2018 Farm Bill – Cannabis Industry

August 14, 2024August 14, 2024 by Seth A. Goldberg

Weighing the Risks of Marketing Delta-8 and Similar Substances

I originally published the blog below with the title “Delta-8 Bans Are Having a Moment,” which on reflection seems a bit flip. The reality is that the ambiguities in the 2018 Farm Bill and the lack of federal regulation of such substances have created a conundrum for those who market Delta-8 and similar substances, as well as for the cannabis industry, and for states that are weighing public safety against financial interests.

Just as those who were participating in the cannabis industry in its early days – before federal cannabis policy was so transparent – had to weigh the risk of federal enforcement and criminal penalties, purveyors of intoxicating substances manufactured from hemp cannabinoids must weigh the risk that the 2018 Farm Bill could be read by some, including Congress and state governments, as not legalizing those substances simply because they have some relation to legal hemp.

As a lawyer who represents clients who manufacture and market cannabis and hemp products, I have seen them weigh the risks attendant to the unclear regulatory landscapes for both cannabis and hemp, and I have not been surprised – and have been disappointed – when some have opted not to make the leap into cannabis or hemp.

Even today, where cannabis is legal and where federal cannabis policy has de-prioritized enforcement against state cannabis activities that comply with state law, the cannabis market is too risky for the vast majority of businesses to expand into. Think about all of the consumer packaged goods companies that have been watching cannabis and hemp, but have not made the move, not even to CBD, not to mention almost the entire financial institution market.

Thus, when those who have decided to market Delta-8 and similar intoxicating substances on the basis that the 2018 Farm Bill legalized them, I can’t help but think about whether they were advised about and accepted the risk that the 2018 Farm Bill could be read differently, or they simply jumped into the market blindly or on poor advice. Yes, the market for those substances has grown and is in the billions, but that does not somehow make the 2018 Farm Bill less ambiguous or somehow make the substances any safer.

The fact that cannabis companies are increasingly moving to hemp and even Delta-8 and similar substances also does not change the ambiguity in the 2018 Farm Bill. It does, however, underscore the risk cannabis market participants took when they entered a space burdened by the capital restraints resulting from federal prohibition and 280E. Many of these companies are now desperately in need of another source of revenue, and hemp is a logical choice, but there is still a risk when it comes to Delta-8 and similar substances.

The tack of saying there is a cannabis and hemp “civil war,” or that state bans against Delta-8 and similar substances and clarifying changes to the 2018 Farm Bill will “kill the hemp industry” seems to miss the mark. This does not seem to be about the “hemp industry” or “hemp farmers,” but rather about a market that has developed for intoxicating ingestible products that may be manufactured using hemp cannabinoids and other chemicals. Every intoxicating substance poses a public safety risk, and the public safety risk resulting from Delta-8 and similar substances should outweigh financial interest. As such, the emphasis should be on whether and how to regulate Delta-8 and similar substances in a way that ensures public safety.

That state legislators and regulators are imposing restrictions in that direction does not seem surprising. States should have the right to govern these types of intoxicating substances. While bans may be undesirable, in the absence of clarity in federal law or federal regulation, it appears to be the solution for some states. As a result, those manufacturing and marketing Delta-8 and similar substances must continue to weigh the risks and manufacture and market their products knowing there is uncertainty as to the legal/regulatory landscape.

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My original blog posted under the title “Delta-8 Bans Are Having a Moment.”

Ingestible products containing substances that are manufactured using naturally occurring hemp cannabinoids, such as CBD, and other chemicals to creating intoxicating hemp substances, such as Delta-8 THC, have become increasingly available throughout the U.S., being sold at gas stations, vape shops, and convenience stores. Such substances are often as or more intoxicating than marijuana, but by and large they have not been regulated with the same product safety requirements as marijuana that has been legalized in states for adult or medical use. The FDA views such intoxicating substances as prohibited in food and beverages, and while the FDA may take enforcement action, which it has done, it has not created a regulatory framework for the manufacture and ingestion of intoxicating hemp substances. Instead, it is waiting for Congress to clarify what some perceive to be a loophole in the 2018 Farm Bill that has allowed the proliferation of such substances, because of language legalizing hemp and its “derivatives.”

Safety concerns have been raised about the intoxicating potency of these substances, as well as about the chemicals used to manufacture them, resulting in state regulations restricting or banning their use. Regardless of where you stand on whether the 2018 Farm Bill legalized intoxicating substances that can be manufactured using cannabinoids from legal hemp, in the absence of federal regulation, states have been banning or heavily restricting them in the name of public safety. While advocates of such substances decry those bans and limits, states who view them as a safety risk are taking action to protect their citizens.

In middle America, where cannabis legalization is spotty, foods and beverages containing intoxicating substances synthesized from hemp seem to have flourished, and those states have treated cannabis and intoxicating hemp substances differently. For example, in Minnesota, marijuana has been decriminalized for personal use, but has been legalized and regulated for medical use and can be sold in a handful of state-licensed dispensaries to medical marijuana card holders, whereas Delta-8 THC and Delta-9 THC artificially derived from hemp may be consumed in foods and beverages with certain serving size limitations that can be sold in stores that register with the state prior to sale.

In contrast, whereas Missouri has legalized and regulates the sale and use of marijuana for medical purposes, on August 1, Missouri Governor Michael Parson issued Executive Order 24-10, which bans “unregulated psychoactive cannabis products,” including “delta-8 tetrahydrocannabinol (THC), delta-10 THC, hexahydrocannabinol (HHC), tetrahydrocannabinol (THC-O), tetrahydrocannabiphoral (THCP), tetrahydrocannabivarin (THCV), and other similar compounds.” As the Executive Order states, “there are currently no safety standards, packaging requirements, or other regulations related to the safety of consuming unregulated psychoactive cannabis products in Missouri,” and “actions must be taken to protect consumers, including children, from the sale of foods that include unregulated psychoactive cannabis products.”

In Iowa, like Missouri, marijuana has been legalized for medical use, and the sale and consumption of marijuana is governed by Iowa’s medical regulatory program, and, like Missouri, Iowa recently issued regulations, effective July 1, 2024, banning “synthetic consumable hemp products,” including “Delta-8 THC, Delta-10 THC, Hexahydrocannabinol (HHC), Tetrahydrocannabiphorol (THC-P), and Tetrahydrocannabinol-O-acetate (THC-O).” Iowa’s ban of synthetic consumable hemp products was challenged in Climbing Kites LLC, et al., v The State of Iowa, et al., et al., 4:24-cv-202 (SD IA), by a low-dose THC beverage manufacturer, along with other low dose-THC beverage manufacturers, but after the Court refused to enjoin the ban, the lawsuit was withdrawn.

As we have previously written, Wyoming, which has not legalized marijuana in any respect also bans substances that have been converted from naturally occurring hemp into a synthetic substance, such as Delta-8, and in South Dakota, where medical marijuana is legal, but recreational marijuana is not, a federal court recently upheld a ban, like Iowa’s, on Delta-8 and other intoxicating substances converted from hemp. Hemp Quarters 605 LLC v. Governor Kristi Noem, et al., 3:24-CV-3016 (SD SD).

South Dakota HB-1125 went into effect on July 1, 2024, and provides that no person may “(1) chemically modify or convert industrial hemp as defined in § 38-35-1, or engage in any process that converts cannabidiol, into delta-8 tetrahydrocannabinol, delta9 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, or any other tetrahydrocannabinol isomer, analog, or derivative; or (2) Sell or distribute industrial hemp or an industrial hemp product that contains chemically derived cannabinoids or cannabinoids created by chemically modifying or converting a hemp extract.” HB 1125 includes the following definition for the term Chemically Derived Cannabinoid: “a chemical substance created by a chemical reaction that changes the molecular structure of any chemical substance derived from the cannabis plant. The term does not include: (a) Cannabinoids produced by decarboxylation from a naturally occurring cannabinoid acid without the use of a chemical catalyst; (b) Non-psychoactive cannabinoids; or (c) Cannabinoids in a topical cream product.”

Clearly, the manufacture and sale of intoxicating substances using hemp cannabinoids, such as Delta-8, is being scrutinized. As such, manufacturers and sellers of such products need to be mindful of the regulatory landscape.

June 19, 2024 by Duane Morris

Congress Could Redefine Hemp to Exclude Intoxicating Substances in Upcoming Farm Bill

There are countless strains of the plant Cannabis sativa L. Depending on the strain, the plant will contain a range of different chemicals called cannabinoids. New cannabinoids are still being discovered. Some of those, such as delta-9 tetrahydrocannabinol (D-9 THC), can cause psychoactive effects, while others such as cannabidiol (CBD) do not cause psychoactive effects. Nonpsychoactive cannabinoids like CBD can be chemically altered to become substances, such as delta-8 tetrahydrocannabinol (D-8 THC), that cause psychoactive effects.

In 2018, Congress passed a Farm Bill that defined “hemp” as:

[T]he 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.

Read the full Alert on the Duane Morris LLP website.

June 19, 2024 by Seth A. Goldberg

Diamond Shruumz Shows Why Intoxicating Products Should be Regulated

Recently, FDA announced issued an alert warning consumers that a brand of ingestible chocolate bars, cones, and gummies called Diamon Shruumz has been linked to a variety of severe heath symptoms, including seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting. As the name suggests, Diamond Shruumz products are marketed as a product that allows consumers to microdose – take in small doses – psilocybin and other psychoactive chemicals in mushrooms. These products are not subject to strict federal and state regulations, and can be purchased in gas stations and c-stores, or online by anyone who passes a simple age-gate. They are marketed with names that could easily be confused by consumers as products that do not contain intoxicating chemicals, such as “Hawaiian punch,” “cookies & cream,” “birthday cake,” and “cookie butter,” and their packaging is colorful and attractive. It seems obvious that intoxicating products like these need to be regulated in the interest of public safety. Regulation does not mean prohibition. It means safeguards that enable consumers to use products without unnecessary health risk, and they can protect manufacturers and supply chain participants from liability risk.

March 20, 2024 by Seth A. Goldberg

Attorney Generals Ask Congress to Fix Farm Bill “Loophole”

In a letter to Congress, 20 state Attorney Generals urge steps be taken in the upcoming Farm Bill to correct the loophole in the 2018 Farm Bill’s definition of hemp that has been exploited by those producing and distributing products chemically synthesized from hemp that are just as intoxicating, if not more so, than the cannabis sold under state-regulated cannabis programs. Noting the public health and safety concerns of such hemp-synthesized intoxicants (HSIs), and the fact that their legalization was not intended by way of the 2018 Farm Bill, the AGs suggest the Farm Bill expected this year explicitly reserve for the states the power to regulate HSIs.

Duane Morris client the American Trade Association for Cannabis & Hemp has taken a similar position in amicus briefs filed in the Eighth and Fourth Circuit Court of Appeals in Bio Gen LLC et al. v. Sanders et al. and Northern Virginia Hemp and Agriculture, LLC et al v. Commonwealth of Virginia et al.

March 13, 2024 by Seth A. Goldberg

Delta-8 THC Public Health and Safety Concerns Mount

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.”

November 8, 2023 by Seth A. Goldberg

Another Lawsuit Challenging State Regulation of Hemp Synthesized Intoxicants

Another lawsuit challenging state regulations that attempt to curb the use of hemp-synthesized intoxicants (HSI) in consumer products was commenced last week.

In a complaint filed in federal court in Alaska on November 2, 2023, AK Industrial Hemp Assoc. et al. v. Alaska Department of Natural Resources, et al, the plaintiffs challenge the constitutionality of Alaska regulations that prohibit the sale in Alakska of hemp products for human consumption that contain delta-9 THC or synthetic cannabidiol.

There are now more than half a dozen lawsuits challenging state regulations that target HSIs, which further demonstrates the need for Congress to make clarifying changes to the definition of hemp in the 2023/24 Farm Bill to correct the loophole that has resulted in the proliferation of these intoxicating and potentially unsafe substances.

On November 17 at 12:00 eastern, Duane Morris will be hosting a webinar about the “loophole” in the definition of hemp in the 2018 Farm Bill that has led to the proliferation of HSIs, including the science behind HSIs; litigation challenging state regulation of HSIs; and the 2023/24 Farm Bill and HSI policy.

October 31, 2023November 2, 2023 by Seth A. Goldberg

AG Consumer Protection Lawsuits Target Delta-8 and Perceived “Loophole” in 2018 Farm Bill

The Nebraska Attorney General and the California Attorney General have filed lawsuits recently under their states’ consumer protection statutes targeting the manufacturers of hemp products containing Delta-8 THC, noting the health and safety risk to consumers of these products. Such products, known as “hemp synthesized intoxicants” or “HSIs” are often just as intoxicating as the Delta-9 THC in state-legal adult-use and medical marijuana, but may not be subject to the same types of licensure, testing, and packaging/labeling requirements imposed under state cannabis programs.

As I have previously written, the manufacture and distribution of HSIs appears to be the result of a perceived loophole in the 2018 Farm Bill’s legalization of hemp and its “derivatives, extracts, cannabinoids, isomers.” Proponents of HSIs assert that, in defining hemp in the 2018 Farm Bill, Congress did not prohibit the chemicals in hemp from being converted into psychoactive compounds.

Opponents of HSIs argue that hemp was legalized as an agricultural commodity, and the 2018 Farm Bill was focused on the production (cultivation) of hemp, not consumer finished products that could be manufactured using its constituents. They posit that Congress did not intend for the chemicals in hemp to be converted into a host of compounds just as intoxicating as Delta-9 THC.

State AG consumer protection lawsuits against manufacturers of products containing HSIs are an attempt to curb their proliferation. Congress may address the perceived loophole that is being exploited to manufacturer HSIs in the forthcoming Farm Bill.

October 30, 2023November 2, 2023 by Seth A. Goldberg

Did Congress Intend to Legalize Intoxicating Hemp Products in the 2018 Farm Bill?

The 2018 Farm Bill legalized “Hemp,” defining it as “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.” The .3% delta-9 THC threshold distinguishes hemp from marijuana, which remains a federally unlawful Schedule I controlled substance, based on the psychoactive effect of delta-9 THC.

Today, consumers can walk into convenience stores, gas stations, and the like, or shop online, and purchase an array of cannabis products that have the same psychoactive effects as delta-9 THC in federally unlawful Marijuana, i.e., delta-9 THC at greater than .3% on a dry weight basis, but, because they were manufactured using “derivatives, extracts, cannabinoids, isomers” found in Hemp, their manufacturers claim they are legal. These products, which contain delta-8 THC, delta-10 THC, and other chemical compounds, are the result of chemical processes that convert the Hemp “derivatives, extracts, cannabinoids, isomers” into compounds that are the functional equivalent of the delta-9 THC in federally unlawful Marijuana.

Manufacturers of delta-8 products believe the 2018 Farm Bill does not prohibit the conversion of the “derivatives, extracts, cannabinoids, isomers” in Hemp into an intoxicating compound, which begs the question: did Congress really intend to legalize intoxicating compounds created from Hemp “derivatives, extracts, cannabinoids, isomers” that are functionally equivalent to the delta-9 THC in federally unlawful Marijuana? It would seem that the .3% delta-9 THC distinction between Hemp and Marijuana is about psychoactive effect, not about a particular chemical.

May 19, 2021 by Seth A. Goldberg

Cannabis Products Liability/Consumer Fraud Litigation and CBD Regulation

Yesterday, a California court federal court judge did not follow other federal courts in staying a consumer class action brought on behalf of CBD product consumers on the basis of the FDA’s primary jurisdiction over the regulation of CBD products. The Court in Rodriguez v. Just Brands USA Inc. et al., 2:20-cv-04829, C.D. Cal., determined that claims that CBD product maker Just Brands’ labeling did not accurately state the amount of CBD in its products could give rise to state law claims for breach of warranty and fraud that should not be stayed because, according to the Court, the FDA’s forthcoming regulations would not alter the expectation that CBD product manufacturers would accurately convey the amount of CBD in their products.

The decision in Rodriguez should be on the radar of the entire cannabis industry, as it demonstrates how products liability and consumer class action lawsuits may be brought under state statutory and common law to seek damages for improperly labeled cannabis products. Cannabis – hemp and marijuana – product manufacturers should be sure to build into their internal compliance safeguards against such claims.

Relatedly, on the radar for hemp-derived CBD is legislation proposing to categorize CBD as a dietary supplement under the FDA’s regulatory regime for drugs, dietary supplements and foods and beverages under the Food, Drugs and Cosmetic Acts. That bill will be introduced today by Sens. Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley.

December 17, 2020December 17, 2020 by Seth A. Goldberg

FTC Ratchets Up Enforcement Against “Spurious” CBD Health Claims

In connection with a crackdown on CBD manufacturers pursuant to its “Operation CBDeceit,” the FTC announced today settlements with six CBD-infused product manufacturers who, according to the FTC, allegedly made a “wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.” Under the settlements of the respective Complaints against them, each of the manufacturers will be required to pay a fine, and cease making “unsupported health claims” in connection with the marketing of their products.

In issuing its press release today the FTC attached the Consent Agreement and the FTC’s findings of violations of the FTC Act, which are set forth in a draft Complaint. These documents illustrate the FTC’s procedures in actions like these, and highlight the FTC’s concerns regarding allegedly misleading representations about CBD-containing products in violation of the FTC Act. Specifically, the FTC views health claims in connection with marketing such products to be misleading unless they “rely upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.”

Significantly, the FTC has not required the settling manufacturers to remove their products from the shelves and to cease selling them. They must, however, remove any unsupported health claims. Moreover, it would not be surprising if the announcement of these settlements spawns consumer fraud litigation against the manufacturers, which is often a much more serious concern to the business.

It is unclear how “Operation CBDeceit” will be implemented when the Biden administration takes over. For now, however, CBD manufacturers should continue to be mindful of their packaging, labeling and other marketing materials.