Q: May a pharmacy legally sell CBD "supplements"?
A: No. On December 20, 2018, FDA Commissioner Scott Gottlieb issued a statement explaining that while the Farm Bill of 2018 removed hemp from the federal Controlled Substances Act, "Congress explicitly preserved the [FDA's] authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act." Hence, the FDA "treat[s] products containing cannabis or cannabis-derived compounds as [it does] any other FDA-regulated products." Importantly, FDA reminded the regulated community that it is "unlawful under the FD&C Act . . . to market CBD or THC products as, or in, dietary supplements, regardless or whether the substances are hemp derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as . . . dietary supplements." The full text of Commissioner Gottlieb's statement may be found here: http://www.ncbop.org/pdf/FDACannabisStatement122018.pdf.
In late February, the North Carolina Department of Agriculture -- which directly regulates industrial hemp products in North Carolina -- began sending letters to businesses that manufacture or sell CBD-containing products emphasizing that "North Carolina has routinely adopted by reference the federal Food, Drug & Cosmetic Act and implementing regulations. The violation of these federal laws and regulations would equally be a violation of state laws and regulations." The Department of Agriculture's letter -- like Commissioner Gottlieb's statement -- emphasizes that "CBD is the active ingredient in the approved drug product Epidiolex" and that "[s]ince CBD is the active ingredient in the approved drug product Epidiolex, it is currently excluded from being a dietary supplement under section 210(ff)(3)(B)(i) and (ii) of the FD&C Act."
The North Carolina Department of Agriculture further emphasized that "CBD products marketed with claims to prevent, mitigate, diagnose, treat or cure diseases" make those products "drugs under the FD&C Act." Accordingly, "CBD in products other than the approved drug Epidiolex and which make health claims would be a new drug that cannot legally be introduced into interstate commerce."
The full text of the Department of Agriculture letter is found here: http://www.ncbop.org/pdf/CBDletterNCDeptAgriculture.pdf.
Board staff trusts this clears up any lingering confusion concerning CBD-containing supplements.