You may have seen, or even tried, gummies or brownies with 10 or more milligrams of delta-9 tetrahydrocannabinol (THC) that were marketed as 2018 Farm Bill-compliant. Maybe you ordered them straight to your door—or sent them to a customer’s.
Within at least the past several months, U.S. hemp companies have advertised edible products with multiple milligrams of delta-9 THC—the main compound in Cannabis sativa traditionally associated with intoxication—as being available for interstate shipping and sale.
Hemp Grower spoke with two attorneys who are active in the cannabis and hemp space to learn more about the legality of these products.
Shawn Hauser, partner at Vicente Sederberg and chair of the firm's Hemp and Cannabinoids Department, said, “The sale of intoxicating cannabinoids and delta-9 products, I think, is in violation of most state hemp laws and certainly federal law, so I certainly wouldn't advise that.”
Here’s how the Agriculture Improvement Act of 2018 (2018 Farm Bill), which legalized hemp production in the U.S., defines “hemp”:
“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.”
Hauser said the 2018 Farm Bill definition of hemp was meant to apply to on-farm biomass, not finished products, and that the U.S. Food and Drug Administration (FDA) still has to come up with a way to account for the weight and moisture of other ingredients in finished products.
But that’s not stopping some operators from interpreting the law in a way that they believe will move their business forward. “It appears that these companies are looking at the 0.3% by dry weight standard that’s in the Farm Bill and determining the legality of their products,” Hauser said. “And the inherent flaw with that [interpretation] is that [the 2018 Farm Bill] said, 'a dry weight basis.' That, by nature, doesn’t account for moisture and the weight of the gummy material, or whatever is in the oil.”
Furthermore, Hauser said, the 2018 Farm Bill outlines that “the FDA preserved its authority to regulate consumable products.” All ingredients intended to be used in food need to be “generally recognized as safe” (GRAS) or otherwise reviewed and approved by the FDA, and ingredients included in dietary supplements must undergo a safety auditing process, according to the agency.
“And considering FDA’s statements relating to just CBD [cannabidiol], I would be very surprised if the level of THC content would be considered safe by FDA, or that these companies have the safety studies to substantiate the safety of their products,” Hauser said.
When asked about the risks that hemp companies can take on when trying to position themselves ahead of potential federal cannabis legalization, Hauser said “compliance becomes even more important,” adding that in-house research and development and safety studies are also imperative.
Rod Kight, principal and founder at Kight Law Office, said products that contain enough delta-9 to cause a psychoactive effect but don’t exceed the 0.3% THC limit have existed for years.
“However, it is only recently that these products have become more visible on the market,” Kight said. “In fact, from a market and consumer-access standpoint, this is a very new trend.”
Arguing that certain products with notable amounts of hemp-derived delta-9 are federally legal, Kight points to a few things. There’s the section of the 2018 Farm Bill hemp definition that includes “cannabinoids,” “derivatives” and “extracts.” There’s also the part of the bill that removed THC in hemp from the Controlled Substances Act.
“Additionally, and importantly, the water weight must be removed in the calculation since the 2018 Farm Bill measures THC concentrations on a ‘dry weight’ basis,” Kight said. “In practical terms, this means that some products, such as gummies, will be easier and more cost-effective to manufacture compliantly than other types of products, such as bottled water.”
At the same time, though, he said the Food, Drug and Cosmetic Act (FDCA) restricts the types of products companies can create or distribute, their marketing and any claims they make.
State Law Impact
With states across the country implementing various hemp and cannabis laws and regulations, Hauser said the delta-9 content in products can vary. Some states require that all finished hemp-derived products remain below a certain THC threshold that often includes a calculation of delta-8, delta-9, delta-10 and tetrahydrocannabinolic acid (THCA).
“They’re developing these more thoughtful calculations with the intent of prohibiting intoxicating ingredients in hemp products, and leaving those products to regulation in cannabis stores,” Hauser said.
She continued: “There are some states, like Colorado, where you can sell a consumable hemp product under state law regardless of the FDA’s position, provided you comply with certain safety, manufacturing and packaging and labeling standards, and that THC content is measured in certain ways. But you would still be, in many cases, likely in violation of federal law, of the FDCA.”
Other states have either limited or outright prohibited consumable hemp and CBD, Hauser said, adding, “so, the notion that these products can be sold in interstate commerce, setting aside FDA legality, I would disagree with, based on state law,” she said.
Meanwhile, Kight said the 2018 Farm Bill “specifically prohibits a state from interfering with the interstate transport of hemp.” The bill reads: “Nothing in this title or an amendment made by this title prohibits the interstate commerce of hemp … or hemp products.”
“That being said, individual states have their own laws and regulations regarding hemp products which distributors should be aware of and comply with when shipping their products across state lines,” Kight said.
While state regulations have matured, CBD enforcement has remained a low priority for the FDA, Hauser said. The agency usually acts when a company makes false, deceptive or misleading claims.
“Their general practice is to send a warning letter and then, if the subject of the warning letter doesn't comply, they can institute further action, including a seizure, some fines and, in some cases, there could be criminal penalties,” Hauser said. “It would be unlikely for them to divert from that process—where they start with a warning letter in the CBD space—unless there was a serious safety concern.
“So, if a product contained a serious contaminant or posed a very serious safety concern, they may take further action. But their resources are very limited, and historically, they’ve resorted to warning letters in the hemp realm.”
Kight said he believes that federal law enforcement agencies such as the Drug Enforcement Administration (DEA) do not have the legal authority to raid a hemp company if it is manufacturing or distributing intoxicating products that comply with the 2018 Farm Bill.
“That being said, we are discussing novel issues of law,” Kight said. “The DEA and other law enforcement agencies may have a different interpretation of the 2018 Farm Bill’s requirements. The DEA has a long history of attempting to interfere with lawful hemp based on its interpretations of law. Fortunately, most of these interpretations were ultimately deemed to be erroneous by federal courts.”
Kight points out that tension exists between those who believe that hemp-derived product can be intoxicating and those that believe it should never be.
“Either way,” he said, “we will continue to see these types of products being produced and distributed to meet market demand, along with vigorous debates about how to regulate them."