As cannabis legalization continues across the U.S. – with New York most recently reaching a deal to legalize recreational use – manufacturers need to ensure they are in compliance not only with their state regulations, but with FDA restrictions as well. In mid-March, FDA issued warning letters to two companies for selling over-the-counter (OTC) products labeled as containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Cannabis-infused topicals, oils, vapes, foods, and drinks have become increasingly popular in states where they are legal. And while the 2018 Farm Bill legalized hemp and its derivatives, that does not necessarily make it legal for use in FDA regulated products. Businesses can be penalized for non-compliant labeling practices, lack of GMPs, as well as interstate commerce issues. The most egregious issue is often that of labeling CBD products as having a therapeutic use, as any product intended to have a therapeutic or medical use (e.g., diagnose, cure, mitigate, treat or prevent a disease) is considered to be a drug – and is therefore under the regulatory arm of FDA regardless of state law.
Such was the case with the two warning letters issued in March, as the products were labeled as providing “pain relief.” With FDA having approved only one drug containing CBD, and no OTCs, no other prescription nor any nonprescription drug product can be labeled as containing CBD as an active or inactive ingredient. In fact, nonprescription drug products that include CBD as an active ingredient are not generally recognized as safe and effective (GRASE) and are new drugs requiring an approved application to be legally marketed. As such, the products were cited for both unapproved drug use and misbranding violations.
However, this is not the first time FDA has sent such warning letters – and it is not likely to be the last. In fact, while the March notice stated that they “remain focused on exploring potential pathways for CBD products to be lawfully marketed,” FDA added, “We will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”
Additionally, both warning letters cited “substandard manufacturing practices, including failure to comply with current good manufacturing practices” (CGMPs). These included citations such as failure to establish, document and maintain an adequate quality control unit, conduct any tests to verify the identity of each component of a drug product, establish a written testing program to assess the stability characteristics and use the results to determine storage conditions and expiration dates; establish written procedures for production and process control designed to assure the products have the represented identity, strength, quality, and purity.
Based upon the nature of the violations, FDA recommended that both companies engage a consultant qualified to assist them in meeting CGMP requirements. While this does not relieve the company’s obligation and responsibility to implement and comply with CGMPs, external consultation can provide the needed expertise, as well as an extra set of eyes, to ensure CGMP and overall regulatory compliance.
If your company has questions on CGMPs, federal or state regulatory compliance, or other areas of quality and/or safety, give HashTAG a call. We can help!