On March 5th, FDA chief Scott Gottlieb signed off on his official Twitter account, setting the stage for him to formally leave the office he held since May 2017. Now, Ned Sharpless, director of the National Cancer Institute, will take the reigns as acting FDA chief until the vacancy is permanently filled.
The loss of Gottlieb has left uncertainty among those interested in the CBD industry. Gottlieb was at the agency when it approved the first CBD-based, and he was poised to give those interested in selling food and dietary supplement products containing CBD a fair hearing about what will happening next.
Unfortunately, it is unclear whether the hearing Gottlieb promised will occur since he has resigned from the post. It is unclear whether Sharpless approach the CBD industry with the same interest.
Background on CBD
After the 2018 farm bill was written into law last year, some states chose to ban the sale of food, such as gummies and cookies, and drinks with added CBD despite the federal government’s move to decriminalize hemp and make it legal to cultivate for certain purposes.
Under the farm law, any part, extract, or derivative of the Cannabis plant that has a THC concentration of not more than 0.3 percent on a dry weight basis is legal. The law in no way legalizes marijuana, which comes from the same plant as hemp.
Then, after the bill passed, the U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb released a statement, explaining the law did not change the agency’s position on food, drinks, or dietary supplements that contained CBD.
Under the U.S. Food, Drug, and Cosmetic Act, it is illegal to market or sell food and supplements that contain CBD even if they are hemp-derived. The problem is that federal laws prohibits the sale of any food or supplement that contains an ingredient that was investigated in clinical trials or approved as a drug by the FDA.
CBD was approved as a drug ingredient in the FDA-approved anti-epilepsy drug, Epidiolex, therefore, the sale of any edible infused with CBD is not permitted.
What the CBD hearing was suppose to accomplish
In February, prior to his announcement to resign, Gottlieb told the House Appropriations Committee that he planned to hold a public meeting in April to revisit the agency’s position on the CBD policy.
The hearing would have provided a forum for those interested in the industry to give comments, suggestions, and ask for instructions on how to move forward. Gottlieb had said the goal of the hearing was to come up with an appropriate, effective framework for regulating these products.
The Future of CBD
Since Gottlieb did not hold a hearing and no new one has been planned, it will be up to his successor to determine what will or won’t happen next. CBD advocates worry that whoever takes charge permanently won’t pursue anything at all or make it a priority.
The only guidance those in the industry are getting is that they should do whatever they can to stay out of the FDA’s crosshairs. Companies are being told to make sure no CBD products have any false or misleading claims, and anything they promote must be backed up with scientific evidence.
If the FDA determines a product is violating any of policies, the agency has the right to remove products from shelves, fine companies, or shut down businesses.
Though states, like Ohio, New York, Texas, and Maine, have banned the sale of edibles, companies in other states may still be able to sell CBD products based on the federal law concerning hemp. Individual business owners need to check for the rules where they live and plan to sell.
Merchants that need CBD merchant accounts, so they can accept and process credit and debit card payments should contact eMerchantBroker.com. It works with high-risk merchants, including those in the CBD industry.