The U.S. Food and Drug Administration issued a revised consumer alert on Cannabidiol (CBD), warning that the agency is aware that some companies are marketing CBD products in ways that violate the federal Food, Drug and Cosmetic Act (FD&C Act), and that may put the health and safety of consumers at risk. The FDA also sent a new round of warning letters to 15 companies in an effort to crack down on illegal selling practices.
The CBD industry is one of the fastest growing markets in the US. CBD-infused ointments, gummy bears, beauty creams, baby oil, dog treats—you name it, they have it—have been widely adopted by many mainstream retailers as the stigma surrounding the cannabis industry fades.
CBD, a chemical component of the Cannabis sativa plant, is believed to not cause the intoxication or “high” that comes from tetrahydrocannabinol (THC). Hemp is a strain of the Cannabis sativa plant that is grown specifically for the industrial uses of its derived products and, in contrast to marijuana, is known for its low concentrations of THC.
Congress appeared to give hemp-derived CBD sales a green light for the first time in December 2018, when President Trump signed theAgriculture Improvement Act of 2018, known as the Farm Bill, into law. This legislation granted general retail stores the right to sell hemp-derived CBD products by removing “hemp”—defined as cannabis and cannabis derivatives with very low concentrations of THC (no more than 0.3% on a dry weight basis)—from the definition of marijuana in the Controlled Substances Act.
Marijuana-derived CBD remains classified as a controlled substance.
Are CBD products now legal to sell in the US?
Under current FDA guidance, CBD may only be marketed in FDA-approved drugs.
Despite the Farm Bill, it is illegal under the FD&C Act to market CBD as intended for therapeutic uses (the treatment or prevention of disease) in humans or animals.
CBD products are also excluded from the dietary supplement definition under the FD&C Act because purified CBD is the active ingredient in an FDA-approved prescription drug to treat two rare forms of epilepsy.
Following the passage of the Farm Bill at the end of 2018, then FDA Commissioner Scott Gottlieb stated:
[I]t’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of 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 foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements….
The companies recently targeted by FDA’s warning letters use online stores and social media to affirmatively market CBD as effective for treating serious diseases such as cancers, or for other therapeutic uses such as pain relief. Others marketed CBD products as dietary supplements and added CBD to human and animal foods. Combined with warning letters FDA has issued periodically throughout 2019, it appears FDA is focusing on CBD products making affirmative efficacy claims. Whether due to limited resources or less concern, FDA has not yet targeted products containing CBD that do not claim to treat maladies or provide pain relief.
It is clear that the FDA’s stance and enforcement efforts have had little effect on the growing popularity of these products. Enthusiasts avow CBD’s effectiveness as a remedy for insomnia, stress, anxiety, aches and pains, and other ailments—all claims that are unquestionably illegal according to the FDA.
The FDA plans to provide an update on its progress regarding the agency’s approach to CBD products in the imminent future. Lowell Schiller, FDA’s Principal Associate Commissioner for Policy, stated that
The CBD working group is evaluating all the data available to us, including data we received through the public hearing and the public docket, and evaluating our policy options. We’re asking not just ‘What should we do?’ but also ‘What can we do within our existing authorities and resources?’ And if we conclude that we need additional authorities or resources, we’ll need to think about going back to Congress.
Lurking danger ahead
Beyond FDA compliance issues, consumer class actions based on the alleged illegality of CBD products are proliferating. A number of cases have been recently been filed, claiming that sellers misled consumers when marketing CBD products as dietary supplements despite FDA’s position. This crop of class actions is still developing, and we will be tracking outcomes and trends.