ACTION: Notice of public hearing; request for comments.
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
DATES: The public hearing will be held on May 31, 2019, from 8 a.m. to 6 p.m. Submit requests to make oral presentations and comments at the public hearing by May 10, 2019. Electronic or written comments will be accepted until July 2, 2019. See the SUPPLEMENTARY INFORMATION section for registration and information.
ADDRESSES: The public hearing will be held at FDA White Oak Campus,10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for the public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. See
parking and security information online.
FDA is establishing a docket for public comment on this hearing. The docket number is FDA-2019-N-1482. The docket will close on July 2, 2019. Submit either electronic or written comments on this public hearing by July 2, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 2, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 2, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Beth F. Fritsch, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5308, Silver Spring, MD 20993, 301-796-8451, StakeholderEngagement@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Purpose of Hearing
Cannabis is a plant of the Cannabaceae family and contains more than 80 biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Federal Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (21 U.S.C. 802(16).1 “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use for marijuana in the United States. Cannabis and cannabis-derived products have been the subject of increasing interest by consumers, industry, researchers, the public, and regulators. Regulatory oversight of products containing cannabis or cannabis-derived compounds is complex and involves multiple Federal and State agencies.
The legality of cannabis has been changing over time at both the State and Federal levels. Currently, 33 States and Washington, D.C., allow “medical” use of marijuana under State law and 14 additional States have State law “medical” programs that are limited to CBD products. In addition, 10 States and Washington, D.C., have legalized marijuana for recreational use under State law, and 13 additional States have decriminalized recreational marijuana possession under State law in some form.
At the Federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334 (the 2018 Farm Bill), was signed into law on December 20, 2018. Among other things, this new law changes certain Federal authorities relating to the production and marketing of hemp, defined as the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under Federal law.
The 2018 Farm Bill explicitly preserved FDA’s 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.2 In doing so, Congress recognized FDA’s important public health role with respect to all the products it regulates.
Therefore, because the 2018 Farm Bill did not change FDA’s authorities, cannabis and cannabis derived products are subject to the same authorities and requirements as FDA-regulated products containing any other substance, regardless of whether the products fall within the definition of “hemp” under the 2018 Farm Bill.
FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the FD&C Act. FDA has taken action against companies illegally selling cannabis and cannabis-derived products that put the health and safety of consumers at risk. For example, FDA has issued warning letters3 to companies illegally selling CBD products that were intended to prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer, and that had not obtained new drug approvals. Selling unapproved drug products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk as the marketing of unproven treatments raises significant public health concerns. Patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.
FDA’s warning letters also cited food products to which CBD had been added and CBD products marketed as dietary supplements. As discussed below, under current law, such products violate the FD&C Act because CBD is an active ingredient in an approved drug and has been the subject of substantial clinical investigations. Allowing drug ingredients in foods can undermine the drug approval process and diminish commercial incentives for further clinical study of the relevant drug substance. It also raises questions about the safety to consumers of exposure from broader consumption of such ingredients.
While the use of cannabis and cannabis-derived products, including hemp and hemp derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products. For example, a 2017 report by the National Academies of Sciences, Engineering, and Medicine reviewed the scientific literature published since 1999 about what is known about the health impacts of cannabis and cannabis-derived products and identified the need for additional research. In addition, during its review of the marketing application for EPIDIOLEX, a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years of age and older that was approved in 2018, FDA identified certain safety concerns (see
FDA’s drug approval package online.)
Specifically, at doses of 20 milligrams per kilogram of body weight per day (mg/kg/day) of EPIDIOLEX in clinical trials, there was a potential for liver injury, evidenced by elevated transaminase levels. This is a potentially serious risk that can be managed when the product is taken under medical supervision in accordance with the FDA approved labeling for the product, but it is less clear how this risk might be managed if this substance is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling. Other serious treatment-emergent adverse events reported in clinical studies of EPIDIOLEX included somnolence and lethargy; and hypersensitivity reactions. Common adverse reactions included decreased appetite, diarrhea, and sleep disorders.
Given the substantial interest in this topic and Congressional interest in fostering the development of appropriate hemp products under the 2018 Farm Bill, while also preserving FDA’s ability to protect the public health, FDA is holding a public hearing. 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 our 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 our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.
