Mintz - Health Care Viewpoints

Enforcement by the Food and Drug Administration (FDA) against cannabidiol (CBD)-containing products continues through the issuance of two new warning letters. On March 22, 2021, FDA published a press release cautioning companies against illegally selling over-the-counter (OTC) CBD products for pain relief. In the warning letters, FDA cited products listing CBD as an inactive ingredient for unapproved drug and misbranding violations.

Regulatory Background of CBD Products

We have previously blogged about the regulation of CBD products by the FDA and provided updates to the government’s actions to create a comprehensive regulatory framework for CBD. But as a brief refresher, FDA does not permit adding CBD as an ingredient of food products or dietary supplements. And while the Agriculture Improvement Act of 2018 (the Farm Bill) legalized the production of industrial hemp and products derived from hemp, it did not legalize all uses of and products containing hemp derivatives (such as CBD).

Under the Federal Food, Drug and Cosmetic Act (FD&C Act), any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the human body is a drug. This definition includes articles and components of drugs, which are regulated as drugs. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law; this includes drug products containing CBD.

Currently, nonprescription drug products containing CBD may not 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. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. However, as noted in a prior blog post, the FDA has approved one CBD-containing prescription drug product for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome, and Dravet syndrome in human patients.

FDA’s primary concerns pertaining to CBD use in products include a lack of safety data and the quality of the CBD products on the market. Currently, there is insufficient safety data to establish cumulative exposure to CBD (and THC), impact on vulnerable populations, or impact on drug development. There are also concerns about contaminants such as heavy metals, microbials, pesticides, and THC. In addition, FDA is concerned that there is a lack of appropriate processing controls and practices regarding the quality of CBD products, which puts consumers at additional risk.

Analysis of OTC CBD Warning Letters and Potential Implications to Industry

To date, FDA’s CBD enforcement has focused on disease or health claims as well as the products’ intended use. FDA commonly determines a product’s “intended use” based on: claims in the labeling, advertising, or promotion; consumer perceptions; and ingredients with well-known therapeutic uses. Products with unsubstantiated or misleading claims may result in a change to the intended use and consequently, a change to the status of the product causing it to become an unapproved drug or adulterated product under the FD&C Act.  A product is adulterated if it fails to conform to FDA’s standards of quality, strength, or purity.  

FDA’s recently issued warning letters to Honest Globe, Inc. and BioLyte Laboratories, LLC are no different with the exception that these warning letters address OTC CBD drug products claiming to provide pain relief. Honest Globe and BioLyte, both manufactured and marketed OTC CBD products that allegedly provide pain relief. Although CBD is labeled as an inactive ingredient on the products, the labeling of these products represent CBD as an active ingredient due to the frequent and prominent placement of CBD claims on the products’ labeling and advertising on the companies’ websites. The labeling and advertising may lead consumers to the conclusion that the product provides benefits due to the CBD contents. To add insult to injury, CBD is not an active ingredient in any applicable final monograph or TFM, for purposes of establishing eligibility for lawful marketing without an approved application under the FD&C Act. Even if CBD was considered an “inactive ingredient” in these nonprescription drug products, the products would still require approval through a new drug application in order to be legally marketed since CBD has no known functional role as an inactive ingredient in a finished product.

In addition, Honest Globe issued a press release on its Instagram page that stated the “Did you know that Elixicure [product in question] was the first over-the-counter CBD-infused topical pain cream product to receive FDA certified registration” (the company made several similar claims identified in the warning letter). FDA noted that to state the product is “FDA registered” is inaccurate. Drugs are subject to listing with FDA, not registration. Moreover, registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drugs of the establishment, nor does it mean that a product may be legally marketed. FDA stated that “[a]ny representation that creates an impression of official approval or that a drug is approved or is legally marketable because of registration or listing is misleading and constitutes misbranding.”

Aside from the labeling and advertising claims and an assessment of the products’ intended use, both companies displayed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals demonstrating FDA’s concerns over safety data and quality control. The companies’ methods, facilities, and controls for manufacturing, processing, packing, and holding did not confirm to CGMP making the product adulterated within the meaning of the FD&C Act.

Neither of the company’s products have been subject to the approval process, nor have there been any evaluation of whether they are effective for the claims used, appropriate dosage, interaction with other drugs or products, or dangerous side effects or other safety concerns.

FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. stated that: “The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country. . . It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, 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.”

Over the past several years, FDA has continued to issue warning letters to companies that market unapproved new drugs that allegedly contain CBD at an increased rate. These new warning letters are unique in that they address OTC CBD pain relief. As noted, demonstrating a product's intended use and making disease and health claims are common pitfalls for companies selling CBD products. The rise of OTC CBD pain relief products make this an area to watch. As this area will no doubt continue to be a hot enforcement area for the FDA, we will continue to update our readers of any important regulatory activity.

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