The U.S. Food and Drug Administration held a public hearing on May 31st to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
In addition to the public hearing, the FDA is also accepting and considering electronic or written comments.
Ice cream company Ben & Jerry’s has already submitted comments on the issue, proving their commitment to including CBD in its ice cream innovations, but the FDA needs to hear from the CBD industry stakeholders that have been consuming and producing CBD long before Ben & Jerry’s began considering the cannabinoid as an ingredient.
How to Submit a Comment to the FDA
Electronic Submissions
To submit electronic comments on the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds:
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.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed below.
Written Submissions
To submit written/paper submissions on the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds by mail, hand delivery, or courier:
Proper Delivery Address: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential.
Confidential Submissions
To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.
You should submit two copies total:
One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in our consideration of comments.
The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff via the address listed above.
If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.
The Format You Should Follow
This is where most people fall off. To be taken seriously, it is important that comments follow the FDA’s requested formatting.
As you will see if you read through the 2,000+ comments that have already been publicized, most people, unfortunately, have not followed the proper format.
While the Tuberous Sclerosis Alliance submitted their comments in accordance with the FDA’s guidelines and can be used as a reference, you’ll see that they’re in support of a Big Pharma approach that requires IND applications for CBD-based products.
The CBD industry’s active participants need to weigh in, and they need to do so in accordance with the FDA’s request.
As stated in the FDA’s Request for Comments, “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.”
Categories and Questions
A. Health and Safety Risks
As 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 Quality
Please 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/Sales
The FDA 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?
Conclusion
On his way out, former FDA Commissioner Scott Gottlieb warned that CBD regulations could take years due to regulatory red tape and oversight.
Clearly stated and credibly cited comments will allow the FDA to speed up its learning process. To optimize impact, CBD industry participants should submit them according to the format above, rather than the one below:
“CBD has helped me so much with aches and pains and much more please allow CBD to be sold over the counter. Its the right thing.”
Comments like the one above, submitted from CBD consumer Lance Schroeder, can certainly help to show the FDA that there is a tremendous demand for the products, but properly formatted comments like the one embedded below are the ones that are truly taken seriously.
Public Comment on CBD from the Tuberous Sclerosis Alliance
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