appropriations Act, 2020. Concurrently, the Commissioner issued a statement that summarizes the agency’s progress to date, and a consumer update that emphasizes …

    • CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary SupplementsNovember 27th, 2019

      FDA has repeatedly declared that cannabidiol (“CBD”) cannot be lawfully used in food or dietary supplements because FDA approved CBD as an active ingredient in an epilepsy drug before the first marketing of CBD as a dietary supplement or food.  This has not stopped the …

    • Will USDA’s Rule Get Hemp Over the Hump? (Maybe Not Without a Little Help from FDA)November 7th, 2019

      USDA published its much-anticipated interim final rule establishing a domestic hemp production program, as directed by the Agriculture Improvement Act of 2018 (a/k/a the Farm Bill).  The rule sets out the requirements for hemp production plans developed by States and Indian Tribes that choose to …

    • FDA Law Alert – November 2019November 6th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …

    • Ease on Down the Road: DEA Still Not Ready to Evaluate Marijuana Manufacturer RegistrationsAugust 29th, 2019

      In a September 2018 post, we observed that the Drug Enforcement Administration (“DEA”) had come to a fork in the road with respect to DEA’s August 12, 2016 policy statement that it would be accepting applications and would in fact issue additional marijuana manufacturer registrations …

    • Consumers Encouraged to “Make Smart Choices” About CBD ProductsJune 24th, 2019

      FDA published a Consumer Update acknowledging the ubiquitous presence of CBD products in the marketplace, and providing the agency’s current perspective on questions regarding the regulatory status, safety, and quality of such products.  The Consumer Update follows closely on the heels of a recent statement issued jointly …

    • Hemp Producers, Rev Your EnginesMay 30th, 2019

      As we discussed in a prior posting, U.S.-based hemp production took a giant leap forward with passage of the 2018 Farm Bill, which directed USDA to establish a regulatory framework for the production of “hemp” as defined in that law.  USDA had signaled its intent to …