Earlier this week, the cannabis industry celebrated the release of the Food and Drug Administration’s draft guidance for the development of cannabis-based drugs. The document, which was considered an essential step forward by many, laid out how researchers could seek approval for new medications derived from cannabis or cannabis compounds via the use of randomly-controlled drug trials. Industry stakeholders had been hoping for more federal regulations for over a year now.
For those in the CBD industry, however, the document did little to quell their anxiety.
According to a new action alert from the internationally recognized law firm Duane Morris, the FDA’s draft guidance did nothing to address the needs of the non-drug, hemp-derived cannabidiol market. In fact, as the law firm itself pointed out, the document “is expressly ‘limited to the development of human drugs and does not cover other FDA-regulated products’ such as dietary supplements, foods, and cosmetics.
What the FDA has done, according to Duane Morris, is clarified their thinking in regards to the sources of cannabis that can be used for clinical research, especially in light of the 2018 Farm Bill. One of the more significant aspects of that bill was to remove hemp from the federal definition of marijuana in the Controlled Substances Act.
The FDA draft guidance now allows researchers access to higher quality hemp products for clinical trials. As PotNetwork noted earlier this week, in the past, federally funded studies using cannabis were forced to rely on one manufacturer of government-approved research cannabis —the University of Mississippi. Now, as long as the product meets federal guidelines, researchers can purchase it from better sources.
“This change gives sponsors and investigators of clinical studies new options that do not involve the [National Institute on Drug Abuse Drug Supply Program],” said the FDA in a statement earlier this week.
According to the Duane Morris action alert, however, because cannabis will be held to the same standards as other botanical products used in clinical research “the recommendations contained in FDA’s Botanical Drug Development (December 2016) industry guidance likewise apply to conducting clinical trials of drugs containing cannabis compounds.”
Meanwhile, the CBD industry continues to wait for its own set of guidelines from the FDA, a situation that continues to create confusion for all concerned. Since the agency’s much-hyped public meeting to discuss the pros and cons of cannabidiol last year, they have mostly relied on warning letters to police the industry. However, as recent research has shown, those seem to have little ability to deter bad actors from making unsubstantiated claims about their products.
As Stanford researchers Chelsea L. Shover and Keith Humphreys published recently, warning letters on the industry have had little impact. “Few letters have been sent and nearly half have been ignored,” they wrote in a recent study. “However, the fact that about half of the retailers that received COVID-19 letters still had other unsupported medical claims on their websites or social media is concerning.”
And while some states try to enforce regulations themselves, it has done little to solve the problem. As Duane Morris noted in their action alert, while the recent draft guidance is helpful, it does little to change the status quo.
“Although the draft guidance provides valuable insight to those interested in developing and testing human drugs containing cannabis or cannabis derivatives, it does not contain any advice to manufacturers, distributors, retailers or consumers in the non-drug, hemp-derived CBD product market―the segment of the U.S. cannabis market fraught with perhaps the greatest lack of clarity,” they wrote.