Regulated Industries Update: FDA Approves Psilocybin for Phase 2 Clinical Trials

We keep a close eye on developments across all regulated industries, and we’re coming to you today with an update on the classification of psilocybin, the main ingredient in psychoactive mushrooms--also known as magic mushrooms.  

Although psilocybin is commonly known as a psychedelic drug, it is recognized in some circles as a productivity aid at low doses, and soon enough it may be used as a prescription drug for treatment-resistant depression. 

In August the Food & Drug Administration (FDA) granted approval to Compass Pathways to perform clinical trials using psilocybin.  Compass is a life sciences company that will participate in Phase 2 trials by administering psilocybin treatment to 216 patients. If successful, the trial will move on to Phase 3 by administering the drug to a larger group. If they pass that hurdle, Compass will have to seek and receive “new drug” approval and the DEA will have to re-schedule the drug.  

6 Things You Show Know About California’s New Industrial Hemp Law

In addition to providing guidance on regulated industries such as cannabis, Brand & Branch LLP regularly advises clients on matters related to industrial hemp, including cross-border licensing for trade secrets and brands used with hemp-derived CBD products.  See one of our previous posts on hemp here.

This post is an introduction to six things you should know about SB 1409, a new California law that opens up industrial hemp production in the state by expanding the allowable parameters of hemp cultivation, among other things. The law goes into effect on January 1, 2019. Here’s what you need to be aware of so you’re ready for the change.  

1.     It removes the prohibition on cultivating hemp, allowing hemp to be grown for extracts and whole plant use.   

SB 1495 changes how industrial hemp is classified under state law. The definition of hemp will no longer be subject to the California Uniform Controlled Substances Act. Although the clandestine cultivation of industrial hemp is still prohibited, this new law removes the prohibition on pruning, tending, and culling industrial hemp. Under the new definition, hemp may now be grown for whole plant use and for extracts, including CBD extraction. This change is especially notable in light of previous FDA guidance on the lawfulness of CBD in food products and subsequent enforcement efforts.

Brand & Branch Issues Public Comment on Proposed California Cannabis Regulation

The proposed regulation would prohibit common industry practices such as white labeling and IP licensing

Our firm has prepared a public comment in opposition to the following Proposed California Regulation issued by the Bureau of Cannabis Control:

§ 5032. Commercial Cannabis Activity
(b) Licensees shall not conduct commercial cannabis activities on behalf of, at the request of, or pursuant to a contract with any person that is not licensed under the Act. Such prohibited commercial cannabis activities include, but are not limited to, the following:
(1) Procuring or purchasing cannabis goods from a licensed cultivator or licensed manufacturer.
(2) Manufacturing cannabis goods according to the specifications of a non-licensee.
(3) Packaging and labeling cannabis goods under a non-licensee’s brand or according to the specifications of a non-licensee.
(4) Distributing cannabis goods for a non-licensee.

You can read the full text of our public comment by clicking here.

Hemp for the Hempless? What Legalized Hemp Could Mean for Cannabusiness

April and June 2018 were months of major moves toward federal legalization of cannabis. Part of that push was led by Senate Majority Leader Mitch McConnell (R-KY), who, in April, introduced the Hemp Farming Act (HFA), which provides for the removal of industrial hemp from Schedule 1 of the Controlled Substance Act  (CSA). In June 2018, the HFA was rolled into the 2018 Farm Bill, and on June 28, 2018, the Senate passed its version of the Farm Bill, which included the entire HFA. The House also passed its version of the Farm Bill, but it’s silent on hemp. Many speculate that the House version stems from confusion of hemp with marijuana that—once cleared up—would greatly increase the chances of the Senate version becoming law.

If the Senate version of the Farm Bill prevails, it would end a nearly century-long federal prohibition of hemp as an agricultural commodity. Ending this prohibition would mean all hemp-derived products—including cannabidiol (CBD)—would be legalized. It would also harmonize the CSA and 2014 Farm Bill (currently in effect) definitions of marijuana and industrialized hemp as well as severely undermine the Drug Enforcement Administration’s position on CBD.

O Cann-ada! Cannabis Opportunities Far and Wide

This year, Canada will become the first G-7 country to legalize recreational cannabis nationwide—at all governmental levels—creating a bounty of business, investment, and brand expansion opportunities.

The Canadian market is attractive not only because cannabis is legal throughout the country, but also because Canadian cannabis companies have international export abilities. Many of Canada’s licensed producers (LPs) (many of which are also publicly traded) are involved in international markets like Europe, Australia, South America, and Israel, creating the potential for an even broader customer base than Canada’s 36 million residents. Many of these LPs are also able to seek cultivation facility licenses with investors abroad. All this combined with a predictable, transparent regulatory system makes Canada ideal for American investors and entrepreneurs looking to seize an opportunity in an emerging market.

Whether you are seeking an investment opportunity or are interested in exploring Canadian partnerships for your brand, the first step is to contact us. We can help you navigate this growing terrain, negotiate licensing and partnership agreements, and maximize your brand value.

State Trademark Registration: Is It Worth It? You Should Work It.

As a business owner, you likely already understand the importance of protecting your brand. Among other things, a strong brand means greater value and increased customer loyalty. But as a canna-business owner, given the tensions between state and federal regulations, brand protection can be challenging, particularly when it comes to trademark law.

            You may know how difficult it is to obtain a federal trademark registration for cannabis products, and perhaps you’ve given up pursuing one. But have you considered a state trademark registration?

Green Crack(down): FDA to Enforce Against Cannabis Health Claims?

Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) thinks it’s “high time to start looking at rules around [cannabis].” Given that twenty-nine states and Washington, D.C. have already legalized medical marijuana, Gottlieb’s concern is a little late, but it signals change is afoot.

From a branding and advertising perspective, what might this mean? For now, that depends on a company’s labeling and advertising. The FDA has extensive power to regulate food and drugs, and it determines whether something is a food or drug by looking to product labels and advertisements. If a label or advertisement makes health claims signaling to the FDA that the substance is a drug, the FDA will view it with great scrutiny.

Trademark Filing Services: To Use or Not to Use?

Trademark filing services, like Legal Zoom or Trademarkia, can be cost-effective solutions in some instances. But they may not be an ideal fit for cannabis companies, which face unique trademark and other legal issues. Trademark protection in the cannabis space requires nuanced, tailored advice, not a one-size-fits-all, quantity-over-quality approach. In determining your trademark protection needs, consider the following, which contrasts guidance available from a trademark filing service with what a firm offers.