All posts by Seth A. Goldberg

CBD’s Big Week – Now Walgreens to Sell in Select States

Seth Goldberg
Seth A. Goldberg

Last week, I wrote about CVS Pharmacy’s decision to sell hemp-derived CBD products in eight states, Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee.  Today, one of its competitors, Walgreens announced a similar decision – Walgreens will be entering the hemp-derived CBD space Walgreens in Oregon, Colorado, New Mexico, Kentucky, Tennessee, Vermont, South Carolina, Illinois and Indiana, where it will sell CBD creams, patches and sprays in nearly 1,500 stores.

As with CVS, Walgreen’s decision to sell hemp-derived in CBD in select states, as opposed to rolling those products out nationally, is likely the result of the still developing federal regulatory framework for hemp, which includes forthcoming regulations and guidance from USDA and FDA, and differences in the laws pertaining to hemp and hemp-derived CBD products from state-to-state.

Notwithstanding the challenging regulatory environment, the mass marketing of hemp-derived CBD, now that hemp is no longer a federal controlled substance, provides a lucrative opportunity for the hemp-derived CBD supply chain – cultivators, processors, and retailers, including the major pharmacy chains.  However, the “select state” approach Walgreens and CVS have taken demonstrates that careful is analysis of the federal and state laws and regulations at play is necessary before entering the hemp-derived CBD market.

 

The Light is Still Yellow, but Hemp-Derived CBD Hits The Mass Market

Seth Goldberg
Seth A. Goldberg

CVS Pharmacy’s announcement  that it will be selling hemp-derived CBD topicals, including creams, sprays, roll-ons, lotions and salves in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee, should really come as no surprise, as the mass marketing of CBD has been an eventuality since hemp was removed from the Controlled Substances Act’s definition of marijuana with the signing of the 2018 Farm Bill in December 2018.  CBD’s therapeutic benefits, without the psychoactivity of THC, have made products containing CBD the darling of the cannabis industry.

However, as CVS’s decision to market hemp-derived CBD products in select states demonstrates, the 2018 Farm Bill was not a total green light.  USDA has yet to establish regulations fully implementing the federal hemp program, which would allow states to establish their own rules for cultivation, processing and sale of hemp, meaning state-by-state differences in the laws concerning cannabis, including hemp, must be assessed before marketing products like hemp-derived CBD.  Such federal regulations should be promulgated later in 2019, ahead of the 2020 growing season.

In addition to USDA, FDA has authority over CBD-containing products under the Food, Drug and Cosmetics Act, adding another layer of regulatory complexity that makes the 2018 Farm Bill’s removal of hemp from the CSA more of a yellow light for marketing hemp-derived CBD. Thus, manufacturers and distributors of CBD products must assess how CBD fits in with FDA and state rules concerning drugs and drug approvals, active pharmaceutical ingredients, health claims and labeling, and foods and beverages. FDA has said it is evaluating CBD closely, and should be providing guidance later in 2019.

Because the light is still yellow on the marketing of hemp-derived CBD, manufacturers and distributors should carefully evaluate the federal and state regulatory framework before marketing their CBD products.

Final 2018 Farm Bill Proposed… Hemp to be Removed from CSA – CBD Derived from Hemp to Be Regulated by the States

Seth Goldberg
Seth A. Goldberg

Update: The Senate passed this bill on December 11, 2018; the House of Representatives passed it on December 12, 2018. It was signed into law on December 20, 2018. 
Duane Morris will be following further developments and issuing updates.

Key Points:

  • The 2018 Farm Bill removes hemp from the Controlled Substances Act;
  • The 2018 Farm Bill confers on the Department of Agriculture (“DOA”) authority over hemp, including CBD derived from hemp;
  • States desiring to have primary regulatory authority over hemp must submit a plan to DOA pursuant to which the state will establish hemp regulations to provide for the growth and use of hemp, including CBD derived from hemp;
  • No laws will be erected to prohibit the interstate transportation of hemp, or CBD derived from hemp;
  • The Food and Drug Administration may intensify its involvement with CBD as more products for human consumption hit the market;
  • Banking and insurance for hemp derived CBD products should become increasingly available as those products are no longer “unlawful”; and
  • CBD derived from unlawful marijuana is still unlawful.

Analysis:

Earlier this year the U.S. Drug Enforcement Administration (DEA) affirmed that cannabidiol (CBD), the non-psychoactive chemical produced by strains of the cannabis plant credited with providing therapeutic health benefits, is unlawful if it is extracted from the parts of the cannabis plant that fall within the definition of marijuana.  This pronouncement added another layer of confusion to a regulatory structure many had trouble understanding.  CBD can also be extracted from industrial hemp and industrial hemp has been lawful since the enactment of the 2014 Farm Bill, provided it is grown pursuant to a state industrial hemp agricultural program.  The 2014 Farm Bill did not include explicit provisions pertaining to the commercialization of CBD derived from industrial hemp, or the interstate transportation of industrial hemp.  The former was left to the states that established industrial hemp programs, and the latter was later passed on by the DEA, which permitted the interstate transport of industrial hemp finished products.  Consequently, the distinction between CBD derived from industrial hemp and CBD derived from unlawful marijuana was narrow enough to impede the development of industrial hemp derived CBD products because of a concern that federal prosecution could follow.

Enter the 2018 Farm Bill, known as the “Agriculture Improvement Act of 2018,” set forth  in final form in a Conference Report yesterday, and which will be voted on as early as this week and could be signed into law next week.  The 2018 Farm Bill defines hemp as follows:  The term ‘hemp’ means the plant Cannabis  sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids,  salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.  It goes on to explicitly remove hemp from the Controlled Substances Act, as follows:

SEC. 12619. CONFORMING CHANGES TO CONTROLLED SUBSTANCES ACT.
(a) IN GENERAL.—Section 102(16) of the Controlled Substances
Act (21 U.S.C. 802(16)) is amended—
(1) by striking ‘‘(16) The’’ and inserting ‘‘(16)(A) Subject to
subparagraph (B), the’’; and
(2) by striking ‘‘Such term does not include the’’ and inserting
the following:
‘‘(B) The term ‘marihuana’ does not include—
‘‘(i) hemp, as defined in section 297A of the Agricultural
Marketing Act of 1946; or
‘‘(ii) the’’.
(b) TETRAHYDROCANNABINOL.—Schedule I, as set forth in section
202(c) of the Controlled Substances Act (21 U.S.C. 812(c)), is
amended in subsection (c)(17) by inserting after
‘‘Tetrahydrocannabinols’’ the following: ‘‘, except for
tetrahydrocannabinols in hemp (as defined under section 297A of
the Agricultural Marketing Act of 1946)’’.

The 2018 Farm Bill confers on the DOA the regulation of hemp, and contemplates federal regulations that would allow for states to become the “primary regulator” of hemp.  Importantly, the 2018 Farm Bill explicitly provides for the interstate transportation of hemp and prohibits states from restricting the interstate transportation of hemp, stating “nothing in this title or an amendment made by this title prohibits the interstate commerce of hemp (as defined in section 297A of the Agricultural Marketing Act of 1946 (as added by section 10113)) or hemp products…No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (as added by section 10113) through the State or the territory of the Indian Tribe, as applicable.”

The passage of the 2018 Farm Bill is expected to result in a quick proliferation of the already expanding CBD product market, as companies that have been developing and marketing CBD products should now feel less constrained by risk to deepen their investment, and companies that have been “waiting to see” may now jump in. Because many of these products are for consumption in food-related products, and/or claim to have therapeutic benefit, the FDA is likely to intensify its involvement with CBD regulation.

Significantly, the 2018 Farm Bill does not remove CBD derived from THC-containing marijuana from the Controlled Substances Act.  Consequently, the DEA’s pronouncement as described above is still in effect, CBD derived from unlawful marijuana is still unlawful.  However, there is now clarity.  CBD derived from “hemp,” as defined in the 2018 Farm Bill, and grown pursuant to state regulations established pursuant to the 2018 Farm Bill, is lawful and may not be the subject of federal prosecution.

Banking:  It should be underscored that banks and other financial institutions, such as investment firms and insurance companies, that have been cautious or reluctant about CBD products because of their connection to unlawful marijuana may view the 2018 Farm Bill as a green light for banking, investing and insuring hemp derived CBD products as hemp and CBD derived from hemp are no longer “unlawful.”

Most importantly, the 2018 Farm Bill does not eliminate the regulation of hemp or CBD derived from hemp.  Rather, it envisions the promulgation of additional federal regulations and state regulations intended to promote its growth and use, and federal agencies like the FDA may increase their involvement with CBD.  Those interested in participating in the hemp and hemp derived CBD markets should retain counsel well-versed in the pertinent state and federal regulations to provide guidance that will allow for the achievement of business objectives.

One last point, there is currently pending in Congress bi-partisan legislation that would confer on states the authority to regulate marijuana.  The 2018 Farm Bill, which confers on states the authority to regulate hemp, could be a precursor and a good model for such states’ rights marijuana legislation.

 

 

Big Tobacco and Big Alcohol Invest Big in Cannabis in 2018

Seth Goldberg
Seth A. Goldberg

Altria announced today its $1.8 billion investment in Cronos Group, a Canadian cannabis grower, processor and dispensary, and the first pure cannabis play to be traded on a major US stock exchange, NASDAQ Earlier this year, Constellation Brands invested $4 billion in Canopy Growth, a large cannabis focused investment fund.

These investments demonstrate the strengthening gravitational pull of the cannabis space on non-cannabis companies.  The significant involvement of major companies like Altria and Constellation likely comes as no surprise to those following the burgeoning cannabis space, and should have their competitors considering similar moves.  There are innumerable legal hurdles to clear in entering the space, but there are few markets today that offer new ground to plow.

The DEA Affirms CBD Derived from “Marijuana” Is Federally Unlawful

Seth Goldberg
Seth A. Goldberg

The Controlled Substances Act defines “marijuana” as:  all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

The DEA has recently affirmed its position that CBD sourced from the parts of the plant that are included in the definition of marijuana are unlawful.   This is true even if the CBD does not contain any THC.  CBD derived from the excluded parts of the marijuana plant does not violate federal law.   Were it to investigate/prosecute a business  or individual for possessing CBD, the DEA would place the onus on the target to prove the CBD was sourced from the lawful parts of the plant.

Just like THC-containing products that are lawful under a state’s marijuana laws, CBD that may be lawful under a state’s marijuana laws, is still federally unlawful if sourced from the parts of the plant included in the definition of marijuana.

Constellation Brands’ $4B Cannabis Investment

Seth Goldberg
Seth A. Goldberg

On August 15, 2018, Constellation Brands, which owns popular beer, wine and spirits products, such as Corona, Robert Mondavi and High West, announced it is investing $4 billion in Canopy Growth, which is one of the leading investors in the global legal cannabis market.  The announcement boosted Cannabis market stocks in the US and Canada, and is likely to catch the eye of big alcohol, big tobacco, big pharma and larger consumer products companies that have been interested in entering the growing legal marijuana markets.  More and more companies once-hesitant about doing so are finding that good counsel can help them navigate the regulatory hurdles that might otherwise stand in the way of profiting from this exciting market.

Momentum Builds With Schumer’s Bill To Legalize Marijuana

Seth Goldberg
Seth A. Goldberg

Just weeks after Senators Elizabeth Warren (D-Mass) and Cory Gardner (R-Colo) introduced bi-partisan legislation to make marijuana lawful under a state’s marijuana laws also lawful under the Controlled Substances Act (CSA), Senate Minority Leader Chuck Schumer (D-NY) introduced legislation removing marijuana from the CSA altogether on Wednesday, June 27.  Schumer’s bill also comes just one day after Oklahoman’s passed legislation legalizing medical marijuana in their traditionally red state, and one day before the U.S. Senate passed legislation legalizing hemp for all purposes, including extracts from hemp, such as cannabidiol.

By removing from the purview of the CSA, state-legal cannabis and proceeds derived therefrom, the Warren/Gardner legislation, if passed, would likely have the effect of nationwide legalization, but state operators and consumers would still need to be concerned about marijuana’s Schedule 1 status under the CSA, whereas the Schumer bill, if passed, would eliminate those concerns by removing marijuana from the CSA.

Cannabis Banking Concerns a Focus of Proposed States’ Rights Bill

Seth Goldberg
Seth A. Goldberg

On Wednesday, an article I wrote describing the public safety concerns that result from the lack of banking in the cannabis industry due to the federal prohibition of marijuana was published in the National Law Journal.

Yesterday, Senators Elizabeth Warren (D-Mass) and Cory Gardner introduced bipartisan legislation that, if passed, would make the regulation of marijuana a state issue. Comments by Senator Gardner show public safety issues resulting from the dearth of banking providing services to the industry are a focus of the newly-proposed legislation. The Hill reports Gardner stating when introducing the legislation:

“This city of Denver, the state of Colorado, can collect taxes … they can take it to the bank,” Gardner said. “But if you’re in the business, if you work for the business, you can’t get a bank loan or set up a bank account because of the concern over the conflict between the state and federal law. We need to fix this public hypocrisy.”

It was widely reported on April 13, 2018, that President Trump promised to Senator Gardner that he would support a states’ rights approach to marijuana, which promise appears to have resulted in this proposed legislation.  A lot has to happen before this bill reaches Trump, but if it does, a veto may be unlikely.  Such states’ rights legislation could then pave the way for more banks to service the industry.

California Attempts to Address Public Safety with Cannabis Banking Legislation

Seth Goldberg
Seth A. Goldberg

I have previously written about the public safety concerns resulting from the lack of banking in the cannabis industry.  As I noted in that article, the elimination of the Cole Priorities in January 2018 has left federally-regulated banks wondering how they can follow FinCen’s guidance for banking cannabis issued in February 2014, which was explicitly dependent on the Cole Priorities.

While the Cole Priorities were in place, that guidance provided a clear path for banking cannabis industry participants adhering to the Cole Priorities.  FinCen’s guidance is still in place, and banking cannabis is still possible, but confusion about how to do so without the Cole Priorities as guideposts has caused greater reluctance on the part of banks.

Enter proposed legislation in California, SB-930,  which passed in the California Senate yesterday.  Not a complete solution to the banking problem by a long shot, but progress nonetheless.  If it becomes law SB-930, would result in the establishment of a California-chartered bank that would permit California cannabis industry participants to deposit the proceeds of their state-lawful cannabis activities, and would provide to them limited banking services that would allow for payment of taxes and vendors by check.

As reported in the Sacramento Business Journal, the Bill’s sponsor, Sen. Bob Hertzberg (D-Van Nuys), characterized SB-930 as an attempt alleviate the public safety concerns resulting from the federal government’s current hands off approach to banking cannabis.  As Herzog stated, “It’s not only impractical from an accounting perspective, but it also presents a tremendous public safety problem. This bill takes a limited approach to provide all parties with a safe and reliable way to move forward on this urgent issue.”

FDA to Consider Approval of Botanical (not synthetic) CBD Drug

Authored by Robert Prince, Ph.D, https://www.duanemorris.com/attorneys/robertwprince.html

On Thursday April 18, 2018, at 8:00AM-12:30PM EST, an FDA advisory panel will consider whether to recommend or not recommend approval of GW Pharmaceutical’s cannabis-based drug Epidiolex ® for use in treating two rare types of epilepsy in children- Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex is an oral formulation of a purified form of cannabidiol (CBD) a component found in cannabis. CBD does not have any psychoactive effects as compared to another component of cannabis tetrahydocannabinol (THC). Epidiolex has less than 0.1 percent of THC.

If approved, Epidiolex would be the first botanical cannabis product approved in the U.S. for any indication. The FDA has approved Marinol® and Syndros® for uses in the U.S. for the treatment of anorexia associated with weight loss in AIDS patients. Both products contain dronabinol, a synthetic delta-9-tetrahydrocannabinol. Another FDA approved drug Cesamet® contains nabilone, which is a synthetic drug with a structure similar to THC that is used to treat nausea and vomiting.

The FDA released briefing documents on April 17, 2018, which did not seem to raise any major issues with Epidiolex, resulting in the share price of GW Pharmaceuticals to rise sharply- up 2.27%. The Center for Drug for Drug Evaluation and Research (CDER) indicates that it plans to provide a free of charge, live webcast of the April 19, 2018 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. Information regarding the webcast, including the web address for the webcast, will be made available at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. At the time of writing this note, the FDA has not provided any login information for the webcast.