In an FDA press announcement issued April 2, 2019, the FDA commissioner, Scott Gottlieb, discussed new steps that the administration will take to address the use of cannabis and cannabis-derived compounds in products, which includes a potential regulatory pathway for cannabis-derived cosmetics, foods and beverages.
Following the passing of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), hemp was removed from the Controlled Substance Act. At the same time, the U.S. Congress preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, the FDA can continue to enforce the law to protect the public from unsafe products, while also providing a potential regulatory pathway for products containing cannabis or cannabis-derived compounds.
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In the announcement, Gottlieb outlined a series of actions that the administration will take to ensure safety under its authority. These new steps include:
- The administration will hold a public hearing on May 31, 2019, which will allow stakeholders to share their experiences and challenges with these products. They will present information and views related to the safety of the products.
- The FDA will create a high-level internal agency working group to explore potential pathways for foods and dietary supplements containing CBD to be lawfully marketed. The working group will consider changes that might be needed and the impact the marketing will be on public health.
- Frequently asked questions and responses to the topic will be posted on the FDA’s webpage.
- Lastly, the FDA issued several warning letters to companies marketing CBD products with unfounded claims that were aimed at vulnerable populations. Warning letters were sent to Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc.
To read the full press statement, visit the FDA website here.