• where experts go to learn about FDA
  • Cannabis

    • 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 …

    • Setting Reasonable Expectations for FDA’s Public Hearing on CannabisMay 24th, 2019

      Yes, FDA’s upcoming public hearing on cannabis is important – and if you registered in time to get a spot in the room, we’ll see you there.  But as stated in the agency’s Federal Register notice announcing the hearing, “FDA does not intend for this hearing …

    • Medical Cannabis Research Act Stirs DEA Marijuana Registration PotApril 10th, 2019

      We sometimes use the term “act of Congress” when referring to something that is difficult or requires large effort to achieve.  But, as nothing else has worked, a real act of Congress may be required to compel the Drug Enforcement Administration (“DEA”) to issue marijuana …

    • Judge Says Lack of State and Federal Plans Means That the Farm Bill’s Interstate Commerce Protections for Hemp Don’t ApplyApril 9th, 2019

      We previously posted about what the Agricultural Improvement Act of 2018 (commonly referred to as the Farm Bill) did, and did not, do with respect to “hemp” and CBD products derived from hemp.  In that post, we noted that the Farm Bill did not preempt …