June 25, 2019, Senator Ron Wyden sent a letter to the Department of Health and Human Services and the Food and Drug Administration urging both entities to provide clarity around CBD products derived from hemp.
The FDA has been under a magnifying glass since hemp was declassified as a schedule I drug, having formerly fallen under the thumb of the Controlled Substances Act of 1970.
With the passing of the 2018 Farm Bill, farmers, manufacturers and consumers are keeping a watchful eye on the agency and how they might address compliance for the thousands of companies selling the product and the millions of consumers vying to use it.
Yet silence and lack of clarification on a potential path towards compliance for supplement producers has left many chomping at the bit for the agency to come up with regulatory guidelines for selling Food and dietary supplements containing CBD. In the interim, well-established companies such as Next Green Wave, Inc. (Next Green Wave, NGW:CSE | NXGWF:OTCQX) have continued to solidify their position in the market, ready and able to serve the exponentially growing demand of what promises to be a $20 plus billion-dollar industry.
A Slow and Arduous Process
In Wyden’s letter, the lawmaker criticized the FDA’s indication that it could take up to 3 to 5 years for the FDA to implement final regulations for companies to lawfully sell CBD infused foods, calling the suggestion “unacceptable.” Wyden wrote that he urges the FDA to quickly implement “enforcement discretion guidelines” by August 1, then issue an interim final rule pending a permanent rule so that companies will have clarity on how CBD in food and dietary products will be regulated.
This argument may have fallen on attentive ears, but as of the date of this publication, the FDA has yet to provide any clear established guidelines. Although the agency has wielded their powers against a handful of “bad actors”, their approach seems to be that of “wait and see” with regards to due process.
The letter penned by Wyden also stressed the economic impact growers in states like Oregon would benefit from by allowing CBD to be in more products, but are halted until the FDA gives the okay that CBD in ingestible products is lawful to sell and okay to use.
However, this isn’t the first letter Wyden has sent to the agency regarding a regulatory pathway to CBD commercialization. In January the lawmaker co-authored a letter with Senator Jeff Merkley telling the FDA they must revamp current legislation around offering CBD products. Both senators advised former commissioner Scott Gottlieb to “immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and give U.S. producers more flexibility in the production, consumption, and sale of hemp products,” according to the letter.
FDA is listening to public demand for clear CBD regulations
The FDA has slowly but surely has been taking measures to develop guidelines around selling CBD ingestible-products. In late May, the agency held a public hearing allowing stakeholders the opportunity to share their reasons why the FDA-regulation for CBD food and dietary products is crucial, according to the Chicago Tribune.
The agency also gave a chance for the public to weigh in on CBD regulation by opening a public docket for individuals to add comments. The deadline to submit comments was July 16, and the agency received over 3,000 comments, according to the Chicago Tribune. In conjunction with the open docket, the FDA also published an article July 17 echoing the agency’s stance on CBD and concern for public safety.
“We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise,” the article said. “At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.”
In the “Listening to and learning from stakeholders” section of the article, the FDA insists that relative questions must be answered in order to develop a clear pathway to regulate CBD products which include the following:
- How much CBD is safe to consume in a day? How does it vary depending on what form it’s taken?
- Are there drug interactions that need to be monitored?
- What are the impacts on special populations, like children, the elderly, and pregnant or lactating women?
- What are the risks of long-term exposure?
In a second article published on the same day, the FDA stressed it has not approved any CBD products besides Epidiolex, a drug which treats seizures caused by epilepsy. And is currently working to figure out how CBD will affect body parts, special populations and pets.
Since both the public hearing and window to submit comments to the FDA have both passed, the agency says it will review submitted information and intends to follow up with its findings “around the end of summer/early fall,” according to the Chicago Tribune.
It is unclear if the FDA will tentatively meet this deadline, but the agency will most likely continue to be pressured by lawmakers and the public to provide a regulatory framework around the selling and obtaining CBD food and dietary supplements.