Food and Drug Administration considering CBD regulations
It seems like CBD products are available on every street corner, but the industry’s unregulated heyday may not last much longer.
A federal Food and Drug Administration working group is gathering information and crafting regulations for the cannabis-derived substance.
“We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise,” the agency said in a statement. “At the same time, there are many unanswered questions about the science, safety and quality of many of these products.”
The agency held a public hearing May 31 where industry representatives, researchers, advocates, retailers and regulators shared their concerns.
The agency is accepting public comments about cannabis products on its website until July 2. As of June 17 it had received more than 1,900 comments.
Health advocacy groups called for clear warning labels and testings standards, while health care providers warned about the lack of research done on CBD, the journal reported.
Mike Moody, chief operating officer of Commonwealth Alternative Medical Options, or CAMO, which grows hemp and produces CBD at a New Stanton facility, said he’s hopeful the FDA will create regulations that will be good for the industry in the long run by providing clarity to retailers and customers.
“The hope is that it will give clearer guidance to non-hemp business so they can understand what rules to operate under,” he said. “There’s still a fair amount of confusion out there among folks not familiar with the 2018 farm bill.”
CBD products grew more popular in the United States over the last few years, despite existing in a legal gray area. Cannabis was illegal under federal law despite being legal in some states until late last year, when a new Farm Bill partially lifted the ban by removing hemp from the federal list of controlled substances.
Hemp is a variety of cannabis with extremely low THC — the psychoactive ingredient in marijuana.
Pennsylvania has no rules regarding CBD products, and the FDA has yet to craft any CBD-specific regulations.
The industry has boomed without government oversight.
CBD products are available almost everywhere. Westmoreland County customers can buy them from Sheetz, boutiques, vape shops, video rental stores and chiropractors’ offices.
The marketing for CBD touts dozens of health benefits. Advocates say it aids sleep, reduces pain, alleviates anxiety, treats seizures and more.
Some of these marketing claims violate federal law, according to former FDA Commissioner Scott Gottlieb.
Gottlieb issued a public statement in April — shortly before leaving the FDA and taking a job in the private sector — warning the agency would be taking a closer look at CBD regulations.
Though the FDA doesn’t yet regulate CBD specifically, it does prohibit making claims of a cannabis product’s therapeutic benefits without agency approval.
In April the FDA sent warning letters to three companies that made “unfounded, egregious claims” about CBD’s ability to treat cancer, opioid addiction and other diseases, Gottlieb said in his statement.
The agency wants to learn more about CBD before deciding on final regulations, including how much is safe to take in a day, how it interacts with other drugs and the impacts of long-term exposure.
The agency could begin sharing information about its regulatory plans this summer, according to Gottlieb.
Jacob Tierney is a Tribune-Review staff writer. You can contact Jacob at 724-836-6646, [email protected] or via Twitter .