The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling copycat food products containing delta-8 THC and introducing them into the marketplace in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
These warnings are part of the FDA and FTC’s ongoing joint effort to take action against companies selling illegal copycat food products containing delta-8 THC. In June 2023, the two agencies worked together to warn six other companies about selling edible food products containing delta-8 THC in packaging that could easily be confused for foods sold by popular national brands.
All six of those companies no longer have such products in stock.
“Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” said FDA Principal Deputy Commissioner Namandjé Bumpus. “As accidental ingestion and/or overconsumption of delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.
“The FDA will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”
In June 2022, the FDA warned consumers about children accidentally ingesting food products containing delta-8 THC. From Jan. 1, 2021, to Dec. 31, 2023, the FDA received over 300 adverse event reports involving children and adults who consumed delta-8 THC products.
Nearly half of these reports involved hospitalization or emergency department visits, and approximately two-thirds of these adverse events followed ingestion of delta-8 THC-containing food products such as candy or brownies. Adverse events included, but were not limited to, hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness.
Floridians will still have access to buying and using delta-8 and other hemp products as Gov. Ron DeSantis vetoed a bill that aimed to reshape Florida’s marketplace.
As the bill, SB 1698, moved through Florida’s legislative process, it was opposed by consumers who said they need the products for their physical and mental health and by businesses that said it would cause thousands of Floridians to lose their jobs.
DeSantis, based on his veto letter, seemed to agree. In the letter, DeSantis said the bill would “impose debilitating regulatory burdens on small businesses” and would “introduce dramatic disruption and harm to many small retail and manufacturing businesses in Florida.”
A study commissioned by a hemp trade group found that Florida’s hemp market racked up more than $10 billion in sales in 2022 and employed more than 100,000 people, according to media reports.
DeSantis said he would encourage the Legislature to return to the topic next session to create a regulatory framework for Florida’s hemp marketplace.
“Sensible, non-arbitrary regulation will provide businesses and consumers alike with much-needed stability — safeguarding public health and safety, allowing legitimate industry to flourish, and removing bad actors from the market,” DeSantis said.
He listed three areas he would like the Legislature to focus on: quality control, product packaging requirements and looking at how and where hemp products are sold.
By Jean Gonnell, Christina Sava and Nicholas Ramos (Troutman Pepper Hamilton Sanders Tobacco and Cannabis Team)
Across the United States hemp products seem to be everywhere. From corner stores to spas, one can find a hemp- or CBD-infused version of almost anything. Hemp and its derivatives are found in foods, cosmetics, hand-rolled cigarettes and vape pens. A new category of “intoxicating hemp products,” such as delta-8 THC products, have taken the hemp industry by storm. Although the market is vast, the regulatory landscape contains many pitfalls. Potential market entrants must carefully research the applicable laws, and take into account any federal-level risks, before deciding to invest in a hemp or hemp-derived products venture. This article reviews the legal status of hemp-derived products, including smokable hemp products, at the state and federal levels.
Marijuana and Hemp
Marijuana and hemp come from the same plant: Cannabis sativa L., or “cannabis” for short. Cannabis has a long history of industrial and medicinal uses, and only a short history of prohibition, which we now see unraveling. “Hemp” is the common term for cannabis with a concentration of delta-9 tetrahydrocannabinol (“THC”) of .3% and under, while “marijuana” is used to mean cannabis with a delta-9 THC concentration over .3%. Marijuana remains a Schedule I substance under the Controlled Substances Act (“CSA”). Hemp production, on the other hand, was legalized by the Agricultural Improvement Act of 2018, or 2018 Farm Bill. At that time, Congress removed “hemp” and “tetrahydrocannabinols in hemp” from the CSA’s definition of “marijuana.” Specifically, the 2018 Farm Bill defined “hemp” 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% on a dry weight basis.” 7 U.S.C. § 1639o.
So, although they are technically the same plant, hemp and marijuana fall under completely different regulatory regimes, with a single cannabinoid – delta-9 THC – determining whether a cannabis plant or product is hemp or marijuana.
THC, CBD, and Other Cannabinoids
There are over 100 cannabinoids found in cannabis. Perhaps the most well-known of these are cannabidiol, or CBD, and delta-9 THC. CBD is considered non-psychoactive and generally prized for its therapeutic potential. Delta-9 THC has long been recognized as the cannabinoid that causes users to feel “high.” Since the 2018 Farm Bill, however, other psychoactive THCs, such as delta-8 and delta-10 THC, have been identified in cannabis. The “high” produced by delta-8 THC has been described as partway between THC and CBD, with relaxing body effects and a less-potent “head-high,” while delta-10 has been described as producing a more cerebral high akin to sativa strains of marijuana.
So why the boom in delta-8 and delta-10 THC products now? They can be derived from hemp. Although found in much lower quantities in hemp than other cannabinoids, manufacturers have found ways to chemically convert hemp-derived CBD into delta-8 and delta-10 THC. Even delta-9 THC is being converted from CBD, and manufacturers are adjusting product ratios to remain within the .3% limit. The Cannabis Regulators Association has called this the “0.3% loophole” and stated: “While the threshold of 0.3% delta-9 THC (tetrahydrocannabinol) by weight is a small amount of THC in a hemp plant, when applied to hemp-derived products (e.g., chocolate bars, beverages, etc.) which can weigh significantly more, 0.3% by weight can amount to hundreds of milligrams of THC. For example, a 50-gram chocolate bar at 0.3% THC would have around 150 mg of THC (30 times the standard 5 mg THC dose established by the National Institute on Drug Abuse).”[1]
The Drug Enforcement Administration (DEA) more or less gave the hemp-derived delta-8 industry a green light in a September 2021 letter to the Alabama Board of Pharmacy. The Board of Pharmacy inquired as to the control status of delta-8 THC under the CSA. DEA concluded that “cannabinoids extracted from the cannabis plant that have a [delta-9]-THC concentration of not more than 0.3 percent meet the definition of ‘hemp’ and thus are not controlled under the CSA.” Thus, so long as delta-8, delta-10, and other extracts are derived from a cannabis plant with less than 0.3% delta-9 THC, they constitute “hemp,” which is federally legal.
Notably, “synthetic tetrahydrocannabinols” remain a schedule I substance under the CSA. Some argue that because delta-8 and delta-10 are produced through a form of synthesis, they are Schedule I “synthetic tetrahydrocannabinols.” Regardless of this argument’s merit, this is not the position DEA has taken thus far, and we do not see any indication that they will suddenly take this position in the near future.
FDA Enforcement and the Future of CBD Regulation
Nonetheless, hemp-derived CBD and THC products are still not legal to be sold as a drug, dietary supplement, or food, according to the Food and Drug Administration (FDA). To the extent a manufacturer markets its delta-8 (or CBD) products as intended to affect the structure or any function of a consumer’s body, FDA’s position is that the product is an unapproved drug. In addition, “food” (almost anything edible that is not an approved drug or lawful dietary supplement) may not contain unapproved additives. Any form of CBD and THC are not approved food additives.
FDA has also concluded that THC and CBD products cannot be marketed as dietary supplements, because the definition of “dietary supplement” excludes active ingredients that have been approved as drugs or have been authorized for investigation as a new drug. THC and CBD are both active ingredients in at least one FDA-approved drug. Other parts of the hemp plant that do not contain THC or CBD might be available for use as dietary supplements, so long as manufacturers abide by related requirements, including notifying FDA.
And, FDA is watching the marketplace closely and taking enforcement action where it sees fit. FDA has issued numerous warning letters to companies selling hemp-derived CBD and THC products with impermissible health or therapeutic claims; for misbranding, such as lacking adequate directions for use; and for using these cannabinoids as an unapproved additive in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle. The agency has also published a general health warning for delta-8 products.
Industry and regulators alike have been anticipating some kind of regulatory action by FDA, but it appears this is yet far off. In January of this year, FDA determined that it does not have the appropriate regulatory pathway to regulate CBD products and called on Congress to pass legislation creating a new pathway separate from the food, drug, or dietary supplement pathway. Despite this regulatory uncertainty, sales of CBD products in the U.S. continue and could reach as high as $20 billion by 2025.
States and Hemp-Derived Products
Given the lack of federal standards and delta-8 and delta-10 (and likely other THCs’) psychoactive effects, state lawmakers are taking action to regulate products containing these extracts. At least 22 states have restricted or banned the sale of delta-8 THC products, while others are in the process of reviewing the cannabinoid’s status. One common way states are doing this is by limiting the total concentration of THC a product can have, rather than mirroring federal law and limiting only delta-9 THC concentrations. In Colorado, lawmakers have passed SB23-271, which goes further and actually classifies nonintoxicating cannabinoids, potentially intoxicating cannabinoids, and intoxicating cannabinoids. Products will be regulated according to which category of cannabinoids they contain.
In many states, a “ban” actually means that these products will only be available in licensed cannabis dispensaries where regulators can more easily track their production and sale, ensure that the products pass required contaminant testing, and prevent the products from being sold to minors. Retailers and manufacturers of hemp derived products, especially those wanting to sell nation-wide, must be diligent in tracking state by state restrictions on hemp-derived products.
Smokable Hemp
Smokable hemp, although it receives less attention than other forms of hemp products, is a major driver of hemp product sales. Smokable hemp is hemp flowers after they have been manicured and dried. Smokable hemp can be sold as “buds” or in pre-rolled hemp cigarettes. This hemp looks and smells a lot like traditional marijuana but is not psychoactive. While some users may feel a mild mellowing effect, most do not feel “high” after smoking hemp. This may be why smokable hemp is the only hemp product category that has experienced wholesale price increases over time.
The legal status of smokable hemp, however, also varies from state to state. Smokable hemp is illegal for sale in a handful of states, including Idaho, Iowa, Kentucky and Massachusetts. Other states do not place any restriction on its sales.
New York has banned hemp flower products that are “clearly labeled or advertised for the purpose of smoking or in the form of a cigarette, cigar or pre-roll.” California does not currently permit the sale of any “inhalable hemp” products, however labeled, having passed a law that prohibits the sale of such products until a tax on the products has been enacted. No such tax is yet in effect.
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Given the above, it is not safe to assume that your hemp product is legal for sale because hemp is federally legally. It is important for retailers and manufacturers to be aware of the laws that apply to the types of hemp products they are selling. Although the DEA has been hands-off since the passage of the 2018 Farm Bill, FDA oversees all foods, drugs, and dietary supplements in the U.S. and maintains that THC and CBD, even though hemp derived, may not be added to foods and dietary supplements, or marketed as drugs. FDA does not oversee inhalable substances generally, and thus has not released statements related to the legality of smokable hemp. Smokable hemp may be a good market entry point, especially for manufacturers and retailers already familiar with highly-regulated inhalable products.
Troutman Pepper’s Cannabis Practice provides advice on issues related to applicable state law. Cannabis remains an illegal controlled substance under federal law. Its attorneys are available to provide more information about these opportunities.
The U.S. state of Virginia recently enacted a law to curb kid-friendly packaging in cannabis products. That law is having hard effects on some local businesses.
Lawmakers have witnessed Delta-8 products sold in packaging that mimic foods that are enticing to kids, but those in the hemp industry say this new crackdown goes too far.
“Were one of hundreds that’s made the hard decision to just shut it down,” Reed Anderson said.
Anderson says he’s shutting down his Goochland hemp business, Kame Naturals, in the wake of a new state law cracking down on THC products like Delta-8.
It limits all hemp products to only two milligrams of THC per package. That’s far lower than most products in many smoke and vape shops. Hemp products must now have at least a 25-to-1 ratio of CBD to THC, according to media reports.
“25-to-1 ratio doesn’t do what we do justice right,” Anderson said. “We started our business as a solventless extraction company, and that over time kind of had to go to the wayside because of the different regulations coming through.”
Breaking the rules could mean fines of up to $10,000.
Anderson said it’s all too much and says lawmakers paid too much attention to the intoxicating effects of THC and very little to the health benefits THC may provide.
“Once you start getting into remediated product and trying to remediate THC out of a product, you lose a lot of the natural quality CBD products offer,” Anderson said.
However, Governor Glenn Youngkin and the law’s supporters said something needed to be done to stop the sale of Delta-8 products. Too many kids were getting sick.
A statement from Gov. Youngkin’s office said in part:
“SB 903 and HB 2294 took critical steps to strengthen consumer safety and regulations around edible and inhaled hemp-derived products as well as delta-8 THC products. Specifically, the amendment continued its efforts to crack down on dangerous THC intoxicants, including synthetic THC products. In addition to the ban on synthetic THC, the limited percentage of total THC allowed in hemp products, the packaging and labeling restrictions, the testing requirements, and the total per package limit for THC, the substitute also requires retailers to register with the Virginia Department of Agriculture and Consumer Services (VDACS) to sell any edible or inhaled hemp-derived product. Additionally, the General Assembly established the registration requirement and fees as a necessary operating cost and to create a database of all regulated hemp product retail stores.”
Anderson said while he’s no longer in the hemp business, he will become an advocate and plan to talk with politicians as often as he can to get these laws reformed.
The Attorney General in Connecticut is suing five retailers for some of the most “egregious violations” related to the illegal sale of delta-8 products.
Attorney General William Tong filed the suits for alleged violations of the Connecticut Unfair Trade Practices Act over the sale of illegal delta-8 THC products mimicking popular youth-oriented snacks and candies.
Tong is additionally in the process of sending warning letters to all Connecticut-licensed retailers of electronic vaping products, according to a statement from Tong’s office.
The letters advise that sale of delta-8 THC by unlicensed retailers may be illegal in Connecticut. Products that exceed .3 percent THC on a dry weight are considered cannabis products and may only be sold in the regulated market.
Cannabis products sold outside of the regulated market continue to be illegal and may subject sellers to civil and criminal penalties.
“If you offer delta-8 THC products for sale in your establishment that exceed .3 percent THC on a dry weight basis and you do not hold such a license, you are in violation of Connecticut law,” Tong states. “For your information, we have included below photographs of products that were recently purchased from retailers in Connecticut that purport to contain delta-8 THC.
“The sale of such products may expose you to criminal and civil liability. Please remove any such products from your shelves and dispose of them immediately.”
Cannabis products in Connecticut cannot be sold by unlicensed retailers and must meet rigorous testing and packaging requirements.
Tong also recently submitted testimony concerning House Bill 6488 stating that he fully supports the state’s proposed ban on flavored vaping and other tobacco products.
A federal judge in Kentucky has ordered a Laurel County sheriff to return hemp products and derivatives that were seized from a pair of stores. The judge found that the store owner is likely to succeed on his claims that they were unlawfully taken.
In an order filed last week, U.S. District Judge Claria Horn Boom said Joseph Bingham most likely has federal and state law on his side and his products were lawful, according to law360. She said Sheriff John Root must return what was seized in the February raid and is blocked from seizing similar products in the future.
According to the suit, Bingham operates two CBD stores and on and Feb. 25, Root and others from the Laurel County Sheriff’s Department raided those businesses and seized products containing delta-8 THC without a warrant.
While Root argued the products were in plain sight, Bingham alleged many of the products were in a back store room. There is also a dispute as to whether an employee at one of the stores consented to the search and seizure, according to the suit.
In the order, Judge Boom noted that the 2018 Farm Bill exempts hemp and its derivatives from the definition of cannabis that is listed in Schedule I of the Controlled Substances Act, and the Farm Bill specifically excludes THC in hemp and its derivatives, with courts finding that this depends on the delta-9 THC concentration.
A judge in the U.S. state of Kentucky has sided with the state’s hemp industry over law enforcement.
The judge ruled that products containing delta-8 THC derived from hemp are legal, a hemp trade association said in a news release.
The Kentucky Hemp Association (KHA) – which sued the state over the issue a year ago – celebrated the ruling as “a huge win for farmers and retailers.”
Police had begun raiding licensed Kentucky hemp shops in an effort to crack down on the delta-8 THC market.
The enforcement stemmed from the state Department of Agriculture releasing a letter that referred to delta-8 THC hemp products as a “Schedule 1 controlled substance,” illegal under U.S. law, despite the federal legalization of hemp in 2018, according to mjbizdaily.
The KHA then sued the department, the state agriculture commissioner and the state police commissioner to halt the raids.
“These delta-8 raids on retailers were … a challenge we were ready and willing to face in order to protect retailers of Kentucky Proud Hemp products,” KHA Vice President Tate Hall said in the release.
In what could have national implications, a federal appeals court has ruled that Delta-8 THC derived from hemp is “lawful” and eligible for trademark protection.
The 9th Circuit Court of Appeals said in its ruling Thursday that because Congress legalized not just hemp but its “derivatives” and “extracts” in the 2018 Farm Bill, delta-8 THC is legal if it is derived from a hemp extract – in this case, CBD.
The ruling gives delta-8 vape maker AK Futures another opportunity to block fellow California company Boyd Street Distro from allegedly selling counterfeit versions of AK Futures’ “Cake” vapes containing delta-8 THC, according to MJ Biz Daily.
The three-judge appeals panel sided with AK Futures and said that delta-8 THC is not a controlled substance under federal law if it comes from hemp.
“Regardless of the wisdom of legalizing delta-8 THC products, this court will not substitute its own policy judgment for that of Congress,” Judge D. Michael Fisher wrote.
However, the ruling does not address the legality of selling consumable delta-8 THC products.
Though Congress legalized hemp derivatives such as delta-8 THC, it also directed the U.S. Food and Drug Administration to oversee how those products could be sold.
So far, the FDA has declined to authorize any cannabinoid products without a prescription, and the agency issued a consumer alert last September warning saying that delta-8 THC “may have potentially harmful by-products (contaminants) due to the chemicals used in the process.”
A Georgia judge has halted efforts by a suburban Atlanta prosecutor to enforce a ban on some cannabis extracts, in a case that could set a statewide precedent, according to the Associated Press.
The Atlanta Journal-Constitution reports that Fulton County Superior Court Judge Craig Schwall on Friday issued a 30-day order restraining Gwinnett County District Attorney Patsy Austin-Gaston from prosecuting people for selling or possessing the extracts.
“I have concerns that this may or may not be a rogue DA,” Schwall said. “I think there may be some prosecutorial priorities misplaced.”
The ruling came in a lawsuit filed by two owners of Gwinnett County vaping stores seeking to have two extracts — delta-8 and delta-10 THC — declared legal in Georgia. The chemicals are similar to the main intoxicating ingredient in marijuana but cause milder highs. They are typically sold in vape cartridges, tinctures, gummies and other edibles.
Other states are also wrangling with the substances’ murky legality.
While the legality of Delta-8 THC products is questionable, retailers say consumer demand is booming.
By Timothy S. Donahue
Delta-8 THC is currently one of the hottest cannabis products on the market. During the Tobacco Plus Expo (TPE) in May, an estimated 75–80 exhibitors out of 350 were offering a Delta-8 product. Many companies were introducing new Delta-8 products at the event; for example, Beard Vape Co., Charlie’s Chalk Dust, JustCBD and TD Distribution Co. all launched their own brands.
Recent estimates predict CBD sales in the U.S. could reach $1.8 billion by 2022. Trevor Yahn-Grode of cannabis industry analytics company New Frontier Data recently told MedPageToday.com that Delta-8 THC had retail sales of at least $10 million in 2020. That number is estimated to double in 2021. Based on the number of Delta-8 vendors at TPE (see “Finally Face to Face,” page 20), sales could triple. It was probably the most heavily hawked cannabis product at the event.
The Beard Vape Co. launched its HRVST Delta-8 brand after numerous distributors started asking about the new cannabinoid hitting the mass market, according to Zachary Kestenbaum, vice president of sales. He said his main objective at TPE was to talk with other distribution companies about where the Delta-8 market is headed. Kestenbaum said consumers like the product because it’s not as overwhelming as the traditional Delta-9 THC, the psychoactive component of marijuana commonly referred to as only THC.
“In the ’70s, ’80s, ’90s, people were smoking marijuana with THC levels at 12 [percent] to 15 percent. Now they’re breeding strains that are 24 [percent] to 26 percent THC (Delta-9 THC). It really can give that head anxiety to people,” he said. “That’s why people like Delta-8 THC because you’re getting a little bit of the psychoactive effect but not at that 25 percent level like you get with the Delta-9 THC. People are preferring the Delta-8. They like it better.”
First discovered in 1941, Delta-8 THC is only slightly different from its cousin compound Delta-9 THC. The two chemicals are only one chemical bond apart, according to Josh Church, a scientist and managing director of Roots Holdings. Research has shown that Delta-8 is a powerful anti-seizure drug. “The issue is it just doesn’t naturally occur at significant levels, so it’s really easy to ban,” said Church, adding that Delta-8 also promotes relaxation, clear-headedness and increased positivity.
Research has also shown that Delta-8 significantly helps reduce stress, stimulate an appetite and lessen nausea. Delta-8 is a less “head high” and more of a body high without the nervousness and paranoia often associated with Delta-9 THC. Delta-8 THC, users should be warned, will also turn up on a drug test as “THC,” according to Church.
Looking at legality
While its popularity is spiking across the U.S., Delta-8 is not without controversy. While hemp itself is federally legal (at or less than 0.3 percent THC), each state has different laws and restrictions regarding byproducts derived from hemp, including Delta-8. No products containing Delta-8 have been tested by the U.S. Food and Drug Administration or are FDA-approved.
Twelve states have completely banned Delta-8 sales. Those states include Alaska, Arkansas, Arizona, Colorado, Delaware, Kentucky, Idaho, Iowa, Mississippi, Montana, Rhode Island and Utah. New York has a proposed rule to ban Delta-8 products, which is under a comment period until July 19. California, Oregon, Vermont and Washington are in the process of enacting regulations for Delta-8 products. Several other states are also considering bans.
The federal legality of Delta-8 products is disputed. The misinformation and ambiguity surrounding its legality is why some manufacturers in the CBD industry took time to develop and market their own Delta-8 products. Jakob Gutierrez, product specialist for JustCBD, which launched its JustDELTA-8 brand at TPE, said it took the company time to launch its Delta-8 product because it wanted to be sure it was working within the law. JustCBD only sells its products to retail shops and distributors; it does not sell directly to consumers.
“We wanted to make sure we were covering ourselves and making sure we were doing it right, complying with the right laws. Now, we were missing out a little bit because of that, but we’re back on track,” Gutierrez said. “We got on the train, and orders are exponential for the Delta-8. People are coming in, just ordering various product, and walking out. It’s insane how fast this stuff is flying out.”
Ask eight people if Delta-8 is legal federally and you’ll get eight different answers. Some believe that the vagueness of the 2018 Farm Bill, which legalized hemp and hemp-derived products, means that Delta-8 is currently legal under federal law. “Because Delta-8 is such a new product, many state laws don’t address it at all, which puts it in a gray area of de facto legality,” according to Leafly, a cannabis information source. The reason states have banned Delta-8 products is an uncertainty about what it is and what it does, according to many Delta-8 manufacturers.
On Aug. 21, 2020, the U.S. Drug Enforcement Administration (DEA) issued an Interim Final Ruling (IFR) that stated hemp-derived Delta-8 is federally prohibited and is to be considered the same for enforcement purposes as Delta-9 THC and that “all synthetically derived tetrahydrocannabinols (THC) remain Schedule I controlled substances.” The memo states that these products cannot be shipped to customers from retailers through the U.S. Postal Service or any other shipping method, and it is illegal to use and possess these products in states where cannabis is not legal.
The U.S. Department of Agriculture’s position on Delta-8 THC is that the Farm Bill mandates only a Delta-9 THC limit and doesn’t regulate Delta-8 at all, so Delta-8 is not part of the agency’s hemp mandate, according to previous statements. Since the amount of Delta-8 THC found naturally in hemp is almost 1,000 times lower than the amount of Delta-9, the agency saw no reason to address it at all, including as part of its “total THC” testing requirement.
A hemp trade association and a hemp company have filed a petition in the U.S. Court of Appeals for the District of Columbia challenging the DEA’s IFR. That case is still being reviewed. The D.C. Circuit petition challenges the IFR on the basis that: 1) the DEA did not follow the appropriate notice and comment procedures, 2) the DEA does not have authority under the Farm Bill to issue the IFR, and 3) the DEA’s acting administrator lacks authority to issue the IFR.
Not all states are anti-Delta-8. For example, Florida’s statute states that “any hemp product intended for human or animal ingestion or inhalation which is sold in Florida must comply with all Florida statutes and rules. Any hemp or hemp extract products offered for sale or sold in Florida must comply with all labeling rules and have a certificate of analysis that shows a total THC (THCA x .8777 + THC Delta-9 = total THC) content of 0.3 percent or less.” Florida is the only U.S. state to have enacted legislation to provide a framework for the legal sale of Delta-8.
Florida’s statement on Delta-8 clarifies that Delta-8 does not run afoul of any Florida law and, in fact, certifies that the manufacture and distribution of Delta-8 is allowed in Florida, according to ACS Laboratory, a Tampa, Florida-based CBD testing facility. “Despite Florida’s conservative legislative trends, the state’s public policy toward Delta-8 is progressive and ultimately beneficial,” ACS’ website states. “By establishing a structured and comprehensive regulatory framework for manufacturers and distributors to follow, Florida is enabling a burgeoning industry to continue to grow and evolve while simultaneously ensuring the safety of buyers by mandating certificates of analysis for all [Delta-8] items sold.”
Chemistry lesson
The proposed updates to those New York rules that ban Delta-8 included a provision declaring that all cannabinoid and cannabinol products made through a chemical process called isomerization can no longer be sold in New York. The new rules specified the compounds Delta-8 and Delta-10.
Isomerization is, in its most basic explanation, adding a chemical bond to a molecule, according to Church. “Basically, anything you can make out of the THC molecule is banned because all isomers of said molecule are banned—technically,” explains Church. “If you remember Spice or K2, they were synthetic THC. The issue was the DEA; the FDA would ban the new molecule—say tetrahydrocannabinol (THC) 9753—and then within the next week, they would come up with THC 9756. And it was this cat-and-mouse game where the DEA, the FDA, and the Chinese authorities couldn’t stop them fast enough until they finally just banned all isomers.”
Many industry players say that the federal government will soon legalize marijuana, and the ambiguity around products like Delta-8 and Delta-10 THC will disappear. President Biden has publicly said that he supports the decriminalization of cannabis and removing it from the Schedule I list while Vice President Kamala Harris has gone further, stating that she supports full legalization. But like all the states that have legalized Delta-9 THC and have specifically banned Delta-8, it would not be surprising to see the federal government make some of those same decisions, according to Church.
“Regulation of these cannabinoids … it’s going to take an act of Congress. Then it’s really hard to try and predict what Congress is going to lay forth in the legislation. I mean, look at the nicotine space with synthetic nicotine still not being closed as a loophole around regulation,” explains Church. “Because so many states are banning it right now (Delta-8), I think the federal government will come in with some sort of hefty regulation on all the isomers or conversion molecules.”
Tony Riva, CEO of TD Distribution Co., parent to the Hi Drip e-liquid brand, also launched a Delta-8 brand at TPE. Riva said he didn’t have the concerns many of the other manufacturers had. He says the vapor industry has been dealing with a harsh regulatory environment for nearly a decade. He doesn’t see why the cannabinoid industry is going to be any different, especially as more and more cannabinoids come to market.
“If I lived in fear all the time in this industry, I’d never get anything done. We are just trying to provide a legal product and hope that the government doesn’t tell us that we can’t. It’s a constant battle with their … tyrannical overreach that they’ve thrown down on the vaping industry,” he says, adding that he expects the cannabis industry to be federally regulated in some form within the next few years. “People like Delta-8; people like Delta-10 or CBD. They feel that it helps them. We are just trying to provide high-quality, legal products to our clients. At the end of the day, it’s just going to be another hula hoop to jump through.”
Church says that he recommends any retailer or manufacturer contemplating entering the Delta-8 market to consider having a firm process of chain-of-custody documentation, adding that the cannabinoid industry should look toward the legal marijuana industry as a guideline. Church emphasized that one bad player could destroy the market by doing something wrong and causing the potential for another situation like the e-cigarette or vaping product use-associated lung injury (EVALI) issues that occurred because a few bad players used vitamin E acetate in black market THC vape pens without doing any research on the chemical.
“Those dirty conversions are out there; there is a lot of risk to a finished good. The last thing you want to see is a dirty lab pumping out a bunch of garbage. Then it gets distributed nationally, and we have another EVALI situation. This isn’t because of the Delta-8, which is largely safe, but because it’s a bad product. I would strongly encourage anyone looking to move into the Delta-8 or Delta-10 space to meet those high standards that are required for any type of legal consumer product,” says Church. “The reality is, though, that the sky’s the limit on these types of products. I think we’re just now seeing it with Delta-8 and Delta-10 … but it’s going to evolve into a crazy world of these new designer cannabinoids. And regulation is coming along for the ride.”
