An Early Look at the FDA’s Plans for Cannabis Compounds like CBD

The Food & Drug Administration has recently announced its plans to further study the effects, potential uses, and overall safety of medical products containing the cannabis compound cannabidiol (CBD).

Recent changes in state law have raised the public’s interest in CBD. The 2018 Farm Bill, for instance, exempted hemp from the Controlled Substances Act, passing regulation of the compound to the FDA’s guidelines. CBD is a popular ingredient in many drugs, dietary supplements, foods, and other health products, but its safety still remains untested.

The only CBD drug that the FDA has approved is Epidiolex, a treatment for epilepsy, which was approved after extensive clinical trials. However, the agency seeks to evaluate and approve more drugs in the future.

Research Priorities

The FDA believes that additional research is necessary to understand and adequately control CBD and other cannabis-related products. Some examples are:

• Its long-term effects on the human body. A current concern is possible toxicity to the liver. While medical supervisors can monitor the consequences of taking CBD in controlled environments, more widespread use not in accordance with FDA approval could carry other unknown risks.
• How cumulative exposure can affect humans. As more and more consumer products adopt CBD, how will the public react? If you eat food or use skincare products containing CBD, how will it affect your health?
• What it means for special populations. The agency will study how CBD affects pregnant women, the elderly, animals, and children.

False Advertising

Because the FDA has not evaluated the safety or efficacy of CBD treatments, other than Epidiolex, information that consumers need, such as dosage instructions and how the chemical interacts with other drugs and foods, is not yet available.

The agency aims to reduce misleading or false claims companies use when advertising products containing CBD. For example,

• The drug may not treat specific diseases or not contain the level of CBD as advertised.
• Some products could contain contaminants like pesticides.
• The compound’s effects on animals are still largely unknown.

Without proper regulation of CBD, false claims can reduce trust in the medical community. The FDA is looking into more ways to evaluate these types of products.

What Are the Next Steps?

To support the development of new drugs, the FDA will develop new drug approval processes and update regulations and legislation accordingly. Further studies on the scientific use of CBD will begin soon, and stakeholders will be aware of the findings.

It is worth noting that the FDA provides the public a lengthy comment period before introducing new guidelines. This practice allows the industry and other interested parties the opportunity to comment on the proposed guidelines prior to final consideration and implementation.

CFPIE Can Help With Pharmaceutical and Biotech Training Courses

Because of the FDA’s interest in establishing guidelines for CBD use, the numerous companies currently considering this market must stay up-to-date on the latest regulatory developments in the US and Europe.

Be ready when the FDA begins actively regulating and approving new drugs. Enroll your staff into CFPIE’s up-to-date biotech and pharmaceutical training courses. Here are a few that you should consider:

• FDA Inspections - What Regulators Expect and How to Prepare [Pharma/Biotech] [Medical Device]
• The Drug Development Process from Concept to Market [Pharma/Biotech]
• Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products [Pharma/Biotech]

If you have any questions about our pharmaceutical and biotech training courses, please feel free to get in touch with a member of our team at 1-610-648-7550.