Nicholas Warrender, who founded Zion, Illinois-based Delta-8 company Lifted Made, doesn’t see it that way.

“The law is very clear. People call it a grey area; it’s not,” says Warrender. “I get it, big cannabis companies are upset because of the competition, but at the same time they’re also a very elite group of special interests that have almost monopolized these states. Small entrepreneurs, who couldn’t participate in the industry because of all the expensive requirements, are also upset.”  FORBES.art↑ 7/1/2021 ¼LEAFLY.art

Delta-8 THC, aka delta-8, the intoxicating cannabinoid synthesized from hemp, is making waves across the United States, and especially in states where marijuana remains illegal.

That’s because delta-8 is derived from federally legal hemp, which by law contains less than 0.3% delta-9 THC. In fact, many manufacturers and retailers label it “delta-8 CBD” to emphasize its CBD-like legal status. (Confusing? Yes. Delta-8 is derived from CBD extracted from hemp, but in scientific terms it is delta-8 THC. For more on the difference between delta-8 THC and delta-9 THC, read Leafly’s complete guide to delta-8.)

Kelly O’Connor, director of business development at Oregon-based Columbia Laboratories, said her company has seen a 30% increase in requests for delta-8 product testing compared to this time last year.

D-8 is legal federally, and most state laws don’t specifically address it. But how long will that last?

“It’s definitely exploded,” she told Leafly. “There’s big enthusiasm [for Delta-8] in the Southeastern states, the Carolinas, the Dakotas, Texas, anywhere…where people can’t get high legally.”

O’Connor was interviewed while attending a recent CBD expo in Indianapolis, the largest city in the prohibition state of Indiana. “I’m surrounded…by delta-8 manufacturers and distributors here,” she noted.

Due to ambiguities in the 2018 farm bill, which legalized hemp and hemp products, delta-8 is currently not prohibited by 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.

But how long will that legal status last?

States already closing loopholes

Many states are now scrambling to close legal loopholes in their drug laws to bring delta-8 into regulatory compliance. A pending bill in Oklahoma would legally define marijuana to include delta-8 THC and delta-10 THC, in addition to the more commonly known delta-9 THC. A similar effort is underway in Alabama’s state legislature. The Washington State Liquor and Cannabis Board recently issued a policy statement that allows delta-8 THC derived from licensed cannabis, but not from unlicensed hemp. In Oregon, lawmakers are working on regulations that would create a definition for “artificially derived” cannabinoids, in order to regulates such compounds under the state’s medical and adult-use cannabis laws.

In North Dakota, a state legislative committee recently voted to accept amendments that would change the state’s definition of THC. “The purpose of the amendments is essentially to address the inconsistencies that delta-8 THC is a legal substance,” Tara Brandner, the state’s assistant attorney general, reportedly told that committee.

Brandner added that hemp growers who flouted the proposed changes would lose their licenses, and that those who synthesized hemp into an intoxicant could face state criminal charges.

A complicated legal question

The state regulatory landscape regarding delta-8 is further complicated by different federal approaches to the compound.

The federal 2018 farm bill, which legalized hemp, removed hemp from the federal Controlled Substances Act’s (CSA) definition of marijuana. The bill also removed “tetrahydrocannabinols in hemp” from the federal CSA definition of THC.

However, Andrea Golan, an associate attorney in the Los Angeles office of Vicente Sederberg and a member of the law firm’s regulatory compliance and hemp practice groups, points out that the Federal Analogue Act—passed in 1986 and meant to combat synthetically-made “designer drugs”—holds that any drugs that are similar in chemical structure, and that have a similar (actual or intended) effect similar or greater to a that of a controlled substance, and are intended for human consumption, must be treated as a Schedule I or Schedule II controlled substance.

Look for test cases soon

Golan expects test cases to arise soon in some states to determine delta-8’s legal status. Those court cases may help clear the legal air regarding the cannabinoid. But test cases require a defendant and a charge—which means somebody must get arrested for selling, buying, or possessing delta-8 THC in order for that test case to exist.

Companies seek legal clarity as the stakes rise

The demand for delta-8 THC, which is derived from CBD extracted from hemp, is keeping many hemp farmers, processors, and distributors afloat right now.

“Some key players in the hemp industry see the potential of delta-8 and other minor cannabinoids” derived from hemp, Golan noted. Those stakeholders, she observed, “may be more likely to bring a legal challenge of state or federal law to obtain a ruling on the legal status of hemp-derived delta-8 THC.”

Rumblings: Delta-8 to be regulated as intoxicant?

For her part, Kelly O’Connor at Columbia Labs isn’t certain as to where delta-8 will end up on the regulatory landscape. “But my contacts at the American Herbal Products Association, as well as the DEA (Drug Enforcement Administration) and the American Western Hemp Professionals, and the U.S. Hemp Roundtable, have all indicated that deltas will likely be regulated as intoxicants,” she told Leafly.

“Anecdotally, we understand that the DEA is actively monitoring the proliferation of delta-8 THC products.”

– Andrea Golan, cannabis industry lawyer

If and when that happens, she added, “it will oust a lot of companies from participating in that market, because of the rigorous demands that are placed on the intoxicant market, the THC market, as it is regulated by the states.”

Andrea Golan expects a federal response to delta-8 will first come from the DEA. “We have heard from at least one state that it is awaiting DEA guidance to determine its enforcement priorities,” she said. “Anecdotally, we understand that the DEA is actively monitoring the proliferation of delta-8 THC products in the marketplace.”

Golan said that while she knows of no special enforcement actions underway against businesses involved in the production or sale of delta-8, she noted that the DEA “appears to be working to identify key actors along the delta-8 THC supply chain in what we assume could be a prelude to more direct action.”

“Ultimately delta-8 needs stronger regulation,” said Kelly O’Connor at Columbia Labs. “Because without it being regulated like a drug, it’s being sold on the open market in a way that is bypassing a lot of the contaminant testing and batch traceability that you get from a highly regulated market, like a delta-9 market.”

Tips for delta-8 retailers and consumers

Golan and others offered some best practices for companies selling hemp-derived delta-8 products, and consumers purchasing delta-8 products.

For delta-8 producers and retailers:

• Ensure the hemp used to produce delta-8 derives from lawful sources.
• Comply with federal and state food and drug laws by complying with the GRAS (Generally Recognized As Safe) and “new dietary ingredient” notification procedures.
• Contract with a manufacturing facility that complies with current Good Manufacturing Practice regulations (cGMPs).
• Limit purchases to consumers 21+: Install age gates on websites and enhanced age verification procedures for online sales.
• Limit concentration of delta-8 THC to safe serving sizes (which are as yet unknown and to be determined via safety studies).
• Do not state or promise that the product will get the consumer “high.”
• Ensure products are compliant with the applicable state laws—including manufacturing, ingredients, labeling, and advertising.
• Ensure appropriate SOPs/structures are in place to deal with consumer complaints and adverse events.
• Maintain adequate insurance coverage and request the same from all other vendors, suppliers, and customers in the supply chain.

For delta-8 consumers:

• Purchase from a seller that provides a link or QR code to a third-party Certificate of Analysis to confirm the product contains the cannabinoids it claims to, is free of chemicals and pesticides, and does not contain unknown compounds.
• In a legal adult-use cannabis state, purchase from a licensed cannabis retailer. This ensures that the delta-8 product has been lab tested for potency and purity. Leafly lists only state-licensed cannabis retailers. Find one near you here.