Draft Guidance: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

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Draft Guidance for Industry

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted by October 30, 2009, as described in the notice announcing the availability of the draft guidance in the Federal Register. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

Additional copies are available from:
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
(Tel) 301-796-4800
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products

October 2009

Table of Contents

I. Introduction

II. Background

III. Discussion

I. Introduction

This guidance document is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. The guidance document explains, among other things:

• The statutory requirement to submit tobacco product establishment registration and product listing submissions;
• Definitions;
• Who is responsible for providing registration and product listing submissions;
• What information is included in the submissions;
• How to submit the information;
• When to submit the information; and
• FDA’s compliance policies.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Background

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act) (Public Law 111-31) into law. The Tobacco Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Among its many provisions, the Tobacco Act added section 905 to the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387e), establishing requirements for tobacco product establishment registration and product listing.

Section 905(b) of the act requires that “every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products” register with FDA the name, places of business, and all establishments owned or operated by that person. Every person must register by December 31 of each year.

Section 905(i)(1) of the act requires that all registrants “shall, at the time of registration . . . file with [FDA] a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution,” along with certain accompanying information, such as all labeling and a representative sampling of advertisements. In addition, section 905(i)(3) of the act requires that certain changes in the product list be submitted biannually.

The failure to register in accordance with section 905 of the act, the failure to provide any information required by section 905(i), and the failure to provide a notice required by section 905(i)(3) is a prohibited act under section 301(p) of the act (21 U.S.C. 331(p)). In addition, under section 903(a)(6) of the act (21 U.S.C. 387c), a tobacco product is deemed misbranded if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 905 or if it was not included in a list required by section 905(i). Persons who commit prohibited acts, including the introduction of misbranded tobacco products into interstate commerce, are subject to regulatory and enforcement action by FDA, including, but not limited to, seizure and injunction.

III. Discussion

FDA has developed an electronic submission tool, eSubmitter, to streamline submission and receipt of registration and product listing information required by section 905 of the act. FDA has developed a paper form (FDA Form 3741) as an alternative submission tool although FDA strongly encourages electronic submission. Both the eSubmitter application and the paper form can be accessed at http://www.fda.gov.

A. What definitions apply?

FDA intends to use the following definitions in implementing the registration and product listing requirements of section 905 of the act.

1. 1. Commercial Distribution: The term “commercial distribution” means any distribution of a tobacco product, except for investigational use under chapter 9 of the act. Commercial distribution includes any distribution of a tobacco product through sale or otherwise. Commercial distribution does not include internal or interplant transfer of a tobacco product between registered establishments within the same parent, subsidiary, and/or affiliate company.
   2. Domestic Establishment: The term “domestic establishment” means an establishment in any State or Territory or possession of the United States.
   3. Establishment: The term “establishment” means a place of business under one management at one general physical location.
   4. Manufacturing: The term “manufacturing” means the manufacture, preparation, compounding, or processing of a tobacco product, including repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package (section 905(a)(1) of the act). This term includes quality control and product release testing.
   5. Owner: The term “owner” means a person, as defined in section 201(e) of the act (21 U.S.C. 321(e)), who has an ownership interest in an establishment.
   6. Operator: The term “operator” means a person, as defined in section 201(e) of the act (21 U.S.C. 321(e)) who has management authority over an establishment.
   7. Pouch: The term “pouch” means a permeable pouch, intended to be filled with pre-portioned tobacco product and placed in the oral cavity with the tobacco product
   8. Tobacco Product: The term “tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” (section 201(rr) of the act (21 U.S.C. 321(rr)). This term does not include an article that is a drug, a device, or a combination product as defined in the act (section 201(rr) of the act (21 U.S.C. 321(rr)). Thus, the term is not limited to products containing tobacco, but also includes components, parts and accessories of tobacco products, whether they are sold for further manufacturing or are ready for consumer use. For example, tobacco papers and filters are tobacco products, whether they are sold to consumers for use with roll-your-own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette.

B. Who registers and submits product listing information under section 905 of the act?

Every person who owns or operates any domestic establishment engaged in manufacturing tobacco products must register under section 905(b) of the act, and every registrant must file a list of its products in accordance with section 905(i) of the act.
At this time, FDA intends to enforce the registration and product listing requirements with respect to:

• establishments engaged in the manufacturing of tobacco products ready for consumer use; and

• establishments engaged in the manufacturing of tobacco, filters, papers, or pouches, whether such products are intended for further manufacturing or are ready for consumer use. This includes papers, tobacco, and filters sold separately, in kits (such as for roll-your-own tobacco), or as part of accessories.

At this time, FDA does not intend to enforce the registration and product listing requirements in other circumstances.

FDA intends to focus enforcement of the registration and product listing requirements to owners and operators involved in the manufacture of this subset of tobacco products because tobacco, filters, papers, and pouches comprise the principal components of most tobacco products sold to consumers. Should the agency find that additional information is needed to protect the public health, the agency may reconsider this compliance policy. We intend to communicate any such compliance policy changes by guidance and/or rulemaking.

In order to reduce redundant submissions, FDA strongly encourages that an owner or operator act as the agent of the other party in submitting registration and product listing information. Under this approach, registration and product listing information for a given business structure (owner, all operators, all establishments) would be submitted once by either an owner or operator, but would satisfy the registration requirements of all parties (owners, operators). Similarly, under this approach, no owner or operator would register an establishment if the establishment is registered by any other owner or operator.

If an owner or operator submits registration and product listing information as an agent of another party, the agent should be specifically authorized by the other party to complete registration on their behalf and should state clearly the person on behalf of whom it is registering. In addition, any owner or operator acting as agent of the other party would need to fully satisfy the registration requirements of the other party.

C. What information is submitted as part of registration and product listing under section 905 of the act?

1. Registration
   Section 905(b) of the act sets forth the requirements for submission of registration information. As required by the statute, any person engaged in the manufacturing of tobacco products must register with FDA and submit the following information:

• The name and full address of each establishment the registrant owns or operates.
• The name of the owner or operator. In the case of a partnership, include the name of each partner. In the case of a corporation, include the name of each corporate officer and director, and the State of incorporation.

An agent submitting information on behalf of another person would need to submit all of the information described above.
The eSubmitter application and the paper form request additional optional information that FDA also recommends be submitted, including:

• An email address, to facilitate correspondence between registrants and FDA.
• A Data Universal Numbering System (D-U-N-S®) Number or other unique identifier (codes) of a business entity. The business entity identifier recognized by the FDA Data Council is the Data Universal Numbering System (D-U-N-S®) Number. Dun & Bradstreet assigns and maintains a database of the D-U-N-S® Numbers, which serve as unique identifiers (codes) of business entities. Upon application, each business entity is assigned a distinct site-specific 9-digit D-U-N-S® Number. The site-specific D-U-N-S® Number for an entity is a useful resource for FDA in identifying the establishment. If the D-U-N-S® Number for a location has not been assigned, a business may obtain one for no cost directly from Dun & Bradstreet (http://www.dnb.com).

2. 2. Product listing information
      Section 905(i) of the act sets forth the requirements for submitting product listing information. The act requires that, at the time of registration, the registrant submit a list of all tobacco products which are being manufactured by the registrant for commercial distribution.
      The product listing information must include one of the following:
      a. If applicable, a reference to the authority for the marketing of any tobacco product subject to a tobacco product standard under section 907 of the act (21 U.S.C. 387g) or to premarket review under section 910 of the act (21 U.S.C. 387j), and a copy of all labeling for that product;
      b. If the tobacco product is not subject to a tobacco product standard or premarket review, then a copy of all consumer information and other labeling as well as a representative sampling of advertisements.

If requested by FDA for good cause, a copy of all advertisements for a particular tobacco product must be submitted. If a registrant has determined that a product in its product listing is not subject to a tobacco product standard under section 907 of the act, FDA may request that the registrant provide a brief statement of the basis for that determination.
We are interpreting section 905(i) of the act to require that each product included in a product listing be clearly identified and distinguished. In the case of products ready for consumer use, this identifying information should include the product category, brand/sub-brand name, and any commercially recognized unique product identification number that identifies the product (e.g., Universal Product Code (UPC)). In the case of a tobacco product intended for further manufacturing use, identifying information should include the product type, commercially recognized name, and any commercially recognized unique product identification number.
FDA interprets section 905(i) of the act to mean that products that differ in any way, other than packaging differences that do not affect characteristics of the product consumed, are considered different tobacco products. For example, if a soft pack and a hard pack of cigarettes have different moisture content, shelf life, or ingredient composition (including ingredients introduced in packaging but expected to become incorporated into the consumed product), they should be reported as distinct products for purposes of section 905(i). Conversely, if the consumed product is identical for different packaging configurations of the same brand/sub-brand, the different package types can be identified under a single product list.

D. How do you submit registration and product listing information?

The FDA eSubmitter tool is an electronic application designed to streamline the data entry process for registration and product listing at the Center for Tobacco Products (CTP). This tool provides an automatic acknowledgement of FDA receipt, and allows users to import large quantities of structured data and attach files (e.g., PDF documents and certain media files).
The FDA eSubmitter tool can also streamline the process for submitting updated registration and product listing information required by sections 905(d) and 905(i)(3) of the act.
While electronic submission is not required, FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data submission and management.
Users of the eSubmitter tool first download and install the computer application, enter all data, and then upload the completed data through the FDA Electronic Submissions Gateway (ESG). The FDA ESG system requires users to apply for a free account before submitting data, a process which can take up to four weeks. FDA therefore urges registrants to apply for ESG accounts well in advance of the statutory deadline for data submission. The eSubmitter tool is available at http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.

E. When must you register and list under section 905 of the act?

Section 905(b) of the act requires registration information to be submitted by December 31, 2009, and to be resubmitted annually on or before December 31st of each year.
Section 905(c) of the act requires every person upon first engaging in the manufacturing of a tobacco product in any domestic establishment owned or operated by that person to register immediately as described above. In addition, section 905(d) of the act requires registered owners and operators to immediately register any new establishment that begins the manufacture, preparation, compounding or processing of tobacco products.

Section 905(i)(1) of the act requires the complete product list information to be submitted at the time of first registration. In addition, section 905(i)(3) of the act requires that certain changes in the product list be submitted biannually.

FDA intends to make the eSubmitter system available to owners and operators for submitting registration and product listing information under section 905 of the act in November, 2009.

Please note that registrants who wish to obtain a new D-U-N-S® Number should obtain one well in advance of FDA’s deadline since the processing time involved in receiving a D-U-N-S® Number may take at least 30 days. Alternatively, you may elect to receive a D-U-N-S® Number within one business day by paying a fee. Please consult Dun & Bradstreet (http://www.dnb.com) directly for more information.