California’s Bureau of Cannabis Control Submits Final Regulations for Administrative Review

The three agencies that regulate the cannabis market in California, the Bureau of Cannabis Control, Department of Food and Agriculture, and Department of Public Health, submitted a final version of regulations to the Office of Administrative Law (“OAL”) in California this month. The OAL reviews regulations for compliance with procedural requirements and substantive standards under California law. The OAL has 30 working days — until January 16, 2019 —  to review the regulations.

This blog post will highlight some of the important changes to the regulations made by the Bureau of Cannabis Control (“BCC”). Continue reading “California’s Bureau of Cannabis Control Submits Final Regulations for Administrative Review”

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.

Mitch McConnell’s Farm Bill Could Blow Up the CBD Market

Seth Goldberg
Seth A. Goldberg

CBD is already big business in America with hundreds of millions of dollars in sales every year. But the market for pot’s second most famous compound might soon skyrocket thanks to a somewhat unlikely ally: Kentucky Senator Mitch McConnell.

The powerful Republican from Kentucky included provisions in this year’s Farm Bill that would fully legalize industrial hemp. That bill is now a top priority for Congress to pass before the end of the year, and if it becomes law we might see CBD on the shelves of every drug store in America.

To read the full text of this article, in which Duane Morris partner Seth Goldberg was quoted, please visit The Stranger’s website.

Mexico’s Supreme Court Strikes Prohibition on Private Consumption of Marijuana, Paving Way for Legalization

On October 31, 2018, the Supreme Court of Justice of Mexico (Suprema Corte de Justicia de la Nación) ruled in favor of two constitutional challenges (amparos) against the prohibition of the recreational consumption of marijuana. This now marks the fifth ruling on this subject and establishes jurisprudence. As a result, this precedent will now have to be followed by Mexican courts.

Although the consumption of marijuana remains illegal, the rulings under amparos 547/2018 and 548/2018 have effectively made laws prohibiting recreational use of marijuana unenforceable by Mexican courts.

The decision is based on the protection of the constitutional right to personal development. This right, held the court, permits adults to freely decide what recreational activities they wish to undertake and extends to protect any action that is necessary for the exercise of said freedom, without interference by the state. While the court recognized that there are necessary limits to this freedom, it nonetheless held that the effect of consumption of marijuana did not rise to the level of a justifiable interference with a constitutional right. Furthermore, this right does not extend to the commercialization of the drug, nor to the right to consume any other type of drug. …

Read the full Duane Morris Alert

Duane Morris LLP Named American Trade Association for Cannabis & Hemp’s “National Law Firm Partner”

Duane Morris LLP and the American Trade Association for Cannabis & Hemp (ATACH) today announced the first-ever partnership agreement between an American Lawyer (Am Law) 100 law firm and a cannabis trade association. Duane Morris LLP is a law firm with more than 800 attorneys in offices across the United States and internationally. It marks the largest and most significant law firm partnership with a cannabis trade association to date.

Read the full announcement on the ATACH website.

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.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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