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FDA Is Open to Public Comment Regarding CBD till July 16


The FDA uses science to base its decisions regarding public health and safety, which applies to regulating CBD. While science is providing a lot of information regarding CBD’s efficacy, there are still many unanswered questions. The agency is now saying that its process to regulate CBD will be transparent.

This month, the agency stated that it doesn’t clearly understand CBD yet. CBD is still categorized as a drug and according to FDA protocol it must be regulated under FDA monograph or FDA drug guidelines. When it comes to CBD-infused food items, food products and dietary supplements are regulated differently.

The FDA is reminding the industry that interstate sales of CBD-infused foods remains illegal. Due to increasing public interest in CBD-infused foods, the FDA is considering making an exception with special provisions that would allow CBD to be included in food items. Since CBD was approved for use in Epidiolex, it complicates things because the FDA now sees CBD as being an acceptable treatment for epilepsy – giving it medicinal value.

Although the potential therapeutic benefits of CBD are recognized, its safety is not yet understood. Stakeholders in the CBD industry have made their opinions known, which is also what’s driving the FDA to find answers and clarify regulations soon. They are also taking public comments into consideration. Public comments regarding CBD are being accepted until July 16th. The initial public comment period was set to expire in April but was extended. Those wishing to submit a comment regarding CBD may do so on the Federal Register website.

The FDA is seeking answers to these questions before it can create formal regulations:

  • Risks of long-term use
  • Drug interactions that require monitoring
  • Impacts of CBD use on pregnant and breastfeeding women, children and the elderly
  • Safe consumption doses/daily limits
  • Does CBD delivery method make a difference in how a dose works

Scientific data will need to be collected in order to answer these questions. Data will be collected and analyzed to determine how the agency will move forward in regulating medical and non-medical uses for CBD. Until the science is available to satisfy the FDA’s requirements, regulations for the CBD industry will remain in limbo.