In 2021, the U.S. Food and Drug Administration (FDA) took enforcement actions against multiple establishments listing Cannabidiol (CBD) as an inactive ingredient in over-the-counter (OTC) drugs. FDA has not formally approved any cannabis-derived compound as an active ingredient for OTC drug use, and has not evaluated CBD under the agency’s OTC Drug Review, the process by which many OTC drugs are reviewed and permitted to be marketed.

Keep reading to see how FDA’s increased enforcement might affect your products that contain CBD.

Products Containing CBD Growing in Popularity

The 2018 “Farm Bill” signed into law on December 20, 2018 removed hemp from the Controlled Substances Act. Cannabis plants and derivatives that contain no more than 0.3 percent tetrahydrocannabinol (THC) on a dry weight basis are no longer controlled substances under federal law. The bill preserves FDA authority to regulate products containing cannabis and cannabis-derived compounds, regardless of whether or not they are classified as hemp. As a result, companies have pounced on this interest, marketing a variety of products with CBD as an ingredient including beverages, supplements, and OTC drugs.

Regulations of Inactive Ingredients

Within the last year, FDA has published statements related to the use of CBD in OTC drugs, but as an inactive ingredient. According to FDA regulation, an active ingredient is “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” An inactive ingredient is “any component of a drug other than an active ingredient.”

FDA expects that substances named as inactive ingredients have a suitable physical or technical function such as preservatives, flavors, propellants, ointment bases and pH control agents. Moreover, FDA has long held that prominence being given to an inactive ingredient in a manner that creates an impression of therapeutic value is inappropriate and may cause the product to be deemed misbranded.

FDA Enforcement Actions

In March 2021, FDA issued warning letters to two companies for selling products that contained CBD as an inactive ingredient. Their products were branded as unapproved drugs “regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient.” FDA’s cited reason was that the products would not meet the general requirement of safety and suitability of inactive ingredients under the regulation 21 CFR 330.1(e). FDA further explained that “CBD has no known functional role as an inactive ingredient in a finished drug product… CBD, however, has known pharmacological activity with demonstrated risks.” Both companies were also cited for highlighting the presence of CBD on their product labels, implying that CBD was functioning as an active ingredient. They were given 15 working days to respond or risk legal action, including seizure and injunction.

In December 2021, FDA contacted companies directly, appearing to target those with products listed with the agency that had CBD as an inactive ingredient. In their email, FDA stated:

You have listed one or more unapproved cannabidiol (CBD)-containing nonprescription drug product(s) with the U.S. Food and Drug Administration (FDA).   

Currently, however, no nonprescription drug products containing CBD as an active ingredient have been determined to be generally recognized as safe and effective and not a new drug, or otherwise able to be legally marketed without an approved new drug application.  Even if CBD could be considered an inactive ingredient in a nonprescription drug product, such product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonprescription drug products under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In particular, such product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e)…

It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations, including listing drug products with FDA.  Any information you would like to send regarding your listed drug products should be sent to FDAADVISORY@fda.hhs.gov, by replying to this email. A firm should discontinue its drug listing in eDRLS after no longer selling the product.  We will continue to regularly monitor the marketplace to ensure compliance with the FD&C Act. 

The email was generated from the FDA’s Office of Unapproved Drugs and Labeling Compliance (OUDLC).

Accordingly, companies marketing OTC drug products in the U.S. would be prudent to review their formulations to determine if this situation applies.