- Who Registers Their Establishment and Submits Product Listing Information Under Section 905 of the Act?
- FDA’s Compliance Policy for Regulated Tobacco Products
- What Information is Submitted as Part of Establishment Registration and Product Listing Submissions?
- Registration Information
- Product Listing Information
- How to Make Registration and Product Listing Submissions
- When Must You Register Your Establishment and List Your Products Under Section 905 of the FD&C Act?
Who Registers their Establishment and Submits Product Listing Information Under Section 905 of the FD&C Act?
Every person who owns or operates any domestic establishment engaged in manufacturing regulated tobacco products must register under section 905(b) of the FD&C Act, and every registrant must file a list of its regulated tobacco products in accordance with section 905(i) of the FD&C Act. An owner or operator may authorize a third party agent to register their establishment and submit product listing information on its behalf. Establishment registration and product listing requirements currently apply only to those persons who own or operate domestic establishments engaged in manufacturing tobacco products; an importer who does not own or operate such an establishment is not subject to the requirements of section 905(b) or section 905(i) of the FD&C Act.
In order to reduce redundant submissions, FDA strongly encourages that the owner act as the agent for all operators within a given business structure in submitting establishment registration and product listing information. Under this approach, the owner would register all establishments it owns and submit the associated product listing information, and the owner would also register on behalf of all operators with management authority over those establishments. An owner acting as the agent for one or more operators would need to submit all information required of the operator(s) (e.g., the operator name(s) and place(s) of business), but could submit all information for both the owner and the operator(s) in a single registration. If an owner registers/lists all of its establishments using this approach, the operators of those establishments would not need to register. For scenarios in which an owner is also the operator of a given establishment, the owner/operator can register in a single registration.
The following example illustrates the registration and product listing requirements for a complex business structure: Firm A owns establishment X, which is engaged in manufacturing tobacco products. Firm B does not own an establishment engaged in manufacturing tobacco products. Firm A and Firm B are wholly owned subsidiaries of Holding Company C. Holding Company C does not own or operate any establishments engaged in manufacturing tobacco products. In this scenario, Firm A would be required to register establishment X and list products, but neither Firm B nor Holding Company C would be subject to registration or product listing requirements.
At this time, with respect to all tobacco products, including cigarettes, cigarette tobacco, RYO, and smokeless tobacco, as well as other tobacco products now regulated as a result of the deeming rule, FDA intends to enforce the registration and listing requirements of section 905 with respect to finished tobacco products only. FDA does not, at this time, intend to enforce these requirements with respect to products that are sold or distributed solely for further manufacturing.
As defined above, the term 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).
Components and parts that are sold separately from other tobacco products are also finished tobacco products if they are sold in final packaging intended for consumer use. FDA intends to enforce the registration and listing requirements under section 905 with respect to such products. Examples of components and parts that are sold or may be sold as finished tobacco products include pipe tobacco filler, filter tubes, e-cigarette batteries, and e-liquids, whether sold separately to consumers or as part of kits.*
Based on our experience with cigarettes, cigarette tobacco, RYO, and smokeless tobacco, we are amending our previous compliance policy. Under our previous policy, FDA intended to enforce the establishment registration and product listing requirements with respect to owners and operators engaged in the manufacture of tobacco, paper, filters, and pouches whether or not such products were for further manufacturing of, or for consumer use as, regulated tobacco products. However, FDA is announcing a change to that policy because we believe we can obtain the necessary information about tobacco product components and parts through other means, such as premarket applications for finished tobacco products and through the use of master files, as explained in the guidance Tobacco Product Master Files. Additionally, we are aligning our compliance policy for cigarettes, cigarette tobacco, RYO, and smokeless tobacco with the products now regulated as a result of the deeming rule to reduce burden on industry. Should FDA find that additional information is needed to protect the public health, the Agency may reconsider this compliance policy. We intend to communicate any compliance policy changes by guidance or rulemaking.
What Information is Submitted as Part of Establishment Registration and Product Listing Submissions?
Section 905(b) of the FD&C Act sets forth the requirements for submission of establishment 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 engaged in manufacturing the registrant owns or operates, as of the date of registration.
- The name and places of business 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.
The registration and listing electronic submission system 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) for the place of business of the owner, the place of business of the operator, and the location of the establishment. The business entity identifier recognized by the FDA Data Standards Council is the D-U-N-S number, and providing the site-specific D-U-N-S number for an entity will help prevent inaccuracies in FDA’s database.
Product Listing Information
Section 905(i) of the FD&C Act sets forth the requirements for submitting product listing information. The FD&C Act requires that, at the time of registration, the registrant submit a list of all tobacco products that are being manufactured by the registrant for commercial distribution.
The product listing must include certain accompanying information, which will vary depending on the circumstances. These circumstances are as follows:
- Under section 905(i)(1)(A), if a tobacco product standard has been established under section 907 of the FD&C Act (21 U.S.C. 387g) with respect to the tobacco product or the tobacco product is subject to premarket review under section 910 of the FD&C Act (21 U.S.C. 387j), then the product listing must include a reference to the authority for the marketing of the tobacco product and a copy of all labeling for that product. We interpret this to mean that labeling is to be submitted as an exact, legible, full color copy.
- Under section 905(i)(1)(B), the product listing for all other tobacco products must include all labeling for that product. It must also include “a representative sampling of advertisements” for the product. If requested by FDA for good cause, a copy of all advertisements for a particular tobacco product must be submitted. We interpret “a representative sampling of advertisements” to mean typical advertising material that reflects the full range of promotional statements made for the tobacco product. For example, if more than one magazine advertisement is used but the promotional content is essentially identical, only one need be submitted. In addition, the product listing must include “a copy of all consumer information” to the extent the information is not advertising and has not already been provided as a form of product labeling. Consumer information does not include information directed at wholesalers, distributors or retailers, where such information is not available to consumers.
If a registrant has determined that a product in its product listing is not subject to a tobacco product standard established under section 907 of the FD&C 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 FD&C Act to require that each product included in a product listing be clearly identified and distinguished. Products that differ in any way, including a difference in any component or part, should be listed separately for purposes of section 905(i). For example, a soft pack and a hard pack of cigarettes should be listed separately, even if the cigarettes included in the pack are identical.
Each product is to be clearly and uniquely identified by the product category*** (e.g., cigarette, smokeless tobacco, paper, filter) and unique name (i.e., brand/sub-brand or other commercial name used in commercial distribution). Tobacco products are to be identified in this way because such names are needed to determine whether products in commercial distribution are listed as required. You are to include product identification numbers (e.g., SKU, catalog number, UPC) as needed to uniquely identify the product.
Section 905(i)(3) of the FD&C Act requires the following changes to the product list to be reported twice a year:
- For any tobacco products you have introduced for commercial distribution and have not included in a previous product listing, the complete product listing information as described above.
- For any tobacco products you have discontinued manufacturing for commercial distribution since the last report, notice of the discontinuance containing the established name of the product as previously listed and the date of discontinuance.
- For any tobacco products you had given notice as being discontinued and have since resumed manufacturing for commercial distribution, notice of the resumption containing the date of resumption and complete product listing information as described above.
- Any material change in any information previously submitted
The registration and listing electronic submission system is designed to streamline the data entry process for registration and product listing at the Center for Tobacco Products (CTP). Although electronic submission is not required, FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data submission and management. The electronic submission system and FDA Form 3741, an alternative tool for paper submissions, are available at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Manufacturing/default.htm.
Section 905(b) of the FD&C Act requires establishment 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 FD&C 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 immediately register. In addition, section 905(d) requires registered owners and operators to immediately register any new establishment that begins manufacturing tobacco products.
Section 905(i)(1) of the FD&C 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, once during June and once during December.
- As of August 8, 2016, persons who own or operate domestic manufacturing establishments engaged in the manufacture of newly deemed tobacco products will be required to register with FDA and submit product listing under section 905 of the FD&C Act. As such, domestic establishments engaged in the manufacture of newly deemed products prior to August 8, 2016 will be required to register and submit product listing under section 905 of the FD&C Act by December 31, 2016.
* As explained above, the Secretary has not deemed accessories of tobacco products other than cigarettes, cigarette tobacco, RYO, and smokeless tobacco, and so they are not currently subject to section 905.
** D-U-N-S numbers are proprietary to and controlled by Dun & Bradstreet. 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). 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, because it may take 30 days (or longer) to process a new number. Please note that the D-U-N-S Number is not required. 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.
*** At this time, some product categories used for product listing may fall under a subcategory for a premarket tobacco product submission (e.g., a filter is a category for listing purposes, but a subcategory under roll your own for a premarket submission).