Curent Hemp-based CBD Product Regulations
There are several different factors which caused the FDA determination that Hemp-based CBD products cannot be marketed as dietary supplements. Here is an explanation of those factors and associated regulations.
The 2018 Farm Bill, signed into law on Dec. 20, 2018, defined hemp as Cannabis sativa L and any part of the plant including, seeds and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3% on a dry weight basis. This bill removed hemp from the Controlled Substances Act (CSA), removing its controlled status. However, this bill also preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds.
Under section 201(ff)(3)(B) of the FD&C Act, if a substance is an active ingredient in a drug product that has been approved as a new drug under section 505 of the FD&C Act, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.
On June 25, 2018, several months prior to the 2018 Farm Bill, Epidiolex™ was approved by FDA as a new drug treatment for epileptic seizures. Epidiolex™ is a purified form of CBD derived from hemp, which validates section 201(ff)(3)(B) of the FD&C Act. As a result, the FDA does not believe CBD can be marketed as a dietary supplement in the US.
There is an exception to 201(ff)(3)(B) of the FD&C Act if a substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized as applicable. However, the FDA has concluded that they do not believe hemp-based CBD was marketed as a dietary supplement prior to the approval of Epidiolex™. Therefore, hemp-derived CBD products cannot be marketed as dietary supplements.