Establishment Registration and Product Listing for Tobacco Products

North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background and Purpose IV. Legal Authority V. Description of the Proposed Rule A. Scope (Proposed § 1108.1) B. Definitions (Proposed § 1108.3) C. Who Must Register and Submit a Tobacco Product List (Proposed § 1108.20) D. When To Submit Establishment Registration and Tobacco Product Listing (Proposed § 1108.22) E. Information Required for Tobacco Product Establishment Registration and Tobacco Product Listing (Proposed § 1108.24) F. Maintaining a Historical File (Proposed § 1108.26) G. Updating Tobacco Product Listing Information (Proposed § 1108.28) H. Assignment of an FDA Establishment Identifier (FEI) Number (Proposed § 1108.32) I. Electronic Registration of Establishments and Listing of Tobacco Products (Proposed § 1108.40) J. Establishment Registration and Tobacco Product Listing for Foreign Establishments Importing or Offering for Import Tobacco Products Into the United States (Proposed § 1108.50) K. Conditions for Registration of Foreign Tobacco Product Establishments (Proposed § 1108.52) L. Public Availability of Registration and Tobacco Product Listing Information (Proposed § 1108.60) M. Misbranding (Proposed § 1108.62) VI. Proposed Effective Date VII. Preliminary Economic Analysis of Impacts A. Introduction B. Overview of Benefits, Costs, and Transfers VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995 X. Federalism XI. Severability XII. Consultation and Coordination With Indian Tribal Governments XIII. References I. Executive Summary

A. Purpose of the Proposed Rule

The Family Smoking Prevention and Tobacco Control Act (Pub. L

nspections by statute, this rule will extend FDA's inspections of establishments to foreign establishments. FDA currently inspects foreign establishments only to support premarket tobacco product application (PMTA) review per 21 CFR 1114.27.

On February 13, 2025, the President signed Executive Order (E.O.) 14212 titled “Establishing the President's Make America Healthy Again Commission.” The E.O. sets forth that “[i]t shall be the policy of the Federal Government to aggressively combat the critical health challenges facing our citizens, including the rising rates of mental health disorders, obesity, diabetes, and other chronic diseases. To do so, executive departments and agencies (agencies) that address health or healthcare must focus on reversing chronic disease.” On September 9, 2025, the Make America Healthy Again Commission released the Strategy Report titled “Make Our Children Healthy Again,” which outlines a strategy of increased enforcement against illegal ENDS products.

Tobacco use is the leading preventable cause of death and disease in the United States, including preventable chronic disease. Accordingly, this rule would support FDA's efforts to advance Administration priorities by helping FDA identify tobacco products sold, distributed, and/or imported into the United States, and the establishments that manufacture them, that do not comply with Federal law, and by enabling FDA to better pursue enforcement actions against non-compliant tobacco products.

B. Summary of the Major Provisions of the Proposed Rule

The proposed rule would prescribe the format, content, and procedures for establishment registration and tobacco product listing for domestic and foreign manufacturers of tobacco products. The proposed rule would extend registration and listing requirements to foreign establishments that engage in the “manufacture, preparation, compounding, or processing” of a tobacco product

f the Proposed Rule

The proposed rule would prescribe the format, content, and procedures for establishment registration and tobacco product listing for domestic and foreign manufacturers of tobacco products. The proposed rule would extend registration and listing requirements to foreign establishments that engage in the “manufacture, preparation, compounding, or processing” of a tobacco product. Registered foreign establishments would be subject to inspection under section 905(g) and 905(h) of the FD&C Act (21 U.S.C. 387e(g) and 387e(h)). Proposed 21 CFR 1108 describes criteria for who would be required to register and list, when and how they would be required to register and list, and the type of information they would be required to submit to FDA. For both domestic and

C. Legal Authority

FDA is issuing this proposed rule under its authority delegated under sections 301, 701(a), 801(p), 902, 903, 905, 907, 909, 910, and 911 of the FD&C Act. Section 301 of the FD&C Act describes the acts that are prohibited by the FD&C Act (21 U.S.C. 331). Section 701(a) of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act (21 U.S.C. 371(a)). Section 801(p) of the FD&C Act requires FDA to report to Congress on exports of tobacco products that do not conform to tobacco product standards established pursuant to the FD&C Act (21 U.S.C. 381(p)). Sections 902 (21 U.S.C. 387b) and 903 (21 U.S.C. 387c) of the FD&C Act describe the scenarios in which a tobacco product will be deemed adulterated and misbranded, respectively. Section 905 of the FD&C Act sets forth establishment registration and product listing requirements for owners and operators of domestic establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products

tional clarity and efficiency for the format, content, and procedures for establishment registration and tobacco product listing for domestic and foreign owners and operators.

3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/registration-and-product-listing-owners-and-operators-domestic-tobacco-product-establishments.

Section 905 of the FD&C Act (21 U.S.C. 387e) requires the owners and operators of domestic establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product to register their establishments with FDA and submit product listings. Currently, domestic establishments are required to submit registration and product listing information and FDA has issued guidance to help tobacco product establishments implement this provision. In this proposed rule, FDA is clarifying that persons who engage in the manufacture of a tobacco product include specification developers, third-party manufacturers, and bulk tobacco product manufacturers. FDA is proposing corresponding changes to the forms currently used by domestic establishments, which would be used by all registrants to submit registration and listing information and proposing that all registration and listing information be submitted electronically, unless a waiver has been granted by FDA for the registrant. Under sections 905 and 909 of the FD&C Act, FDA is also proposing

Section 905(h) of the FD&C Act provides FDA with the authority to issue regulations requiring foreign manufacturers to register their establishments and list their products

nformation and proposing that all registration and listing information be submitted electronically, unless a waiver has been granted by FDA for the registrant. Under sections 905 and 909 of the FD&C Act, FDA is also proposing

Section 905(h) of the FD&C Act provides FDA with the authority to issue regulations requiring foreign manufacturers to register their establishments and list their products. Section 905(h) states, “[a]ny establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products, shall register under this section under regulations promulgated by [FDA].” Because FDA has not issued such regulations, foreign owners or operators are not currently required to register their establishments or list their tobacco products that are imported or offered for import into the United States, unlike domestic owners or operators who are subject to the already effective, self-implementing registration and listing requirements of section 905 of the FD&C Act (21 U.S.C. 387e). This discrepancy creates gaps in information for FDA to perform its public health mission. This proposed rule would therefore extend registration and listing requirements to foreign establishments that engage in the manufacture, preparation, compounding, or processing of a tobacco product. Registered foreign establishments would be subject to inspection under section 905(g) and 905(h) of the FD&C Act (21 U.S.C. 387e(g) and 387e(h)). FDA believes that issuing this regulation to apply these requirements to foreign owners and operators would bring parity between foreign and domestic owners and operators and in doing so improve FDA's understanding of the types of tobacco products being manufactured, the tobacco products sold in the United States, and the location of all establishments engaged in manufacturing them

en.” Company Q uses 100 percent burley tobacco for its Acme products and 100 percent flue-cured tobacco for its Bravo products. Since Company Q selected the product names primarily to distinguish the type of tobacco used in each, the company has chosen to market its cigarettes under two separate brands (“Acme” and “Bravo”) and indicates subbrands as Gold or Blue for Acme and Red or Green for Bravo.

The term “brand owner” would be defined as a person that owns a brand, through creation, acquisition, trademark, patent, copyright, or otherwise, and has directly or through license, the control and/or direction of the brand.

The term “bulk tobacco product” would be defined as a tobacco product not sealed in final packaging but otherwise suitable for consumer use as a tobacco product ( e.g., bulk cigarettes, bulk roll-your-own (RYO) tobacco, bulk pipe tobacco). The proposed definition of bulk tobacco product also includes components or parts of tobacco products that are not sealed in final packaging but are otherwise suitable for consumer use as tobacco products ( e.g., bulk filters, bulk e-liquids). Products that are suitable for consumer use as tobacco products are those products that do not require further processing by a tobacco product manufacturer, such as mixing, cutting, curing, blending, or adding components or parts, ingredients, additives and materials, before they can be used by a consumer. For example, an e-liquid not sealed in final packaging is suitable for consumer use as a tobacco product because it requires no additional processing by a tobacco product manufacturer before it can be used by a consumer in an ENDS device; it requires only final packaging and labeling to be a finished tobacco product. A product can be suitable for consumer use as a tobacco product even if it could undergo additional processing by a manufacturer, such as blending, as long as it does not require further processing by a manufacturer before use by a consumer

cco product manufacturer before it can be used by a consumer in an ENDS device; it requires only final packaging and labeling to be a finished tobacco product. A product can be suitable for consumer use as a tobacco product even if it could undergo additional processing by a manufacturer, such as blending, as long as it does not require further processing by a manufacturer before use by a consumer. For example, coconut and pineapple flavored e-liquids not sealed in final packaging would be considered bulk tobacco products because they are suitable for consumer use as tobacco products, even if they might later be blended together by a manufacturer to make piña colada flavored e-liquid.

The term “commercial distribution” would be defined the same way it is in 21 CFR 1107.12. It would mean any distribution of a tobacco product, whether domestic or imported, to consumers or to any person, but does not include interplant transfers of a tobacco product between establishments within the same parent, subsidiary, and/or affiliate company, nor does it include providing a tobacco product for product testing where such product is not made available for consumption or resale. This definition is consistent with FDA's “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, Guidance for Industry” (revised March 2023). This term would not include the handling or transfer of a tobacco product from one consumer to another for personal consumption. The term would have the same meaning for foreign establishments, but it would not include the distribution of any tobacco products that are neither imported nor offered for import into the United States. Finally, the definition would not include shipment of a tobacco product into a foreign trade zone if the product is then exported and not further distributed in the United States

onal consumption. The term would have the same meaning for foreign establishments, but it would not include the distribution of any tobacco products that are neither imported nor offered for import into the United States. Finally, the definition would not include shipment of a tobacco product into a foreign trade zone if the product is then exported and not further distributed in the United States.

The term “component or part” would be defined as any software or assembly of materials intended or reasonably expected: (a) to alter or affect the tobacco product's performance, composition, constituents, or characteristics; or (b) to be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product. This definition is consistent with FDA's “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, Guidance for Industry” (revised March 2023).

The term “domestic establishment” would be defined as an establishment in any State or Territory or possession of the United States. 6 This definition is consistent with FDA's “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, Guidance for Industry” (revised March 2023). We note that this definition includes establishments on Tribal land. FDA respects tribal sovereignty and understands the importance of collaboration and consultation, as appropriate, with federally-recognized tribal governments

Establishments, Guidance for Industry” (revised March 2023).

The term “owner” would be defined to mean a person, as defined in section 201(e) of the FD&C Act, who has an ownership interest in an establishment. This definition is consistent with FDA's “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, Guidance for Industry” (revised March 2023).

The term “Product Identification Number (PD #)” would be defined to mean the number that FDA assigns to each product within a submission to distinguish among the products included in that submission. A PD # is only relevant within the context of a specific Submission Tracking Number (STN).

The term “Registration Identification Number (RGID #)” would be defined to mean the FDA-assigned unique identifier for a registered establishment's registration. The RGID # is assigned to each new electronic tobacco product registration and listing system submission and attaches to the establishment(s) and the product(s) in the initial submission. This information is important to ensure FDA and industry are referring to the same registered establishments and listed products. Updates to establishment registration and product list information would reference the RGID # from the initial FDA submission.

The term “representative sampling of advertisements” would be defined to mean advertising material that gives a comprehensive picture of the promotional claims and campaigns in use for each tobacco product and which includes representative material from each medium being used to promote the product ( e.g., advertisements that appear in or on magazines, newspapers, direct mail materials, retail or point-of-sale displays, posters, billboards, and via internet and mobile communications, such as web pages, banner advertisements, and text messages).

The term “specification developer” would be defined as a person who controls the design and development of a tobacco product or initiates or creates the specifications for the product

n or on magazines, newspapers, direct mail materials, retail or point-of-sale displays, posters, billboards, and via internet and mobile communications, such as web pages, banner advertisements, and text messages).

The term “specification developer” would be defined as a person who controls the design and development of a tobacco product or initiates or creates the specifications for the product.

The term “Submission Tracking Number (STN)” would be defined to mean the number that FDA assigns to submissions that are received from an applicant, such as a PMTA, supplemental PMTA, SE reports, SE exemption requests (EX REQ), MRTPA, and submissions related to investigational tobacco products.

The term “third-party manufacturer” would be defined as an entity, including a contract manufacturer, that physically manufactures a tobacco product on behalf of, or to specifications established by, another party, such as a brand owner or specification developer.

The term “tobacco product” would be defined the same way as in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)). It would mean any product made or derived from tobacco, or containing nicotine from any source, 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). The term “tobacco product” does not mean an article under the FD&C Act that is a drug (section 201(g)(1)), a device (section 201(h)), or a combination product (section 503(g)). The term “tobacco product” does not mean an article that is a food (section 201(f)) if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine. This definition is consistent with FDA's “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, Guidance for Industry” (revised March 2023)

n product (section 503(g)). The term “tobacco product” does not mean an article that is a food (section 201(f)) if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine. This definition is consistent with FDA's “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, Guidance for Industry” (revised March 2023).

The term “Tobacco Product Number (TP #)” would be a product-specific number that is generated by FDA for each product listed on an establishment's registration.

C. Who Must Register and Submit a Tobacco Product List (Proposed § 1108.20)

Proposed § 1108.20(a) and (b) specify those persons who would be required to register and to submit a tobacco product list to FDA. This paragraph would require an owner or operator of an establishment, except those listed in § 1108.20(c), engaged in the manufacture, preparation, compounding, or processing of a tobacco product to register in accordance with section 905 of the FD&C Act. This includes any owner or operator of any domestic establishment that manufactures a tobacco product for export, as well as any owner or operator of any establishment engaged in the manufacture of free smokeless tobacco samples. Manufacturers of tobacco products also include specification developers, third-party manufacturers, bulk tobacco product manufacturers, and repackagers/relabelers.

FDA is aware that some tobacco product manufacturers have established an organizational structure that places the specification development functions in an entity separate from the entity in charge of physically manufacturing the tobacco product; these entities develop and usually control changes to the specifications of the tobacco product. Such entities are specification developers under the proposed rule

re that some tobacco product manufacturers have established an organizational structure that places the specification development functions in an entity separate from the entity in charge of physically manufacturing the tobacco product; these entities develop and usually control changes to the specifications of the tobacco product. Such entities are specification developers under the proposed rule. If a specification developer designs, establishes, or provides the specifications of a tobacco product to another entity to physically manufacture the product, both the specification developer and the other entity would be engaged in the manufacture of tobacco products for purposes of this rule and would be required to comply with this proposed rule. Product design and the development of product specifications are integral parts of manufacturing.

Additionally, owners or operators are required to register every domestic establishment engaged in the manufacture, preparation, compounding, or processing of tobacco products, whether those establishments are distributing their tobacco product into domestic commerce or exporting them. FDA has the authority to inspect these establishments regardless of the destination of their shipments, and registration and listing information helps FDA ensure that products produced by export-only manufacturers comply with the FD&C Act and applicable regulations.

To avoid unnecessary duplicate registrations, proposed § 1108.20(a) would permit a parent, subsidiary, or affiliate company to submit registration information for all establishments when operations are conducted at more than one establishment and the establishments are under common or joint ownership or control, which is consistent with FDA's drug registration requirements for domestic and foreign establishments (see 21 CFR 207.17(a))

ations, proposed § 1108.20(a) would permit a parent, subsidiary, or affiliate company to submit registration information for all establishments when operations are conducted at more than one establishment and the establishments are under common or joint ownership or control, which is consistent with FDA's drug registration requirements for domestic and foreign establishments (see 21 CFR 207.17(a)). To reduce duplicative submissions, registration information for an establishment should be submitted by only one entity—the owner or operator of that establishment, or the establishment's parent, subsidiary, or affiliate establishment. Duplicate submissions would create unnecessary burden for the Agency in its submission review and create unnecessary work for registrants. For example, if the parent company has a subsidiary and an affiliate, the parent company can submit the registration information on behalf of the parent, the subsidiary, and the affiliate. Additionally, an owner or operator may authorize a third-party agent to register the establishment(s) on its behalf.

Proposed § 1108.20(b) provides that every person who is required to register, as specified in § 1108.20(a), would also be required to submit a listing of all tobacco products that are being manufactured, prepared, compounded or processed by such person for commercial distribution, in accordance with section 905(i) of the FD&C Act and this proposed regulation. To reduce duplicative submissions, when operations are conducted at more than one establishment and the establishments are under common or joint ownership or control, this section would permit the parent, subsidiary, or affiliate company to submit listing information for all establishments.

Proposed § 1108.20(c) specifies persons who would not be required to register their establishments or submit a tobacco product list

missions, when operations are conducted at more than one establishment and the establishments are under common or joint ownership or control, this section would permit the parent, subsidiary, or affiliate company to submit listing information for all establishments.

Proposed § 1108.20(c) specifies persons who would not be required to register their establishments or submit a tobacco product list. Proposed § 1108.20(c)(1) states that persons engaged only in manufacturing investigational use tobacco products where the product is not available for sale or distribution other than as part of an investigation would not be required to register their establishments or list their products. However, if a manufacturer manufactures products for both investigational use and for commercial distribution, that manufacturer would be required to register its establishment and would be required to list its tobacco products that are manufactured for commercial distribution.

Proposed § 1108.20(c)(2) states that manufacturers of only raw materials, other than tobacco, used in manufacturing a component or part of a tobacco product would not be required to register their establishments or list their products. Examples of such raw materials would be unprocessed acacia gum (taken from a tree and not processed) and minted titanium dioxide (used for whitening cigarette and tipping paper). For example, a manufacturer that only produces acetate tow used in the manufacturing of a filter for a cigarette would not be required to register its establishment or list its products. However, a manufacturer of both a tobacco product and raw material would have to register the establishment and list the tobacco product.

Proposed § 1108.20(c)(3) states that common carriers, in their receipt, carriage, holding, or delivery of a tobacco product in the usual course of business would not need to register their establishment or submit a tobacco product list

ation described in § 1108.20(a) must register each of its establishments, and certify that all information associated with the registered establishments and its listed products is accurate and up to date. Each owner or operator of a registered establishment would need to review, change as needed, or confirm there have been no changes to, the registered establishment information and listed products. Annual registration would still be required even to confirm that there have been no changes.

Proposed § 1108.22(b)(2) would require each owner or operator of an establishment engaged in an operation described in § 1108.20(a) to review, change as needed, or confirm there have been no changes to their tobacco product listing information on file with FDA in June and December of every year. Owners or operators would be required to report any changes or deletions to listings previously reported, including any material changes to product listings previously reported, as described in § 1108.28, and list any new products not previously reported. For example, if the labeling for a product is changed in October, the product listing information would have to be changed accordingly in December of the same year. This information would be used to help ensure the products marketed are in compliance with the FD&C Act and its implementing regulations.

E. Information Required for Tobacco Product Establishment Registration and Tobacco Product Listing (Proposed § 1108.24)

Proposed § 1108.24 would contain the requirements for an owner or operator to submit information about their establishment and tobacco products. The Tobacco Control Act and its implementing regulations establish a framework that enables FDA to request and receive information on establishment registration and tobacco product listing, and to set up systems through which FDA would have an integrated picture of the tobacco product distribution system

specified by the strategy. This information would likewise facilitate the recall strategy and effectiveness checks for foreign establishments that initiate recalls.

Proposed § 1108.24(a) would contain the establishment registration information required, if applicable, to be submitted to FDA using FDA's electronic tobacco product registration and listing system, except as provided in § 1108.40(b). Proposed § 1108.24(a)(1) would require the full name, physical address, mailing address, and contact information for the establishment. Proposed § 1108.24(a)(2) would require the name, address, phone number, fax number, and email address of the owner and operator; if a partnership, the name of each partner; if a corporation, the place of incorporation and the name of each corporate officer and director; any trade names used by the owner and operator or other names under which the owner and operator conducts business or additional names by which the owner and operator is known. This information is important for FDA to efficiently coordinate inspections under section 905(g) of the FD&C Act, including by reducing duplication of registered establishments.

Proposed § 1108.24(a)(3) would require the name, address, phone number, fax number, and email address of the official correspondent designated by the owner or operator. This information is necessary in order for FDA to efficiently correspond on issues regarding the registration and listing submissions.

Proposed § 1108.24(a)(4) would require any trade names used by the establishment or other names under which the establishment conducts business or additional names by which the establishment is known. This information would allow FDA to reduce duplication and properly identify establishments to determine whether they are properly registered and would eliminate confusion if an establishment is known by multiple names or if different establishments are known by similar names

r, the place of business of the operator, and the location of the establishment. If submitted, this information would help FDA determine whether an establishment has been duly registered and to distinguish between registered establishments, especially if they have similar names.

Lastly, proposed § 1108.24(a)(8) would require the name of the Tribe if the establishment is located on Indian Country. The name of the Tribe for establishments located on Indian Country would help FDA coordinate compliance directly with the appropriate tribal government and respect statutory limits on contracting with third parties for inspections in Indian Country.

FDA is considering requiring establishments to provide additional contact information in their registration. The Agency requests comments on whether to also require the name, address, and contact information for the establishment's direct accounts, if applicable. Because tobacco products move through direct accounts, knowing those accounts would be helpful for FDA to verify compliance, facilitate the identification of adulterated or misbranded tobacco products that have entered commercial distribution, and take prompt compliance and enforcement actions when warranted.

FDA also requests comments on whether to require the name, address, phone number, fax number, email address, and contact information for the establishment's importers and consignees, if applicable. Section 905(h) of the FD&C Act requires registration of foreign establishments whose products are imported or offered for import into the United States. Importer and consignee information would help FDA determine whether imported tobacco products originate from registered establishments and would help FDA identify such products that may be in commercial distribution, including those that may be adulterated or misbranded under sections 902 and 903 of the FD&C Act

tablishments whose products are imported or offered for import into the United States. Importer and consignee information would help FDA determine whether imported tobacco products originate from registered establishments and would help FDA identify such products that may be in commercial distribution, including those that may be adulterated or misbranded under sections 902 and 903 of the FD&C Act.

FDA also requests comments on whether to require, for any tobacco product brand manufactured by the establishment that is not owned by the establishment, the name, address, phone number, fax number, email address, and contact information for the establishment's tobacco product brand owners. Requiring contact information for tobacco product brand owners would ensure that FDA can associate all manufacturers of finished and bulk tobacco products with brand owners. Section 905 of the FD&C Act requires owners or operators to register each establishment engaged in the manufacture, preparation, compounding, or processing of a tobacco product. Because brand owners may contract out these functions while retaining ultimate control over the product, the information that would be required would enable FDA to identify the brand owners on whose behalf manufacturers are producing a specific tobacco product. This information would help FDA identify the entity responsible for marketing or introducing such products into commercial distribution, including tobacco products that may be adulterated or misbranded under sections 902 and 903 of the FD&C Act.

FDA also requests comments on whether to require the name, address, phone number, fax number, email address, and contact information for the establishment's tobacco product specification developers, if any. As discussed in proposed § 1108.20(a), manufacturers of tobacco products include specification developers, so specification developers would be required to register their establishments and list their tobacco products

ts on whether to require the name, address, phone number, fax number, email address, and contact information for the establishment's tobacco product specification developers, if any. As discussed in proposed § 1108.20(a), manufacturers of tobacco products include specification developers, so specification developers would be required to register their establishments and list their tobacco products. Because specification developers exercise functional control over product design and specifications, even if physical manufacturing is performed by another manufacturer, requiring the specification developer's contact information would help FDA associate manufacturers that physically manufacture finished and bulk tobacco products with the manufacturers that develop their specifications. To this end, this information would help FDA efficiently identify establishments operating in violation of the FD&C Act, such as products that are adulterated or misbranded under sections 902 and 903 of the FD&C Act, or products that are non-compliant with FDA's premarket authorization requirements under section 910 of the FD&C Act, or to facilitate the recall of non-compliant tobacco products that have entered United States commercial distribution.

FDA requests comments on whether to require the brand owner, direct account, consignee, and importer information described above that the Agency is considering requiring, or any other information, and the reasons why.

Proposed § 1108.24(b) would provide that owners or operators of tobacco product establishments who have been granted a waiver under § 1108.40(b) from filing electronically through FDA's tobacco product registration and listing system must submit the information required by § 1108.24(a) in paper form using the procedures provided by FDA in accordance with § 1108.40(c)

mation, and the reasons why.

Proposed § 1108.24(b) would provide that owners or operators of tobacco product establishments who have been granted a waiver under § 1108.40(b) from filing electronically through FDA's tobacco product registration and listing system must submit the information required by § 1108.24(a) in paper form using the procedures provided by FDA in accordance with § 1108.40(c).

Proposed § 1108.24(c) would require the owner or operator to designate an official correspondent for the registration to serve as their point of contact with FDA on issues relating to establishment registration and listing of tobacco products. Similar to what is recommended by the R&L Guidance, proposed § 1108.24(c)(1) and (c)(2) state that the official correspondent would be responsible for electronically transmitting to FDA all required registration and listing information unless a waiver from electronic submission has been granted in accordance with § 1108.40(b) as well as serving as a liaison for all correspondence with FDA concerning registration and listing.

FDA is proposing to require identification of an official correspondent for two reasons. First, an official correspondent is important to help FDA ensure adequate notice is provided to registrants through official Agency communications. As such, the designation of an official correspondent provides the agency with an official contact who can receive the information or documentation on behalf of the registrant. Second, identification of an official correspondent would assist FDA in communication with the registrant and help the Agency to efficiently process submissions and avoid delays. An official correspondent would act as a communications link between FDA and the registrant and would facilitate timely correspondence between FDA and the registrant, including responding to questions concerning registrations

nd, identification of an official correspondent would assist FDA in communication with the registrant and help the Agency to efficiently process submissions and avoid delays. An official correspondent would act as a communications link between FDA and the registrant and would facilitate timely correspondence between FDA and the registrant, including responding to questions concerning registrations.

Proposed § 1108.24(d) would provide that the designation of an official correspondent does not in any manner affect the liability of the owner or operator of the establishment or any other individual under section 301(p) of the FD&C Act or any other provision of

Proposed § 1108.24(e) would require owners or operators to submit listing information identified in paragraphs (e)(1) through (e)(10) for each tobacco product manufactured, prepared, compounded, or processed for commercial distribution. This information is important for FDA to identify the specific tobacco products that are being manufactured at each establishment. For example, FDA would be able to determine whether the same or similar products are being marketed under different brands or subbrands of tobacco products. The information must be submitted electronically through FDA's tobacco product registration and listing system unless FDA grants a waiver from electronic submission under § 1108.40(b).

Proposed § 1108.24(e)(1) would require each listing to include the current electronic tobacco product registration and listing system RGID # and the name of each establishment. The RGID # and name of each establishment would help FDA identify the products manufactured at that establishment, especially where multiple establishments have similar names. In the case of an owner or operator with multiple establishments, FDA would be able to use the manufacturing location to determine where to inspect to determine each tobacco product's compliance with the requirements of the FD&C Act

• Wattage ( e.g., 100 W, 200 W);

• Battery capacity ( e.g., 100 mAh, 200 mAh);

• Characterizing flavor(s) ( e.g., menthol, tobacco, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, unflavored), which is from the packaging or other labeling if applicable; and

• Additional properties needed to uniquely identify the tobacco product (if applicable).

The following table is not exhaustive and does not encompass all potential products and their uniquely identifying properties and is intended to serve as an example.

Table 1—Elements of Uniquely Identifying Information by Tobacco Product Category and Subcategory Tobacco product category Tobacco product subcategory Product properties Cigarettes • Filtered • Package type ( e.g., hard pack, soft pack, clam shell). • Product quantity ( e.g., 20 cigarettes, 25 cigarettes). • Length ( e.g., 89.1 mm, 100.0 mm). • Diameter ( e.g., 6.0 mm, 8.1 mm). • Filter ventilation percentage ( e.g., none, 10.0%, 25.0%). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). Cigarettes • Non-filtered • Package type ( e.g., hard pack, soft pack, clam shell). • Product quantity ( e.g., 20 cigarettes, 25 cigarettes). • Length ( e.g., 89.1 mm, 100.0 mm). • Diameter ( e.g., 6.0 mm, 8.1 mm). • Filter ventilation percentage ( e.g., none, 10.0%, 25.0%). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). Cigarettes • Other • Package type ( e.g., hard pack, soft pack, clam shell). • Product quantity ( e.g., 20 cigarettes, 25 cigarettes). • Length ( e.g., 89.1 mm, 100.0 mm)

erived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). Cigarettes • Other • Package type ( e.g., hard pack, soft pack, clam shell). • Product quantity ( e.g., 20 cigarettes, 25 cigarettes). • Length ( e.g., 89.1 mm, 100.0 mm). • Diameter ( e.g., 6.0 mm, 8.125 mm). • Filter ventilation percentage ( e.g., none, 10.0%, 25.0%). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Roll-Your-Own Tobacco Filler • Package type ( e.g., bag, pouch). • Product quantity ( e.g., 20.1 g, 16.0 oz). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Rolling Paper • Package type ( e.g., box, booklet). • Product quantity ( e.g., 50 sheets, 200 papers). • Length ( e.g., 79.1 mm, 100.0 mm, 110.2 mm). • Width ( e.g., 28.1 mm, 33.0 mm, 45.2 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Cigarette Tube, Filtered • Package type ( e.g., bag, box) • Product quantity ( e.g., 100 tubes, 200 tubes). • Length ( e.g., 89 mm, 100.0 mm). • Diameter ( e.g., 6.0 mm, 8.1 mm). • Filter ventilation percentage ( e.g., none, 10.0%, 25.0%). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol)

, Filtered • Package type ( e.g., bag, box) • Product quantity ( e.g., 100 tubes, 200 tubes). • Length ( e.g., 89 mm, 100.0 mm). • Diameter ( e.g., 6.0 mm, 8.1 mm). • Filter ventilation percentage ( e.g., none, 10.0%, 25.0%). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Cigarette Tube, Non-filtered • Package type ( e.g., bag, box). • Product quantity ( e.g., 100 tubes, 200 tubes). • Length ( e.g., 89.1 mm, 100.0 mm). • Diameter ( e.g., 6.0 mm, 8.1 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Filter • Package type ( e.g., bag, box). • Product quantity ( e.g., 100 filters, 200 filters). • Length ( e.g., 8.0 mm, 12.1 mm). • Diameter ( e.g., 6.0 mm, 8.1 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Paper Tip • Package type ( e.g., bag, box). • Product quantity ( e.g., 200 tips, 275 tips). • Length ( e.g., 12.0 mm, 15.1 mm). • Width ( e.g., 27.1 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Other • Package type ( e.g., bag, box). • Product quantity ( e.g., 200 tips, 100 filters, 200 tubes)

th ( e.g., 27.1 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). RYO tobacco • Other • Package type ( e.g., bag, box). • Product quantity ( e.g., 200 tips, 100 filters, 200 tubes). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). Smokeless tobacco • Moist Snuff, Loose • Package type ( e.g., plastic can with metal lid, plastic can with plastic lid). • Product quantity ( e.g., 20.0 g, 2.1 oz). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). Smokeless tobacco • Moist Snuff, Portioned • Package type ( e.g., plastic can with metal lid, plastic can with plastic lid). • Product quantity ( e.g., 22.5 g, 20.0 g). • Portion count ( e.g., 15 pouches, 20 pieces). • Portion mass ( e.g., 1.5 g/pouch, 1.0 g/piece). • Portion length ( e.g., 15.0 mm, 20.1 mm). • Portion width ( e.g., 10.0 mm, 15.1 mm). • Portion thickness ( e.g., 5.0 mm, 7.1 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). Smokeless tobacco • Snus, Loose • Package type ( e.g., plastic can with metal lid, plastic can with plastic lid). • Product quantity ( e.g., 20.0 g, 2.1 oz)

mm). • Portion thickness ( e.g., 5.1 mm, 7.0 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). Smokeless tobacco • Other • Package type ( e.g., bag, box, can). • Product quantity ( e.g., 20.1 g, 22.5 g, 3.0 oz.). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). ENDS • E-Liquid, Open • Package type ( e.g., bottle, box, pod). • Product quantity ( e.g., 1 bottle, 5 bottles). • E-liquid volume ( e.g., 0.5 ml, 2.0 ml, 5.1 ml). • Nicotine concentration ( e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/bottle). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Propylene glycol (PG)/vegetable glycerin (VG) ratio ( e.g., not applicable [N/A], 0/100, 50/50, 100/0). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). ENDS • E-Liquid, Closed • Package type ( e.g., cartridge, pod). • Product quantity ( e.g., 1 cartridge, 5 cartridges). • E-liquid volume ( e.g., 0.5 ml, 2.0 ml, 5.1 ml). • Nicotine concentration ( e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 2.0 mg/bottle). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • PG/VG ratio ( e.g., N/A, 0/100, 50/50, 100/0). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable)

tration ( e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 2.0 mg/bottle). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • PG/VG ratio ( e.g., N/A, 0/100, 50/50, 100/0). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). ENDS • E-Cigarette, Closed • Package type ( e.g., box, none, plastic clamshell). • Product quantity ( e.g., 1 e-cigarette, 5 e-cigarettes). • Length ( e.g., 100.0 mm, 120.0 mm). • Diameter ( e.g., 6.0 mm, 8.0 mm). • Wattage ( e.g., 100 W, 200 W). • Battery capacity ( e.g., 100 mAh, 200 mAh). • E-liquid volume ( e.g., 0.5 ml, 2.0 ml, 5.1 ml). • Nicotine concentration ( e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/e-cigarette). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • PG/VG ratio ( e.g., N/A, 0/100, 50/50, 100/0). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). ENDS • E-Cigarette, Open • Package type ( e.g., box, none, plastic clamshell). • Product quantity ( e.g., 1 e-cigarette, 5 e-cigarettes). • Length ( e.g., 100.0 mm, 120.0 mm). • Diameter ( e.g., 6.0 mm, 8.0 mm). • E-liquid volume ( e.g., 0.5 ml, 2.0 ml, 5.1 ml). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Wattage ( e.g., 100 W, 200 W). • Battery capacity ( e.g., 100 mAh, 200 mAh). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). ENDS • ENDS Component • Package type ( e.g., box, none, plastic clamshell). • Product quantity ( e.g., 1 coil). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none)

h). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). ENDS • ENDS Component • Package type ( e.g., box, none, plastic clamshell). • Product quantity ( e.g., 1 coil). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, cherry, wintergreen). • Additional properties needed to uniquely identify the tobacco product (if applicable). ENDS • ENDS Other • Package type ( e.g., box, none, plastic clamshell). • Product quantity ( e.g., 1 e-cigarette, 5 bottles). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, cherry, wintergreen, tobacco, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). Cigars • Cigar, Filtered Sheet-Wrapped • Package type ( e.g., hard pack, soft pack, clam shell). • Product quantity ( e.g., 20 filtered cigars, 25 filtered cigars). • Length ( e.g., 89.1 mm, 100.0 mm). • Diameter ( e.g., 6.0 mm, 8.1 mm). • Filter ventilation percentage ( e.g., none, 0%, 10.0%, 25.0%). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor ( e.g., unflavored, menthol). • Additional properties needed to uniquely identify the tobacco product (if applicable). Cigars • Cigar, Unfiltered Sheet-Wrapped • Package type ( e.g., box, film sleeve). • Product quantity ( e.g., 1 cigar, 5 cigarillos). • Length ( e.g., 100.1 mm, 140.0 mm). • Diameter ( e.g., 8.0 mm, 10.1 mm). • Tip ( e.g., none, wood tips, plastic tips). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor ( e.g., unflavored, menthol)

(NTN), both, or none). • Characterizing flavor ( e.g., unflavored, menthol, cherry). • Additional properties needed to uniquely identify the tobacco product (if applicable). Cigars • Other • Package type ( e.g., box, booklet). • Product quantity ( e.g., 1 cigar, 5 cigars, 20 leaves, 16 g). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, menthol, cherry). • Additional properties needed to uniquely identify the tobacco product (if applicable). Pipe Tobacco Products • Pipe • Package type ( e.g., box, none). • Product quantity ( e.g., 1 pipe). • Length ( e.g., 200.0 mm, 300.1 mm). • Diameter ( e.g., 25.1 mm). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, menthol, cavendish, cherry). • Additional properties needed to uniquely identify the tobacco product (if applicable). Pipe Tobacco Products • Pipe Tobacco Filler • Package type ( e.g., bag, none). • Product quantity ( e.g., 20.0 g, 16.1 oz). • Tobacco cut style ( e.g., standard cut, such as shag cut, bugler cut, loose cut, etc., or a pressed cut, such as flake, cube cut, roll cake, etc., or a mixture). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, menthol, cavendish, cherry). • Additional properties needed to uniquely identify the tobacco product (if applicable). Pipe Tobacco Products • Pipe Component • Package type ( e.g., box, bag, none). • Product quantity ( e.g., 1 bowl, 1 stem, 100 filters). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, cherry). • Additional properties needed to uniquely identify the tobacco product (if applicable). Pipe Tobacco Products • Other • Package type ( e.g., bag, box, none)

., box, bag, none). • Product quantity ( e.g., 1 bowl, 1 stem, 100 filters). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, cherry). • Additional properties needed to uniquely identify the tobacco product (if applicable). Pipe Tobacco Products • Other • Package type ( e.g., bag, box, none). • Product quantity ( e.g., 1 pipe). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, cherry). • Additional properties needed to uniquely identify the tobacco product (if applicable). Waterpipe Tobacco Products • Waterpipe • Package type ( e.g., box, none). • Product quantity ( e.g., 1 waterpipe). • Height ( e.g., 200.0 mm, 500.1 mm). • Width ( e.g., 100.1 mm, 300.0 mm). • Diameter ( e.g., 100.1 mm, 300.0 mm). • Number of hoses ( e.g., 1, 2, 4). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored). • Additional properties needed to uniquely identify the tobacco product (if applicable). Waterpipe Tobacco Products • Waterpipe Tobacco Filler • Package type ( e.g., bag, pouch). • Product quantity ( e.g., 20.0 g, 16.1 oz.). • Nicotine source ( i.e., tobacco-derived nicotine (TDN), non-tobacco derived nicotine (NTN), both, or none). • Characterizing flavor(s) ( e.g., unflavored, tobacco, menthol, apple). • Additional properties needed to uniquely identify the tobacco product (if applicable). Waterpipe Tobacco Products • Waterpipe Heat Source • Package type ( e.g., box, film sleeve, bag, none). • Product quantity ( e.g., 150.0 g, 680.0 g). • Portion count ( e.g., 20 fingers, 10 discs, 1 base). • Portion mass ( e.g., 15.0 g/finger, 10.0g/brick). • Portion length ( e.g., 40.0 mm, 100.0 mm). • Portion width ( e.g., 10.0 mm, 40.0 mm). • Portion thickness ( e.g., 10.0 mm, 40.0 mm)

rds, (2) the destinations of the exported tobacco products for the previous year, and (3) the quantity of the product shipped to each country during the previous year. This information would need to be provided in the June biannual listing update required by § 1108.22(b)(2) and would assist FDA in preparing its tobacco product export report to Congress required under section 801(p) of the FD&C Act.

Proposed § 1108.24(e)(9) would require, per section 905(i)(1)(A) of the FD&C Act, registrants to submit, for a tobacco product subject to a tobacco product standard established under section 907 of the FD&C Act or which is subject to section 910 of the FD&C Act for any new tobacco product, a reference to the authority for the marketing of the tobacco product (the submitter would have a list to choose from to indicate the type of market authorization status, such as a marketing granted order, SE order, SE exemption order, and would be able to enter STN as free text, as applicable), a legible, full color copy of all labeling for the product, indication of the category ( e.g., labeling) of material being submitted and the associated product(s), and the original date the labeling materials were first disseminated and date when their dissemination was discontinued. Proposed § 1108.24(e)(10) would require registrants to submit, for all tobacco products not covered by paragraph (9), a legible, full color copy of all consumer information and other labeling for the product, a representative sampling of advertisements for the product, indication of the category ( i.e., labeling, advertising, consumer information) of material being submitted and the associated product(s), and the original date the materials were first disseminated and date when their dissemination was discontinued. For labeling under §§ (9) and (10), only one representative package label need be submitted where differences exist only in the bar code, tax stamp, or pricing sticker. A material change to product labeling would require resubmission

aterial being submitted and the associated product(s), and the original date the materials were first disseminated and date when their dissemination was discontinued. For labeling under §§ (9) and (10), only one representative package label need be submitted where differences exist only in the bar code, tax stamp, or pricing sticker. A material change to product labeling would require resubmission. Resubmission would not be required if the labeling change is insignificant ( e.g., pertains only to grammar, non-substantial typographical errors, or to the tax stamp or bar code).

The dates of dissemination will facilitate FDA's surveillance of labeling and advertising by helping FDA determine when a tobacco product with violative labeling is being sold and when violative advertising for a tobacco product is in use. This information will enable FDA to more efficiently and effectively identify violations for current tobacco product labeling and advertising and pursue compliance and enforcement as appropriate. For example, if in its review FDA identifies evidence of a violation in labeling and/or advertising for a tobacco product ( e.g., product labeling indicating that the product presents a reduced health risk without a modified risk tobacco product order in effect, or labeling that is false or misleading), the dates of dissemination will help FDA target its surveillance to determine whether the violative labeling is for a product currently being sold and whether the violative advertising is currently being used. This information, in turn, will help FDA more effectively ensure compliance with the requirements of the law and take enforcement action as appropriate.

Currently, FDA reviews advertisements to help determine whether the advertisements and the product comply with the requirements in the FD&C Act

is for a product currently being sold and whether the violative advertising is currently being used. This information, in turn, will help FDA more effectively ensure compliance with the requirements of the law and take enforcement action as appropriate.

Currently, FDA reviews advertisements to help determine whether the advertisements and the product comply with the requirements in the FD&C Act.

The representative sampling of advertisements must include representative material from each medium being used to promote the product, such as advertisements that appear in or on magazines, newspapers, direct mail material, retail or point-of-sale displays, posters, billboards, and via internet and mobile communications ( e.g., web pages, banner advertisements, text messages). For example, if more than one magazine advertisement is used for a brand of tobacco product, only one would need to be submitted, provided the promotional message is the same and the overall presentation only differs superficially, such as in background color, font type or border style.

In addition, the proposed requirement would require the product listing to include a copy of all consumer information. Consumer information would not include information directed at wholesalers, distributors, or retailers, where such information is not available to consumers or the public ( i.e., potential consumers).

Proposed § 1108.24(f) states per section 905(i)(1)(C) of the FD&C Act that, upon FDA's request, each owner or operator must submit: (1) A brief statement of the basis of the determination, if the registrant has determined that a tobacco product being listed is not subject to a tobacco product standard established under section 907 of the FD&C Act, and (2) for good cause, a copy of all advertisements for a particular tobacco product not subject to a standard established under 907 of the FD&C Act or to section 910 of the FD&C Act. The required information would be required to be submitted within 30 calendar days of FDA's request

co product being listed is not subject to a tobacco product standard established under section 907 of the FD&C Act, and (2) for good cause, a copy of all advertisements for a particular tobacco product not subject to a standard established under 907 of the FD&C Act or to section 910 of the FD&C Act. The required information would be required to be submitted within 30 calendar days of FDA's request.

FDA requests comments on whether to require an owner or operator that has manufactured a tobacco product for distribution under a label other than its own to submit, upon request by FDA, the names of all distributors for whom it has been manufactured. This requirement would help FDA to efficiently and effectively ensure that currently marketed tobacco products are not adulterated or misbranded and protect the public health, by enabling FDA, for example, to identify, locate,

F. Maintaining a Historical File (Proposed § 1108.26)

We believe the creation and maintenance of a historical file is reasonably required under section 909 of the FD&C Act for FDA to ensure that the tobacco product is not adulterated or misbranded and to otherwise protect the public health. First, we believe this information is necessary for FDA to have access to a complete and accurate picture of the consumer information, labeling, and advertisements for the tobacco product, to more effectively and efficiently ensure compliance with the requirements of the FD&C Act and its implementing regulations, which is necessary for the protection of the public health

protect the public health. First, we believe this information is necessary for FDA to have access to a complete and accurate picture of the consumer information, labeling, and advertisements for the tobacco product, to more effectively and efficiently ensure compliance with the requirements of the FD&C Act and its implementing regulations, which is necessary for the protection of the public health. Further, a historical file is necessary to ensure that the manufacturer can adequately comply with an FDA request made under section 905(i)(1)(B) of the FD&C Act, which allows FDA to request for good cause “a copy of all advertisements for a particular tobacco product.” Moreover, the requirement for a historical file would not be unduly burdensome, taking into account that most manufacturers likely already maintain records of the labeling, advertising, and consumer information that a historical file would contain. FDA has observed on inspections of tobacco product manufacturers that most manufacturers are maintaining these types of records.

A historical file would help FDA to determine whether the labeling or advertising would render a tobacco product adulterated or misbranded. Under sections 903(a)(1) and (a)(7) of the FD&C Act, a tobacco product is misbranded if its labeling or advertising, respectively, is false or misleading in any particular, and under section 902(8) of the FD&C Act, a tobacco product is deemed adulterated if it is in violation of section 911 of the FD&C Act. A historical file would enable FDA and registrants to evaluate compliance across all labeling and advertising, whether included in a representative sample or not. For example, FDA may make a determination that a piece of advertising contained in the representative sample submitted to FDA indicates that a product is being marketed as a modified risk tobacco product without a modified risk tobacco product order from the FDA order in effect

ain products, including the requirement that such random display and distribution is done in accordance with an FDA approved warning plan.

Accordingly, proposed § 1108.26(a) and (b) would require each owner or operator to maintain a copy of all consumer information, labeling, and advertisements in use on the effective date of this rule for all tobacco products listed in accordance with this part. In addition, they would require each owner or operator to maintain a copy of all consumer information, labeling, and advertisements that is first used after the effective date of this rule. For the purposes of this subsection, consumer information, labeling, and advertisements are first used when the owner or operator had not used them previously or had used them previously but made a material change to them. This requirement would apply regardless of the type of consumer information, labeling, and advertisements, including when they are inserts, onserts, coupons, flyers, store circulars, direct mailers, email messages, social media sites, information contained in audio or video formats, point-of-sale materials, and any other promotional activities targeting consumers. This would include consumer information and other labeling (including package labels) for each tobacco product included in the product listing and advertisements (including those advertisements not submitted to FDA as part of a representative sampling of advertisements) for such tobacco products.

To satisfy this requirement, a registrant could maintain actual copies of the consumer information and other labeling (including labels), and advertisements disseminated for tobacco products. Alternatively, a registrant could maintain artwork files that show the design, layout, and content of the consumer information, labeling, and advertisements disseminated for use on or for the tobacco products. For example, a manufacturer may have labeling materials with different warning statements or different product inserts or onserts

ibuted free samples that were not in compliance with 21 CFR 1140.16(d). This is particularly concerning to the extent free samples have allowed individuals younger than 21 years of age to obtain and use smokeless tobacco. FDA expects that owners or operators required to register and list are the entities that distribute, or cause the distribution of, most free samples of smokeless tobacco products. Nonetheless, in addition to this rulemaking, FDA would consider whether to expand this requirement to other entities that distribute, or cause the distribution of, free samples of smokeless tobacco products.

Proposed § 1108.26(d) would provide a timeframe for each owner or operator to maintain consumer information and other labeling or advertisements, as well as free sample distribution information for smokeless products, in the historical file. Specifically, this provision would state that each owner or operator must retain consumer information or other labeling or advertisements from the historical file while currently in use and retain for a period of not less than four years after the date of final dissemination for materials that are discontinued. In addition, each owner or operator would have to retain free sample distribution information for smokeless products for a period of not less than four years after the date of the event documented. The four-year timeframe is based on the particular material, not the continuous commercial distribution of the tobacco product. For example, if an owner or operator creates a magazine advertisement for a tobacco product, it would be required to maintain a copy of that advertisement until four years after the last time that particular advertisement was disseminated. In addition, each owner or operator would be permitted to discard free sample distribution information for smokeless products four years after the date the event was held

e, if an owner or operator creates a magazine advertisement for a tobacco product, it would be required to maintain a copy of that advertisement until four years after the last time that particular advertisement was disseminated. In addition, each owner or operator would be permitted to discard free sample distribution information for smokeless products four years after the date the event was held.

FDA's ability to address potentially violative labeling and advertising may be hampered if firms were not required to maintain a historical file of labeling, advertising, and consumer information it disseminated for a sufficient time period. For example, FDA would be limited in its ability to ensure that firms comply with the requirements of the FD&C Act and its implementing regulations if FDA could not demonstrate or verify that the firm commercially marketed violative products. In addition, FDA's ability to pursue violations of the FD&C Act identified through routine internet and publication surveillance and investigate reports of tobacco related violations received from consumer complaints would be similarly affected. The materials maintained in a historical file would help FDA to address potentially violative tobacco products on the market by providing information that a manufacturer commercially marketed a tobacco product in a particular timeframe and/or location(s). Such evidence can help FDA target surveillance, collect additional evidence, and take appropriate action with respect to violative tobacco products on the market.

FDA has selected four years to help ensure that the records would be available for at least one FDA inspection under sections 704 and 905(g) of the FD&C Act (21 U.S.C. 374). FDA's biennial inspections under section 905(g) are required to occur at least once in every 2-year period after a manufacturer registers an establishment with FDA, which could result in inspections occurring nearly 4 years apart

has selected four years to help ensure that the records would be available for at least one FDA inspection under sections 704 and 905(g) of the FD&C Act (21 U.S.C. 374). FDA's biennial inspections under section 905(g) are required to occur at least once in every 2-year period after a manufacturer registers an establishment with FDA, which could result in inspections occurring nearly 4 years apart. The four-year timeframe also takes into account that advertising can and sometimes does remain in use for several years since it is first disseminated for tobacco products that are sold or distributed, such as advertising in retail environments accessible to youth. We seek comments on whether the four-year timeframes are an appropriate length of time for each owner or operator to maintain such information and documentation in the historical file. Please explain the basis for your comment and any sources for reference.

Proposed § 1108.26(e) contains the proposed requirements for the location of the historical file. Proposed § 1108.26(e)(1) and (e)(2) state that the contents of the historical file must be readily available at the registered establishment for inspection and copying by FDA and that it must be accessible within a reasonable time

G. Updating Tobacco Product Listing Information (Proposed § 1108.28)

Proposed § 1108.28 would provide the proposed requirements for an owner or operator to update its tobacco product listing information in accordance with section 905 of the FD&C Act. These updates would assist FDA in conducting inspections and any investigations into the source of a reported adverse experience or complaint. Inaccurate or outdated product listing information would interfere with FDA's ability to effectively perform inspections and understand the scope of any such issues

en discontinuing a tobacco product and later resuming its commercial distribution, respectively. Proposed § 1108.28(c) would require an owner or operator who discontinues commercial distribution of a product to update the listing information using FDA's electronic tobacco product registration and listing system, except as provided in § 1108.40(b), to indicate the listed tobacco product is inactive. Additionally, proposed § 1108.28(d) would state that if commercial distribution is later resumed, the owner or operator must reactivate the previously inactivated product listed using FDA's electronic tobacco product registration and listing system and indicate the date on which commercial distribution resumed, except as provided in § 1108.40(b).

H. Assignment of an FDA Establishment Identifier (FEI) Number (Proposed § 1108.32)

Proposed § 1108.32 states that FDA would assign each establishment an FEI number after confirming that complete initial establishment registration information has been submitted. FDA would send this information to the official correspondent of the owner or operator by email or postal mail (if the establishment has been granted a waiver under § 1108.40(b) of this part). Because an establishment can have a different address from the owner or operator, each establishment is assigned a unique FEI number.

I. Electronic Registration of Establishments and Listing of Tobacco Products (Proposed § 1108.40)

Proposed § 1108.40 contains the procedural requirements for electronically registering an establishment and listing tobacco product(s) and for obtaining a waiver from electronic submission. The majority of facilities, both in the United States and outside of the United States, have access to the internet, either within their companies or via other public means ( e.g., public libraries or internet cafes)

m the TRLM NG website. This online system allows users to view and update their registration and listing information from any location and at any time. This system makes registration and listing information more accessible for both FDA and industry. When an establishment wants to view its establishment registration and product listing data, TRLM NG allows the establishment to do so via one website. This system reduces the burden on industry by eliminating the need to submit first-party Freedom of Information Act requests (as was the case with eSubmitter). TRLM NG also allows establishments to distinguish the items that need to be updated from those that do not need to be updated, thereby eliminating any confusion that previously led to duplicate data submissions. Lowering the number of duplicate data submissions reduces the administrative burden on industry and FDA.

Electronic registration benefits both registering establishments and FDA. FDA can accept submissions from anywhere in the world, 24 hours a day

However, FDA recognizes that some owners or operators might be unable to access the internet and the electronic tobacco product registration and listing system. Proposed § 1108.40(b) states that waivers would be granted only if use of electronic means is not reasonable for the person requesting the waiver. To request a waiver, applicants would be required to send a letter to FDA requesting the waiver and provide certain information. Under proposed § 1108.40(b)(1) and (b)(2), the owner or operator would be required to submit the name and address of the tobacco product establishment(s) to be registered, a contact person for the owner or operator of the establishment, and the telephone number at which that person can be reached. If the establishment(s) has/have registered in the past, the letter would also have to include the RGID # and each registered establishment's FEI number

of the qualifications of the person that made the translation.

J. Establishment Registration and Tobacco Product Listing for Foreign Establishments Importing or Offering for Import Tobacco Products Into the United States (Proposed § 1108.50)

Proposed § 1108.50 sets forth the proposed establishment registration and tobacco product listing requirements for foreign tobacco product establishments. The proposed requirements are similar to those we are proposing for domestic owners or operators. FDA believes that applying these requirements similarly to domestic and foreign owners or operators would bring parity between them and improve FDA's understanding of the types of tobacco products being manufactured, the tobacco products sold in the United States, and the location of all establishments engaged in manufacturing them. This approach is consistent with FDA's drug registration and listing requirements, which likewise apply requirements similarly to domestic and foreign establishments (see 21 CFR 207).

Under proposed § 1108.50(a), any foreign establishment engaged in the manufacture, preparation, compounding, or processing of a tobacco product that is imported or offered for import into the United States would have to register such establishment and submit its tobacco product listing information for products manufactured for commercial distribution in the United States.

Proposed § 1108.50(a)(1) would require the foreign establishment's official correspondent to facilitate communication among the establishment, the government of such foreign country, and representatives of FDA regarding matters related to establishment registration and tobacco product listing under section 905(h) of the FD&C Act

ant regulatory actions “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” This proposed rule, if finalized as proposed, is expected to be an E.O. 14192 regulatory action.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the additional costs per entity of this rule are small, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (Section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” The current threshold after adjustment for inflation is $187 million, using the most current (2024) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

B. Overview of Benefits, Costs, and Transfers

Section 905 of the FD&C Act (21 U.S.C § 387e) requires owners and operators of domestic establishments, upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product, to immediately register their establishment, and to register annually thereafter. 7 It also requires owners and operators who register their establishment to submit, at the time of registration, a list of all tobacco 8 Changes to the product list are to be reported twice a year. Section 905 also requires foreign establishments to register in accordance with regulations published by FDA

co product, to immediately register their establishment, and to register annually thereafter. 7 It also requires owners and operators who register their establishment to submit, at the time of registration, a list of all tobacco 8 Changes to the product list are to be reported twice a year. Section 905 also requires foreign establishments to register in accordance with regulations published by FDA. This proposed rule would prescribe the format, content, and procedures for registration and product listing of domestic establishments and extend those requirements to foreign establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product that is imported or offered for import into the United States.

7 See Section 905(b), (c).

8 See Section 905(i). The product listing includes additional information, such as a copy of all consumer information and other labeling as well as a representative sample of advertising for certain listed tobacco products.

Table 2 presents estimated annualized total costs associated with the provisions in this proposed rule for both domestic and foreign establishments as well as for FDA. The 20-year annualized total costs range from $6.80 million to $26.55 million at a 7 percent discount rate, with a primary estimate of $15.57 million. The annualized total costs range from $6.81 million to $26.55 million at a 3 percent discount rate, with a primary estimate of $15.57 million. Estimated costs to establishments are derived from registration and listing activities and from inspection costs. Total annualized costs to domestic tobacco product establishments are estimated at $13,574 and $13,429 per year using a discount rate of 7 and 3 percent respectively (primary estimate), over a period of 20 years. Total annualized costs to foreign tobacco product establishments are estimated at $370,215 and $377,071 per year using a discount rate of 7 and 3 percent respectively (primary estimate)

12.56 5.43 21.50 Annualized Cost Savings 0 0 0 Annualized Net Costs 12.56 5.43 21.50 We have developed a Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 3, FDA) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

VIII. Analysis of Environmental Impact

We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. No extraordinary circumstances exist to indicate that the specific proposed action may significantly affect the quality of the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the PRA. A description of these provisions is given in the Description section with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information would have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology

the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Establishment Registration and Product Listing for Tobacco Products. OMB Control Number 0910-0650—Revision.

Description: 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. The Agency is proposing a rule, in accordance with section 905 of the FD&C Act, requiring owners or operators of domestic and foreign establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products, to register their establishments. Further, the proposed rule would require owners or operators of both domestic and foreign establishments to, at the time of registration, list all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution. Currently, in accordance with section 905 of the FD&C Act, only domestic owners and operators are required to register their establishments and list their tobacco products with FDA while foreign owners and operators are not subject to these requirements, creating significant gaps in Agency information. If finalized, this rule would extend registration and listing requirements to include owners and operators of foreign establishments.

Description of Respondents: This proposed rule would require owners or operators of an establishment engaged in the manufacture, preparation, compounding, or processing of a tobacco product to register those establishments and list their tobacco products that are being manufactured, prepared, compounded, or processed by that person for commercial distribution

their tobacco product listing information in June and December of every year. Owners or operators would be required to report any changes or deletions to listings described in § 1108.28 and list any new products not previously reported. For example, if the labeling for a product is changed in October, the product listing information would have to be updated accordingly in December of the same year. This information would be used to help ensure the products marketed are in compliance with the FD&C Act and implementing regulations.

Proposed § 1108.24(a) would specify the information required for tobacco product establishment registration ( e.g., information about the establishment, owner and operator, official correspondent, trade names, website address(es), RGID #, FEI number, Tribe). Proposed § 1108.24(e) would specify the tobacco listing information to be provided for each tobacco product listed ( e.g., RGID # and name of each establishment, product information, product numbers and tracking information, operation and process information, product standard information, marketing authority, labeling information). In addition, proposed § 1108.24(f) would specify that owners or operators may be required to submit to FDA upon request information for products that have been determined to not be subject to tobacco product standards or products manufactured for distribution under a label other than its own.

Proposed § 1108.26 would require owners or operators who manufacture a tobacco product to maintain a historical file containing a copy of all consumer information, labeling, and advertisements in use as of the effective date of the rule for all tobacco products contained in the product list for four years (including any information which has had a material change after the effective date of the rule). Additionally, those who distribute smokeless samples must keep, for four years after the date of the event, information about the events ( e.g., compliance information, details about the event)

a waiver. For owners or operators that have obtained a waiver, if information changes that might result in termination of the waiver, § 1108.40(d) would require that the owner or operator to notify FDA within 30 calendar days.

FDA's burden estimates are based on FDA's experience with tobacco registration and listing, FDA inspection reports, and Preliminary Regulatory Impact Analysis assumptions. The requirements in the proposed rule would apply to both domestic and foreign manufacturers of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution in the United States.

The currently approved information collection under OMB Control Number 0910-0650 includes the following annual burden estimates for establishment registration and product listing activities:

Table 4—Existing Burden for OMB Control Number 0910-0650, Estimated Annual Reporting Burden FDA Form/activity/FD&C Act section Number of respondents Number of responses per respondent Total annual responses Hours per response Total hours Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741, Form FDA 3741a, and the new Form FDA 3741 (Electronic and Paper submissions). 1 Sections 905(b), 905(c), 905(d), 905(h), or 905(i) 37 1 37 1.65 (99 minutes) 61 Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741, Form FDA 3741a, and the new Form FDA 3741 (Electronic and Paper submissions). 2 Sections 905(b), 905(c), 905(d), 905(h), or 905(i) 900 1 900 0.28 (17 minutes) 252 Product Listing (Initial), the initial listing of tobacco products. (New) Form FDA 3741b, “Tobacco Product List Spreadsheet” 37 1 37 0.22 (13 minutes) 8 Total 974 321 1 This initial submission is averaged over the three years of the information collection utilizing the current Form FDA 3741 and 3741a, which will be combined in updated Form FDA 3741 in Spring 2026

i) 900 1 900 0.28 (17 minutes) 252 Product Listing (Initial), the initial listing of tobacco products. (New) Form FDA 3741b, “Tobacco Product List Spreadsheet” 37 1 37 0.22 (13 minutes) 8 Total 974 321 1 This initial submission is averaged over the three years of the information collection utilizing the current Form FDA 3741 and 3741a, which will be combined in updated Form FDA 3741 in Spring 2026. 2 This renewal submission is averaged over the three years of the information collection utilizing the current Form FDA 3741 and 3741a, which will be combined in Form FDA 3741 “Registration and Product Listing of Tobacco Product Manufacturing Establishments” with product listing and material file information updates. The currently approved information collection also includes burden for ingredient listing activities under Form FDA 3742 (180 hours) and obtaining a D-U-N-S number (19 hours), which total 199 hours. These activities are not part of this proposed rule and are therefore excluded from the comparison. The total currently approved burden is 520 hours, but only 321 hours are relevant to the establishment registration and product listing activities covered by this proposed rule (see Table 4). The currently approved information collection does not include registration and listing requirements for foreign establishments and historical file

FDA estimates the burden of this collection of information as follows:

Table 5—Estimated Annual Reporting Burden—Domestic Establishments 1 FDA Form/activity/21 CFR section Number of respondents Number of responses per respondent Total annual responses Hours per response Total hours First Time Burden Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741. Proposed 1108.22(a), 1108.24, 1108.22(b)(1) 47 1 47 1.83 (110 minutes) 86 Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, “Product List Spreadsheet”

nses per respondent Total annual responses Hours per response Total hours First Time Burden Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741. Proposed 1108.22(a), 1108.24, 1108.22(b)(1) 47 1 47 1.83 (110 minutes) 86 Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, “Product List Spreadsheet”. 1108.24, 1108.22(b)(2) 47 1 47 0.42 (25 minutes) 20 Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741. 1108.24, 1108.28 (update to Product Listing) 947 1 947 0.33 (20 minutes) 313 Waiver from electronic submission requirement. 1108.40 2 1 2 0.25 (15 minutes) 1 Total First Time Burden Hours—Domestic 419 Annual Recurring Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741. Proposed 1108.22(a), 1108.24, 1108.22(b)(1) 37 1 37 1.83 (110 minutes) 68 Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, “Product List Spreadsheet”. 1108.24, 1108.22(b)(2) 37 1 37 0.42 (25 minutes) 16 Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741. 1108.24, 1108.28 (update to Product Listing) 910 1 910 0.33 (20 minutes) 300 Waiver from electronic submission requirement. 1108.40 1 1 1 0.25 (15 minutes) 1 Total Annual Recurring Burden Hours—Domestic 384 Total Burden Hours—Domestic 803 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 6—Estimated Annual Reporting Burden—Foreign Establishments 1 FDA Form/activity/21 CFR Section Number of respondents Number of responses per respondent Total annual responses Hours per response 2 Total hours First Time Burden Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741 (foreign)

ated with this collection of information. Table 6—Estimated Annual Reporting Burden—Foreign Establishments 1 FDA Form/activity/21 CFR Section Number of respondents Number of responses per respondent Total annual responses Hours per response 2 Total hours First Time Burden Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741 (foreign). Proposed 1108.22(a), 1108.24, 1108.22(b)(1) 3,253 1 3,253 2.61 (157 minutes) 8,490 Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, “Product List Spreadsheet” (foreign). 1108.24, 1108.22(b)(2) 3,253 1 3,253 0.60 (36 minutes) 1,952 Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741 (foreign). 1108.24, 1108.28 (update to Product Listing) 3,253 1 3,253 0.47 (28 minutes) 1,529 Waiver from electronic submission requirement. 1108.40 130 1 130 0.36 (22 minutes) 47 Total First Time Burden Hours—Foreign 12,018 Annual Recurring Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741. Proposed 1108.22(a), 1108.24, 1108.22(b)(1) 134 1 134 2.61 (157 minutes) 350 Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, “Product List Spreadsheet”. 1108.24, 1108.22(b)(2) 134 1 134 0.60 (36 minutes) 80 Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741. 1108.24, 1108.28 (update to Product Listing) 3,253 1 3,253 0.47 (28 minutes) 1,529 Waiver from electronic submission requirement. 1108.40 5 1 5 0.36 (22 minutes) 2 Total Annual Recurring Burden Hours—Foreign 1,961 Total Burden Hours—Foreign 13,979 1 There are no capital costs or operating and maintenance costs associated with this collection of information

initial year of implementation, reflecting the transition to the new requirements. The proposed rule includes a total first-time burden of 12,018 hours for foreign establishments in the initial year of implementation, reflecting the new requirement for foreign establishments to register and list their products. We expect a total annual recurring burden for foreign establishments to be 1,961 hours.

Further, FDA estimates an overall increase in average hours per response associated with initial registration using Form FDA 3741 (from 100 minutes to 110 minutes), and the initial product listing spreadsheet (Form FDA 3741b) submission (from 20 minutes to 25 minutes) for domestic entities. Separate tables for domestic and foreign estimated annual hourly burden are provided.

Table 5 displays the estimated annual reporting burden for domestic tobacco establishments and Table 6 displays the estimated annual reporting burden for foreign tobacco establishments. The foreign hours per response rate were adjusted by multiplying the domestic hours per response by 1.43. This adjustment accounts for potential differences in English proficiency and availability of internet access.

Proposed § 1108.22(a) and § 1108.24 set forth when to submit initial establishment registration and product listing and the information required for submission. FDA estimates that domestic establishments will need approximately 110 minutes (1.83 hours) to complete the initial Form FDA 3741 for establishment registration and labeling, advertising, and consumer information submission, while foreign establishments will require 157 minutes (= 1.43 × 1.83 hours, or 2.61 hours). The Agency estimates that with 47 domestic and 3,253 foreign tobacco establishments each submitting one initial form, the total burden would result in 3,300 total respondents and 8,576 burden hours (86 hours domestic + 8,490 hours foreign) for the initial year after the rule goes into effect

ion submission, while foreign establishments will require 157 minutes (= 1.43 × 1.83 hours, or 2.61 hours). The Agency estimates that with 47 domestic and 3,253 foreign tobacco establishments each submitting one initial form, the total burden would result in 3,300 total respondents and 8,576 burden hours (86 hours domestic + 8,490 hours foreign) for the initial year after the rule goes into effect. In the following years, FDA estimates the number of initial registrations to decrease to 37 domestic and 134 foreign establishments submissions via Form FDA 3741, resulting in a total burden of 418 hours (68 hours domestic + 350 hours foreign) annually.

FDA also estimates that it would take approximately 25 minutes (0.42 hours) to prepare and complete the initial product listing registration using Form FDA 3741b for a domestic establishment, and approximately 36 minutes (= 1.43 × 0.42, or 0.60 hours) for foreign establishments. The Agency estimates that the same 3,300 total respondents will each submit 1 initial product listing Form FDA 3741b, for a combined total of 1,972 burden hours (20 hours domestic + 1,952 hours foreign). In the following years, FDA estimates these numbers to decrease to 37 domestic and 134 foreign establishments submitting initial product listings via Form FDA 3741b, resulting in a total burden of 96 hours (16 hours domestic + 80 hours foreign) annually.

Both domestic and foreign establishment submissions would be required to be completed electronically using Form FDA 3741 and Form FDA 3741b via TRLM-NG or, if FDA has granted a waiver, through paper submissions

37 domestic and 134 foreign establishments submitting initial product listings via Form FDA 3741b, resulting in a total burden of 96 hours (16 hours domestic + 80 hours foreign) annually.

Both domestic and foreign establishment submissions would be required to be completed electronically using Form FDA 3741 and Form FDA 3741b via TRLM-NG or, if FDA has granted a waiver, through paper submissions.

In terms of proposed § 1108.22 (b) and § 1108.28, continued establishment registration and product list filing via Form FDA 3741 ( i.e., the confirmation or updating of establishment registration and product listing information as required by section 905 of the FD&C Act), FDA estimates that it will take each domestic respondent approximately 20 minutes (0.33 hours) to complete the renewal submission, while foreign establishments will require approximately 28 minutes (= 1.43 × 0.33 hours, or 0.47 hours). FDA estimates that up to 947 domestic and 3,253 foreign owners or operators will be submitting registration renewals during the first year after the proposed rule goes into effect. This results in a total of 4,200 respondents and a total burden of 1,842 hours (313 hours domestic + 1,529 hours foreign) for the initial year after the rule goes into effect. These renewals may encompass an acknowledgment of accurate product listing through a certification statement, or a more substantive review that includes updates to product listings, with updates typically occurring in June and the completion of the renewal processes taking place in December. In the following years, FDA estimates these renewal submission numbers to decrease to 910 for domestic establishments and to remain at 3,253 for foreign establishments submitting renewal registrations and product listings via Form FDA 3741, resulting in a total burden of 1,829 hours (300 hours domestic + 1,529 hours foreign) annually

he completion of the renewal processes taking place in December. In the following years, FDA estimates these renewal submission numbers to decrease to 910 for domestic establishments and to remain at 3,253 for foreign establishments submitting renewal registrations and product listings via Form FDA 3741, resulting in a total burden of 1,829 hours (300 hours domestic + 1,529 hours foreign) annually.

Proposed § 1108.40 would require an applicant to submit Forms FDA 3741 and 3741b and all supporting and related documents to FDA in electronic format that FDA can process, review, and archive unless an applicant requests, and FDA grants, a waiver from this requirement under proposed § 1108.40(b). FDA estimates that 4 percent of the respondents may request a waiver. Consistent with our other application estimates for waivers, we estimate it would take 15 minutes (0.25 hours) per waiver for domestic establishments, and approximately 22 minutes (= 1.43 × 0.25, or 0.36 hours) for foreign establishments. During the initial year after the proposed rule takes effect, the Agency estimates that approximately 2 domestic and 130 foreign waiver applications will be submitted, for a total of 48 burden hours (1 hours domestic + 47 hours foreign). In the following years, FDA estimates these numbers to decrease to 1 domestic and 5 foreign waiver applications, resulting in a total burden of 3 hours (1 hour domestic + 2 hours foreign) annually.

Table 7—Estimated Annual Recordkeeping Burden 1 FDA form/activity/21 CFR section Number of respondents Number of responses per respondent Total annual responses Hours per response Total hours First Time—Single Year Burden (Domestic and Foreign) Maintaining historical file. 1108.26 4,200 1 4,200 0.10 (6 minutes) 420 Recurring Annual (Domestic and Foreign) Maintaining historical file. 1108.26 4,163 1 4,163 0.10 (6 minutes) 416 Total Recordkeeping Burden 836 1 There are no capital costs or operating and maintenance costs associated with this collection of information

response Total hours First Time—Single Year Burden (Domestic and Foreign) Maintaining historical file. 1108.26 4,200 1 4,200 0.10 (6 minutes) 420 Recurring Annual (Domestic and Foreign) Maintaining historical file. 1108.26 4,163 1 4,163 0.10 (6 minutes) 416 Total Recordkeeping Burden 836 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 7 describes the annual recordkeeping burden per the requirements in this proposed rule. The currently approved collection has no recordkeeping burden, therefore all burden hours for recordkeeping are new. FDA estimates that in the initial year 4,200 recordkeepers, encompassing both domestic and foreign establishments, will maintain records at 0.10 hours per record, for a total of 420 hours. In the following years, FDA estimates these numbers to decrease to 4,163 recordkeepers, resulting in a total burden of 416 hours annually. Firms would have already established the required records when submitting the initial or renewal registration and listing submission. We believe this time is usual and customary for these firms and it would take 6 minutes to establish and/or update the required historical file. Proposed § 1108.26 requires respondents to maintain a historical file for 4 years and keep records related to smokeless tobacco product sample distribution for 4 years.

FDA estimates that the total burden for the activities in this rulemaking is 15,618 hours (14,782 hours reporting + 836 hours recordkeeping).

If finalized, the new collections of information will revise OMB Control Number 0910-0650. Our estimated burden for the proposed rule reflects an overall increase of 15,098 hours from the currently approved information collection. We attribute this increase to the proposed rule's clarification of industry requirements and the extension of establishment registration and product listing requirements to owners and operators of foreign establishments

ill revise OMB Control Number 0910-0650. Our estimated burden for the proposed rule reflects an overall increase of 15,098 hours from the currently approved information collection. We attribute this increase to the proposed rule's clarification of industry requirements and the extension of establishment registration and product listing requirements to owners and operators of foreign establishments.

To ensure that comments on information collection are received, OMB recommends that written comments be submitted through https://www.reginfo.gov/public/do/PRAMain (see ADDRESSES ). All comments should be identified with the title of the information collection.

In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These information collection requirements will not be effective until FDA publishes a final rule, OMB approves the information collection requirements, and the rule goes into effect. FDA will announce OMB approval of these requirements in the Federal Register .

X. Federalism

We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13132. Section 4(a) of the E.O. requires Agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.”

Section 916(a)(2) of the FD&C Act (21 U.S.C. 387p) is an express preemption provision. Section 916(a)(2) provides that “no State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to . .

enforced to the fullest extent possible. Each provision of the rule is independently supported by data and analysis as described or referenced in this preamble and, if issued separately, would remain a proper exercise of FDA authority.

XII. Consultation and Coordination With Indian Tribal Governments

We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.

XIII. References

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

1. FDA. Draft Form FDA 3741 (Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution). 2. FDA. Draft Form FDA 3741b (Tobacco Product List Spreadsheet). 3. FDA. Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis, Establishment Registration and Product Listing for Tobacco Products. Silver Spring, MD: U.S. Department of Health and Human Services, FDA, Center for Tobacco https://www.fda.gov/economics-staff/regulatory-impact-analyses-ria. List of Subjects in 21 CFR Part 1108

Tobacco products, Registration, Product listing

alysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis, Establishment Registration and Product Listing for Tobacco Products. Silver Spring, MD: U.S. Department of Health and Human Services, FDA, Center for Tobacco https://www.fda.gov/economics-staff/regulatory-impact-analyses-ria. List of Subjects in 21 CFR Part 1108

Tobacco products, Registration, Product listing.

Therefore, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and under authority delegated to the Commissioner of Food and Drugs, it is proposed that chapter I of title 21 of the Code of Federal Regulations be amended by adding part 1108 to subchapter K to read as follows:

PART 1108—REGISTRATION OF TOBACCO PRODUCT ESTABLISHMENTS AND LISTING OF TOBACCO PRODUCTS IN COMMERCIAL DISTRIBUTION

Subpart A—General Provisions

1108.1 Scope. 1108.3 Definitions. Subpart B—Procedures for Tobacco Product Establishments

1108.20 Who must register and submit a tobacco product list. 1108.22 When to submit establishment registration and tobacco product listing. 1108.24 Information required for tobacco product establishment registration and tobacco product listing. 1108.26 Maintaining a historical file. 1108.28 Updating tobacco product listing information. 1108.32 Assignment of an FDA Establishment Identifier (FEI) number. Subpart C—Format for Establishment Registration and Tobacco Product Listing

1108.40 Electronic registration of establishments and listing of tobacco products. Subpart D—Procedures for Foreign Tobacco Product Establishments

1108.50 Establishment registration and tobacco product listing for foreign establishments importing or offering for import tobacco products into the United States. 1108.52 Conditions for registration of foreign tobacco product establishments. Subpart E—Miscellaneous

1108.60 Public availability of registration and tobacco product listing information. 1108.62 Misbranding. Authority:

21 U.S.C. 331, 371(a), 374, 381(p), 387b, 387c, 387e, 387g, 387i, 387j, and 387k

oreign establishments importing or offering for import tobacco products into the United States. 1108.52 Conditions for registration of foreign tobacco product establishments. Subpart E—Miscellaneous

1108.60 Public availability of registration and tobacco product listing information. 1108.62 Misbranding. Authority:

21 U.S.C. 331, 371(a), 374, 381(p), 387b, 387c, 387e, 387g, 387i, 387j, and 387k.

Subpart A—General Provisions

§ 1108.1 Scope. (a) This part prescribes the format and content for registration of domestic and foreign establishments that manufacture tobacco products and listing of tobacco products manufactured by such establishments, along with requirements of this part that will help ensure tobacco products are not adulterated or misbranded and comply with FDA's premarket authorities. The requirements of this part apply to domestic and foreign establishments that manufacture, prepare, compound, or process tobacco products that are subject to chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

(b) The requirements in this part are intended to protect the public health and ensure that tobacco products are in compliance with the relevant provisions of the FD&C Act and its implementing regulations.

§ 1108.3 Definitions. For purposes of this part:

Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco or nicotine, and is not made or derived from tobacco or nicotine from any source; and meets either of the following:

(a) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or

hat is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco or nicotine, and is not made or derived from tobacco or nicotine from any source; and meets either of the following:

(a) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or

(b) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but:

(1) Solely controls moisture and/or temperature of a stored tobacco product; or

(2) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product.

Brand means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name(s), identifiable pattern of colors, or any combination of such attributes.

Brand owner means a person that owns a brand, through creation, acquisition, trademark, patent, copyright, or otherwise, and has directly or through license, the control and/or direction of the brand.

Bulk tobacco product means a tobacco product not sealed in final packaging but otherwise suitable for consumer use as a tobacco product.

Commercial distribution means any distribution of a tobacco product, whether domestic or imported, to consumers or to any person, but does not include interplant transfers of a tobacco product between establishments within the same parent, subsidiary, and/or affiliate company, nor does it include providing a tobacco product for product testing where such product is not made available for consumption or resale. “Commercial distribution” does not include the handling or transfer of a tobacco product from one consumer to another for personal consumption

rship. Establishment refers to both domestic and foreign establishments unless otherwise noted.

Finished tobacco product means a tobacco product, including all components and parts, sealed in final packaging intended for consumer use ( e.g., filters or filter tubes sold separately to consumers or as part of kits).

Foreign establishment means an establishment other than a domestic establishment.

Industry product identification number means a unique, product-specific identifier or alphanumeric code, such as a universal product code (UPC), stock keeping unit (SKU), Item #, or Catalog #, that industry generates for internal record keeping and tracking. FDA intends to utilize an industry product identification number when corresponding with industry as a point of reference to help distinguish a specific product from other similar products made by the same manufacturer but with slight differences in product attributes (such as volume or quantity or packaging).

Labeling means all labels and other written, printed, or graphic matter:

(a) upon any tobacco product or any of its containers or wrappers, or;

(b) accompanying such tobacco product.

Manufacturer means any person who manufactures, prepares, compounds, or processes a tobacco product, including repackaging or relabeling of any tobacco product. Examples of manufacturing include assembling, processing, homogenizing, mixing, formulating, labeling, or packaging. Manufacturers include specification developers, third-party manufacturers, bulk tobacco product manufacturers, and repackagers/relabelers.

Material change includes:

(a) any change in the tobacco product name (including brand or subbrand), warnings, or instructions for use;

(b) any change in the owner or operator, or establishment;

(c) any other significant change with respect to consumer information, to other labeling, or to the advertisements for the tobacco product, such as changes to the logo(s), identifiable patterns of color, or product descriptors;

(a) any change in the tobacco product name (including brand or subbrand), warnings, or instructions for use;

(b) any change in the owner or operator, or establishment;

(c) any other significant change with respect to consumer information, to other labeling, or to the advertisements for the tobacco product, such as changes to the logo(s), identifiable patterns of color, or product descriptors;

(d) any change in the marketing authorization or status for the marketing of such product; and

(e) any change with respect to whether or not the product is subject to a tobacco product standard established under section 907 of the FD&C Act (21 U.S.C. 387g).

With respect to changes in consumer information or other labeling of the tobacco product, changes that are not significant include changes to grammar, correction of typographical errors that do not change the content of the labeling, and changes in tax stamp or bar code.

Operator means a person, as defined in section 201(e) of the FD&C Act, who has management authority over an establishment.

Owner means a person, as defined in section 201(e) of the FD&C Act, who has an ownership interest in an establishment.

Product Identification Number (PD #) means the number that FDA assigns to each product within a submission to distinguish among the products included in that submission. A PD # is only relevant within the context of a specific STN.

Registration Identification Number (RGID #) means the FDA-assigned unique identifier for a registered establishment's registration. The RGID # is assigned to each new electronic tobacco product registration and listing system submission and attaches to the establishment(s) and the product(s) in the initial submission

e (SE) reports, SE exemption requests (EX REQ), Modified Risk Tobacco Product Application (MRTPA), and submissions related to investigational tobacco products.

Third-party manufacturer means an entity, including a contract manufacturer, that physically manufactures a tobacco product on behalf of, or to specifications established by, another party, such as a brand owner or specification developer.

Tobacco product means any product made or derived from tobacco, or containing nicotine from any source, 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). The term “tobacco product” does not mean an article that is a drug under section 201(g)(1) (21 U.S.C. 321(g)(1)), a device under section 201(h) (21 U.S.C. 321(h)), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C. 353(g)). The term “tobacco product” does not mean an article that is a food under section 201(f) (21 U.S.C. 321(f)), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.

Tobacco Product Number (TP #) refers to a product-specific number that is generated by FDA for each product listed on an establishment's registration.

Subpart B—Procedures for Tobacco Product Establishments

§ 1108.20 Who must register and submit a tobacco product list

f) (21 U.S.C. 321(f)), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.

Tobacco Product Number (TP #) refers to a product-specific number that is generated by FDA for each product listed on an establishment's registration.

Subpart B—Procedures for Tobacco Product Establishments

§ 1108.20 Who must register and submit a tobacco product list. (a) An owner or operator of any establishment, except those entities as provided in paragraph (c) of this section, engaged in the manufacture, preparation, compounding, or processing of a tobacco product must register in accordance with section 905 of the FD&C Act, including specification developers, third-party manufacturers, bulk tobacco product manufacturers, repackagers/relabelers, any owner or operator of any domestic establishment that manufactures a tobacco product for export, and any owner or operator of any establishment that manufactures free smokeless tobacco samples. When operations are conducted at more than one establishment and the establishments are under common or joint ownership or control, the parent, subsidiary, or affiliate company may submit registration information for all establishments on behalf of their respective owners and operators, in lieu of each establishment registering separately. In this case, duplicative registration for any establishment need not also be submitted by the owner and operator of the establishments.

(b) Every person who registers under this part must submit a list of all tobacco products that are being manufactured, prepared, compounded, or processed by that person for commercial distribution in the form and manner prescribed in this part in accordance with section 905(i) of the FD&C Act (21 U.S.C. 387e(i)). When operations are conducted at more than one establishment and the establishments are under common or joint ownership or control, the parent, subsidiary, or affiliate company may submit listing information for all establishments.

cessed by that person for commercial distribution in the form and manner prescribed in this part in accordance with section 905(i) of the FD&C Act (21 U.S.C. 387e(i)). When operations are conducted at more than one establishment and the establishments are under common or joint ownership or control, the parent, subsidiary, or affiliate company may submit listing information for all establishments.

(c) Persons not required to register their establishments or submit a tobacco product list:

(1) Persons engaged only in manufacturing investigational use tobacco products where the product is not available for sale or distribution other than as part of an investigation.

(2) Manufacturers of only raw materials, other than tobacco, used in manufacturing a component or part of a tobacco product.

(3) Common carriers, in their receipt, carriage, holding, or delivery of a tobacco product in the usual course of business.

(d) Registration and listing do not constitute an admission, agreement, or determination by FDA that a product is

§ 1108.22 When to submit establishment registration and tobacco product listing. (a) Initial establishment registration and product listing. An owner or operator of a domestic establishment engaged in an operation described in § 1108.20(a) must register the establishment and submit tobacco product listing information within five business days from first engaging in the operation. An owner or operator of a foreign establishment engaged in an operation described in § 1108.20(a) must register the establishment and submit tobacco product listing information before any tobacco product manufactured, prepared, compounded, or processed at the establishment is imported or offered for import into the United States.

ion within five business days from first engaging in the operation. An owner or operator of a foreign establishment engaged in an operation described in § 1108.20(a) must register the establishment and submit tobacco product listing information before any tobacco product manufactured, prepared, compounded, or processed at the establishment is imported or offered for import into the United States.

(b) Continued establishment registration and product list filing. Owners or operators shall review, change as needed, or confirm there have been no changes to, their establishment registration and tobacco product listing information that is on file with FDA, documenting any changes that were not previously reported as follows:

(1) Annual establishment registration. By December 31 of each year, each owner or operator of an establishment engaged in an operation described in § 1108.20(a) must register each of its establishments, and certify that all information associated with the registered establishments and its listed products is accurate and up to date. Each owner or operator of a registered establishment must review, change as needed, or confirm there have been no changes to, the registered establishment information and listed products. Annual registration is still required even to confirm that there have been no changes.

(2) In June and December of every year, each owner or operator of an establishment engaged in an operation described in § 1108.20(a) shall review, change as needed, or confirm there have been no changes to, their tobacco product listing information that is on file with FDA, reporting any changes or deletions to listings as described in § 1108.28 and any new listings that were not previously reported.

§ 1108.24 Information required for tobacco product establishment registration and tobacco product listing

quired under paragraph (c) of this section;

(4) Any trade names used by the establishment or other names under which the establishment conducts business or additional names by which the establishment is known;

(5) The establishment's website address(es) that concern tobacco products;

(6) The Registration Identification Number (RGID #) of the establishment, if previously assigned by FDA; and

(7) The FDA Establishment Identifier (FEI) number of the establishment, if previously assigned by FDA. If not previously assigned by FDA, FDA will assign an FEI number as provided in § 1108.32. An additional unique establishment identifier, such as a Data Universal Numbering System (DUNS) Number, for the place of business of the owner, the place of business of the operator, and the location of the establishment, is optional.

(8) The name of the Tribe if the establishment is located on Indian Country.

(b) Owners or operators who have been granted a waiver under § 1108.40(b) from filing electronically through FDA's tobacco product registration and listing system must submit the establishment registration information described in paragraph (a) of this section in paper form using the procedures provided by FDA in accordance with § 1108.40(c).

(c) An official correspondent for the registration must be designated by the owner or operator to serve as a point of contact with FDA on matters relating to the registration of tobacco product establishments and the listing of tobacco products. The official correspondent is responsible for:

(1) Electronically transmitting to FDA all required registration and listing information unless a waiver from electronic submission has been granted in accordance with § 1108.40(b); and

(2) Serving as a liaison for all correspondence with FDA concerning registration and listing.

tobacco product establishments and the listing of tobacco products. The official correspondent is responsible for:

(1) Electronically transmitting to FDA all required registration and listing information unless a waiver from electronic submission has been granted in accordance with § 1108.40(b); and

(2) Serving as a liaison for all correspondence with FDA concerning registration and listing.

(d) The designation of an official correspondent does not in any manner affect the liability of the owner or operator of the establishment or any other individual under section 301(p) of the FD&C Act or any other provision of the FD&C Act and its implementing regulations.

(e) Tobacco product listing information must be submitted to FDA electronically through FDA's tobacco product registration and listing system unless a waiver from electronic submission has been granted in accordance with § 1108.40(b). Owners or operators who have been granted a waiver must submit, in accordance with § 1108.20, the required tobacco product listing information, including information required by this paragraph, and any additional listing information required under § 1108.28, in paper form using the procedures provided by FDA in accordance with § 1108.40(c). The following listing information must be provided for each tobacco product manufactured, prepared, compounded, or processed for commercial distribution by the registrant:

(1) The current electronic Registration Identification Number (RGID #) and name of each establishment.

(2) The name, including brand and subbrand name, or other commercial name(s) used in commercial distribution, for each tobacco product manufactured, prepared, compounded, or processed at a registered establishment.

, manufacturing for export, or manufacturing activities other than those listed).

(8) In the case of a tobacco product manufactured in any domestic establishment for export that does not conform to tobacco product standards established pursuant to section 907 of the FD&C Act, the following information shall be provided each year with the June biannual listing update required by § 1108.22(b)(2):

(i) The manner in which the exported tobacco product does not conform to applicable tobacco product standards;

(ii) Each country of destination of the exported tobacco product during the previous calendar year; and

(iii) The quantity of the tobacco product shipped to each country of destination during the previous calendar year.

(9) In the case of a tobacco product subject to a tobacco product standard established under section 907 of the FD&C Act or which is subject to section 910 of the FD&C Act, a reference to the authority for the marketing of the tobacco product, a legible, full color copy of all labeling for the product (except that only one representative package label need be submitted where differences exist only in the bar code, tax stamp, or pricing sticker), indication of the category ( e.g., labeling) of material being submitted and the associated product(s), and the original date the labeling materials were first disseminated and date when their dissemination was discontinued.

(10) For all tobacco products not covered by Paragraph (e)(9) of this section, a legible, full color copy of all consumer information and other labeling for the product (except that only one representative package label need be submitted where differences exist only in the bar code, tax stamp, or pricing sticker), a representative sampling of advertisements for the product, indication of the category ( i.e., labeling, advertising, consumer information) of the material being submitted and the associated product(s), and the original date the materials were first disseminated and date when their dissemination was discontinued

bmitted where differences exist only in the bar code, tax stamp, or pricing sticker), a representative sampling of advertisements for the product, indication of the category ( i.e., labeling, advertising, consumer information) of the material being submitted and the associated product(s), and the original date the materials were first disseminated and date when their dissemination was discontinued.

(f) An owner or operator shall submit to FDA, upon request (for good cause for paragraph (2)), the following information:

(1) If the registrant has determined that a tobacco product being listed is not subject to a tobacco product standard established under section 907 of the FD&C Act, a brief statement of the basis for that determination.

(2) A copy of all advertisements for a particular tobacco product that is not subject to section 907 or section 910 of the FD&C Act. Such information must be submitted within 30 calendar days of the date of FDA's request.

§ 1108.26 Maintaining a historical file. (a) Each owner or operator shall maintain a historical file containing a copy of all consumer information, labeling, and advertisements in use on the effective date of this rule for all tobacco products contained in the product list.

(b) In addition to the requirements set forth in paragraph (a) of this section, each owner or operator shall maintain in the historical file a copy of all consumer information, labeling, and advertisements that is first used after the effective date of this rule. For the purposes of this subsection, consumer information, labeling, and advertisements is first used if the owner or operator had not used it previously or had used it previously but made a material change to it.

onsumer information, labeling, or advertisements from the historical file while currently in use and retain for a period of not less than four years after the date of final dissemination for materials that are discontinued. Each owner or operator must retain free sample distribution information for smokeless products for a period of not less than four years after the date of the event documented.

(e) Location of the file:

(1) The contents of the historical file must be readily available at the registered establishment for inspection and copying by officers or employees duly designated by the Secretary.

(2) The contents of the historical file must be made accessible within a reasonable time during inspection or upon FDA request.

§ 1108.28 Updating tobacco product listing information. (a) Each owner or operator shall update its tobacco product listing with the following information:

(1) All changes to the manufacture, preparation, compounding, or processing for commercial distribution of a listed tobacco product, such as when a registrant begins or discontinues performing such activity on or to the tobacco product, or resumes performing such activity if notice of discontinuance was previously reported.

(2) All material changes to product listing information previously submitted, including when a registrant has begun to engage in manufacture, preparation, compounding or processing of a listed tobacco product at an additional establishment added to the previously submitted registration or material changes to the previously submitted labeling, representative sampling of advertisements, or other consumer information for the product.

(3) Updates shall be made within the timeframes specified in § 1108.22(b) and shall include the brand name of the product and the date it was introduced, or activities were begun, discontinued, or resumed.

icial correspondent by email, or by postal mail if the owner or operator has been granted a waiver under § 1108.40(b) from the requirement to file registration and listing information electronically.

Subpart C—Format for Establishment Registration and Tobacco Product Listing

§ 1108.40 Electronic registration of establishments and listing of tobacco products. (a) Electronic format requirement. Owners and operators that are subject to the registration and listing requirements of this part must provide the following information to FDA using the electronic tobacco product registration and listing system, except as provided in paragraphs (b), (c), and (d) of this section:

(1) Initial establishment registration information as required by §§ 1108.22(a) and 1108.24;

(2) Updates to registration information as required by §§ 1108.22(b) and 1108.24;

(3) Initial tobacco product listing information as required by §§ 1108.22(a), 1108.24, and 1108.28;

(4) Updates to tobacco product listing information as required by §§ 1108.22(b), 1108.24, and 1108.28.

(b) Waivers from electronic format requirement. If the establishment registration and tobacco product listing information cannot be submitted electronically through FDA's tobacco product registration and listing system, a waiver may be requested. Waivers will be granted only if use of electronic means is not reasonable for the person requesting the waiver. To request a waiver, applicants must send a letter to the Food and Drug Administration, Center for Tobacco Products, Attn: Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, which includes the following information:

o product registration and listing system. This statement must be signed by the owner or operator of the establishment or by an employee of the owner or operator who is authorized to make the declaration on behalf of the owner or operator.

(c) If FDA grants the waiver from filing registration and listing information electronically, FDA will provide information on how to submit such information.

(d) Termination of waivers. Those owners or operators who have obtained a waiver from filing registration and listing information electronically must notify FDA within 30 calendar days of any changes in the information described in paragraph (b)(2) of this section, including if the owner or operator obtains an email address, access to a computer, or an internet service provider that can access the electronic tobacco product registration and listing system. This notification must be submitted by letter to the Food and Drug Administration, Center for Tobacco Products, Attn: Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Changes in this information terminate the owner or operator's waiver. Owners or operators whose waivers are terminated must follow the procedures outlined in paragraph (a) of this section for submitting registration and listing information, or must apply for a new waiver under paragraph (b) of this section and explain why use of the internet is still not reasonable for the person.

MD 20993-0002. Changes in this information terminate the owner or operator's waiver. Owners or operators whose waivers are terminated must follow the procedures outlined in paragraph (a) of this section for submitting registration and listing information, or must apply for a new waiver under paragraph (b) of this section and explain why use of the internet is still not reasonable for the person.

(e) English language. Registration and listing information must be provided in the English language, except that if any part or whole of any consumer information or other labeling, or advertisements is in a foreign language, a copy of the material shall be provided in the language in which it is published or disseminated. If any such foreign language consumer information or other labeling, or advertisements are submitted, an accurate and complete English translation of the material must be appended to that part of the submission along with a signed statement by an authorized representative of the establishment certifying that the English language translation is complete and accurate and a brief statement of the qualifications of the person that made the translation.

Subpart D—Procedures for Foreign Tobacco Product Establishments

§ 1108.50 Establishment registration and tobacco product listing for foreign establishments importing or offering for import tobacco products into the United States. (a) Any foreign establishment engaged in the manufacture, preparation, compounding, or processing of a tobacco product that is imported or offered for import into the United States must register such establishment and list such tobacco products in conformance with the procedures in this section and subparts B and C of this part.

ting or offering for import tobacco products into the United States. (a) Any foreign establishment engaged in the manufacture, preparation, compounding, or processing of a tobacco product that is imported or offered for import into the United States must register such establishment and list such tobacco products in conformance with the procedures in this section and subparts B and C of this part.

(1) The official correspondent for the foreign establishment shall facilitate communication among the foreign establishment, the government of such foreign country, and representatives of FDA regarding matters related to establishment registration and tobacco product listing under section 905(h) of the FD&C Act.

(2) Exceptions to registration of foreign establishments:

(i) If an establishment only manufactures, prepares, compounds, or processes a tobacco product that has entered a foreign trade zone and is exported from that foreign trade zone without being further distributed in the United States, it is not required to register or list its products.

(ii) If the establishment is otherwise not required to register or submit a tobacco product list in accordance with subpart B of this part.

§ 1108.52 Conditions for registration of foreign tobacco product establishments. Any establishment in a foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product that is imported or offered for import into the United States shall register under the provisions of section 905 of the FD&C Act and this part provided that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from

Subpart E—Miscellaneous

§ 1108.60 Public availability of registration and tobacco product listing information. Establishment registration and tobacco product listing information is available for public inspection and will be posted on the FDA website in a manner consistent with 21 CFR part 20