Last week, the outgoing FDA commissioner, Scott Gottlieb, announced that his agency will be using “enforcement discretion” to target products containing cannabidiol (CBD) that are making ‘over-the-line’ claims on their products. Gottlieb defines ‘over-the-line’ claims as claiming to cure cancer or prevent Alzheimers or other diseases. These claims could mislead a patient to forgoing an otherwise effective therapy.
Gottlieb acknowledged that the FDA has not been able to take action against a large number of CBD products on the market due to FDA’s limited resources. Enforcement priorities have been put in place due to the lack of resources. Commissioner Gottlieb is expected to depart the FDA within the next 2 weeks. We will have to wait and see how his successor will view the debate of CBD in this critical transition period.
For now, companies should be careful on the claims they make on their CBD products. The FDA will continue to search the industry websites and you can be sure that the FDA will be sending out warning letters to companies making OVER-THE-LINE claims for their products containing CBDs.
We will continue to closely monitor the ongoing process of the FDA establishing legislation to regulate CBD products.
If you have any questions about CBD and the claims, you intend to use and the FDA compliance or your regulatory requirements, feel free to contact us at firstname.lastname@example.org or use our contact form re: CBD.