SHARON BLINKOFF*¹, CRAIG WEISS²
*Corresponding author
1. Locke Lord, USA
2. CPT Labs, USA

Abstract

Cannabis has had a checkered past. First it was taxed, and then effectively banned as a result of being classified Schedule 1 substance under the Federal Controlled Substances Act, thus criminalizing all activity associated with Cannabis use. Approval by the U.S. Food and Drug Administration (FDA) of the drug Epidiolex with its active ingredient Cannabidiol (CBD) changed the Category 1 status to 5, and passage by Congress of the 2018 Farm Bill legalized Hemp and the CBD’s in hemp. However, the Farm Bill left product control for FDA regulated products to the FDA. And of course, the states have stepped into the act by passing laws which permit recreational and medicinal use of Cannabis. By permitting medical use of marijuana the states are basically abrogating the safety and efficacy standards required by the FDA and the manufacturing controls required by the FDA.

Cannabis has had a checkered regulatory history in the U.S.

First it was taxed, and then essentially banned by its Schedule 1 listing under the Federal Controlled Substances Act, a designation of Category 1 listing effectively criminalizing any activity involving Cannabis. This includes activities of selling, using, growing, or conducting research or any related banking activity. Research activities unless specifically approved by the U.S. Drug Enforcement Authority and the FDA would also be criminal.

The category 1 listing of these ingredients was based upon the high risk of abuse from the hallucinogenic properties of delta-9 tetrahydrocannabinol (“THC”), a component which is present in high concentrations in marijuana and low concentrations in Industrial Hemp. However because of the definition, the Hemp version of the plant which should have been excluded from category 1 listing was not.

In 2003 the Drug Enforcement Agency (DEA), the agency responsible for enforcing the Controlled Substances Act, announced it would permit use of Industrial Hemp in cosmetics and personal care products. The DEA in granting the exemption remarked that ...