Allay Consulting August Newsletter: Cannabis Federal Legalization

It appears that federally legalized marijuana might be a reality! Since removing hemp from the definition of marijuana through the passage of the 2018 Farm Bill, we have looked to the legalization of marijuana. It was never “if” but “when”, and it looks to be on the horizon.

Senator Cory Booker, Ron Wyden, and Chuck Schumer’s drafted a published discussion called “Cannabis Administration & Opportunity Act”. The 30 page draft bill details ending the decades of harm caused from the War of Drugs, removing cannabis from the federal list of controlled substances, encouraging states to create their own cannabis laws, establishing tax expectations, and imposing federal regulatory oversight. There is much to cover within the published document; we are here to cover the public health portion of the drafted discussion.

Federal Agencies to Oversee Cannabis Products: FDA & TTB

Under this drafted proposal, the DEA would no longer have primary jurisdiction over cannabis. While removing the DEA from overseeing cannabis is a relief to most, we must assume that additional federal regulatory oversight will be involved. According to the discussion draft, expect to see the Food and Drug Administration (FDA) and Tobacco Tax and Trade Bureau (TTB) have a hand in regulating the cannabis industry.

The FDA would have the responsibility to oversee the producing and marketing of cannabis products. The TTB would have the authority to uphold the taxation of cannabis products, tracking and tracing cannabis, oversee trade practices, and overseeing market trade practices. Both federal agencies would share jurisdiction over product label and packaging, advertising and other consumer information. Where does state, local government, and Indian tribes fall with the potential federal oversight?  They may impose any law, rule, regulation, etc. as long as requirements established by the federal agencies are adopted. Although adding the oversight of these federal agencies will provide much needed guidance for the cannabis industry, these additional agencies may conflict with current state regulations. This may result in  tons of untangling of current and proposed marijuana regulations.

FDA Would Create “Center for Cannabis Products”

The discussion draft stated we should expect the FDA to create a “Center for Cannabis Products” to spearhead regulating cannabis products. Under the proposal, “food and cosmetics that contain cannabis would continue to be regulated as food and cosmetics by the Center for Food Safety and Applied Nutrition and also by the Center for Cannabis Products”.

An interesting twist is the proposal to allow structure-function claims for cannabis products. This is mainly allowed because cannabis products would not be regulated as dietary supplements. Historically, dietary supplements are allowed to have certain claims on product labels. In today’s regulated market, dietary supplements may only allow structure-function claims if it’s supported by scientific evidence and accompanied by specific FDA statements on the product labels.

The Center for Cannabis Products would have the obligation to ensure companies are registered, abide by recordkeeping requirements, implementation good manufacturing practices (GMP), establish product standards, oversee product distribution, recall, and product labeling. The FDA will have regulations detailing GMPs for planting, cultivation, growing, and harvesting of cannabis products.

Legal Pathway for CBD in Dietary Supplements

You read that right! The draft detailed creating a legal pathway for CBD to be marketed as a dietary supplement but with limitations on the amount of CBD per serving. The allowed concentrated CBD per serving was not covered in the proposal; however, the draft noted that certain infused supplements will be required to have a New Dietary Ingredients (NDI) submitted to the FDA.

What’s Not Allowed Under Discussion Draft

The FDA detailed the minimum age for purchasing cannabis – 21 years of age. No surprise there. The proposal would prohibit electronic cannabis product delivery systems from containing natural or artificial flavors. Other cannabis products not allowed include products that contain alcohol, caffeine or nicotine, which aligns with most states regulating cannabis products. The proposal specified that if cannabis products are not in compliance, these products would be deemed adulterated or misbranded which is a violation of federal law. 

Love or Hate the Drafted Discussion, It’s a Start for Future Federal Legalization

The Cannabis Opportunity and Administration Act could be seen as a bit of a double-edged swordhowever we finally are discussing potential federal legalization, which is a win for the War on Drugs and the cannabis community. See something you’d like to change? See below for information on submitting a comment to the Sponsoring Office.

Cannabis Administration and Opportunity Act Sponsoring Offices are Requesting Comments

The Cannabis Administration and Opportunity Act Sponsoring Office is requesting comments from stakeholders and members of the public, including social and criminal justice advocates, industry stakeholders, members of the public health and law enforcement communities, members of Congress, federal officials, state and local officials, and others for review and comment.

Submit comments in writing by September 1, 2021 to email: Cannabis_Reform@finance.senate.gov.

“Please note that while the Sponsoring Offices do not intend to publicly post all submissions, details from comment letters may become part of the public record through the course of the legislative process. If a comment involves sensitive information, stakeholders may contact the Sponsoring Offices directly to discuss the appropriate way to securely submit such information.”