The U.S. Food & Drug Administration (FDA) has sent warning letters to an additional two companies selling CBD products, suggesting they are in violation of the federal Food, Drug and Cosmetic Act (FD&C Act).
FDA cited BioLyte Laboratories of Grand Rapids, Michigan, and Honest Globe, Santa Ana, California – in the process effectively declaring that the presence of CBD as an active or inactive ingredient in topical over-the-counter (OTC) drug products is against the law. FDA said marketing of the companies’ products violates the FD&C Act in that the labels “clearly represent CBD as an in active ingredient.”
“Currently, a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient,” FDA wrote in the letter to Honest Globe.
Sorting out risk
Because CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an ingredient in OTC drug products that are not reviewed and approved by the FDA, the agency informed the companies.
The agency said the companies’ products were also in violation the FD&C Act because they were not manufactured according to current good manufacturing practices (cGMP) for drugs.
The FDA, which so far has not approved any OTC drugs containing CBD, has periodically cracked down on mislabeled CBD products, most recently warning Cannafyl, an Arizona company, about potential FD&C Act violations. Five CBD marketers received warnings late last year. Previous warnings went out in April and November of 2019 and again in April 2020.
The jurisdiction of hemp-derived products in the U.S. moved from the Drug Enforcement Administration to the Department of Agriculture with passage of the 2018 Farm Bill, which legalized hemp federally. FDA asserted its authority to regulate products derived from cannabis, including hemp, and therefore has a major role to play in the development of markets for CBD, food, cosmetics and drugs.
While FDA knows clear regulations for CBD are needed, it has yet to write formal rules for hemp, although the agency has put forth enforcement discretion guidance for hemp products. There is no legal deadline for the FDA to clear a path to market for over-the-counter CBD.