The Food & Drug Administration has announced new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products.
These steps apply to use in humans and animals and involve a public hearing scheduled for May and the formation of a high-level internal agency working group. FDA also took action against three companies on the human side this week for making unverified claims.
FDA commissioner Dr. Scott Gottlieb said in recent years there has been 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). He said FDA has seen, 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. Gottlieb announced the new steps April 3, a final move before he ends his term at the agency April 5.
To date, FDA has not approved cannabis for use in any animal - livestock or pets. Likewise, no approved food additive petitions or ingredient definitions exist for any substances derived from hemp for inclusion in animal food nor any GRAS conclusions regarding the use of any substances derived from hemp in animal food. According to Gottlieb, stakeholders overall are looking to FDA for clarity on how the agency’s authorities apply to these products, what pathways are available to market such products lawfully under these authorities and how FDA is carrying out its responsibility to protect public health and safety with respect to such products.
Since Congress passed the Agriculture Improvement Act of 2018 in late 2018, interest has been on the rise in these products. Among other things, the farm bill established a new category of cannabis classified as “hemp” – defined as cannabis and cannabis derivatives with extremely low (no more than 0.3% on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). In addition, the farm bill removed hemp from the Controlled Substances Act, making it no longer a controlled substance under federal law.
At the same time, Congress explicitly preserved FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug & 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 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.
When the farm bill became law, FDA issued a statement explaining its current approach to these products and its intended next steps. Consistent with the approach and commitments described in that statement, FDA has more recently announced a number of important new steps and actions to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under its existing authorities. These new steps include:
• 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.
• Updates to the FDA webpage with answers to frequently asked questions on the topic to help members of the public understand how 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.
Back in 2015, the Association of American Feed Control Officials (AAFCO) asked the hemp industry to come forward and present information for scientific review to establish definitions for animal foods made from the hemp plant. AAFCO said it expected information on hemp seed oil, hemp seed meal and whole hemp seeds, but that to date, the industry has not provided any data showing that ingredients derived from the hemp plant are safe and useful in animal food. AAFCO is a voluntary membership association of local, state and federal agencies charged by law to regulate the sale and distribution of animal feeds and animal drug remedies.
AAFCO said state regulatory members continue to ask for the information prior to distribution of hemp seed products in their respective states. "To allow an entire industry to enter the market without the appropriate safety data is unfair to other ingredient manufacturers that are doing their due diligence. There are some potential safety concerns related to the presence of certain compounds, including THC and CBD, in parts of the hemp plant that must be addressed," AAFCO said.
"One thing has become clear as we have had discussions with the hemp industry, materials and products that are CBD infused need to be treated as drugs. There is no nutritional intended use for this compound. This means that several parts of the hemp plant will not be appropriate for animal feeding," according to AAFCO. As stated by FDA, AAFCO said, at this time, "it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which cannabidiol has been added.”
The public hearing in May 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 FDA can make these legal pathways more predictable and efficient. Gottlieb said FDA hopes to gain additional information and data to consider with respect to products containing cannabis and cannabis-derived compounds, including CBD.
As is the case with other FDA-regulated products, Gottlieb said products containing cannabis or cannabis-derived compounds (hemp-derived or otherwise) marketed with a claim of therapeutic benefit must be approved by 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. He said 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. Gottlieb said the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use.
“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. … There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products. Additionally, there are open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance,” said Gottlieb. He noted that it is critical that these unanswered questions about CBD and other cannabis and cannabis-derived products be explored so to help inform 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 he said back in December, Gottlieb again noted that 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.
As part of the public hearing and related public comment period, the agency is interested in whether there are particular safety concerns that it should be aware of as it considers its regulatory oversight and monitoring of these products.
FDA working group
Gottlieb also announced that FDA has formed a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. Principal deputy commissioner Amy Abernethy, M.D., Ph.D., and principal associate commissioner for policy Lowell Schiller will co-chair the group and have been charged with considering what options might be appropriate under FDA’s current authorities. The group also will consider whether there are legislative options that might lead to more efficient and appropriate pathways than might be available under current law.
“This is a complicated topic and we expect that it could take some time to resolve fully. Nevertheless, we are deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward. The working group plans to begin sharing information and/or findings with the public as early as summer 2019,” Gottlieb said.
New compliance actions
Gottlieb further noted that FDA will continue to use its authorities to take action against companies illegally selling these types of products when they are putting consumers at risk. This week the agency took action against three companies on the human side for making unverified claims.
“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.