The Delta-8 Saga Continues with Latest FDA Action

Ever since it began appearing on the cannabis market two year ago, delta-8 THC has been greeted with equal parts celebration and scorn, depending on who’s talking. The grace period surrounding these products introduced consumers in prohibition states to a kinder, gentler high than delta-9 THC usually provides. However, bans and restrictions upon delta-8 products began appearing in states like New York, California and Colorado, and in September 2021, the FDA released a consumer update which warned consumers about the unregulated nature of the delta-8 industry at large. And in early May, it announced in a press release that it had sent out five cease-and-desist letters to delta-8 manufacturers. The letters are the first legal activity carried out by the federal government since the advent of delta-8, which has found its way into foods, beverages, hemp-cigarettes and vapes sold online and throughout the country.

In the meantime, the hemp industry is fighting back against the DEA’s attempt to regulate the THC limits of their products in court. A 2020 DEA rule insists that once a product measures over 0.3% THC, it legally becomes a cannabis product, not hemp. The Hemp Industries Association and RE Botanicals, a CBD business based in South Carolina, is currently fighting the details of its implementation, which has confused hemp cultivators and intimidated banks from working with extractors, in federal appeals court. Taken together, both developments exhibit the growing pains felt by a hemp industry whose proximity to cannabis continues to help and hinder it at the same time.

THE FDA GOES ON THE ATTACK

The FDA has used the cease-and-desist tactic before numerous times on the CBD industry; such letters date back to 2015. Many of these same violations are enumerated in the most recent correspondence, as all of the delta-8 websites named by the FDA also sell CBD products as well. According to the FDA, the companies all make unsubstantiated claims regarding the efficacy of their products in treating a host of mental and physical illnesses in both humans and pets. The website of Kingdom Harvest, for instance, lists the effects of delta-8 as offering “relief from some symptoms such as pain… Delta-8 can also help with insomnia.” M Six Labs, on the other hand, claimed that delta 8 “may also have cancer-fighting properties,” citing a tumor-reduction study in mice,” and also touted “anxiolytic properties.” The letters state that neither delta 8 nor CBD are generally recognized as safe or effective for any of these claims in humans, and labeled their products as drugs, which need FDA approval before being sold across state lines. Minus scientific data, often difficult and costly to develop, demonstrating safety and efficacy, the FDA pulled enforcement upon them.

The companies were given 15 days to remove the claims or stop selling the products. If they don’t comply, they can face criminal charges or product seizures. In a statement, FDA Principal Deputy Commissioner Janet Woodcock asserted about the FDA’s mission, “The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety.” However, because of this popularity, it’s doubtful that delta 8 will go away anytime soon. As Larry Shor of CBD distribution company Cleveland Botanical Distribution told Marijuana Business Daily last year, “[Products like Delta-8] are not going to die off… their pipeline already exists.”

THE FIGHT FOR “HOT” HEMP

In the meantime, the CBD industry is currently waging a battle against the DEA concerning an interim rule the Agency released in 2020. The rule banned certain kinds of extraction and intoxicating hemp products. Normally, since the passage of the 2018 Farm Bill which legalized hemp, jurisdiction for the plant would be held by the US Department of Agriculture, but for any extract or hemp product which contains more than 0.3% THC, the DEA insists it has jurisdiction. The HIA and RE Botanicals want the court to declare that the products are still hemp, whether or not the THC levels rise above 0.3%, as is commonly the case during certain regularly used extraction techniques, and that the DEA should butt out.

The HIA and RE Botanicals claims that if the DEA’s rule stands, then CBD extraction would be made illegal. According to the HIA lawyer Shane Pennington, Congress intended to remove hemp CBD from DEA jurisdiction with the 2018 Farm Bill, and the DEA is attempting a power grab at the industry. A final ruling from the federal appeals court should come by the end of this year.