Five CBD Regulatory Myths

February 12, 2019
Volume: 
2
Issue: 
1
Abstract / Synopsis: 

Where does cannabidiol’s (CBD) legal status stand following the 2018 Farm Bill? One attorney looks at common misperceptions.

The passage of the 2018 Farm Bill capped off a momentous year for cannabidiol, or CBD, a nonpsychoactive derivative of cannabis. The year kicked off with the January 2018 rescission of the Cole Memo, the U.S. Department of Justice’s policy statement regarding cannabis enforcement in states where cannabis is legal, which essentially stated that, given limited resources, the federal government would not enforce the federal marijuana prohibition in states that had legalized marijuana in some form. Following this move, many expected an increase in federal marijuana enforcement. The feared enforcement uptick never materialized, though. By mid-year, the U.S. Food and Drug Administration (FDA) approved Epidiolex, a prescription drug made from a CBD isolate for treatment of rare forms of epilepsy. Later in the year, Senate Majority Leader Mitch McConnell (R-KY) saw opportunity with the Farm Bill update to expand industrial hemp legalization at the federal level and introduced new legislation within the Farm Bill to legalize U.S. industrial hemp as an agricultural commodity. Following conference committee work to iron out differences, the House and Senate passed the final version of the Farm Bill in mid-December, and the President signed it on December 20, 2018.

Companies are now considering which new business opportunities will result following the Farm Bill’s passage. It’s important to separate the myths regarding what the Farm Bill did from the realities of where CBD’s legal status stands.

Myth #1: CBD Is Fully Legal Since It’s Not a Controlled Substance Anymore

It’s more complicated than that. Regulation exists at the federal and state levels. At the federal level, the 2018 Farm Bill deschedules industrial hemp and various derivatives thereof, including CBD, from the Controlled Substances Act when produced in compliance with a state hemp program. Industrial hemp is defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low (less than 0.3% on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The U.S. Drug Enforcement Administration (DEA) retains jurisdiction over CBD from marijuana because marijuana remains a Schedule I substance. The DEA isn’t the only relevant regulator, though. The FDA and the states also have jurisdiction.

State laws currently are a patchwork. Approximately one-third of states have hemp programs set up pursuant to the 2014 Farm Bill. One-third of states do not have hemp programs and therefore do not have legal mechanisms for sale. Finally, approximately one-third of states have programs in some developmental stage, but regulations are not final.

Myth #2: The FDA Has Approved CBD, So the Claims I’m Seeing Online Must Be Substantiated

The FDA has only approved Epidiolex for treatment of rare forms of epilepsy. This approval does not mean that other CBD claims are approved or that the FDA agrees that CBD can be lawfully used in other products. The FDA’s position is that CBD from any source is an active drug ingredient. The FDA has voiced this position in warning letters and reiterated it in late December. The agency also highlighted its continuing concern about consumer safety and disease treatment claims featured on unapproved CBD products.

Disclosures: 

This article was originally published in the January/February 2019 issue of our sister publication, Nutritional Outlook (http://www.nutritionaloutlook.com/regulatory/5-cbd-regulatory-myths).