Tell the FDA What’s on Your Mind

The FDA is asking for input on how to regulate CBD and cannabis. Project CBD gave oral comments at last week’s public hearing, and we plan on submitting written comments and supporting documents to their public docket. You should, too.

You have until July 2 to share your thoughts on the best path forward. The FDA’s ask is a big one, and it concerns more than just CBD (the full prompt is attached below). Whatever regulation is coming will shape not only CBD regulation, but that of cannabis and cannabinoids more generally.

In their announcement, the FDA clearly states that they’re looking for information about 1) health and safety risks; 2) manufacturing and product quality; and 3) marketing/labeling/sales. Each category is broken into specific queries, all aimed at seeking input on how they should regulate cannabis and cannabis-derived products.

The FDA is faced with the challenge of crafting regulation in a way they’ve never done before. Both THC (Marinol, Syndros, Nabilone) and CBD (Epidiolex) have been approved by the FDA for the treatment of specific diseases. This means that the FDA has, until this point, regulated single-molecule cannabinoids just like any other pharmaceutical. Now the FDA is tasked with regulating those same compounds for general consumption as food supplements and nutraceuticals. But the FDA is not generally in the business of approving the same plant compound both as a prescription medication and an over-the-counter food supplement – there is little precedent to draw upon.

Given the enormous public interest in cannabis and the huge demand for CBD products, the FDA says they’re willing to listen. So, tell them your story. Write about how CBD has helped (or not helped) you and your family (including your dog!). If you’ve researched how cannabis and CBD can impact a particular medical condition, share the data with the FDA. If you are involved in manufacturing hemp or cannabis products, tell the FDA how that’s working in your state.

DO:

• Read the entire prompt that the FDA has provided. The FDA is looking for specific information about a broad range of topics related to cannabis. It was apparent that some of the people who spoke at the public hearing hadn’t taken into account the information the FDA already has. The FDA knows about Epidiolex, the pharmaceutical version of CBD. They approved it as a drug and are aware of the high-dose hepatotoxicity data from clinical trials.
• Submit data and studies to support the information in your comments. Be specific. If you know of a study that backs up your experience with managing a specific condition, cite it and provide the article. One of the FDA’s most frequent requests at the recent public hearing was for more data to support claims.
• If possible, include dosage amounts (in milligrams of cannabinoids) when sharing stories about how cannabis or CBD has helped you or those you care for.
• Read the FAQs.
• Submit your comments by 11:59 PM EST on July 2, 2019.

DO NOT:

• Do not try to address the entire FDA prompt. Address the areas that directly apply to your experience or body of expertise.
• Don’t use profanity or casual, lingo-laden language. You’re speaking to government officials, after all. The more formal, specific, and detailed, the better. Personal stories are wonderful, but make sure to support your story with specific dosages so that the FDA has some data to work with.
• Do not make up data. If there isn’t data to support your experience, state that plainly and encourage the FDA to facilitate crucial research in that area.

Zoe Sigman is Project CBD’s Program Director.

Copyright, Project CBD. May not be reprinted without permission.