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  • Cannabis

    • 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 …

    • Farm Bill Creates Legal Framework for Hemp, But Challenges RemainDecember 21st, 2018

      In a rare display of bipartisanship in Washington, Congress has passed, and the President has signed, the Agricultural Improvement Act of 2018.  The agricultural legislation is far-ranging, but its most significant aspect from a controlled substance perspective is that it removes “hemp” as defined in the …

    • HP&M Director Larry Houck Receives NASCSA President’s AwardNovember 6th, 2018

      Last week during the 34th annual National Association of State Controlled Substances Authorities (“NASCSA”) conference in Scottsdale, Arizona, Hyman, Phelps & McNamara, P.C. (“HP&M”) Director Larry Houck was honored with the organization’s 2018 President’s Award. NASCSA provides a forum for state, federal and local regulators, …

    • Upcoming WHO and CND Meetings Could Impact Scheduling of CBD and CannabisOctober 18th, 2018

      We previously blogged on the Drug Enforcement Administration’s (DEA’s) rescheduling of Epidiolex. In that blog we highlighted that further action by the World Health Organization (“WHO”) and the UN Commission on Narcotic Drugs (“CND”) could further affect scheduling of cannabidiol (“CBD”) and cannabis in the …

    • DEA Limits Rescheduling of CBD to FDA-Approved EpidiolexOctober 1st, 2018

      In a much-anticipated action since the Food and Drug Administration (“FDA”) approved Epidiolex, G.W. Pharma’s oral cannabidiol (“CBD”) solution for the treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, today the Drug Enforcement Administration (“DEA”) issued a Final Order placing “FDA-approved drugs that contain …

    • Proposed Doubling of 2019 Marijuana Production Quota Brings DOJ and DEA To A Fork in the RoadSeptember 21st, 2018

      In the words of the inimitable Yogi Berra: “When you come to a fork in the road, take it.” Last month the U.S. Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) proposed significant reductions of Schedule II opioid pain medication quantities to be manufactured …

    • Up in Smoke? Will the Feds Ramp Up Enforcement Action Against Budding State Marijuana Industry?January 4th, 2018

      Federal law continues to prohibit the possession, cultivation or distribution of marijuana and prohibits operating a business for these purposes. A number of states continue to follow Federal law and prohibit the use of marijuana under any circumstance, but a growing majority of other states …