Food and Drug Administration (FDA) To Regulate CBD
Posted: June 7, 2019 in CBD Regulation Hearing at FDA HQ in Silver Springs, Epidiolex, FDA and CBD, FDA Hearing on Regulating CBD, Food and Drug Administration
The first-ever public hearing addressing the regulation of the CBD market convened on Friday, May 31, 2019. 120 applicants, both opponents and proponents, voiced their opinions to a panel of FDA officials. The event took place at the Maryland FDA Headquarters located at the White Oak Campus, in Silver Springs. This article covers what transpired during the hearing.
Estimated US sales of CBD products are expected to reach $16 billion by 2025. Congress is pressing the FDA to legitimize and regulate what many people consider to be the “Wild West” CBD market. The current FDA position on CBD is that the compound is banned from foods, drinks, and dietary supplements. However, thousands of companies are currently selling such products, both in stores and online.
Enforcement of these rules by the FDA has been lax at best. The goal of the hearing was to gather enough information to make a decision in regards to which CBD products may continue to be sold. The major concern of the FDA is to ensure public safety. They believe that the absence of research data from well controlled studies on CBD products is a stumbling block to making an informed decision.
As a result of the passage of the 2018 Farm Bill, both hemp and CBD were removed from the Controlled Substance List as a Schedule 1 drug. It left in place the FDA jurisdiction over the regulation of CBD products.
Both proponents and opponents did agree on one thing. The current lack of supervision over the selling and marketing of CBD products is not sustainable. The FDA must act quickly to put regulations in place.
Even proponents of the benefits of CBD products agree that there are many products which should be disallowed. Some contain more CBD than stated on the label, some contain less CBD than stated, some contain no CBD at all and some make ridiculous, unsubstantiated claims about its benefits. Some products do not provide any benefits to consumers. Some even contain pesticides, lead and metals, and are potentially dangerous to the public. Many lack dosing directions at all, or incorrect ones.
Oversight of the cannabis plant involves 3 federal US agencies:
- DEA (Drug Enforcement Agency) regulates the growing and cultivation of cannabis for medical research
- Department of Agriculture regulates hemp although it allows individual states to do so as long they meet certain criteria
- FDA regulates drugs and has the authority to take legal action against companies selling CBD in foods, drinks and dietary supplement. The only companies the agency has prosecuted are those that they consider to make outrageous health claims.
Representing one of the applicants, the US Hemp Roundtable, was lawyer Jonathan Miller. He maintained that CBD products are inherently safe, but he agrees that companies selling bad products, and/or making false health claims must be stopped. He believes that his organization can be helpful in collaborating with the FDA in establishing guidelines for quality and safety. Transparency by the CBD industry is in the interest of both vendors and consumers.
Suggestions on how to proceed included the following:
- Require CBD vendors to submit a document that demonstrates the safety of their products
- Follow the current FDA regulation for folic acid as a model for CBD regulation. Some folic acid products are available over-the-counter, while those containing a higher concentration require a doctor’s prescription.
Another consideration raised by both FDA officials and industry proponents was on the potential effect of enforcing more stringent regulations of CBD products. It may actually discourage more scrupulous research which is necessary to insure safety for an FDA approved, CBD-based drug such as Epidiolex. The makers of Epidiolex, Greenwich Biosciences, emphasised that a rigorous approval process in developing a drug is crucial in understanding what disease it will treat, who will use it while assuring its safety. Clinical studies are of paramount importance in recognizing all the potential health risks for patients.
This hearing was the first step towards CBD product regulation. The Acting FDA Commissioner, Ned Sharpless, was not forthcoming on a timeline as to when regulation might happen. He ended by saying that “there is still much that we don’t know.” The former FDA Commissioner, Dr. Scott Gottlieb, thought the prospect of adding CBD to pet food was absurd.
Sources: nytimes.com, Cannabis Companies Push FDA to Ease Rules on CBD Products, May 31, 2019, Sheila Kaplan
statsnews.com, At First-Ever Public Hearing on CBD, Advocates an FDA Try to Blaze Trail to Regulatory Compromise, May 31, 2019, Nicholas Florko