[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Proposed Rules]
[Pages 37555-37559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2015-N-1514]
RIN 0910-AH24


Nicotine Exposure Warnings and Child-Resistant Packaging for 
Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco 
Products; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking (ANPRM) to obtain information related to 
the regulation of ``tobacco products'' subject to the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act), and 
restrictions regarding the sale and distribution of such tobacco 
products. Specifically, this ANPRM is seeking comments, data, research 
results, or other information that may inform regulatory actions FDA 
might take with respect to nicotine exposure warnings and child-
resistant packaging for liquid nicotine and nicotine-containing e-
liquid(s) that are made or derived from tobacco and intended for human 
consumption, and potentially for other tobacco products including, but 
not limited to, novel tobacco products such as dissolvables, lotions, 
gels, and drinks. In April 2014, FDA published a proposed rule seeking 
to deem products meeting the statutory definition of ``tobacco 
product,'' except accessories to proposed deemed tobacco products, to 
be subject to the FD&C Act, as amended by the Tobacco Control Act. 
Specifically, the proposed rule seeks to extend the Agency's ``tobacco 
product'' authorities to those products that meet the statutory 
definition of ``tobacco product,'' prohibiting the sale of ``covered 
tobacco products'' to individuals under the age of 18, and requiring 
the display of health warnings on certain tobacco product packages and 
in advertisements. The deeming

[[Page 37556]]

rulemaking does not address the issues raised in this ANPRM.

DATES: Submit either electronic or written comments by August 31, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-1514 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryant M. Godfrey, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 1-877-CTP-1373, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Tobacco Control Act was enacted on June 22, 2009, amending the 
FD&C Act and providing FDA with the authority to regulate tobacco 
products (Pub. L. 111-31). Specifically, section 101(b) of the Tobacco 
Control Act amends the FD&C Act by adding a new chapter that provides 
FDA with authority over tobacco products. Section 901 of the FD&C Act 
(21 U.S.C. 387a), 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 of Health and Human Services by regulation 
deems to be subject to this chapter. Accordingly, in the Federal 
Register of April 25, 2014 (79 FR 23142), FDA published a proposed rule 
seeking to deem all products meeting the statutory definition of 
``tobacco product'' in section 201(rr) of the FD&C Act (21 U.S.C. 
321(rr)), except accessories to those products, to be subject to 
chapter IX of the FD&C Act.
    FDA has evaluated data and science (including all of the evidence 
submitted to the docket of the proposed ``deeming'' rule cited below) 
related to the risks, especially to infants and children, from 
accidental exposure to nicotine, including exposure to liquid nicotine 
and nicotine-containing e-liquid(s), which are primarily used with 
electronic nicotine delivery systems (ENDS), such as electronic 
cigarettes. Recent increases in calls and visits to both poison control 
centers (see, e.g., CDC's Morbidity and Mortality Weekly Report, 
available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6313a4.htm) and 
emergency rooms in the United States involving liquid nicotine 
poisonings and exposures has increased the public health concerns of 
these exposure risks. As a result of FDA's evaluation and these recent 
trends, FDA is considering whether, based on the acute toxicity of 
nicotine (up to and including nicotine poisoning), it would be 
appropriate for the protection of the public health to warn the public 
about the dangers of nicotine exposure, especially due to inadvertent 
nicotine exposure in infants and children, and/or require that some 
tobacco products be sold in child-resistant packaging. Comments 
submitted in response to FDA's proposed rule seeking to deem all 
tobacco products to be subject to the FD&C Act support such actions, 
and many request that FDA take prompt action to mitigate nicotine 
exposure risks (see Docket No. FDA-2014-N-0189, http://www.regulations.gov).
    As previously discussed, the FD&C Act provides FDA with authority 
to regulate tobacco products. Sections 906(d)(1) and 910(c)(1)(B) of 
the FD&C Act provide FDA the authority to, by regulation or in a 
marketing authorization order, require restrictions on the sale and 
distribution of a tobacco product. The restrictions on the sale and 
distribution of a tobacco product may include restrictions on the 
access to, and the advertising and promotion of, the tobacco product, 
if FDA determines such restrictions would be appropriate for the 
protection of the public health. The FD&C Act also provides FDA with 
authority to adopt a tobacco product standard under section 907 of the 
FD&C Act if the Secretary finds that it is appropriate for the 
protection of the public health.
    In making such a finding under either section 906(d)(1) or section 
907 of the FD&C Act, the Secretary must consider: (1) The risks and 
benefits to the population as a whole, including users and nonusers of 
tobacco products; (2) the increased or decreased likelihood that 
existing users of tobacco products will stop using such products; and 
(3) the increased or decreased likelihood that those who do not use 
tobacco products will start using such products.
    FDA intends to use the information submitted in response to this 
ANPRM to further inform its thinking about options for issuing 
potential regulations that would require nicotine exposure warnings 
and/or child-resistant packaging for some tobacco products, as 
articulated in this document. For the purposes of the questions in this 
ANPRM:
     ``Liquid nicotine and nicotine-containing e-liquid(s) 
(liquid nicotine combined with colorings, flavorings, and/or 
potentially other ingredients)'' are generally referred to as liquid 
nicotine.
     ``Liquid nicotine'' (as used throughout this document) 
refers to liquid nicotine that is made or derived from tobacco and 
intended for human consumption.
     ``Novel tobacco products'' (as used throughout this 
document) refers to products such as dissolvables, lotions, gels, and 
drinks.

II. Requests for Comments and Information

    FDA is seeking comments, data, research results, and other 
information related to the following questions. Please explain your 
responses and provide any evidence or other information supporting your 
responses to the following questions:

A. Nicotine Exposure Warnings

    1. Should FDA consider requiring nicotine exposure warning(s) text 
on liquid nicotine? If so, why?
    2. Should FDA consider requiring nicotine exposure warning(s) text 
on tobacco products other than liquid nicotine, including, but not 
limited to, novel tobacco products? If so, which products and why?
    3. On what basis (e.g., physical characteristics or appearance of 
the product or packaging, product risks, form of marketing, route of 
exposure, type of packaging) should FDA determine which products should 
be

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required to carry the warning(s)? What data or information would be 
helpful to demonstrate the need for a warning or warnings?
    4. If FDA were to require nicotine exposure warning(s) text for 
liquid nicotine, what issues should the warning(s) address and what 
wording should be used? Please consider: (a) Whether the warning(s) 
should be broad, or directed at specific dangers; (b) whether the 
warning(s) should specifically address oral, ocular, and dermal 
exposure dangers; (c) whether the warning(s) should focus exclusively 
on the risks to children and youth, or include the risks to vulnerable 
populations, such as pregnant women, adults with medical conditions, 
and pets; (d) whether the warning(s) should contain instructions to 
avoid the dangers altogether, such as ``keep out of the reach of 
children''; (e) whether there are other dangers of liquid nicotine 
exposure that should be covered by the warning(s); and (f) whether 
information about what to do in the case of an accidental exposure to 
liquid nicotine should be included (e.g., when to seek medical 
attention, when to contact a Poison Control Center). Please submit data 
or evidence to support your position.
    5. With preceding question 4 in mind, should there be multiple 
textual warnings that randomly display to convey different dangers, or 
should there be a single, consistent textual warning that covers all of 
the different dangers? Please submit data or evidence to support your 
position.
    6. If FDA were to require nicotine exposure warning(s) text for 
tobacco products other than liquid nicotine, including, but not limited 
to, novel tobacco products, what issues should the warning(s) address 
and what wording should be used? Please consider: (a) Whether the 
warning(s) should be broad, or directed at specific dangers; (b) 
whether the warning(s) should specifically address oral, ocular, and 
dermal exposure dangers; (c) whether the warning(s) should focus 
exclusively on the risks to children and youth, or include the risks to 
vulnerable populations, such as pregnant women, adults with medical 
conditions, and pets; (d) whether the warning(s) should contain 
instructions to avoid the dangers altogether, such as ``keep out of the 
reach of children''; (e) whether there are other dangers of nicotine 
exposure that should be covered by the warning(s); and (f) whether 
information about what to do in the case of an accidental exposure to 
liquid nicotine should be included (e.g., when to seek medical 
attention, when to contact a Poison Control Center). Please submit data 
or evidence to support your position.
    7. With preceding question 6 in mind, please respond to the 
following questions: Should there be multiple textual warnings that 
randomly display to convey different dangers, or should there be a 
single, consistent textual warning that covers all of the different 
dangers? Should different types of tobacco products carry different 
warnings? If so, which type(s) of tobacco products should carry what 
warning(s) and what is the reasoning for different warnings for 
different types of tobacco products? Please submit data or evidence to 
support your position.
    8. If FDA were to require nicotine exposure warning(s) text for 
liquid nicotine, should FDA consider requiring color(s) or graphic 
elements, such as symbols, as part of the warning(s)? If so, what color 
or graphic elements should FDA consider?
    (a) Are there data on graphic elements and/or colors that would be 
most effective in communicating the dangers associated with nicotine 
exposure? If so, please provide these data.
    (b) Would a graphic element alone (as opposed to text alone or any 
combination of text, color, or graphic elements) be sufficient to 
effectively communicate the dangers associated with nicotine exposure? 
Please provide data or evidence to support your position.
    (c) How could the warning(s) text and graphic image(s) add to or 
detract from each other?
    9. If FDA were to require nicotine exposure warning(s) text for 
tobacco products other than liquid nicotine, including, but not limited 
to, novel tobacco products, should FDA consider requiring color(s) or 
graphic elements as part of the warning(s)? If so, what color or 
graphic elements should FDA consider?
    (a) Are there data on graphics and/or colors that would be most 
effective in communicating the dangers associated with nicotine 
exposure? If so, please provide these data.
    (b) Would a graphic image alone be sufficient to effectively 
communicate the dangers associated with nicotine exposure? Please 
provide data or evidence to support your position.
    (c) How could the warning(s) text and graphic image(s) add to or 
detract from each other?
    (d) Should different tobacco products carry different color or 
graphic elements? If so, what criteria should FDA use to determine 
which type of tobacco products should carry what color or graphic 
elements?
    10. If FDA were to require a nicotine exposure warning(s) (text and 
any applicable color or graphic element) for liquid nicotine, should 
FDA adopt a different nicotine exposure warning(s) requirement based on 
the packaging/containers (e.g., a brief/abbreviated warning(s) for 
liquid nicotine in small packaging/containers, omit the warning(s) if 
the tobacco product is in a child-resistant package)? If so, how should 
the warning(s) differ? Please submit data or evidence to support your 
position.
    11. With respect to tobacco products other than liquid nicotine, 
including, but not limited to, novel tobacco products, if FDA were to 
require a nicotine exposure warning(s) (text and any applicable color 
or graphic element), should FDA adopt a different nicotine exposure 
warning(s) requirement based on the packaging/containers (e.g., a 
brief/abbreviated warning(s) for tobacco products in small packaging, 
omit the warning(s) if the tobacco product is in a child-resistant 
package)? If so, how should the warning(s) differ? Please submit data 
or evidence to support your position.
    12. Are you aware of data or information that would support any 
required font sizes, formatting, and display considerations for 
nicotine exposure warnings (textual and/or graphic)? If so, please 
provide that evidence.
    13. Should FDA require the inclusion of the American Association of 
Poison Control Centers' telephone number on the container labeling and/
or packaging of liquid nicotine and tobacco products other than liquid 
nicotine? Why or why not?
    14. Are there any nicotine exposure warnings (textual and/or 
graphic) for liquid nicotine required by authorities at the local, 
State, or Federal (i.e., other agencies) level, or by foreign 
governments that you particularly would like to highlight? If so, which 
ones and why? Are there any data regarding the effectiveness or utility 
of these warnings? If so, please provide these data.
    15. Are there any nicotine exposure warnings (textual and/or 
graphic) for tobacco products other than liquid nicotine required by 
authorities at the local, State, or Federal (i.e., other agencies) 
level, or by foreign governments that you particularly would like to 
highlight? If so, which ones and why? Are there any data regarding the 
effectiveness or utility of these warnings? If so, please provide these 
data.
    16. Are you aware of any existing evidence regarding whether 
warnings

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(text and any applicable color or graphic element) are effective for 
mitigating the risks of nicotine exposure? If so, please provide that 
evidence.

B. Child-Resistant Packaging

    1. Should FDA require child-resistant packaging for liquid 
nicotine? If so, why?
    2. Should FDA require child-resistant packaging for liquid nicotine 
if the liquid nicotine product is not intended to be opened by the 
consumer (e.g., liquid nicotine in permanently sealed, prefilled, and/
or disposable cartridges)? Please provide the reason for your response.
    3. Should FDA consider requiring child-resistant packaging for 
tobacco products other than liquid nicotine, including, but not limited 
to, novel tobacco products? If so, which ones and why?
    4. If FDA were to require child-resistant packaging for liquid 
nicotine (including for those products that are not intended to be 
opened by the consumer), what type of exposure risks (e.g., oral, 
ocular, dermal) should FDA seek to mitigate with the requirement?
    5. If FDA were to require child-resistant packaging for tobacco 
products other than liquid nicotine, including, but not limited to, 
novel tobacco products, what risks (e.g., oral, ocular, dermal) should 
FDA seek to mitigate with the requirement?
    6. If FDA were to require child-resistant packaging for liquid 
nicotine, how should the requirement be articulated? Please consider: 
(a) Whether the requirement should be based on mandated physical 
characteristics of the packaging (e.g., must have a squeeze-to-turn 
lid, flow restrictor); (b) whether the requirement should be 
performance based (e.g., unable to be opened by 80 percent or more of 
5-year-olds who try to open the package, and more than 90 percent of 
adults on average between the ages of 50-70 can successfully open the 
package); or (c) whether the requirement should be based on a 
combination of (a) and (b), or is there some other basis for the 
requirement that FDA should consider? Is your proposal technically 
feasible? Please submit data or evidence to support your position.
    7. If FDA were to require child-resistant packaging for tobacco 
products other than liquid nicotine, including, but not limited to, 
novel tobacco products, how should the requirement be articulated? 
Please consider: (a) Whether the requirement should be based on 
mandated physical characteristics of the packaging (e.g., must have a 
squeeze-to-turn lid, child-resistant cap, blister packaging); (b) 
whether the requirement should be performance based (e.g., unable to be 
opened by 80 percent or more of 5-year-olds who try to open the 
package, and more than 90 percent of adults on average between the ages 
of 50-70 can successfully open the package); or (c) whether the 
requirement should be based on a combination of (a) and (b), or is 
there some other basis for the requirement that FDA should consider? Is 
your proposal technically feasible? Please submit data or evidence to 
support your position.
    8. Are there other factors FDA should consider to further prevent 
or discourage people (especially infants and children) from 
inadvertently consuming or being exposed to liquid nicotine? If so, 
please explain. Examples of other factors may include: attractiveness 
of the product or packaging (e.g., appealing images, fragrance, 
flavors), resemblance of packaging to food and drink items (e.g., 
candy, fruit), color of the product (e.g., resemblance to beverages 
such as juice), resemblance of packaging to that of medications (e.g., 
eye drops).
    9. If FDA were to require child-resistant packaging, what should 
FDA consider and what actions should FDA take to mitigate the risk that 
users of products with child-resistant packaging will defeat the 
purpose of the packaging by leaving the packaging open, by disabling 
the protection mechanism, or by moving the product to a different 
container?

C. Other Actions and Considerations

    1. With respect to liquid nicotine, should FDA require both 
nicotine exposure warnings (text and/or any applicable color or graphic 
element) and child-resistant packaging, or should only one and not the 
other be required? Please explain your reasoning and provide data or 
evidence to support your position.
    2. With respect to tobacco products other than liquid nicotine, 
including, but not limited to, novel tobacco products, should FDA 
require both nicotine exposure warnings (text and/or any applicable 
color or graphic element) and child-resistant packaging, or should only 
one and not the other be required? Please explain your reasoning and 
provide data or evidence to support your position.
    3. With respect to liquid nicotine and the dangers of nicotine 
poisoning, should FDA consider requiring any additional warnings beyond 
a nicotine exposure warning (text and/or any applicable color or 
graphic element)? If so, please describe the warning(s) (textual and/or 
graphic) and provide evidence or data to support your recommendation.
    4. With respect to tobacco products other than liquid nicotine, 
including, but not limited to, novel tobacco products, and the dangers 
of nicotine poisoning, should FDA consider requiring any additional 
warnings beyond a nicotine exposure warning (text and/or any applicable 
color or graphic element)? If so, for which products? Also, please 
describe the warning(s) (textual and/or graphic) and provide evidence 
or data to support your recommendation.
    5. Should FDA consider any additional measures to mitigate nicotine 
exposure risks for people (especially infants and children) beyond 
nicotine exposure warnings (text and any applicable color or graphic 
element) and child-resistant packaging? If so, what measures should FDA 
consider and why? Please provide evidence or data to support your 
recommendation.

III. Comments

A. General Information About Submitting Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document.

B. Public Availability of Comments

    Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on http://www.regulations.gov. This is 
determined by information indicating that the submission is written by 
an individual, for example, the comment is identified with the category 
``Individual Consumer'' under the field entitled ``Category 
(Required)'', on the ``Your Information'' page on http://www.regulations.gov; for this ANPRM, however, FDA will not be following 
this general practice. Instead, FDA will post on http://www.regulations.gov comments to this docket that have been submitted by 
individuals in their individual capacity. If you wish to submit any 
information under a claim of confidentiality, please refer to 21 CFR 
10.20.

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C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other 
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your State/province and country (if 
provided), the name of your representative (if any), and the category 
identifying you (e.g., individual, consumer, academic, industry). For 
written submissions submitted to the Division of Dockets Management, 
FDA will post the body of your comments on http://www.regulations.gov, 
but you can put your name and/or contact information on a separate 
cover sheet and not in the body of your comments.

    Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16151 Filed 6-30-15; 8:45 am]
 BILLING CODE 4164-01-P