Definition of the Term “Tobacco Product” in Guidances Issued Under the Federal Food, Drug, and Cosmetic Act, 16636-16639 [2023-03951]

Download as PDF 16636 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Notices burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by May 19, 2023. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: ll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–P–0015A Medicare Current Beneficiary Survey Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is VerDate Sep<11>2014 17:19 Mar 17, 2023 Jkt 259001 defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of currently approved collection; Title of Information Collection: Medicare Current Beneficiary Survey; Use: CMS is the largest single payer of health care in the United States. The agency plays a direct or indirect role in administering health insurance coverage for more than 120 million people across the Medicare, Medicaid, CHIP, and Exchange populations. A critical aim for CMS is to be an effective steward, major force, and trustworthy partner in supporting innovative approaches to improving quality, accessibility, and affordability in healthcare. CMS also aims to put patients first in the delivery of their health care needs. The Medicare Current Beneficiary Survey (MCBS) is the most comprehensive and complete survey available on the Medicare population and is essential in capturing data not otherwise collected through our operations. The MCBS is a nationallyrepresentative, longitudinal survey of Medicare beneficiaries that we sponsor and is directed by the Office of Enterprise Data and Analytics (OEDA). MCBS data collection includes both inperson and phone interviewing. The survey captures beneficiary information whether aged or disabled, living in the community or facility, or serviced by managed care or fee-for-service. Data produced as part of the MCBS are enhanced with our administrative data (e.g., fee-for-service claims, prescription drug event data, enrollment, etc.) to provide users with more accurate and complete estimates of total health care costs and utilization. The MCBS has been continuously fielded for more than 30 years, encompassing over 1.2 million interviews and more than 140,000 survey participants. Respondents participate in up to 11 interviews over a four-year period. This gives a comprehensive picture of health care PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 costs and utilization over a period of time. The MCBS continues to provide unique insight into the Medicare program and helps CMS and our external stakeholders better understand and evaluate the impact of existing programs and significant new policy initiatives. In the past, MCBS data have been used to assess potential changes to the Medicare program. For example, the MCBS was instrumental in supporting the development and implementation of the Medicare prescription drug benefit by providing a means to evaluate prescription drug costs and out-ofpocket burden for these drugs to Medicare beneficiaries. Beginning in 2024, this proposed revision to the clearance will add a few new measures to existing questionnaire sections and will remove COVID–19-related content that is no longer relevant for administration. Updated respondent materials are also included in this request. The revisions will result in a net decrease in respondent burden as compared to the current clearance due to the removal of COVID–19 items. Form Number: CMS–P–0015A (OMB control number: 0938–0568); Frequency: Occasionally; Affected Public Sector: Business or other for-profits and Notfor-profit institutions; Number of Respondents: 13,568; Total Annual Responses: 35,015; Total Annual Hours: 34,380. (For policy questions regarding this collection contact Bill Long at 410– 786–7927). Dated: March 15, 2023. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2023–05628 Filed 3–17–23; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–3261] Definition of the Term ‘‘Tobacco Product’’ in Guidances Issued Under the Federal Food, Drug, and Cosmetic Act Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA, Agency, or we) is announcing conforming changes to its guidances issued under the Federal Food, Drug, and Cosmetic Act (FD&C SUMMARY: E:\FR\FM\20MRN1.SGM 20MRN1 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Notices Act) as required by the Consolidated Appropriations Act of 2022, which amended the term ‘‘tobacco product’’ in the FD&C Act to include products that contain nicotine from any source. DATES: Conforming changes to reflect the changes to FDA’s guidance are made beginning March 20, 2023. ADDRESSES: You may submit comments on any guidance at any time as follows: 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’’). lotter on DSK11XQN23PROD with NOTICES1 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 name of the guidance(s) that the comments address and the docket number for the guidance(s) (see table 1). Received comments will be placed in the docket(s) and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the VerDate Sep<11>2014 17:19 Mar 17, 2023 Jkt 259001 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • 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 its 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 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.govinfo.gov/content/pkg/FR-201509-18/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 (see table 1) into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Paul Hart or Laura Chilaka, Center for PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 16637 Tobacco Products (CTP), Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 877–287–1373, AskCTP@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background 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. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defined the term ‘‘tobacco product’’ to mean 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). It further stated that the term ‘‘tobacco product’’ does not mean an article that is a drug under section 201(g)(1), a device under section 201(h), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C. 353(g)). The Consolidated Appropriations Act of 2022 (the Appropriations Act) (Pub. L. 117–103), enacted on March 15, 2022, amended the definition of the term ‘‘tobacco product’’ in section 201(rr) of the FD&C Act to include products that contain nicotine from any source. It further amended the definition to exclude articles that are foods under section 201(f) of the FD&C Act if such articles contain no nicotine or no more than trace amounts of naturally occurring nicotine. The Appropriations Act also amended section 901(b) of the FD&C Act (21 U.S.C. 387a(b)), which concerns FDA authority over tobacco products, by adding a sentence stating chapter IX of the FD&C Act shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco. As a result, tobacco products that contain non-tobacco nicotine (NTN), including synthetic nicotine, are now subject to the provisions in chapter IX of the FD&C Act (21 U.S.C. 387 to 387t), including but not limited, to the: • Adulteration and misbranding provisions (sections 902 and 903 of the FD&C Act); • Required submission of ingredient listing and reporting of harmful and potentially harmful constituents for all tobacco products (section 904 of the FD&C Act); E:\FR\FM\20MRN1.SGM 20MRN1 16638 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Notices • Required establishment registration and product listing (section 905 of the FD&C Act); • Prohibition of selling tobacco products to individuals under 21 years of age (section 906(d)(5) of the FD&C Act); • Requirement that new tobacco products have an FDA marketing order (section 910 of the FD&C Act) in effect; and • Requirement that modified risk tobacco products have a modified risk order in effect (section 911 of the FD&C Act). The Appropriations Act further states that products that are tobacco products under the amended definition in section 201(rr) of the FD&C Act shall be subject to all requirements of regulations for tobacco products and specifies that the term ‘‘tobacco product’’ in regulations and guidance issued, in whole or in part, under the FD&C Act shall have the meaning of, and shall be deemed amended to reflect the meaning of, the amended definition in section 201(rr). As a result, beginning April 14, 2022, tobacco products that contain NTN, including synthetic nicotine, are subject to the provisions that apply to tobacco products in FDA’s regulations, including, but not limited to: • Refuse to accept criteria for premarket submissions (21 CFR 1105.10); • Content and format requirements for premarket tobacco product applications (21 CFR part 1114); • Exemption from substantial equivalence requirements (21 CFR part 1107, subpart A); and • Prohibition of the distribution of free samples (21 CFR 1140.16(d)). The Appropriations Act directs FDA to publish a notice in the Federal Register to update the Code of Federal Regulations (CFR) to reflect the deemed amendment to existing regulations and guidance. Accordingly, in this notice we are making conforming changes to reflect the statutory amendments made by the Appropriations Act to tobacco product guidance issued in whole or in part under the FD&C Act. Elsewhere in this edition of the Federal Register, we are issuing a final amendment to make conforming changes to regulations to reflect the statutory amendments made by the Appropriations Act. II. Description of Changes to FDA Guidances FDA is updating the definition of ‘‘tobacco product’’ in guidances issued, in whole or in part, under the FD&C Act, to reflect the amendments made by the Appropriations Act. The definition of ‘‘tobacco product,’’ where included in the text of FDA guidance, is being updated to reflect the statutory amendments by adding the phrase ‘‘or containing nicotine from any source’’ after the words ‘‘from tobacco,’’ and incorporating the exclusion of articles that are foods as defined in section 201(f) of the FD&C Act if such articles contain no nicotine or no more than trace amounts of naturally occurring nicotine. The guidance documents listed in table 1 are, or will be,1 updated to reflect the statutory amendments made by the Appropriations Act. In certain cases, FDA is also making Level 2 changes to these guidance documents for clarity in light of the statutory amendments. TABLE 1—UPDATED GUIDANCE DOCUMENTS Title of guidance OMB control No. (if applicable) 1 Docket No. FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements *. Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems. Interpretation of and Compliance Policy for Certain Label Requirements; Applicability for Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops. Listing of Ingredients in Tobacco Products * ......................................................... Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments *. Health Document Submission Requirements for Tobacco Products * .................. Prohibition of Distributing Free Samples of Tobacco Products ............................. Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers ........ Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance with an Order. Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 *. Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products. FDA–2014–N–0189 N/A. FDA–2015–D–2496 FDA–2017–D–0120 Refers to previously approved FDA collections of information. N/A. FDA–2009–D–0524 FDA–2009–D–0508 0910–0650. 0910–0650. FDA–2009–D–0600 FDA–2017–D–0113 FDA–2010–D–0431 FDA–2011–D–0147 0910–0654. N/A. N/A. 0910–0673. FDA–2015–D–0404 N/A. FDA–2011–D–0125 0910–0775. FDA–2011–N–0121 N/A. lotter on DSK11XQN23PROD with NOTICES1 1 See section III of this document for additional information about the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521) as it relates to these guidance documents. These revised final guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115) and represent the current thinking of FDA on the topic discussed in each guidance. They do not establish any legally enforceable rights or responsibilities for any person and are not legally binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and 1 Guidance titles in table 1 marked with an asterisk will be published in updated form as changes are finalized or when the associated information collections are updated in accordance VerDate Sep<11>2014 17:19 Mar 17, 2023 Jkt 259001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 regulations. You may submit comments on any guidance at any time (see ADDRESSES). III. Paperwork Reduction Act of 1995 The amendments made by the Appropriations Act result in changes to with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). E:\FR\FM\20MRN1.SGM 20MRN1 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Notices some previously approved collections of information that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The OMB control numbers for these information collections are listed in table 1. FDA has published, and intends to continue publishing, notices concerning proposed changes to the relevant information collection activities in other editions of the Federal Register. In addition, in compliance with the PRA, we will submit revisions to the current information collections to OMB for review. IV. Electronic Access Persons with access to the internet may obtain an electronic version of the guidance documents at https:// www.fda.gov/tobacco-products/rulesregulations-and-guidance/guidance, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Dated: February 22, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–03951 Filed 3–17–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–E–1941] Determination of Regulatory Review Period for Purposes of Patent Extension; JIVI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JIVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by May 19, 2023. Furthermore, any interested person may lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:19 Mar 17, 2023 Jkt 259001 petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 18, 2023. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 19, 2023. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received 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– PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 16639 2019–E–1941 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; JIVI.’’ 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, 240–402–7500. • 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 its 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 as ‘‘confidential’’ will not be disclosed except in accordance with section 10.20 (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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: E:\FR\FM\20MRN1.SGM 20MRN1

Agencies

[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16636-16639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03951]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-3261]


Definition of the Term ``Tobacco Product'' in Guidances Issued 
Under the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing conforming changes to its guidances issued under the Federal 
Food, Drug, and Cosmetic Act (FD&C

[[Page 16637]]

Act) as required by the Consolidated Appropriations Act of 2022, which 
amended the term ``tobacco product'' in the FD&C Act to include 
products that contain nicotine from any source.

DATES: Conforming changes to reflect the changes to FDA's guidance are 
made beginning March 20, 2023.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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 name of the 
guidance(s) that the comments address and the docket number for the 
guidance(s) (see table 1). Received comments will be placed in the 
docket(s) 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, 240-402-7500.
     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 
its 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 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.govinfo.gov/content/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 (see table 1) into the 
``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Paul Hart or Laura Chilaka, Center for 
Tobacco Products (CTP), Food and Drug Administration, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 
20993, 877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as 
amended by the Tobacco Control Act, defined the term ``tobacco 
product'' to mean 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). It further stated that the term ``tobacco product'' 
does not mean an article that is a drug under section 201(g)(1), a 
device under section 201(h), or a combination product described in 
section 503(g) of the FD&C Act (21 U.S.C. 353(g)).
    The Consolidated Appropriations Act of 2022 (the Appropriations 
Act) (Pub. L. 117-103), enacted on March 15, 2022, amended the 
definition of the term ``tobacco product'' in section 201(rr) of the 
FD&C Act to include products that contain nicotine from any source. It 
further amended the definition to exclude articles that are foods under 
section 201(f) of the FD&C Act if such articles contain no nicotine or 
no more than trace amounts of naturally occurring nicotine. The 
Appropriations Act also amended section 901(b) of the FD&C Act (21 
U.S.C. 387a(b)), which concerns FDA authority over tobacco products, by 
adding a sentence stating chapter IX of the FD&C Act shall also apply 
to any tobacco product containing nicotine that is not made or derived 
from tobacco. As a result, tobacco products that contain non-tobacco 
nicotine (NTN), including synthetic nicotine, are now subject to the 
provisions in chapter IX of the FD&C Act (21 U.S.C. 387 to 387t), 
including but not limited, to the:
     Adulteration and misbranding provisions (sections 902 and 
903 of the FD&C Act);
     Required submission of ingredient listing and reporting of 
harmful and potentially harmful constituents for all tobacco products 
(section 904 of the FD&C Act);

[[Page 16638]]

     Required establishment registration and product listing 
(section 905 of the FD&C Act);
     Prohibition of selling tobacco products to individuals 
under 21 years of age (section 906(d)(5) of the FD&C Act);
     Requirement that new tobacco products have an FDA 
marketing order (section 910 of the FD&C Act) in effect; and
     Requirement that modified risk tobacco products have a 
modified risk order in effect (section 911 of the FD&C Act).
    The Appropriations Act further states that products that are 
tobacco products under the amended definition in section 201(rr) of the 
FD&C Act shall be subject to all requirements of regulations for 
tobacco products and specifies that the term ``tobacco product'' in 
regulations and guidance issued, in whole or in part, under the FD&C 
Act shall have the meaning of, and shall be deemed amended to reflect 
the meaning of, the amended definition in section 201(rr). As a result, 
beginning April 14, 2022, tobacco products that contain NTN, including 
synthetic nicotine, are subject to the provisions that apply to tobacco 
products in FDA's regulations, including, but not limited to:
     Refuse to accept criteria for premarket submissions (21 
CFR 1105.10);
     Content and format requirements for premarket tobacco 
product applications (21 CFR part 1114);
     Exemption from substantial equivalence requirements (21 
CFR part 1107, subpart A); and
     Prohibition of the distribution of free samples (21 CFR 
1140.16(d)).
    The Appropriations Act directs FDA to publish a notice in the 
Federal Register to update the Code of Federal Regulations (CFR) to 
reflect the deemed amendment to existing regulations and guidance. 
Accordingly, in this notice we are making conforming changes to reflect 
the statutory amendments made by the Appropriations Act to tobacco 
product guidance issued in whole or in part under the FD&C Act. 
Elsewhere in this edition of the Federal Register, we are issuing a 
final amendment to make conforming changes to regulations to reflect 
the statutory amendments made by the Appropriations Act.

II. Description of Changes to FDA Guidances

    FDA is updating the definition of ``tobacco product'' in guidances 
issued, in whole or in part, under the FD&C Act, to reflect the 
amendments made by the Appropriations Act. The definition of ``tobacco 
product,'' where included in the text of FDA guidance, is being updated 
to reflect the statutory amendments by adding the phrase ``or 
containing nicotine from any source'' after the words ``from tobacco,'' 
and incorporating the exclusion of articles that are foods as defined 
in section 201(f) of the FD&C Act if such articles contain no nicotine 
or no more than trace amounts of naturally occurring nicotine.
    The guidance documents listed in table 1 are, or will be,\1\ 
updated to reflect the statutory amendments made by the Appropriations 
Act. In certain cases, FDA is also making Level 2 changes to these 
guidance documents for clarity in light of the statutory amendments.
---------------------------------------------------------------------------

    \1\ Guidance titles in table 1 marked with an asterisk will be 
published in updated form as changes are finalized or when the 
associated information collections are updated in accordance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

                   Table 1--Updated Guidance Documents
------------------------------------------------------------------------
                                                         OMB control No.
      Title of guidance               Docket No.         (if applicable)
                                                               \1\
------------------------------------------------------------------------
FDA Deems Certain Tobacco     FDA-2014-N-0189            N/A.
 Products Subject to FDA
 Authority, Sales and
 Distribution Restrictions,
 and Health Warning
 Requirements for Packages
 and Advertisements *.
Premarket Tobacco Product     FDA-2015-D-2496            Refers to
 Applications for Electronic                              previously
 Nicotine Delivery Systems.                               approved FDA
                                                          collections of
                                                          information.
Interpretation of and         FDA-2017-D-0120            N/A.
 Compliance Policy for
 Certain Label Requirements;
 Applicability for Certain
 Federal Food, Drug, and
 Cosmetic Act Requirements
 to Vape Shops.
Listing of Ingredients in     FDA-2009-D-0524            0910-0650.
 Tobacco Products *.
Registration and Product      FDA-2009-D-0508            0910-0650.
 Listing for Owners and
 Operators of Domestic
 Tobacco Product
 Establishments *.
Health Document Submission    FDA-2009-D-0600            0910-0654.
 Requirements for Tobacco
 Products *.
Prohibition of Distributing   FDA-2017-D-0113            N/A.
 Free Samples of Tobacco
 Products.
Civil Money Penalties and No- FDA-2010-D-0431            N/A.
 Tobacco-Sale Orders for
 Tobacco Retailers.
Demonstrating the             FDA-2011-D-0147            0910-0673.
 Substantial Equivalence of
 a New Tobacco Product:
 Responses to Frequently
 Asked Questions.
Determination of the Period   FDA-2015-D-0404            N/A.
 Covered by a No-Tobacco-
 Sale Order and Compliance
 with an Order.
Establishing That a Tobacco   FDA-2011-D-0125            0910-0775.
 Product Was Commercially
 Marketed in the United
 States as of February 15,
 2007 *.
Small Entity Compliance       FDA-2011-N-0121            N/A.
 Guide: Further Amendments
 to General Regulations of
 the Food and Drug
 Administration to
 Incorporate Tobacco
 Products.
------------------------------------------------------------------------
\1\ See section III of this document for additional information about
  the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) as it
  relates to these guidance documents.

    These revised final guidances are being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115) and represent 
the current thinking of FDA on the topic discussed in each guidance. 
They do not establish any legally enforceable rights or 
responsibilities for any person and are not legally binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. You may submit 
comments on any guidance at any time (see ADDRESSES).

III. Paperwork Reduction Act of 1995

    The amendments made by the Appropriations Act result in changes to

[[Page 16639]]

some previously approved collections of information that are subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The 
OMB control numbers for these information collections are listed in 
table 1. FDA has published, and intends to continue publishing, notices 
concerning proposed changes to the relevant information collection 
activities in other editions of the Federal Register. In addition, in 
compliance with the PRA, we will submit revisions to the current 
information collections to OMB for review.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the guidance documents at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03951 Filed 3-17-23; 8:45 am]
BILLING CODE 4164-01-P

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