The close of 2020 continues to bring developments of high interest to the cannabis and hemp communities.

U.S. Legislative actions
On Tuesday December 15th, the U.S. Senate passed the Cannabidiol and Marihuana Research Expansion Act (S. 2032) by voice vote, becoming the first marijuana reform bill to pass the Senate. The bill combined two separate pieces of legislation sponsored by Sens. Diane Feinstein (D-CA), Chuck Grassley (R-IA), Brian Schatz (D- HI), and former Senator Orrin Hatch (R-UT).

The bill contains the following provisions:
  • Reduces current barriers to medical research on marijuana and its components.
  • Streamlines the processes for development of FDA-approved drugs based on cannabidiol (CBD), marijuana, and other cannabis derivatives.
  • Allows physicians to discuss treatment with marijuana or CBD with parents of minor children.
  • Encourages the federal government to encourage expanded research on marijuana and its components, and requires the department of Health and Human Services (HHS) to report to Congress on barriers to research on marijuana produced in states where its use has been legalized.

Sen. Feinstein’s office released on statement on the bill’s passage. Proponents of the bill plan to push it to the House for consideration, where a similar bill, the Medical Marijuana Research Act (H.R. 3797), was recently passed.

Also on Tuesday December 15th, Sen. Rand Paul (R-KY) introduced the Hemp Economic Mobilization Plan (HEMP) Act of 2020. This legislation proposes changes to the Agricultural Marketing Act of 1946.  The proposal would provide for the following, among other amendments:
  • Change the definition of hemp to a limit of not more than 1.0% delta-9 tetrahydrocannabinol (THC), a significant increase from the current threshold of not more than 0.3%.
  • Mandate compliance testing of finished products produced from hemp, rather than testing of unprocessed plant material.
  • Establish that hemp shipments be accompanied by a hemp seed certificate documenting that the hemp product was derived from hemp seed genetics compliant with the 1.0% THC threshold.
  • Establish an upper limit of 0.075% for measurement uncertainty for THC analysis.

Sen. Paul’s office has provided a brief background paper on the proposed legislation. The bill has been designated S. 5017 and has been assigned to the Senate Committee on Agriculture, Nutrition, and Forestry. It currently has no co-sponsors and is unlikely to progress during the current Congressional session.

FTC “Operation CBDeceit”
On Thursday December 17th, the Federal Trade Commission (FTC) announced enforcement action against six marketers of CBD products for deceptive marketing claims. This action is part of FTC’s crackdown on such illegal claims, named “Operation CBDeceit.”
Some of the identified issues with the six marketers include claims, in the absence of scientific substantiation, that the CBD products can treat chronic pain and age-related cognitive decline, and that CBD is “medically proven” to treat numerous medical conditions.

FTC (as well as FDA) has taken prior action against marketers of CBD for similar alleged deceptive claims. FTC applies the same substantiation principles to health claims for CBD products as it does for other consumer products. Companies that represent expressly or by implication that their product can prevent, treat, or cure serious medical conditions will be held to the highest substantiation standards and marketers can expect careful scrutiny of such claims. AHPA has included compliance with federal requirements for health claims as a recommendation in its guidance policy for marketers of hemp and hemp-derived CBD products.

Australia’s Therapeutic Goods Administration Action on CBD
On December 15th, Australia’s Therapeutic Goods Administration (TGA) finalized its recommendations on the scheduling of cannabidiol. While interim recommendations in September 2020 indicated TGA would down-schedule CBD to schedule 3 and set a 60 mg/day limit for adult over-the-counter access to CBD products, the finalized limit is 150 mg/day. The daily limit was increased following review of additional safety data, public comments submitted on the interim decision, and the advice of an advisory committee.

The TGA regulations require marketers to demonstrate efficacy of the products in Schedule 3, and even with the higher daily limit it may be challenging for the industry product the necessary data. The TGA decision also includes limitations on dosage forms and packaging requirements. Products must be approved by the TGA and listed on the Australian Register of Therapeutic Goods (ARTG) to be lawfully marketed. It is expected to be several months before any CBD products are listed on the ARTG.

The final TGA decision can be found here.