Despite not being illegal by federal law, the FDA still has the authority to regulate cannabis and cannabis-derived compounds. Moreover, the FDA has announced that it is unlawful to introduce food containing CBD or THC into interstate commerce or to market CBD or THC-containing materials as a dietary supplement. While it is not illegal, FDA can and will still take enforcement action.
“Be careful what you say about CBD. Be careful what you communicate about CBD. Pay attention to your state and the federal regulations of CBD as well,” said Karla L. Palmer, Esq, director, Hyman Phelps & McNamara, P.C, at the NCPA meeting. “Pay attention to the FDA’s website for warning letters. This is a very gray area, in terms of what is permitted, and what isn’t permitted. It’s legal, but we don’t know what you can and cannot do with it, but FDA is making headway about what you can and cannot say about CBD. Pharmacists need to be careful.”
With the passage of the Hemp Farming Act of 2018, regulation of cannabis became based on THC content. Under the law, if the THC content is below 0.3%, it is considered hemp and no longer defined as marijuana. This allows hemp to no longer be defined as a controlled substance by the Drug Enforcement Agency. The passage of this law allowed for interstate commerce of hemp-derived products and established a framework for regulation of hemp production, although regulation is still in its infancy. For the most part, the law leaves it up to the states to regulate hemp production and marketing.
Although the federal law allows for hemp, other laws still greatly vary from state to state, as does the definition of hemp. Staying up to date on the regulations is one of the more challenging issues, as the laws around cannabis, CBD, and hemp are evolving rapidly, Palmer noted.
“The best thing to do is to lay low on what you’re claiming for your CBD. Be careful of your website and social media claims,” Palmer said. “Disease claims are not permitted for dietary supplements, food, or cosmetics. Since Epidiolex is approved, CBD cannot be a supplement. You can say you have it, but be very careful not to say it is for anything.”
Unlike marijuana, CBD is nonpsychoactive and does not result in feelings of euphoria or intoxication, even if large quantities are taken. In addition to the endocannabinoid receptors CB1 and CB2, CBD also acts on the serotonin receptor, vanilloid receptors, orphan receptor, and nuclear receptor.
“CBD interacts with our endocannabinoid system at CB1 and CB2 receptors. It interacts indirectly, unlike marijuana, and in 2019 we really aren’t sure how it works,” said Jesica Thomason Mills, PharmD, MBA, RPh, CNHP, Pharmacist, Naturopath, Hemp Expert, Owner, Owensboro Family Pharmacy and Wellness. “The endocannabinoid system uses neuromodulatory lipids to wake and strengthen the immune system, nervous system, and digestive system.”
Since its legalization, many formulations of CBD have emerged, some with low levels (<0.3%) of THC (labeled as full spectrum) or THC-free isolates. Additionally, differences exist between products, based on extraction method. CBD has been formulated into different methods, including oils, capsules, balms and salves, vape or flowers, and edibles. The edibles, since added to food, can present potential regulatory issues, Mills warned. The quickest acting method are the oils, she added, but the method with the highest bioavailability is through the lungs.
Although CBD is not meant to treat, mitigate, or prevent a disease, many patients believe in its effects. In most cases, they take oils for systemic issues, such as chronic inflammation, and balms for localized concerns, like joint pain. Moreover, the THC-free isolate version of the oil allows individuals to take CBD without failing a drug test, Mills noted. However, all full spectrum varieties of CBD will cause a positive drug test result.
Some of the adverse effects of CBD could include drowsiness, GI upset, and drug interactions, as CBD uses CYP enzymes for metabolism. There have been signs of liver issues in some studies, Mills noted. If an individual is on a narrow therapeutic index drug, continue to monitor the patient once the begin taking CBD.
“It does mess with other drugs, there are studies that show this,” she added.
For her patients and even local providers, Mills holds educational events on CBD in her pharmacy, with samples available. She has also used social media to promote the availability of CBD at her pharmacy, but noted that potential issues have occurred on Facebook and with credit card vendors to process payments.
Although the prices per unit are near $60 to $70, Mills said she had no problem quickly selling out of CBD. She recommended placing the products near the register and within a locked case. If utilized with caution, CBD has the potential to substantially improve the revenue of a community pharmacy.
Mills J, Palmer K. Hemp: Positioning Yourself as the Truth Expert. Presented at: NCPA 2019 Annual Convention & Expo; October 26, 2019; San Diego, CA.