Earlier this week, the FDA made significant movement on issues and policy involving cannabis and its components, including cannabidiol (CBD). The agency issued a notice in the Federal Register announcing a hearing and requesting comments on “scientific data and information about products containing cannabis or cannabis-derived compounds.” 84 Fed. Reg. 12,969. FDA and the Federal Trade Commission also jointly issued three warning letters to three companies that make claims about the use of CBD products for the treatment of various diseases.
In addition, Commissioner Scott Gottlieb issued a statement, where he outlined how the agency intends to address stakeholders’ need “for clarity on how [FDA] authorities apply to such [CBD] products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.” The Commissioner’s statement referenced his December 2018 statement, where he clarified FDA policy and the current law that means “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” The Commissioner’s December 2018 statement came after the passage of the 2018 Farm Bill that legalized the production and marketing of hemp that contains less than .03 percent delta-9-tetrahydrocannabinol (THC). Hemp that contains less than .03 percent THC was also removed as a controlled substance under Federal law.
The steps that we outline below, and as proposed by Commissioner Gottlieb, are not intended to put in place a framework for cannabis and cannabis-derived products. Rather, the next steps and actions used by FDA are “to advance [the agency’s] consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.”
- Public hearing and solicitation of comments
The public hearing will be held on May 31, 2019 and include an opportunity for written comment, and public testimony. The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform regulatory oversight of these products. FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in the evaluation of cannabis and cannabis-derived compounds in FDA-regulated products. The public hearing will give stakeholders an opportunity to provide the agency with additional input relevant to regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how FDA can make these legal pathways more predictable and efficient.
The Federal Register notice poses questions and requests information relating to the safety, manufacture, and marketing/labeling of cannabis and cannabis-derived substances, including, for example:
- How the levels of (or exposure to), delivery method, and interaction with other substances effect health and safety risks. FDA also asks about population-based risks; how to collect safety and other data that might support the use of such substances in food or dietary supplements; and how the incentives for, and the feasibility of, drug development might be affected if food products containing cannabis-derived compounds, such as CBD, were to become widely commercially available?
- How are such products containing cannabis and cannabis-derived compounds manufactured; and are standards, processes, validation and testing needed to address safety and quality issues involved in manufacturing and processing such products?
- Are there standardized definitions used for ingredients in cannabis products and would standardized definitions be helpful?
- What are the functional purposes of adding cannabis-derived compounds, such as CBD, to foods (e.g., nutritive value; technical effect) both in terms of manufacturer intent and consumer perceptions?
- What risks should consumers be informed about, and how should consumers be informed of such risks?
- What other information should FDA consider in the labeling of specific product categories of cannabis and cannabis-derived products?
FDA is currently accepting requests for presentations during the public meeting and is accepting comments to the above questions through July 2, 2019.
2. The formation of an internal agency working group
FDA will form a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed, including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health. Commissioner Gottlieb indicates that this working group will consider feedback from stakeholders to help inform consideration of important scientific, technical and policy questions. Principal Deputy Commissioner, Amy Abernethy, M.D., Ph.D. and Principal Associate Commissioner for Policy, Lowell Schiller, will co-chair the group. Significantly, the Commissioner has requested that the working group consider whether legislation is needed to lead to more efficient and appropriate pathways. The working group will begin sharing information and/or findings with the public “as early as summer 2019.”
3. FDA Enforcement
As mentioned above, FDA issued three new Warning Letters in conjunction with the FTC to companies marketing CBD products that make unfounded claims specific to treatment of various diseases, conditions, and symptoms. This action is significant, particularly given that in the past year, a substantial number of new products containing cannabis-derived ingredients, including CBD, have been brought to market over the past year. During 2018, however, FDA did not issue one Warning Letter involving such products.
The FDA Warning Letters posted this week were issued to Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc. and involve the marketing of more than a dozen products spanning multiple webpages, online stores and social media websites. The companies made claims about their products’ ability to limit, treat, or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence or FDA approval.
Examples of claims made by these companies include:
- “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
- “CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.”
- “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
- “Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
- “Cannabidiol May be Effective for Treating Substance Use Disorders.”
- “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.”
- “CBD may be used to avoid or reduce withdrawal symptoms.”
In his statement, Commissioner Gottlieb firmly took the position that “[FDA] won’t tolerate this kind of deceptive marketing to vulnerable populations.” Commissioner Gottlieb also committed that FDA will continue to “monitor the marketplace and take enforcement action as needed against companies that illegally sell cannabis and cannabis-derived products that put consumers at risk and are being marketed and distributed in violation of the FDA’s authorities.” Despite this assertion, the Commissioner indicated in his testimony before Congress this week that the agency does not have sufficient resources to enforce the proliferation of such products on the market. In response to a question from Rep. Andy Harris (R-Md.) before the House Appropriations Agriculture-FDA Subcommittee, the Commissioner said the agency needs a “framework that could allow us to better differentiate between where [marketing CBD in conventional foods] could be permissible and where it’s clearly crossing the line.” He added that “[w]e could be taking enforcement action against all of it, [but] [i]f I do that, that’s the only thing that my agency will be doing right now.”
Although it remains unclear whether or how FDA and/or Congress will clarify its regulatory authority over cannabis and cannabis-derived products, FDA seems to have put its enforcement foot down and has laid out a roadmap to obtain further input from stakeholders in order to examine possible approaches and considerations in the marketing and regulation of such products.