US Food & Drug Administration (FDA) Commissioner Scott Gottlieb today outlined new steps and actions to advance FDA’s consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.In a statement made today, Gottlieb said, “In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD). This interest spans the range of product categories that the agency regulates. For example, we’ve seen, or heard of interest in, products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things. We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such 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.”
Interest in these products increased last December when Congress passed the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), which among other things, established a new category of cannabis classified as hemp that was removed from the Controlled Substances Act. At the same time, Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.
“In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways, to the extent permitted by law, for products containing cannabis and cannabis-derived compounds,” write Gottleib.
According to Gottlieb, FDA's new steps to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities incude:
· A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
· The formation of 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.
·Updatesto our webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
· The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.
The public hearing on May 31 will give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s 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 we can make these legal pathways more predictable and efficient. We hope to gain additional information and data for the FDA to consider with respect to products containing cannabis and cannabis-derived compounds, including CBD.
“As we’ve stated before, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce. Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because CBD and THC are active ingredients in FDA-approved drug products and were the subject of substantial clinical investigations before they were marketed as food. In such situations, with certain exceptions that are not applicable here, the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use,” Gottlieb wrote in his statement.
While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use, said the commissioner.
“It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products – especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods. As I stated in December, the FDA would only consider this path if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients,” said Gottlieb.
As part of the public hearing and related public comment period, the agency is interested in whether there are particular safety concerns as it considers its regulatory oversight and monitoring of these products. For example, FDA is seeking comments, data and information on a variety of topics including: what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients; and other questions outlined in the hearing announcement.
Additionally, we’re interested in how the incentives for, and the feasibility of, drug development with CBD and other cannabis-derived compounds would be affected if the commercial availability of products with these compounds, such as foods and dietary supplements, were to become significantly more widespread.
Gottlieb said that he asked principal deputy commissioner Amy Abernethy, M.D., Ph.D. and principal associate commissioner for policy Lowell Schiller to co-chair the working group, which will begin sharing information and/or findings with the public as early this summer.
In addressing risks, Gottlieb noted new compliance actions.
“We’ll continue to use our authorities to take action against companies illegally selling these types of products when they are putting consumers at risk. I am 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,” he said.
In that vein, FDA announced that it had issued warning letters, in collaboration with the Federal Trade Commission, to three companies – Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc. – in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded, egregious 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 and the legally required FDA approval.
“I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients. The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. Often such products are sold online and are therefore available throughout the country.”