WASHINGTON — Regulated tetrahydrocannabinol (THC) levels, governmental policies, agricultural effects, consumer safety and medical purposes were among the topics discussed at the U.S. Food and Drug Administration’s (FDA) first public hearing regarding cannabidiol (CBD)—the nonpsychoactive component of cannabis—on May 31.
This was the first regulatory discussion of CBD since the 2018 Farm Bill made growing industrial hemp, a key source for CBD, legal. The goal of the hearing was to gather information on the safety and challenges of working with products containing cannabis and cannabis-derived compounds. The FDA previously stated that the hearing was not about making a decision but instead an opportunity for various stakeholders to discuss what they’d like to see in a set of guidelines.
"There are lots of questions we will need to answer to ensure that the FDA is taking an appropriate, well-informed and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD," said Norman Sharpless, acting commissioner of the FDA, at the start of the hearing. "We hope that this meeting, and the comments submitted to our public docket, will help us as we try to approach this issue in an informed way. This hearing is an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products."
Here are six takeaways from the hearing …
Full spectrum vs. isolate
When it comes to labeling, consumers often don’t know what they’re getting in terms of full spectrum vs. isolate CBD, said Crystal Guess, senior client relations associate for NuLeaf Naturals LLC, a Denver-based CBD oil producer, during the hearing. Guess requested that the FDA provide this clarity in every CBD product—either a seal on labels or a table of definitions on shelves defining what full spectrum and isolate are and which is apparent in these products.
“We have to educate the public, and a lot of these things can be addressed through labeling and holding these companies with false claims accountable so we can raise the flags,” she said.
A quarter of U.S. consumers have now tried CBD, according to an April study by the Food Marketing Institute (FMI), Arlington, Va. This increased demand heightens the need for FDA guidance, since the main goal should be protecting the consumers who buy it, Peter Matz, director of food and health policy for FMI, said during the hearing.
As the commercial availability of CBD and hemp grows, so does its ambiguity—and there’s currently a mass confusion in the marketplace, he said.
“Consumers, suppliers, retailers and state legislatures are all confused on how CBD should be handled,” he said. “Not just in food and beverages, but in creams and lotions, too.”
Not really THC-free
Just because a CBD product is labeled as THC-free doesn’t meant it is THC-free, said Jaclyn Bowen, executive director for Clean Label Project, Broomfield, Colo., a nonprofit focused on health and transparency in consumer product labeling. This is a major issue in the industry right now, because up to 30% of leading CBD brands have inaccurate or misleading labeling regarding its THC levels, she said. Bowen suggests the FDA craft a clean-label policy for CBD products that is similar to that of gluten-free items.
“Currently, there is no rule or regulation that says how much THC can be present in a concentrate or manufactured product,” she said.
Lucille Vega, a physician and owner of the Rhode Island Health Care Family Practice, Warwick, R.I., was convinced that CBD was a hoax until her patients took some during a test trial. The results were a sign that this product needs to be a common medicine, she said.
“We ran a trial with full-sectrum CBD oil for patients with pain, anxiety and sleep issues,” she said. “Sixty-five percent of consumers dropped their pain scale by 2 points after using CBD. Forty-three percent gained more than two hours of sleep after using, and 75% had significantly less anxiety. Overall, 88% of these consumers said they would recommend CBD oil to their friends and family.”
Vega emphasized that while sublingual dosing—ingesting products underneath the tongue—and topical application of CBD are two of the most effective ways to take the product, many doctors are still unaware, and the FDA must further educate physicians on the subject.
“People are coming to the ER asking what to do,” she said. “We need more education for physicians.”
Change the 0.3%
As long as CBD contains less than 0.3% THC—giving it the legal definition of hemp—then it may be sold in the marketplace, according to the 2018 Farm Bill. Bill Grubb, vice president of business development and innovation for Noramco, Wilmington, Del., a manufacturer of controlled substances for the pharmaceutical industry, argues that this percentage should be reduced to 0.1% to ensure complete safety.
“Our biggest challenge right now is that if you extract hemp in an unregulated matter, you are not subject to [Drug Enforcement Administration] controls,” he said. “We don’t believe the 0.3% is good enough—we’d prefer 0.1%, and we feel this should be adopted as an FDA standard. If you are following guidelines for control related substances it is very important and ensures public safety.”
CBD task force
The FDA has created a working group to spearhead the questions surrounding CBD and cannabis in food and beverages. This group will be co-chaired by two FDA principals: Amy Abernethy, principal deputy commissioner; and Lowell Schiller, principal associate commissioner for policy.
“When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety,” said Sharpless. “To help us evaluate these questions, as well as potential pathways for CBD products, the FDA has formed an internal working group to address these data gaps specifically. You’ll be hearing more from this group in the months to come."