Inside The FDA\’s Evaluation and Considerations of Cannabis Products

Some more information on the actions of the FDA to further analyze and study cannabis products lies with the stakeholders. They are the community who is interested in CBD. The FDA recognized that in 2018, when the Farm Bill, or Agriculture Improvement Act, was passed, that it was important for them to interact with the CBD stakeholders. This began with a public hearing in May 2019, and the FDA called upon these stakeholders to work with them in order to develop high quality, CBD data.

The FDA has also reopened the files of the May 2019 public hearing, and they will keep it open in the future, as a means for the CBD stakeholders to share data. In July 2020, the FDA then collected both industry input and stakeholders\’ input on the topic of the challenges about the quality, safety and monitoring of the current cannabis market. They also held a multidisciplinary conference in November 2020 to provide more insight regarding the scientific evidence of the absence of presence of gender disparities in the use and response to CBD and other cannabis substances. The FDA conducts regular sessions with stakeholders who are willing to share their perspectives and data with them.

The FDA continues to evaluate the regulatory processes that are applicable to certain cannabis-derived products intended for non drug-related uses. This process includes whether new regulations by the FDA may be needed, and they continue to actively work with drug developers in investigating and reviewing new drugs and their approval processes. The work of the FDA in this area includes meetings with drug developers to provide drug-specidic advice as to the development of the intended products, and also the development of guidance documents. These consist of high priority issues on both the safety and regulations of the targeted drug. The FDA recently published a draft that is about the quality considerations for research on cannabis and cannabis-derived compounds. When this draft is finalized, it will represent the opinion of the FDA on cannabis sources, as well as contain information on quality, and the calculation of the delta-9 tetrahydrocannabinol, THC, percentage. The FDA are evaluating comments submitted to their agency about this draft.