What You Need to Know About the Legal Status of CBD
There is no substitute for personal accountability by every pharmacy owner 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 varied 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% THC by weight, it is legal. However, The FDA, each state as well as each State Board of Pharmacy have something to say about that! Let’s first discuss the FDA’s stance on their 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 marijuana in the Controlled Substance Act, the legislation specifically preserved the FDA’s responsibility over such products. In the time since the 2018 Farm Bill the FDA has made several clear and concise statements regarding that mandate. The primary statement that should be of concern to CBD marketers and sellers is that the FDA is very clear in stating their top priority: that there shall be no therapeutic claims about the ability of CBD to prevent, diagnose, treat, or cure disease. They have 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 U.S. stores and homes. The FDA has little confidence that there is comprehensive knowledge of its safety and efficacy, this puts the FDA in a tough position. There are warnings and concerns with CBD that are known 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? Are there drug interactions that need to be monitored? Are there any long-term risks?
So, although the FDA is aware of these usual responsibilities, concerns and mandates, they at the same time recognize that the consumer explosion of CBD use requires further action on their part. The FDA understands the importance of communicating with the public about their approach to CBD and they are taking an Agency-wide, integrated and collaborative approach to addressing the regulation of CBD that falls under their 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 35 states have either no opinion on CBD or have laws that allow the marketing, transport, sale and use of CBD. The other states are where each of us must make ourselves aware of laws and rulings that affect us and our business when it comes to CBD! Several states, possibly as many as 10 at the time of this writing, have laws that affect the sale of CBD within state jurisdiction. Roughly an equal number of State Boards of Pharmacy have made specific statements regarding the sale of CBD on pharmacy shelves by a Pharmacist. On several occasions there was conflict between a state statute and that state’s Board of Pharmacy rulings, while both were in conflict with federal laws.
We will provide a couple examples here that are for illustration purposes only because it has been our experience that these laws are changing almost daily. Couple that with the fact that the FDA has promised an announcement very soon in response to their Public Hearing held on May 31, 2019, and you will understand our hesitancy to make any definitive statements pertaining to individual rulings in any given state. We will use a familiar Midwest state as an example of how state laws change in response to fluid circumstances. In the Fall of 2018 this state’s board of Pharmacy warned Pharmacy owners that CBD was not allowed on pharmacy shelves and could only be sold in medical marijuana dispensaries because the definition of marijuana still included hemp products. Even after the Farm Bill was passed in December 2018 the ban stayed in effect in Pharmacies even though there were many non-pharmacy retail outlets selling CBD. This caused a situation where the only retailers not allowed to sell CBD were pharmacies, so people were buying this “drug” in gas stations but couldn’t t get advice from nor purchase it from their pharmacist. In late July the state board of pharmacy ruled that it was permissible to sell CBD in pharmacies.
At this time, there are still several states that share similar inconsistencies in definition and rulings that make the sale of CBD illegal even though it is not considered illegal nationwide. That is why we strongly recommend that each pharmacist contact his or her board of Pharmacy for guidance.
If you have additional questions please call and speak with our CBD for Pharmacy experts anytime by calling 833-786-6522.