Understanding the FDA's Stance on CBD
by Harry Lattanzio, RPh; and Tim Gregorius, RPh, as seen in America's Pharmacist Magazine's March 2020 Issue
Obviously there is exciting potential for community pharmacies in the CBD market.
Still, it is important that pharmacy owners be well versed and educated when it comes to the legality of selling CBD to customers. There are innumerable confusing and conflicting laws, rulings, statements, letters, and announcements by the various entities that influence and control the legal status of CBD. Federally, the 2018 Farm Bill has stated that if CBD is derived from hemp and has no more than 0.3 percent THC by weight, it is legal. However, the Food and Drug Administration and each state board of pharmacy have something to say about that.
Let’s discuss the FDA’s stance on its mandate to protect public health. In December 2018 when the Farm Bill (Agriculture Improvement Act of 2018) removed cannabis and cannabis derivatives that are very low in THC from the definition of marujuana in the Controlled Substances Act, the legislation specifically preserved the FDA’s jurisdiction over such products. In the time since passage of the 2018 Farm Bill, the FDA has made several clear and concise statements regarding that mandate.
The primary statement that should be of interest to CBD marketers and sellers is that the FDA is very clear in stating its top priority, that there shall be no therapeutic claims about the ability of CBD to prevent, diagnose, treat, or cure disease. It has already sent out dozens of warning letters to CBD companies and marketers for making therapeutic claims. The fact that CBD is already the sole ingredient in the FDA-approved legend drug, Epidiolex, only further complicates matters, not only for us, but admittedly for the FDA as well.
The other important mandate the FDA has is to validate the safety of food and drugs. But CBD products are already flooding US stores and homes. The FDA does not have much confidence that there is comprehensive knowledge of its safety and efficacy, and this puts it in a tough position. There are known warnings and concerns with CBD from Epidiolex studies, but the FDA is equally concerned about CBD safety and efficacy outside of the approved drug context. For example: How much CBD is safe to consume daily? What are the drug interactions that need to be monitored? Are there any long-term risks?
The FDA understands the importance of communicating its approach about CBD to the public, and it is taking an agency-wide, integrated, and collaborative approach to addressing CBD regulation that falls under its jurisdiction. In the meantime, where does that leave you and your pharmacy?
Each state has reacted to these federal directives in different ways. As many as 40 state boards of pharmacy have either remained silent on CBD or have regulations that allow the marketing, transportl, sale, and use of CBD. It is especially important that you check with your state board in the 10 remaining states to make yourself aware of rulings that affect your business when it comes to CBD.
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