FDA’s Tobacco Products Deeming Rule: Establishment Registration & Product Listing

FDA’s tobacco products Deeming rule imposes many regulatory requirements on tobacco products retailers, manufacturers, distributors, importers,including establishment registration and product listing. 

An FDA Walk through the regulatory labyrinth

Handily, FDA provides a list of guidance documents to help the tobacco products industry comply with existing laws and regulations.

These include guidance documents for those involved in Manufacturing tobacco products.

Among relevant FDA guidance documents for manufacturers are the following, regarding establishment registration for owners and operators of domestic tobacco product establishment, and product listing for tobacco product manufacturers, importers, and their agents:

• Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
• Electronic Registration and Product Listing: Step-by-Step Instructions
• Establishment Registration & Tobacco Product Listing database
• Final Guidance for Industry: Listing of Ingredients in Tobacco Products 

Included are sample submissions with respect to:

• Cigarettes
• Roll Your Own Tobacco
• Smokeless Tobacco

Other relevant industry submissions include:

• tobacco health document submissions
• report of HPHCs
• tobacco product review submissions (substantial equivalence; premarket approval)

And there are various rules specific to tobacco products retailers.

Electronic Submission

As noted above, FDA maintains a searchable database of tobacco products Establishment Registration and Product Listing.

In addition to paper submission, FDA accepts electronic submission, and uses the FDA Unified Registration and Listing Systems (FURLS) is utilized for Establishment Registration and Product Listing.  (For Listing of Ingredients, Tobacco Health Document Submissions, and Reporting of Harmful and Potentially Harmful Constituents, FDA uses the eSubmitter tool and the Electronic Submissions Gateway (ESG)).

FDA provides step-by-step instruction in the Tobacco Registration and Product Listing (TRPL) Instructions.

Who Must Register

Section 905(b) of the Family Smoking Prevention & Tobacco Control Act, 21 USC 387e, describes the registration and listing requirements.

These require 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 shall register with the Secretary the name, places of business, and all such establishments of that person.”

“Manufacture, preparation, compounding, or processing” includes “repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.”

There are also provisions for biennial FDA inspection.

As to foreign establishments:

Any establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products, shall register … and shall include provisions for registration of any such establishment upon condition 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 time to time whether tobacco products manufactured, prepared, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.

As to listings, registrants “shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution.”

A few added wrinkles:

•  Enforcement: As of this writing, FDA’s guidance explains that it intends to enforce the registration requirements with respect to the “principal components of most tobacco products sold to consumers,” namely, establishments engaged in the manufacturing of cigarettes, smokeless tobacco, roll-your-tobacco for consumer use, tobacco, paper, filters, or pouches, but not in other circumstances. Note, though, that FDA enforcement priorities can change at any time.
• Similarly, FDA’s Guidance on Listing of Ingredients in Tobacco Products explains that FDA intends to enforce the ingredient listing requirements with respect to manufacturers and importers of cigarettes, smokeless tobacco, roll-your-tobacco for consumer use, tobacco, paper, filters, or pouches, but not in other circumstances.
• Avoiding redundant registration: FDA encourages that an owner register and list as agent for all operators within a given business structure.

What Does Establishment Registration and Product Listing Involve?

In brief, registration involves:

• The name and full address of the establishment.
• The name and places of business of the owner or operator.
• Email address.
• DUNS (Data Universal Numbering System) number or other unique identifier codes for the place of business of the owner, operator, and establishment.

Product listing involves such items as:

• labeling
• representative sampling of advertisements

There are also detailed rules regarding product identification, ingredient identification (single chemical substance, leaf tobacco, complex purchased ingredients, products formed by chemical reaction during tobacco product manufacturing, etc.), part to which the ingredient is added, ingredient quantity.

Contact us if you have questions about compliance with the Deeming rule or FDA tobacco products regulation.