FDA Public Hearing: Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, May 31, 2019
The Food and Drug Administration has announced 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. 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. Stakeholders are invited to share their experiences and challenges with products containing cannabis and cannabis-derived compounds, including information and views related to the safety of such products, as well as to offer input relevant to the agency’s regulatory strategy related to existing products. As part of that hearing, FDA has also opened a docket for the public to submit comments. Electronic or written comments will be accepted until July 2, 2019.
Accessing the Public Hearing
Registration: To register to attend the public hearing, either in person or by webcast, on “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” please register at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm634550.htm. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone and whether you want to attend in person or by webcast.Request for Presentations: During online registration, you may indicate if you wish to make a formal presentation (with accompanying slide deck) or present oral comments during the public hearing session (with no slide deck) and which topic(s) you would like to address. FDA will do its best to accommodate requests to make public presentations. We are seeking to have a broad representation of ideas and issues presented at the meeting. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each presentation is to begin and will select and notify participants by May 21, 2019. All requests to make presentations must be received by the close of registration on May 10, 2019, Eastern Time.An agenda for the hearing and any other background materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm634550.htm.Those without internet or email access can register and/or request to participate by contacting Beth F. Fritsch by the above dates (see FOR FURTHER INFORMATION CONTACT).Streaming Webcast of the Public Hearing: For those unable to attend in person, FDA will provide a live webcast of the hearing. To join the hearing via the webcast, please go to https://collaboration.fda.gov/cannabispart15.Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm634550.htm. It may be viewed at the Dockets Management Staff (see ADDRESSES) and also will be available at https://www.regulations.gov.
Issues for Consideration and Request for Data and Information
from https://www.regulations.gov/document?D=FDA-2019-N-1482-0001We encourage public comments and presentations at the public hearing. In submitting comments, data, and information to the docket, please identify available references for the data and information, as well as the general category area and specific question number listed below.A. Health and Safety RisksAs noted above, there are many unanswered questions about the safety of cannabis and cannabis-derived products. To inform FDA’s regulatory oversight of these products, especially as we consider whether it is appropriate to exercise our authority to allow the use of CBD in dietary supplements and other foods, we are interested in obtaining information, including data and studies, on, among other things:1. Based on what is known about the safety of products containing cannabis and cannabis-derived compounds, are there particular safety concerns that FDA should consider regarding its regulatory oversight and monitoring of these products? For example:What levels of cannabis and cannabis-derived compounds cause safety concerns?How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety and exposure to cannabis and cannabis-derived compounds?How do cannabis and cannabis-derived compounds interact with other substances (e.g., drug ingredients)?2. Are there special human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g. species, breed, or class) that should be considered when assessing the safety of products containing cannabis and cannabis-derived compounds?3. What are the characteristics of a successful system to collect representative safety information at the national or State level about products containing cannabis and cannabis-derived compounds?Are there systems that currently exist for the collection of this information (other than FDA’s systems)?Are there particular safety concerns related to the overlap of therapeutic dose levels from approved drug products, with potential exposure from other uses (e.g., from food, dietary supplements, cosmetics)? Please identify any safety concerns and include relevant data or studies.4. What endpoints or outcomes would define a maximal acceptable daily intake from all products?What margin of exposure would represent an appropriate and safe level from anticipated cumulative exposure? Does that margin of exposure vary based on the form of consumption (e.g., from ingestion, absorption, inhalation)? Please explain your reasoning and include relevant data or studies.What mechanisms would be available to help ensure that this margin of exposure was maintained at a level sufficiently protective of public health?5. Are there any data known that would support the safe use of cannabis and cannabis-related compounds in general food use (including dietary supplements), including data regarding exposure levels to cannabis and cannabis-related compounds in foods (including dietary supplements) that would be acceptable from a food safety perspective?What data are available about residues of cannabis-derived compounds in human foods (e.g., meat, milk, or eggs) that come from animals that consume cannabis or cannabis-derived compounds? Are there residue levels that should be tolerated in these foods? Please provide data or other information to support your reasoning.6. How does the existing commercial availability of food products containing cannabis-derived compounds such as CBD (which may in some cases be lawful at the State level but not the Federal level) affect the incentives for, and the feasibility of, drug-development programs involving such compounds?How would the incentives for, and the feasibility of, drug development be affected if food products containing cannabis-derived compounds, such as CBD, were to become widely commercially available? How would this change if FDA established thresholds on acceptable levels of cannabinoids, including CBD, in the non-drug products it regulates? What else could FDA do to support drug development from cannabinoids?B. Manufacturing and Product QualityPlease provide data and information on how products containing cannabis or cannabis-derived compounds (other than those marketed as drugs in compliance with the FD&C Act) are currently manufactured, including information about methods for ensuring product quality and consistency. More specifically, we are interested in obtaining information on, among other things:1. Are there particular standards needed to address any safety issues related to the manufacturing, processing, and holding of products containing cannabis and cannabis-derived compounds (e.g., genotoxic impurities, degradation of active compounds)? Please identify or describe those standards.2. Are there particular standards or processes needed to ensure manufacturing quality and consistency of products containing cannabis or cannabis-derived compounds, including standards applied to evaluate product quality? Please identify or describe those standards.3. What validated analytical testing is needed to support the manufacturing of safe and consistent products?4. Are there any currently used standardized definitions for the ingredients in cannabis products (e.g., “hemp oil”)? If standardized definitions would be helpful, what terms should be defined and what should the definition(s) be?5. 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 and/or expectations? To the extent a compound is added to food to achieve a particular functional purpose, what evidentiary support is available to demonstrate that the addition of such compound has the intended or perceived effect?C. Marketing/Labeling/SalesFDA is interested in information about how products containing cannabis or cannabis-derived compounds, other than drug products approved by FDA for human or animal use, are marketed, labeled, and sold. More specifically, we seek information on, among other things:1. How should consumers be informed about the risks associated with such products (e.g., directions for use, warnings)? What specific risks should consumers be informed about? Are there any subpopulations for which additional warnings or restrictions are appropriate? Please explain your reasoning.2. What conditions, restrictions, or other limitations on the manufacturing and distribution of these products have been put in place under State or local law, particularly with respect to food products containing cannabis-derived compounds such as CBD (which may, in some cases, be lawful at the State level but not the Federal level)? What other conditions, restrictions, or other limitations might be appropriate to ensure adequate consumer information and to protect the public health?3. What statutory or regulatory restrictions are in place under State or local law to warn about the use of these products by certain vulnerable human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g. species, breed, or class)? Are there other steps that should be taken to warn about use by vulnerable populations? Please identify such steps and how they would apply to a particular subpopulation.4. What other information should FDA consider in the labeling of specific product categories of cannabis and cannabis-derived products?