Delta-8 THC Public Health and Safety Concerns Mount

Seth Goldberg
Seth A. Goldberg

Public health and safety concerns about delta-8 THC appear to be on the rise. A study published by JAMA this week showed that approximately 11% of all 12th graders in the US reported using products containing D-8 THC, with a higher prevalence in states that do not have existing D-8 THC regulations., and a related JAMA editorial, entitled “The Public Health Challenge of Δ8-THC and Derived Psychoactive Cannabis Products,” noted that D-8 THC products pose a risk to public health and safety because they are largely unregulated, in contrast to state-regulated medical and adult use marijuana.  As the authors of that editorial explain:

“The weak regulatory infrastructure for Δ8-THC has led to manufacturing, advertising, and sales practices that are inconsistent with public health and safety.Δ8-THChas been marketed to consumers as a low-risk medicinal cannabinoid product despite limited evidence for effectiveness. It has also been sold directly to minors through brick-and-mortar and online vendors, some of which do not restrict sales based on age. Inaccurate content labeling and potentially harmful adulterants are serious problems in the unregulated cannabinoid market. Products sold under the Δ8-THC designation vary considerably with regard to dosing and constituent ingredients.13 In an analysis of 20 commercial products marketed as Δ8-THC, authors observed that 5% of the products did not contain Δ8-THC and, among samples that did contain Δ8-THC, the quantities in each product varied markedly from advertised values.13 There is also evidence that products sold as Δ8-THC contain unlabeled constituents that may be dangerous for consumers.14 It is not known whether the constituents were added during manufacturing processes or whether they were added intentionally or because of poor
quality control procedures.”

The editorial’s authors note the need for more rigorous manufacturing, advertising, and sales standards for D8-THC and other intoxicating cannabis-related products, and encourage federal legislators to use the next Farm Bill to address the loophole in the 2018 Farm Bill that has resulted in the proliferation of D8-THC and other intoxicating substances chemically synthesized from hemp: 

“Given the potential harms posed by the widespread availability of Δ8-THC and other derived psychoactive cannabis products, more rigorous standards for manufacturing, advertising, and sales are warranted. The 2018 Agriculture Improvement Act is set to expire in September 2024, and legislators may take the opportunity to strengthen the regulatory infrastructure for derived psychoactive cannabis products or exclude certain derivative products from the statutory definition of hemp.”

 

 

 

FDA Warning Letter Targets Delta-8 THC

Seth Goldberg
Seth A. Goldberg

On December 5, 2023, FDA issued a warning letter to a manufacturer (Hemp XR) of food products, such as gummies, cookies, etc., that contain delta-8 THC.  The warning letter notes that delta-8 THC has not been generally recognized  as safe (GRAS) for use in food, and has not received pre-market approval to be used as a food ingredient, which requires data demonstrating safety.  As a result, FDA warns that the interstate marketing of the food products at issue violates the Food, Drugs and Cosmetics Act.  The warning letter makes similar assertions with respect to the manufacturer’s food products containing CBD. 

FDA notes that its concerns with respect to delta-8 THC include:  “1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children.”

As I have previously written, manufacturers of products containing delta-8 THC are exploiting an ambiguity in the definition of hemp under the 2018 Farm Bill that they assert legalized chemical substances converted from hemp cannabinoids through chemical processes on the notion that such substances were “derived” from hemp.      

California AG Targets Online Sales of Hemp Synthesized Delta-9 Inhalable Products

Seth Goldberg
Seth A. Goldberg

On September 11, 2023, the California Attorney General’s Office filed a Complaint against a handful of manufacturers of “inhalable hemp products” because they contained hemp-synthesized Delta-9 THC and beta-Myrcene.   The Complaint alleges that the sales of such inhalable hemp products violates California’s Proposition 65 and California’s Unfair Competition statutes.   Although under California’s AB 45 hemp and cannabinoids, extracts, or derivatives of hemp are permitted to be included in food and beverages , dietary supplements, cosmetics, processed pet food, AB 45 explicitly prohibits the sale of inhalable hemp products in California.  Likewise, Prop 65 identifies Delta-9 THC and beta-Myrcene as chemicals known to cause developmental harm, and are thus required to be labeled accordingly; Defendants products were not so labeled.  Importantly, none of the Defendants are California residents, and all of the products at-issue appear to have been purchased online and delivered from outside California.  Thus, this action should send a strong message to hemp synthesized D-9 manufacturers selling inhalable products into California.

“How to Free CBD from the FDA’s Grasp: Call It GRAS,” The Cannabis Reporter Radio Show with Rick Ball

Duane Morris partner Rick Ball was a guest speaker on The Cannabis Reporter Radio Show, hosted by Snowden Bishop, on May 20, 2019. The episode is titled “How to Free CBD from the FDA’s Grasp: Tell Congress to Call It GRAS,” and can be found on The Cannabis Reporter website.

About the Episode

When Congress legalized agricultural hemp with the passage of the 2018 Farm Bill, it seemed like the hemp industry would finally be out of the woods from a regulatory standpoint. So, it defies logic that the FDA is creating obstacles for hemp CBD producers and that every-day people are still being arrested for possession of hemp biomass and extracts.

Just last week, a 67-year-old great grandmother was arrested at the happiest place on earth when a Disney World employee discovered a bottle of CBD in her purse after a routine inspection at the park entrance. You may recall the truck driver who was arrested in Idaho with a load of freshly harvested hemp on its way from Oregon to a processing plant in Colorado just weeks after the hemp measure was signed into law.

Incidents like that leave most of us scratching our heads, considering that hemp is now legal at the federal level and hemp-derived CBD is a harmless molecule that is naturally produced in our own bodies when we’re young.

Let’s face it, legal hemp seems to be an oxymoron. Minutes after the hemp measure was signed into law, the FDA blindsided the elated industry with its stern warning that only one CBD product has ever been approved for sale in the U.S. and that all other hemp CBD products would remain illegal to sell until they can be approved by the FDA. The only exceptions would apply to the manufacturing and sale of CBD limited to states that had included CBD provisions in their state marijuana policy measures.

To read more about this episode and listen to the interview with Duane Morris attorney Rick Ball, please visit The Cannabis Reporter Radio Show page here.

USDA Issues Guidance on Importation of Hemp Seeds

USDA has issued its first guidance since the passage of the 2018 Farm Bill. Because the Farm Bill removed hemp from the Controlled Substances Act, the importation of hemp seeds will now be regulated by USDA as an agricultural product, not DEA.  USDA stated that by removing hemp from the CSA, the Act “removed hemp and hemp seeds from DEA authority for products containing THC levels not greater than 0.3 percent. Therefore, DEA no longer has authority to require hemp seed permits for import purposes.” Importation of hemp seeds from international sources will now be permitted if accompanied by the appropriate phytosanitary certification and will be subject to inspection by Customs and Border Patrol.

The reference to DEA authority is significant and confirms that DEA no longer has jurisdiction over hemp or products derived from hemp such as CBD oil.  DEA  needs to update its own guidance documents in light of the 2018 Farm Bill. USDA is working on regulations to implement the state cultivation program provisions of the Farm Bill.  They are expected to be in place in time for the 2020 growing season.

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.

 

No Hemp Transport Through Idaho

A recent decision by a Federal Magistrate Judge for the United States District Court for the District of Idaho upheld the seizure of an industrial hemp shipment in January after the enactment of the 2018 Farm Bill.

On January 24, 2019, Big Sky, a Colorado-based company, shipped industrial hemp from Oregon thorough Idaho on its way to Colorado. The hemp was seized in Idaho and the driver arrested for illegal transportation of marijuana. The crime carries a 5 year mandatory sentence. Big Sky sued for a temporary restraining order to release the hemp under the 2018 Farm Bill. The Court found that because no plan from the State of Oregon had been approved by the Department of Agriculture, the seized hemp was not produced in accordance the 2018 Farm Bill. The Court held that at this point time, without USDA approval of a state hemp plan, the Interstate Commerce Clause provisions of the Farm Bill do not apply.  A Temporary Restraining Order was denied on 2/2 and the Preliminary Injunction was denied on 2/20. Big Sky Scientific LLC v. Idaho State Police et al., No. 1:19-cv-00040-REB (D. Idaho, February 2, 2019). The case is on expedited appeal to the Ninth Circuit. Opening brief is due 3/20.

This decision is contrary to the intent, if not the letter, of the Farm Bill. It creates confusion about the what is permissible now, prior to USDA regs and approval of state plans.

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.

 

 

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

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

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