Stakes Are ‘Enormous’ for CBD Regulations as FDA Hearing Draws Nearer
FDA holds first-ever hearing on cannabidiol as pressure grows from the food and beverage industry and supplement makers.
The U.S. Food and Drug Administration will hold its first ever hearing on cannabis compound CBD on Friday, amid immense pressure from the food and beverage industry and dietary supplements makers move quickly on CBD regulations.
Friday’s long-awaited hearing, announced prior to the departure of former FDA Commissioner Scott Gottlieb, will serve only as a listening session for the agency. Policy won’t be determined right away ー it could take months or even years to establish official regulations ー and yet the stakes are still high.
“The FDA is on an information gathering mission,” said Rod Kight, cannabis legal expert and attorney at Kight Law. “There’s not any immediate stakes involved, but in the big picture the stakes are enormous.”
CBD, or cannabidiol, is a compound derived from hemp or marijuana that has been praised for various health and wellness benefits, as well as for not getting its consumers high. It has existed in something of a legal gray area for years, meaning very little research has actually been done on it. And because there is virtually no regulation in the industry, it is difficult if not impossible for consumers to know exactly what the CBD products they purchase actually contain and what effects they can expect.
When Congress passed the 2018 Farm Bill in December, it removed industrial hemp and its compounds, like CBD, from the purview of the Controlled Substances Act. The FDA immediately stepped up to say that in spite of the shift, adding CBD to food and beverages or making health claims about it are strictly prohibited, in part because the compound has already been regulated by the FDA through prescription seizure reduction medication Epidiolex from GW Pharmaceuticals ($GWPH).
A decision to permit the use of a prescription compound in over-the-counter supplements would greatly undermine the FDA’s own established clinical trial process, Kight said.
“If companies are going to be willing to spend millions of dollars and years and years on research and development to push these products through, the FDA wants to encourage that,” Kight said, adding that “CBD itself and cannabis compounds have been in the food supply … for hundreds and maybe thousands of years.”
“On the one hand the FDA has to preserve the integrity of the its process and by the law, on the other hand there is such an enormous push to have it available and to regulate it properly that it’s at a crossroads,” he said.
Much of that push is coming from a rash of businesses that popped up hawking everything from burgers with CBD-infused sauce to cosmetics in an effort to take advantage of a market that is projected to hit $22 billion by 2022. Any decisions the agency makes concerning banning or limiting the use of hemp-derived CBD in food, beverages, and supplements could hurt those businesses. But experts like Kight and Eric Berlin, partner at Dentons and a leading cannabis legal authority, speculate that the FDA will ultimately end up with a bifurcated system in which lower potency cannabinoids like CBD can be included in food and supplements, while higher potency forms will be reserved for prescription drugs.
“I believe the FDA’s concern is with very high doses of CBD, and of course adulterated product, and of course [health] claims. I believe that their efforts in this area will be geared mostly to those three and that they will be trying to find a way to not have a whole industry-wide crackdown,” Berlin said.
Long term, regulations for CBD could form the basis for the entire industry should marijuana be legalized on the federal level.
As the FDA inches closer to regulating hemp and CBD, other government agencies are clarifying their own stance on the issue.
The U.S. Department of Agriculture on Tuesday released guidance on hemp as it relates to interstate commerce. According to a legal opinion from Stephen Vaden, general counsel to the Department of Agriculture, states and Native American tribes have the authority to prohibit or more stringently regulate hemp, but they cannot interfere with hemp shipments across state lines. The opinion referenced a case earlier this year in which Idaho police confiscated a shipment of hemp from Oregon to Colorado ー and a local judge ruled they did have to return it.
The Transportation Security Administration, an agency within the Department of Homeland Security, also updated its official policy over the Memorial Day weekend to allow travelers to pack hemp and CBD in their checked and carry on luggage. The TSA still forbids traveling with any federally illegal substances, including medical and recreational marijuana. How exactly agents are expected to gauge THC content ー the only differentiator between marijuana and hemp ー of various, unregulated products found in luggage is still an open question.
“The final decision rests with the TSA officer on whether an item is allowed through the checkpoint,” the TSA clarified on its site.
