Per our last article on Delta-8, The Food and Drug Administration (FDA) issued the first round of warning letters to businesses regarding the sale of items containing delta-8 THC, marking the first instance of delta-8 THC’s subjection to formal enforcement action. However, new court rulings claim that Delta-8 is “generally legal” because federal law defines hemp as “any part of” the cannabis plant, including “all derivatives, extracts, [and] cannabinoids,” that contains less than 0.3 percent delta-9 THC by weight. The law, the court determines, “is silent with regard to delta-8 THC.” This means that delta-8 is now officially considered legal, which is promising news for the hemp and cannabis industries.
The Landmark Case
Delta-8, while psychoactive, has gentler effects than delta-9 THC. The Ninth Circuit also noted that because the law on hemp specifically mentions delta-9 and delta-9 only, delta-8, therefore, falls under the state’s legal definition of hemp and is thus considered legal.
The ruling came from a trademark and copyright infringement lawsuit. AK Futures, an e-cigarette and vape manufacturer, alleged that Los Angeles company Boyd Street Disco was selling counterfeit products of AK Future’s branded delta-8 THC products. Boyd Street Disco’s defense rested on the claim that delta-8 was illegal, an argument which both the lower preliminary court and the Ninth Court Circuit found to be substantially untrue.
“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 for the three-judge panel of fellow Republican-appointed Judges Andrew Kleinfeld and Mark Bennett. The panel claimed that if Congress were to seek an amendment, they themselves must overrule the 2018 Farm Bill.
“The record on appeal convinces us that AK Futures’ delta-8 THC products are lawful under the plain text of the Farm Act and may receive trademark protection,” concludes the Ninth Court Circuit. Even the Drug Enforcement Administration (DEA) is signaling that, at the federal level, delta-8 THC is not illegal.
The DEA essentially seceded jurisdiction of the delta-8 cannabinoid, delegating control and legislation to the FDA and the U.S. Department of Agriculture (USDA). The FDA is pushing for its removal from shelves due to its psychoactive properties despite its legality under the 2018 Farm Bill, even in light of the DEA’s ratification of this stance.
The FDA’s Role
A bipartisan Senate coalition mandated the FDA in 2019 to provide an update on its regulatory approach to CBD. It did so in 2020, saying at the time that FDA “is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions” Unfortunately, time has demonstrated that this was not the case.
In early May, the head of the FDA spoke to a congressional panel, acknowledging the agency’s cannabis regulation latency. While Dr. Robert M. Califf insisted he wanted the FDA to move forward with rulings on CBD products, he said the agency likely needs broader regulatory powers from Congress to get it done.
“I don’t think the current authorities we have on the food or drug side necessarily give us what we need to have to get the right pathways forward,” the commissioner said. “We’re going to have to come up with something new. I’m very committed to doing that.”
“The research so far has shown that there are some risks with CBD, so we’re going to need a different pathway rather than just the standard pathway,” says Califf. “You know, when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over.”
The cannabis industry can certainly look forward to clarification on the FDA’s cannabis stance in light of even more assertions about its federal legality. We hope that this ruling helps transform the legal landscape’s view of cannabis, allowing for more research and eventually full legalization.
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