FDA head admits little movement on CBD regulations

The federal Food and Drug Administration is once again calling for more research into CBD before allowing it to be sold over the counter.

Last week the FDA published an article by agency Commissioner of Food and Drugs Stephen M. Hahn and Principal Deputy Commissioner Amy Abernethy that boasted of the agency’s efforts to inform the public about CBD while also listening to the concerns of industry stakeholders and citizens.

But the agency’s calls for more research can come across as disheartening for those looking to see the drug made more readily available to the public. “While the FDA appreciates the information and engagement from numerous stakeholders on CBD-related issues, many evidence gaps remain,” wrote Hahn and Abernathy. “Filling these gaps will not be a trivial exercise but will require high-quality data analyzed using robust methods.”

The laws surrounding CBD-based products are confusing, to say the least. While hemp was made legal thanks to the 2018 Farm Bill, CBD products are still under the purview of the FDA. This is because, earlier in the year, the agency approved a pharmaceutical that utilized CBD as its active ingredient: Epidiolex. The drug was made specifically to treat rare epileptic seizures found in children.

According to federal regulation, any substance that’s used as an active ingredient in a pharmaceutical drug cannot be sold over the counter without being approved for general consumption first. Ironically, the very event that cheered advocates only months earlier—that the FDA was recognizing the healing powers of CBD by approving a drug that totally relies on the substance—led to a pronouncement that is still tying up the CBD industry two years later.

For the most part, the agency has refrained from prosecuting CBD companies for selling supplements, although there were a few incidents in 2018 and 2019. Currently, the FDA is only targeting companies that make unsubstantiated health claims about CBD to market their products.

Efforts to force the agency to speed up the approval process seem to be working; but as this latest report attests, the agency clearly isn’t planning on lifting the ban any time soon.

DEA Sued By Hemp Industry

The U.S. Drug Enforcement Agency is trying to get a lawsuit dismissed that alleges the agency isn’t playing by the rules when it comes to CBD extract production.

According to The Bulletin, the lawsuit was initiated by the Hemp Industries Association. The nonprofit group says the DEA overstepped its authority when it declared that hemp-based CBD concentrates passing through a specific stage of the manufacturing process were illegal. According to the complaint, the DEA is applying the rule that differentiates illegal marijuana from legal “hemp” to all the interim substances produced during the process of producing CBD oil. The group seeks protection for CBD manufacturers while the agency’s policies are reviewed.

Hemp was legalized when President Donald Trump signed the 2018 Farm Bill. In the bill was language that differentiated “hemp” as cannabis with less than 0.3 percent THC. In practice, CBD manufacturers have been able to produce extracts from hemp plants as long as they meet the criteria at the time of harvest and the final product remains within the legal THC limit.

But CBD companies say that during the process of making CBD extract, a substance is produced that has a THC volume higher than 0.3 percent. This concentrated substance is then diluted before being turned into the final product. But some manufacturers are complaining that the DEA is seizing this substance and declaring it contraband before they can complete the process.

The HIA is accusing the DEA of trying to “destroy the burgeoning hemp industry” and claims that the agency is working outside the law. The DEA wants the judge to dismiss the case, claiming that the suit is invalid and should be appearing before the U.S. Court of Appeals for the D.C. Circuit instead. HIA says it has filed the appeal, adding that this suit is seeking to protect hemp processors from criminal charges until the appellate court rules on the DEA’s policy.

Biden’s Commerce Secretary Pick is Pro-Legalization

Concerns over whether a Biden administration will be pro- or anti-cannabis are being put to rest after the president-elect announced he is looking to appoint Rhode Island Governor Gina Raimondo as his commerce secretary.

Raimondo has been an advocate for recreational marijuana legalization in the past and has touted it as a positive way to generate revenue. In 2018 she called to legalize cannabis in Rhode Island to compete with neighboring states that had already taken steps to establish recreational pot tourist markets. In 2020 she spurred controversy by promoting the concept of state-run marijuana dispensaries, an idea that was also included in New Mexico’s 2020 legalization bill.

While it’s still far too early to be making predictions, with the additional announcement that Joe Biden plans to install two civil rights advocates that have been pro-cannabis in the past into leadership positions in the Justice Department—former prosecutor Vanita Gupta and President of the Lawyers Committee for Civil Rights Under Law Kristen Clarke—things are looking better for pot this administration.

Even more encouraging are the recent wins by Democrats in Georgia. With a Democrat-controlled Senate, the way toward federal legalization is being paved. In September Sen. Chuck Schumer (D-N.Y.) took to Twitter to promise voters that a Democrat-controlled Senate would prioritize cannabis reform.

“If Democrats retake the Senate, I am going to do everything I can to end the federal prohibition on marijuana and undo harms of the War on Drugs,” tweeted Schumer.

We won’t forget it, Chuck.

This story is a staff report from The Paper.