[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12969-12975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2019-N-1482]


Scientific Data and Information About Products Containing 
Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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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. For parking and 
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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.
     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 (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): 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, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-1482 for ``Scientific Data and Information about Products 
Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; 
Request for Comments.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     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. 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

[[Page 12970]]

as ``confidential'' will not be disclosed except in accordance with 21 
CFR 10.20 and other applicable disclosure law. For more information 
about FDA's posting of comments to public dockets, see 80 FR 56469, 
September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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, [email protected].

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.
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    \1\ Under the CSA, the term ``marihuana'' means all parts of the 
plant Cannabis sativa L., whether growing or not; the seeds thereof; 
the resin extracted from any part of such plant; and every compound, 
manufacture, salt, derivative, mixture, or preparation of such 
plant, its seeds or resin. Such a term does not include hemp or the 
mature stalks of such plant, fiber produced from such stalks, oil or 
cake made from the seeds of such plant, any other compound, 
manufacture, salt, derivative, mixture, or preparation of such 
mature stalks (except the resin extracted therefrom), fiber, oil, or 
cake, or the sterilized seed of such plant which is incapable of 
germination.
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    The legality of cannabis has been changing over time at both the 
State and Federal levels. Currently, 33 States and Washington, DC, 
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, DC, 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, 
Public Law 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.
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    \2\ For a discussion of FDA's legal authorities, see section IV 
of this notice.
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    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 letters \3\ 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.
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    \3\ https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm.
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    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 \4\ 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 at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm). Specifically, at 
doses of 20

[[Page 12971]]

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.
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    \4\ http://www.nationalacademies.org/hmd/Reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx.
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    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.

II. Participating in 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.
    If selected for a formal oral presentation (with a slide deck), 
each presenter must submit an electronic copy of their presentation 
(PowerPoint or PDF) to [email protected] with the 
subject line ``Scientific Data and Information about Products 
Containing Cannabis or Cannabis-Derived Compounds'' on or before May 
28, 2019. No commercial or promotional material will be permitted to be 
presented or distributed at the public hearing.
    Persons notified that they will be presenters are encouraged to 
arrive at the hearing room early and check in at the onsite 
registration table to confirm their designated presentation time. 
Actual presentation times may vary based on how the meeting progresses 
in real 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.

III. Issues for Consideration and Request for Data and Information

    We 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 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.

[[Page 12972]]

     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

    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?

IV. FDA Legal Authorities

    There are FD&C Act provisions that are relevant to the legality of 
cannabis or cannabis-derived products. To help in understanding the 
context of the public hearing and current FDA actions, a synopsis of 
FDA legal authorities is provided below.

A. Human Drugs

    A drug is an article intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease in man or other animals 
(section 201(g) of the FD&C Act (21 U.S.C. 321(g)). A drug is also 
defined as an article (other than food) intended to affect the 
structure or any function of the body of man or other animals. Thus, 
the determination of whether a product is a drug turns in part on the 
``intended use'' of the product.
    By statute, it is a prohibited act to introduce a new drug into 
interstate commerce unless it has an approved marketing application 
(New Drug Application (NDA) or Abbreviated New Drug Application (ANDA)) 
(section 301(d) of the FD&C Act (21 U.S.C. 331(d)). FDA reviews the 
data submitted in a marketing application to evaluate whether a drug 
product meets the statutory standards for approval. To conduct clinical 
research that can lead to an approved new drug, including research 
using materials from plants such as cannabis, researchers submit an 
Investigational New Drug (IND) application to FDA, as described in 21 
CFR part 312.
    FDA has approved several drug products that contain compounds found 
in cannabis. Most recently, FDA has approved EPIDIOLEX,\5\ which 
contains the purified drug substance CBD for the treatment of seizures 
associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 
2 years of age and older. We also have approved MARINOL and SYNDROS for 
therapeutic uses in the United States, including for the treatment of 
anorexia associated with weight loss in AIDS patients. MARINOL and 
SYNDROS include the active ingredient dronabinol, a synthetic THC which 
is considered the psychoactive component of marijuana. Another FDA-
approved drug, CESAMET, contains the active ingredient nabilone, which 
has a

[[Page 12973]]

chemical structure similar to THC and is synthetically derived.
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    \5\ https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm.
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B. Human Foods/Dietary Supplements

    By statute, any substance intentionally added to food is a food 
additive, and therefore subject to premarket review and approval by 
FDA, unless the substance is generally recognized as safe (GRAS) by 
qualified experts under the conditions of its intended use, or the use 
of the substance is otherwise excepted from the definition of a food 
additive (sections 201(s) and 409 of the FD&C Act (21 U.S.C. 321(s) and 
348)). Three hemp seed ingredients--hulled hemp seeds, hemp seed 
protein, and hemp seed oil--have gone through the FDA GRAS process and 
can be legally marketed in human foods for certain uses without food 
additive approval, provided they comply with all other requirements. 
More specifically, these three ingredients were the subject of a GRAS 
notice in which the submitter concluded that the ingredients were GRAS 
for specific uses in human foods. FDA evaluated these notices and had 
no questions \6\ regarding the submitter's conclusions.
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    \6\ https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm628910.htm.
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    No other cannabis-derived compounds have been the subject of a food 
additive petition, an evaluated GRAS petition, or have otherwise been 
approved for use in food by FDA. Food companies that wish to use 
cannabis or cannabis-derived compounds in their foods are subject to 
the relevant laws and regulations that relate to the food additive \7\ 
and GRAS \8\ processes.
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    \7\ https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/default.htm.
    \8\ https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/.
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    In addition, it is prohibited by statute to introduce or deliver 
for introduction into interstate commerce any food (including any 
animal food) to which has been added a substance which is an active 
ingredient in a drug product approved under section 505 of the FD&C Act 
(21 U.S.C. 355) or a drug for which substantial clinical investigations 
have been instituted and for which the existence of such investigations 
has been made public (section 301(ll) of the FD&C Act (21 U.S.C. 
331(ll)). There are exceptions, including when the drug was marketed in 
food before the drug was approved or before the substantial clinical 
investigations involving the drug had been instituted or, in the case 
of animal food, that the drug is a new animal drug approved for use in 
animal food and used according to the approved labeling. Based on 
available evidence, FDA has concluded \9\ that it is a prohibited act 
to introduce or deliver for introduction into interstate commerce any 
food (including any animal food) to which THC or CBD has been added. 
When this statutory prohibition applies to a substance, the substance 
cannot be added to any food that is sold into interstate commerce 
unless the Secretary of the Department of Health and Human Services 
(the Secretary),\10\ in the Secretary's discretion, has issued a 
regulation approving the use of the substance in the food (section 
301(ll)(2) of the FD&C Act. To date, no such regulation has been issued 
for any substance.
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    \9\ https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#legal.
    \10\ The authority to make this determination has been delegated 
to FDA.
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    For similar reasons, FDA has determined that products that contain 
THC or CBD cannot be marketed as dietary supplements.\11\ By statute, 
if an ingredient is approved as a new drug under section 505 of the 
FD&C Act or has been authorized for investigation as a new drug for 
which substantial clinical investigations have been instituted and for 
which the existence of such investigations has been made public, then 
products containing that substance are excluded from the statutory 
definition of a dietary supplement (sections 201(ff)(3)(B)(i) and (ii) 
of the FD&C Act. There is an exception if the substance was ``marketed 
as'' a dietary supplement or as a food before the new drug 
investigations were authorized. Based on available evidence, FDA has 
concluded that this is not the case for THC or CBD. There is also an 
exception if FDA has issued a regulation finding that the article would 
be lawful under the FD&C Act (section 201(ff)(3)(B) of the FD&C Act). 
At this time, no such regulation has been issued.
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    \11\ https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#dietary_supplements.
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    Some ingredients are derived from parts of the cannabis plant that 
may not contain THC or CBD, in which case those ingredients might fall 
outside the scope of this exclusion, and therefore might be able to be 
marketed as dietary supplements. However, the product must still comply 
with all other applicable laws and regulations governing dietary 
supplement products. For example, manufacturers and distributors who 
wish to market dietary supplements that contain ``new dietary 
ingredients'' (i.e., dietary ingredients that were not marketed in the 
United States in a dietary supplement before October 15, 1994) 
generally must notify FDA \12\ about these ingredients (section 413(d) 
of the FD&C Act (21 U.S.C. 350b(d)). Generally, the notification must 
include information demonstrating that a dietary supplement containing 
a new dietary ingredient will reasonably be expected to be safe under 
the conditions of use recommended or suggested in the labeling. A 
dietary supplement is adulterated if it contains a new dietary 
ingredient for which there is inadequate information to provide 
reasonable assurance that the ingredient does not present a significant 
or unreasonable risk of illness or injury (section 402(f)(1)(B) of the 
FD&C Act (21 U.S.C. 342(f)(1)(B)).
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    \12\ https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm109764.htm.
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    Numerous other legal requirements apply to food and dietary 
supplement products, including requirements relating to CGMPs, 
labeling, allergens, and various provisions of the FDA Food Safety 
Modernization Act. Information about these requirements, and about FDA 
requirements across all product areas, can be found on FDA's website, 
https://www.fda.gov.

C. Animal Food and Drugs

    FDA regulates animal food in a variety of ways, including by 
approving safe food additives and establishing standards for animal 
food contaminants. FDA has not reviewed any food additive petitions for 
cannabis-derived animal feed, nor have any cannabis-derived feed 
ingredients been the subject of a GRAS determination by FDA, a GRAS 
notice that underwent FDA evaluation and received a ``no questions'' 
response, or otherwise been approved for use in animal feed by FDA. 
Animal food companies that wish to use cannabis or cannabis-derived 
compounds in their animal food products are subject to the relevant 
laws and regulations that relate to the food additive and GRAS 
processes. With respect to THC and CBD specifically, as discussed 
above, it is a prohibited act under section 301(ll) of the FD&C Act, to 
introduce or deliver for introduction into interstate commerce any 
animal food to which THC or CBD has been added.
    As stated above, a drug is an article intended for use in the 
diagnosis, cure, mitigation, treatment, or prevention of disease in man 
or other animals (section 201(g) of the FD&C Act. A drug is also 
defined as an article (other than food) intended to affect the 
structure or any function of the body of man or other animals. Thus, 
the determination of whether a product is a drug turns in part on the 
``intended use'' of the product.

[[Page 12974]]

    Currently, there are no legally marketed new animal drugs that 
contain cannabis or cannabis-derived compounds. A new animal drug is 
deemed ``unsafe'' under section 512(a) of the FD&C Act (21 U.S.C. 
360b(a)), and may not be sold into interstate commerce under section 
301(a) of the FD&C Act), unless it has an approved new animal drug 
application (NADA), abbreviated NADA (ANADA), conditional approval 
(CNADA) or index listing. FDA reviews the data submitted in a marketing 
application to evaluate whether an animal drug product meets the 
statutory standards for approval. To conduct clinical research that can 
lead to an approved new animal drug, including research using materials 
from plants such as cannabis, researchers establish an Investigational 
New Animal Drug (INAD) file with FDA, and comply with the requirements 
described in 21 CFR part 511.

D. Cosmetics

    Under the FD&C Act, cosmetic products and ingredients are not 
subject to premarket approval by FDA, except for most color additives. 
Certain cosmetic ingredients are prohibited or restricted by 
regulation,\13\ but currently that is not the case for any cannabis or 
cannabis-derived ingredients. Ingredients not specifically addressed by 
regulation must nonetheless comply with all applicable requirements, 
and no ingredient--including a cannabis or cannabis-derived 
ingredient--can be used in a cosmetic if it causes the product to be 
adulterated or misbranded in any way. A cosmetic generally is 
adulterated if it bears or contains any poisonous or deleterious 
substance which may render it injurious to users under the conditions 
of use prescribed in the labeling, or under such conditions of use as 
are customary or usual (section 601(a) of the FD&C Act (21 U.S.C. 
361(a)).
---------------------------------------------------------------------------

    \13\ https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm127406.htm.
---------------------------------------------------------------------------

E. Tobacco Products

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) was enacted on June 22, 2009, amending 
the FD&C Act and providing FDA with the authority to regulate tobacco 
products. Specifically, the Tobacco Control Act amends the FD&C Act by 
adding a new chapter that provides FDA with authority over tobacco 
products. Section 901(b) of the FD&C Act (21 U.S.C. 387a(b)), as 
amended by the Tobacco Control Act, states that the new chapter in the 
FD&C Act (chapter IX--Tobacco Products) (21 U.S.C. 387 through 387u) 
applies to all cigarettes, cigarette tobacco, roll-your-own tobacco, 
smokeless tobacco, and any other tobacco products that the Secretary by 
regulation deems to be subject to chapter IX. In the Federal Register 
of May 10, 2016 (81 FR 28973), FDA issued a final rule deeming all 
products that meet the statutory definition of ``tobacco product'' in 
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), except accessories 
of deemed tobacco products, to be subject to FDA's tobacco product 
authority (the deeming rule). The products now subject to FDA's tobacco 
product authority include electronic nicotine delivery systems 
(sometimes referred to as vapes, vaporizers, or electronic cigarettes, 
among other terms), cigars, waterpipes (hookah), pipe tobacco, nicotine 
gels, dissolvables that were not already subject to the FD&C Act, and 
other tobacco products that meet the statutory definition of ``tobacco 
product'' (other than accessories) that may be developed in the future. 
The term ``tobacco product'' means any product made or derived from 
tobacco that is intended for human consumption, including any 
component, part, or accessory of a tobacco product (except for raw 
materials other than tobacco used in manufacturing a component, part, 
or accessory of a tobacco product) (section 201(rr)(1) of the FD&C Act. 
For example, an e-liquid mixture that contains both a cannabis-derived 
ingredient and nicotine made or derived from tobacco, and that is 
intended for human consumption, would likely be subject to FDA's 
chapter IX authorities.
    Numerous legal requirements apply to tobacco products, including 
legal requirements that relate to new tobacco products that are to be 
introduced, or delivered for introduction into interstate commerce. 
Other requirements relate to registration and listing, and sales and 
distribution, among other things. For more information on these topics, 
including the statutory standards that must be met for FDA to permit 
new tobacco products to be marketed, we encourage interested parties to 
go to the Center for Tobacco Products' web page at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm246129.htm.

F. Medical Devices

    An article is a device if it is an instrument, apparatus, 
implement, machine, contrivance, implant, in vitro reagent, or other 
similar related article which is intended for use in the diagnosis of 
disease or other conditions, or in the cure mitigation, treatment, or 
prevention of disease, or is intended to affect the structure or any 
function of the body of man (section 201(h) of the FD&C Act). A device 
is also defined as not achieving its primary intended purposes through 
chemical action in or on the body of man and which is not dependent 
upon being metabolized for the achievement of its primary intended 
purpose (Id.). For example, an article that is used to aid intake of a 
product that contains cannabis or a cannabis-derived compound could be 
properly classified as a device if it meets all aspects of the above 
definition.
    The FD&C Act establishes a comprehensive system for the regulation 
of medical devices intended for human use. The FD&C Act categorizes 
medical devices into one of three classes based on their risks and the 
extent of the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness (see section 513 of the 
FD&C Act (21 U.S.C. 360c)). The three categories of devices are class I 
(general controls), class II (special controls), and class III 
(premarket approval). Class I devices generally pose the lowest risk to 
the patient and/or user and class III devices pose the highest risk.
    The class to which a device is assigned determines, among other 
things, the type of premarket submission required for FDA authorization 
to market. In general, if a device is classified as class I or II, and 
if it is not exempt, manufacturers must obtain FDA clearance of a 
premarket notification (also referred to as a 510(k) submission) (see 
sections 510(k) and 513(i) of the FD&C Act (21 U.S.C. 360(k) and 
360c(i))). For class III devices, manufacturers generally must obtain 
FDA approval of a premarket approval application (PMA) (see section 515 
of the FD&C Act (21 U.S.C. 360e)). It is a prohibited act to market a 
device without its requisite premarket approval (see section 501(f)(1) 
of the FD&C Act (21 U.S.C. 351)).

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that this public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
hearing will be conducted by a presiding officer, who will be 
accompanied by FDA senior management from relevant program areas. Under 
Sec.  15.30(f), the hearing is informal and the rules of evidence do 
not apply. No participant may interrupt the presentation of another 
participant. Only the presiding officer and panel members can pose 
questions; they can question any person during or at the

[[Page 12975]]

conclusion of each presentation. Public hearings under part 15 are 
subject to FDA's policy and procedures for electronic media coverage of 
FDA's public administrative proceedings (21 CFR part 10, subpart C).
    Under Sec.  10.205, representatives of the media may be permitted, 
subject to certain limitations, to videotape, film, or otherwise record 
FDA's public administrative proceedings, including presentations by 
participants. Persons attending FDA's public hearings are advised that 
FDA is not responsible for providing access to electrical outlets.
    The hearing will be transcribed as stipulated in Sec.  15.30(b) 
(see Supplementary Information). To the extent that the conditions for 
the hearing, as described in this notice, conflict with any provisions 
set out in part 15, this notice acts as a waiver of those provisions as 
specified in Sec.  15.30(h).

    Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06436 Filed 4-2-19; 8:45 am]
 BILLING CODE 4164-01-P


