New FDA Guidance Document on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments Published
Just two weeks before the September 30,
Has the Deadline Changed?
No. Registrations and product listings are still due by September 30,
How Do I Register?
FDA strongly encourages electronic submission of establishment registrations and product listings through the FDA Unified Registration and Listing System (FURLS) which can be accessed here. FURLS is only used to register an establishment and submit a product listing. Do not confuse this with the CTP Portal, which you can use to submit
View FDA's latest Webinar "Using the Tobacco Registration and Listing Module of FURLS - Tips and Recent Enhancements" here (published September 18, 2017).
Who Registers their Establishments and Submits Product Listing Information?
The revised guidance clarifies that owners and operators of domestic U.S. establishments engaged in manufacturing regulated tobacco products are required to register and provide a product list to FDA. This requirement does not extend to foreign establishments (e.g., e-vapor device manufacturers in China) or U.S. importers, distributors or retailers who merely distribute and sell products, but are not engaged in any manufacturing activity (e.g., manufacture, preparation, compounding, or processing, including bottling,
What Products Need to be Listed?
Despite the fact that the Form 3741a and the template FURLS product listing spreadsheet provided by FDA allow companies to indicate whether a particular product is for "Consumer Use" or "Further Manufacturing", FDA's revised guidance clarifies that the listing requirement only applies to finished tobacco products sealed in final packaging intended for consumers use. This includes components and parts sold directly to consumers in final sealed packaging. For example, an e-liquid sold in a sealed bottle for use by consumers in an open-system device would be a finished tobacco product, but an e-liquid intended to be filled into a closed system
Information Should be Submitted as Part of Establishment Registration and Product Listing?
The following information is needed to register manufacturing establishments:
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,
includethe name of each partner. In the case of a corporation, include the name of each corporate officer and director, and the State of incorporation.
Optional information includes an email address and a Data Universal Numbering System (D-U-N-S) number or
Product Listing Information
For the product list, FDA's template product listing spreadsheet (available in FURLS) should be used, particularly if you are processing the registration online through FURLS. The spreadsheet identifies the information that must be submitted for each product, e.g., product identification number (SKU), intended use (consumer use), product category (ENDS), subcategory (e-liquid), open/closed system, flavor, and advertising, labeling and consumer information. Please note that each unique product must be identified on your product list including, for example, e-liquids under the same brand or flavor that vary in terms of
Do I need to submit labels for all my product variations?
In addition, the product listing must include labeling information, but FDA's revised guidance clarifies that e-liquid
However, FDA recognizes that product listing for some tobacco products may result in numerous labeling submissions that the manufacturer must prepare and submit. For example, variations in package size, nicotine strength, Propylene Glycol (PG)/Vegetable Glycerin (VG) ratio, and flavor can result in thousands of individual product labeling submissions.
In order to reduce
Rather, as described in Appendix A to the revised guidance, registrants may submit a separate "package label plan", which is a model/generic product label with placeholder text for the specific variations, along with a "product variation index" which lists all the variations for a specific product, e.g. package size, nicotine strength, PG/VG ratio and flavor. The product variation index must list all combinations of the variations that will be using the model label. The examples from FDA's revised guidance are copied below.
The Package Label Plans, including the Model/Generic Labels and Product Variation
Example A - Sample Model Label (Package Label Plan) for nicotine containing products from the revised FDA guidance:
Example A - Product Variation Index
Example B - Sample Model Label (Package Label Plan) for 0 mg nicotine products from the revised FDA guidance:
Example B - Product Variation Index
What about advertisements and "consumer information"?
Finally, we note that despite previously implying that this information was optional, FDA's revised guidance states that if product advertising exists, a representative sampling of such advertisements must be provided with the product listing. FDA interprets "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.
FDA's revised guidance further notes that, 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 (e.g., product specifications intended for manufacturing purposes, photos of components or parts not intended for individual sale, or communications between companies), but may include items like consumer brochures.