On March 28, 2019, the Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), issued warning letters to Advanced Spine and Pain, LLC, Nutra Pure, LLC, and PotNetwork Holdings, Inc. The letters claim that these companies were marketing or distributing CBD dietary supplement products for humans and/or pets which were misbranded, adulterated, and/or contained unsubstantiated health claims.
The letters highlight certain claims that the FDA considers drug claims made by these companies on various platforms, including the following:
“We carry cannabinoid oil and CBD salve for treating your conditions. If you have any of the indications listed below, please consider trying our cannabis treatment products! … Anxiety … Chronic Inflammation … Cancer Pain … Depression … Chronic Pain”
“CBD successfully stopped cancer cells in multiple different cervical cancer varieties”
“CBD may be used to avoid or reduce withdrawal symptoms”
“For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease”
“[CBD] treats neuropsychiatric disorders”
“CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent”
Products intended to diagnose, cure, mitigate, treat, or prevent diseases are “new drugs” under the Food Drug & Cosmetic Act (FDCA) and are subject to FDA approval. It is the FDA’s position that supplement products making such disease claims are being sold illegally, as they have not been approved by the FDA as safe and effective.
The letters also reinforce the FDA’s position that CBD products marketed as dietary supplements are misbranded because CBD is an active ingredient in an approved drug, Epidiolex, and the FDA has no evidence to suggest that CBD was marketed as a dietary supplement or conventional food prior to authorization of the new drug investigations.
It is the FDA’s position that any products containing CBD are excluded from the FDCA definition of a dietary supplement and therefore cannot be labeled or marketed as such. In one instance, even though the product was not labeled as a dietary supplement, the FDA determined it was intended to be one due to inclusion of the phrase “[a]s a hemp supplement” contained in the directions for use.
Federal Trade Commission Act Warning
In addition to the products’ violations of the FDCA, the letters also warned the companies that it is a violation of the Federal Trade Commission Act (FTCA) to advertise that a product can treat, prevent, or cure human disease unless the marketer possesses reliable and competent scientific evidence substantiating that the claims are true when made. The letters expressed the FTC’s belief that one or more claims may be in violation of the FTCA, and urged the producers to re-evaluate all claims for their products.
In its letter to Advanced Spine and Pain, LLC, the FDA further evaluated claims made in connection with its “CBD for Dogs” product. Similarly, the FDA asserted that because the product is intended to cure, mitigate, treat, or prevent diseases in animals, and is not generally recognized among experts as safe and effective for use under the conditions prescribed, that CBD for Dogs is a “new animal drug” under the FDCA, and is being sold illegally as it was not the subject of a new animal drug application.
The warning letters are consistent with outgoing Commissioner Scott Gottlieb’s statements regarding the FDA’s policy of selective enforcement with respect to CBD products, namely, that it will only take action against companies making egregious and outrageous health claims. Accordingly, the letters warned the producers that violations may result in legal action, including seizure, injunction, and repayment of money to consumers.
A Path Forward for CBD
Despite its current position that inclusion of CBD in dietary supplements and conventional foods is illegal, the market is currently flooded with CBD-related products. The FDA has made clear its desire to create pathways for the lawful marketing of CBD in dietary supplements and conventional foods, which may include regulatory changes, and announced that it will hold a public hearing on May 31, 2019 on products containing cannabis or cannabis-derived products.
Other public health officials have also given CBD products their attention, as we explain in an earlier Harris Beach legal advisory regarding a decision by the New York City Department of Health and Mental Hygiene (NYCDOH) to ban sale of any food products containing cannabidiol (CBD) in New York City bars and restaurants.
At this hearing, the FDA will solicit information regarding the safety, quality, manufacturing, labeling, and sale of such products. However, the FDA maintains its emphasis on public health and safety, asserting that it is “deeply concerned about any circumstance where product developers make unproven claims to treat serious or life-threatening diseases, and where patients may be misled to forgo otherwise effective, available therapy and opt instead for a product that has no proven value or may cause them serious harm.”
Outgoing Commissioner Gottlieb issued a statement on April 2, 2019 detailing steps the FDA intends to take to advance its framework for the lawful marketing of cannabis-related products. In addition to the public meeting, other actions include the formation of a high-level internal agency working group, updates to its website to include clearer guidance, and issuance of warning letters to companies illegally marketing CBD products.
Given current enforcement actions by the FDA, coupled with the continuous evolution of the CBD regulatory framework, it is important to consult with counsel before proceeding with the development of any food, beverage, or supplement products containing CBD.