FDA Commissioner Dr. Robert Califf was brought before the House Committee on Oversight and Accountability on April 11 to discuss, among other issues, the Food and Drug Administration's regulation of hemp and hemp-derived products.
Chairman Comer Criticizes FDA Over Hemp Regulations
The House Oversight Committee's Chairman, Rep. James Comer (R-KY) critiqued the FDA for its alleged inaction on hemp regulation, highlighting the dangers of an unregulated hemp market and calling for additional research.
THE FDA'S REFUSAL TO REGULATE HEMP PRODUCTS IS CREATING A SIGNIFICANT CONFUSION IN THE MARKET AND RESULTING IN PRODUCTS WITH INTOXICANTS THAT CAN BE DANGEROUS TO AMERICANS WHO USE THESE PRODUCTS
- CHAIRMAN COMER
This critique comes after the FDA announced in January 2023 that it would not be developing CBD regulations due to the lack of an available pathway to create such rules without further guidance from Congress.
In addition to health and safety concerns for consumers, Comer also referenced the impacts on the hemp industry, underscoring significant challenges legitimate businesses face due to the FDA's inaction. Entrepreneurs attempting to operate within legal bounds find themselves hampered by uncertainty, while less scrupulous entities can capitalize on the regulatory void. This dynamic puts good-faith companies at a competitive disadvantage and stifles market growth.
Commissioner Califf Calls for a Rulebook
Throughout the hearing and in response to multiple questions from various committee members, FDA Commissioner Califf repeatedly referenced the need for further guidance from Congress, referring to an analogy that the FDA acts as a referee, whereas Congress writes the rulebook.
“THE FDA IS A REFEREE, AND WE NEED A RULE BOOK, AND YOU GUYS WRITE THE RULE BOOK"
- FDA COMMISSIONER CALIFF
In response, Chairman Comer stated that he "hopes to do so," implying that he is motivated to create clearer rules regarding hemp regulation. Comer's insights resonate with a broader industry call for increased hemp regulation in order to validate the industry, ensure safety standards, and quell the proliferation of substandard, potentially dangerous goods.
Rep. Burchett "Concerned About Hemp"
As the hearing continued, Rep. Tim Burchett (R-TN), expressed frustration over the restrictive regulations on hemp farming, suspecting the influence of the cotton industry and criticizing the complexity added by the varied jurisdictions of oversight bodies.
"WE PASS THIS THING IN THE FARM BILL, AND ALL THESE FOLKS THAT WANT TO GROW HEMP, THEY ALL SAY, OH, WE'VE GOT THE GREATEST THING IN THE WORLD. BUT DAD GUM IT. I'M A UNITED STATES CONGRESSMAN. AND I'VE GOT A LITTLE FARM, I CHECKED INTO GROWING HEMP. IT'S NOT GOING TO MAKE YOU A FORTUNE, BUT I HAVE TO GET A DAD GUM FINGERPRINT TO DO IT. IT JUST SEEMS TO ME THAT THE BIG BOYS IN THE COTTON INDUSTRY, I'M SURE THEY'LL BE RUSHING UP TO MY OFFICE RIGHT AFTER I SAY THIS, BUT THEY WROTE THESE DAD GUM REGULATIONS. YOU AND I BOTH KNOW IT."
- Rep. Tim Burchett
This conversation ultimately highlights the need for more regulatory clarity to foster a thriving hemp industry. Lawmakers and regulators must grapple with balancing the promotion of agricultural growth while ensuring public safety and fair competition.
Rep. Palmer Questions the FDA's Monitorization of CBD
Citing additional concern for the health and safety of hemp-derived products, Rep. Gary Palmer (R-AL), asked Commissioner Califf if the FDA was currently involved in monitoring the use of CBD and if it should be more involved than it currently is. In response, Commissioner Califf stated that CBD does not fall within any regulatory scheme that the FDA currently has, but that the FDA "very much would like Congress to establish a regulatory pathway for CBD."
"WE VERY MUCH WOULD LIKE CONGRESS TO ESTABLISH A REGULATORY PATHWAY FOR CBD."
- FDA COMMISSIONER CALIFF
With CBD and cannabis gaining mainstream popularity, and as federal and state laws continue to change, the call for a clear regulatory pathway has never been more pressing. Califf emphasized the FDA's eagerness for congressional support in establishing a concrete regulatory pathway for CBD, indicating that the FDA requires a "rule book," supplied by Congress, to define their regulatory scope effectively.
Rep. Mace Considers the Impact of Packaging and Marketing on Misuse of Cannabis and Hemp-derived Products
Representative Nancy Mace (R-SC) questioned Commissioner Califf about the FDA's role in providing safeguards for youth concerning intoxicating hemp-derived products. While Representative Mace highlighted established health benefits of medical-use marijuana, in addition to the potential benefits of recreational use of marijuana and other hemp-derived products, such as the reduction of morbidity and addiction associated with doctor-prescribed opioids, while highlighting concerns about product packaging which can appear to market to children. She questioned if the FDA plays a role in regulating the marketing of hemp- and cannabis-derived products. Commissioner Califf echoed these concerns, but again called for help from Congress in establishing a regulatory pathway which would allow the FDA to step in.
"THE QUESTION IS, HOW DO WE REDUCE HARM THAT'S DONE WHEN IT'S USED INAPPROPRIATELY OR AT A DOSE WHICH IS DANGEROUS, OR WHEN IT'S PACKAGED IN A WAY TO MARKET IT SPECIFICALLY TO CHILDREN? WE'RE SEEING SOME OF THIS STUFF PACKAGED IN GUMMY BEARS THAT EASILY MISTAKEN FOR CHILDREN'S CANDY. BUT WE'RE GOING TO NEED HELP IN A REGULATORY PATHWAY"
- FDA COMMISSIONER CALIFF
Rep. Mace also referred to a South Carolina Bill that seeks to further regulate the marketing and packaging of hemp-derived products within the state.
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