Photo of Owen Chaput

Owen Chaput practices in the area of food law, as well as tobacco and e-vapor regulation. He advises domestic and foreign clients on establishing clearances for food additives and food contact materials under FDA and comparable international regulations.  Mr. Chaput also counsels tobacco and e-vapor manufacturers and suppliers in matters of state and federal compliance.

Prior to joining the firm, Mr. Chaput held the position of Regulatory Counsel at FDA's Center for Tobacco Products (CTP), where he analyzed industry submissions for compliance with FDA advertising laws and worked on retailer compliance and enforcement matters with respect to sales of tobacco products.

While in law school, Mr. Chaput served as a law clerk in the Federal Trade Commission, Bureau of Consumer Protection.


On Friday July 28, 2017, the U.S. Food and Drug Administration (FDA) announced its new “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death” that refocuses the Agency’s implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule. FDA’s new strategy appears to be moving away from its “one-size-fits-all” approach to tobacco product regulation by recognizing that a “continuum of risk” of tobacco and nicotine-containing products exists. While FDA has indicated that its long-term plan is to, among other things, potentially lower nicotine in cigarettes to non-addictive levels, it also made major changes to its compliance policy for recently “deemed” tobacco products that immediately impacts manufacturers of e-vapor, e-liquid, cigars, hookah and pipe tobacco products.

Background: FDA Compliance Policy for Deemed Tobacco Products

The Deeming Rule became effective on August 8, 2016, extending FDA’s tobacco product authority over newly deemed products and subjecting manufacturers to the requirements in the Tobacco Control Act, including adulteration and misbranding prohibitions, establishment registration and product listing for manufacturing facilities located in the United States, ingredient reporting, testing for Harmful and Potentially Harmful Constituents (HPHCs), a ban on unauthorized modified or reduced-risk claims and, most significantly, premarket authorization for any new products first marketed or modified after the February 15, 2007 “grandfather date”.

In the Deeming Rule, FDA proposed a “compliance policy” delaying enforcement of the premarket authorization requirements for deemed products already on the market when the rule went into effect. More specifically, for non-grandfathered deemed products on the market on August 8, 2016, manufacturers initially had either two years (i.e., by August 8, 2018) to submit a Premarket Tobacco Product Application (PMTA) or 18 months (i.e., by February 8, 2018) to submit a Substantial Equivalence (SE) Report. Products intended to be introduced to the market or existing products modified in any way after August 8, 2016 are not subject to the compliance policy and would first need to obtain FDA authorization before they can be marketed (enforcement of this requirement, however, has not been a priority for FDA to date).

Moreover, even if a company could submit a timely PMTA or SE Report that FDA accepted for review, the “sunset provision” in the compliance policy only allowed that product to be marketed for an additional 12 months (i.e., until August 8, 2019 for PMTAs) while the agency reviewed the application (FDA could extend this on a case-by-case basis).  If FDA was unable to complete its review by then, the product would have to be removed from the market, and could only be re-introduced if the Agency ever granted marketing authorization.

Due to the copious amounts of data and associated expenses needed for a PMTA, which potentially includes clinical and epidemiological studies to demonstrate that a product is “appropriate for the protection of the public health”, this resulted in a particularly dire situation for the vapor industry – which faced effectively being banned – because there are no known grandfathered e-vapor or e-liquid products and, therefore, no way to make use of the less arduous SE pathway. Indeed, through September 2016, FDA had refused to accept 362 PMTAs submitted, presumably, without the data needed to even begin the substantive review process. (To date, only Swedish Match’s PMTAs for its snus smokeless tobacco products have survived the review process, and those applications included a substantial amount of clinical and long-term epidemiological data from Sweden.)

Earlier this year, in light of multiple lawsuits filed by the industry, the PMTA deadline (as well as all other forthcoming TCA compliance deadlines for deemed products) was delayed by three months to November 8, 2018 “to allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final [Deeming Rule].”

The new leadership, led by FDA Commissioner Dr. Scott Gottlieb, has now announced FDA’s revised compliance policy for deemed products. Under the new timelines, the February 15, 2007 grandfather date remains in place, but the deadlines for “applications” (i.e., SE Reports or PMTAs) for deemed products on the market have been delayed. Specifically, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, are due by August 8, 2021, and applications for non-combustibles, such as e-vapor and e-liquid products, are due by August 8, 2022. In his remarks, Dr. Gottlieb also indicated that FDA would be revising the sunset policy so that existing products under review remain on the market.

How Will This Impact Your Vape Business?

While the PMTA delay provides much needed breathing room on the most complicated and expensive requirement – and saves the vapor industry from a de facto ban – it is important for vape businesses to understand that none of the other fast approaching TCA deadlines have been impacted by FDA’s new policy.

Specifically, the Agency noted in its press release that its new policy will not (1) apply to provisions of the Deeming Rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors, or (2) affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., “light,” “low,” or “mild,” or similar descriptors. The table below summarizes the major compliance deadlines for e-vapor product manufacturers:
Deadline for Large-Scale Manufacturers
Deadline for Small-Scale Manufacturers
Free sample ban, age restriction, photo-ID check, use of modified/reduced risk claims and descriptors, adulteration and misbranding prohibitions
August 8, 2016
Introduction of new, deemed products without FDA premarket authorization (products on the market before this date are subject to the new compliance policy deadlines)
August 8, 2016
Registration of U.S. manufacturing establishments and submission of List of Products manufactured in such establishments [does not apply to foreign establishments]
September 30, 2017
Submission of Health Document Notification
February 8, 2017
November 8, 2017
Submission of Ingredient Listing Reports
November 8, 2017
May 8, 2018
Submission of Harmful and Potentially Harmful Constituents (HPHCs) reports
November 8, 2019
Nicotine Addiction Warning on Labels and Advertisements
August 10, 2018
 (distribution of products without the required warning must cease by September 10, 2018)
PMTA or SE Report for deemed combustible products (e.g. cigars or hookah) on market on August 8, 2016
August 8, 2021
PMTA or SE Report for deemed non-combustible products (e.g., vapor products) on August 8, 2016
August 8, 2022

To learn more about the U.S. manufacturing establishment registration & product listing, health document submission, and ingredient listing requirements, see herehere and here. If you have any questions about how to complete these submissions, please let us know.

What’s Next?

Beyond the immediate PMTA delay, FDA broadly announced that it is working to develop foundational rules and guidance, including rules and guidance to clarify the requirements for the SE Reporting process, PMTAs, and Modified Risk Tobacco Product (MRTPs) applications and the standards of review. Specifically, FDA:

  1. Plans to issue product standards for vapor products to protect against known public health risks;
  2. Will issue new “foundational rules” and guidance to modify the product review process and clarify the requirements for the SE Reporting process, PMTAs, and Modified Risk Tobacco Product (MRTPs) applications;
  3. Will study the effects of flavors (including menthol), both on young people and adult smokers looking for a less harmful alternative;
  4. Will begin a public dialogue through an Advanced Notice of Proposed Rulemaking (ANPRM) on the impact of reducing nicotine in cigarettes to non-addictive levels (FDA stressed that, at this time, it is only contemplating a reduction in nicotine in cigarettes and not for other tobacco (i.e., vapor) products); and
  5. Will issue an ANPRM soliciting comments and data relating to the use and public health impacts of premium cigars.
If you are interested in obtaining additional guidance regarding tobacco and e-vapor compliance contact Azim Chowdhury (+1 202.434.4230, For more information on Keller and Heckman LLP’s Tobacco and E-Vapor practice in general, visit Follow Azim Chowdhury on Twitter.
Although we are still waiting for an official announcement, FDA’s Stakeholder Relations Office recently indicated that the Agency will be delaying enforcement of all future Deeming Regulation compliance deadlines set for May 10, 2017 or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports. We understand that this does not apply to provisions of the Deeming Regulation where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.

The Stakeholder Relations Office further indicated that “this extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court”.

Click here to learn more about Keller and Heckman LLP’s lawsuit on behalf of the e-vapor industry currently pending before the U.S. District Court for the District of Columbia.

We will let you know as soon as FDA officially announces the new deadlines or issues new guidance.

Updated Compliance Deadlines Under Deeming Rule [Pending FDA Official Announcement]

Deadline for Large-Scale Companies 
Deadline for Small-Scale Companies 
Registration of U.S. manufacturing establishments
 September 30, 2017
 September 30, 2017
Submission of List of Products manufactured in U.S. establishments
 September 30, 2017
 September 30, 2017
Health Document Submission
February 8, 2017
[Note: this deadline has passed]
 November 8, 2017
 Submission of Ingredients Listing Reports
November 8, 2017
 May 8, 2018
Premarket Tobacco Product Application (PMTA) for products on market on August 8, 2016
November 8, 2018
 November 8, 2018
Submission of Harmful and Potentially Harmful Constituents (HPHCs) Reports
November 8, 2019
 November 8, 2019

For more information on our tobacco and e-vapor practice, please contact Azim Chowdhury (+1 202.434.4230; and visit Follow Keller and Heckman Tobacco and E-Vapor partner Azim Chowdhury on Twitter

UPDATE – FDA’s Ingredient Listing Deadline For Deemed Products Extended by Six Months

On December 28, 2016, FDA finalized its Guidance for Industry, “Listing of Ingredients in Tobacco Products” which is available here. In the new guidance FDA states that, “considering that some manufacturers of newly deemed products are not familiar with the forms for listing ingredients, and, therefore may need additional time to complete them accurately,” the Agency does not intend to enforce the Section 904(a)(1) ingredient listing requirement for manufacturers and importers of newly deemed products that were introduced into commerce on or before August 8, 2016 for an additional six months until August 8, 2017 for non-small scale manufacturers, and until February 8, 2018 for small-scale manufacturers. FDA believes that this additional time will allow manufacturers to prepare higher quality submissions, and encourages manufacturers to begin the process as early as possible.

Note, however, that FDA has not yet extended the deadlines to submit “Health Documents” to the Agency. As described here, manufacturers and importers of newly deemed tobacco products that were on the market on August 8, 2016 are required to submit health documents developed during June 23, 2009 and December 31, 2009 by February 8, 2017 and August 8, 2017 (for small companies), respectively. If you do not have any documents that meet these criteria in your possession, you must still inform FDA by the appropriate deadline using either FDA Form 3743 or the eSubmitter tool. We will let you know if this deadline is also extended by FDA.


On August 8, 2016 the U.S. Food and Drug Administration’s (FDA’s) “Deeming Regulation” became effective, extending the Agency’s regulatory authority over tobacco products beyond traditional cigarettes, smokeless tobacco and roll-your-own tobacco products to include “other” tobacco product categories such as cigars, pipe tobacco, hookah/shisha, electronic vapor and e-liquid products, and components and parts of such products. Now, manufacturers of newly deemed products are subject to the Tobacco Control Act (TCA) requirements, including reporting ingredients to FDA.

Section 904(a)(1) of the TCA requires “each tobacco product manufacturer or importer, or agents thereof” to submit to FDA a list of all ingredients that are “added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product….” On October 28, 2016, the FDA Center for Tobacco Products (CTP) released a revised Draft Guidance document regarding

Listing of Ingredients in Tobacco Products, which we summarize here.

Products that are not subject to a Section 904 ingredient list are considered misbranded pursuant to Section 903(a)(10) of the TCA. It is a prohibited act to distribute in interstate commerce a misbranded tobacco product.

When are the Ingredient Listing Reports Due?

Non-small scale manufacturers of deemed products that were on the market on August 8, 2016 must report the ingredients in those products to FDA by February 8, 2017, while “small-scale” manufacturers have until August 8, 2017 (these same deadlines also apply to the health document submission requirement described here). A small-scale tobacco product manufacturer is one that (1) employs 150 or fewer full-time equivalent employees and (2) has annual total revenues of $5 million or less. (See FDA’s guidance document for small-scale tobacco companies here.) Please note that although FDA did recently extend the Registration and Product Listing deadline for U.S. manufacturing establishments by six months to June 30, 2017, as of the time of this writing, the ingredient reporting deadlines have not been amended. 

For products that are first marketed after August 8, 2016, Section 904(c)(1) requires that 90 days before delivering a product for introduction into interstate commerce, the manufacturer of the new product must provide FDA with the ingredient report. Please note, however, that this does not change the fact that newly deemed products cannot be introduced to the U.S. market after August 8, 2016 without first submitting a Premarket Tobacco Product Application (PMTA) and obtaining marketing authorization from FDA. Pursuant to FDA’s compliance policy, only products marketed on August 8, 2016 can take advantage of a two-year grace period before the PMTA deadline on August 8, 2018.

As a practical matter, we interpret this to mean that if a manufacturer of a deemed product (which was on the market on August 8, 2016) fails to report its ingredients to FDA by either the February 8 or August 8, 2017 deadline, respectively, that manufacturer must remove its products from the market until it reports the ingredients in those products, and then wait 90 days before re-introducing those products to the market. Again, this only applies to deemed products that were demonstrably on the market on the August 8, 2016 effective date of the rule.

Who Submits Ingredient Listing Information?

While the Registration and Product Listing requirement only applies to U.S. manufacturing establishments, the ingredient listing requirement applies to all deemed tobacco products marketed in the U.S., regardless of where the product is manufactured.

As noted above, under the TCA, manufacturers or importers (or their agents) of deemed products may submit ingredient listing reports. Domestic manufacturers should submit this information directly to FDA. For foreign manufacturers, including manufacturers of e-vapor devices, either the manufacturer or an importer of the product may submit the required ingredient information. 

As a practical matter, however, typically only the original manufacturer will have the necessary information on the ingredients/raw materials and the ingredient suppliers to complete the reports. Moreover, an ingredient listing report for a particular product should only be submitted to FDA once. U.S. importers of e-vapor products should coordinate with their foreign suppliers to ensure that the ingredient listing reports for those imported products are prepared and submitted in a timely manner.  

What Products are Subject to Ingredient Listing?

In its guidance document, FDA clarifies that it intends to enforce the ingredient listing requirement with respect to finished tobacco products only. A finished tobacco product is a tobacco product, including components and parts, sealed in final packaging intended for consumer use. Components and parts of e-vapor products that may be considered “finished” products because they are often packaged and intended for sale to consumers include, but are not limited to: e-liquids, cartridges, atomizers, certain batteries, cartomizers, clearomizers, tanks, coils, drip tips, and e-liquid flavorings.

While the manufacturer or importer of a finished tobacco product is ultimately responsible for submitting the ingredients information, suppliers of components or parts that are used in the finished tobacco product may need to submit information about products used by their downstream customers. These suppliers may prefer to keep certain information regarding their products confidential from their customer, i.e. the finished tobacco product manufacturer. To maintain confidentiality, FDA states that these suppliers may establish a Tobacco Product Master File (TPMF), and submit the required ingredient information to FDA without sharing it with their customer. FDA’s guidance regarding TPMFs is available here.

However, as discussed below, FDA’s ingredient listing guidance clarifies that for “complex purchased ingredients” (e.g., e-liquid flavors and raw materials used in devices) only information related to the supplier, the quantity and quality/specifications of the ingredient need to be provided, rather than confidential chemical formulations (CAS Reg. Nos.). In other words, at this time it is not necessary for flavor companies who supply the e-liquid industry, for example, to provide their confidential formulations to FDA in master files to be referenced in their customers’ ingredient listing reports. TPMFs detailing the formulations of such flavors, as well as toxicity and other information, will certainly be required for PMTAs, however.

How to Submit Ingredient Information

FDA strongly encourages electronic submission of the ingredient listing reports through either the CTP Portal or FDA Electronic Submissions Gateway (ESG) (CTP recommends using the CTP Portal). Do not confuse this with the FDA Unified Registration and Listing System (FURLS) which is only for U.S. establishment registration and product listing.

The first step in obtaining a CTP Portal account is to designate an Industry Account Manager (IAM) for your company who will be primarily responsible for creating and managing user accounts and submitting filings. To request an IAM, you must email the CTP Portal Helpdesk ( with subject line “IAM Request” and attach a signed letter which designates the IAM, provides contact information, and certifies compliance with regards to electronic signatures should be attached to your request email. Information regarding IAMs along with instructions for executing the request letter can be found here. Once you send this letter electronically, you will need to mail a hard copy to this address:

Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

After the hard copy has been received by CTP, the IAM will be contacted via email after their portal account has been created.

Next, you will need eSubmitter, FDA’s free software which must be used to package files for submission through the CTP Portal. Download eSubmitter here. According to FDA, the eSubmitter software and any output files reside locally on your computer, allowing you to work on a submission offline, save, and continue later. The eSubmitter tool does not transmit any data across the Web to the FDA. Once you package a submission in eSubmitter, you can securely submit it through the portal. The eSubmitter tool contains submission templates for various FDA submissions, including ingredient listing.

Alternatively, in lieu of submitting your reports to FDA electronically, you may manually complete paper submissions using FDA Form 3742 and mail them to the CTP Document Control Center.

What Information Is Submitted With the List of Ingredients?

The information you should expect to submit to FDA is summarized as follows:

1. Manufacturer/Importer Identification
2. Product Identification
3. Ingredient Information
a. Single Chemical Substance

b. Leaf Tobacco
c. Complex Purchased Ingredients
d. Reaction Products
4. Part to Which the Ingredient Is Added
5. Ingredient Quantity

We discuss each item below.

1. Manufacturer/Importer Identification

A “tobacco product manufacturer” is defined in Section 900(20) of the TCA to include any person, including a repacker or relabeler, who “manufactures, fabricates, assembles, processes, or labels a tobacco product; or imports a finished tobacco product for sale or distribution in the United States.” The ingredient listing report for each product must include the name and address of the manufacturer or importer (or agent thereof). FDA also requests that you provide:

  • Corporate email address
  • Data Universal Numbering System (D-U-N-S) number or other unique identifier. A business may obtain a D-U-N-S number for free at
  • The Facility Establishment Identifier (FEI) number assigned to your U.S. establishment by FDA. This number is assigned when you register your U.S. manufacturing establishment with FDA. This would not apply to foreign establishments which are currently exempt from establishment registration.
2. Product Identification

Separate ingredient lists must be submitted for all unique products. Products that “differ in any way” with the exception of “packaging differences that do not affect characteristics of the product” are considered unique. For e-liquids, for example, we interpret this to mean that each unique formulation (i.e., nicotine concentration, flavor combination, PG/VG ratio, etc.) is a unique product that must be the subject of its own ingredient listing report. Similarly, e-vapor devices or components of devices that differ in any way would be considered unique products.

Each product must be identified in its report by:
  • Brand and subbrand;
  • Unique identifier such as SKUs, UPCs, or catalog numbers;
  • Product type or category (e.g., cigarettes, cigars, Electronic Nicotine Delivery System (ENDS), pipe tobacco, roll-your-own tobacco, smokeless tobacco, waterpipe tobacco and other);
  • Product subcategory (for ENDS, this includes closed e-cigarette, open e-cigarette, closed e-liquid, open e-liquid, and other).
(All categories and subcategories are provided in the eSubmitter submission template.)

3. Ingredient Identification

Section 904(a)(1) of the TCA requires a listing of all ingredients that are added by the manufacturer to the “tobacco, paper, filter, or other part of each tobacco product” including:

  • Tobacco
  • Substances
  • Compounds
  • Additives

FDA considers an ingredient to be added to the tobacco product by the manufacturer if it is:

  • Added directly by the manufacturer;
  • Added at the direction of the manufacturer;
  • Created through a chemical reaction knowingly or intentionally by the manufacturer; or
  • Added to any type of packaging and incorporated into the consumer product knowingly or intentionally by the manufacturer.
Ingredients can be categorized as either “single chemical substances” or “complex purchased ingredients”.  

a. Single Chemical Substance

If an ingredient is a discrete chemical that can be uniquely identified, and not a mixture of chemicals, it is a single chemical substance (either purchased or prepared in-house and purified). That ingredient should be identified with the unique scientific name, quantity, quality of the ingredient, any internal identification number used within the manufacturer’s company to reference the ingredient, and the expected function(s) of each ingredient.

Unique scientific names or codes, include:

If the leaf tobacco has been processed by the vendor with any chemical, additive, or substance other than potable water, report it as a “Complex Purchased Ingredient,” discussed below.

b. Complex Purchased Ingredient

If your ingredient is neither a single chemical substance nor a single type of leaf tobacco, it should be identified as a complex ingredient. Examples of complex purchased ingredients may include:

  • Flavor extracts (e.g., flavors used in e-liquids)
  • Components of vaping devices
  • Tobacco leaf blends
  • Reconstituted tobacco
FDA’s guidance further divides complex purchased ingredients into two groups, those made to manufacturer specifications and those not made to manufacturer specifications.

If the complex ingredient is not made to your specifications (i.e., purchased “off the shelf”), you must provide:

  • Complete name of ingredient manufacturer;
  • Uniquely identifying name and/or number used by the ingredient manufacturer (e.g. catalog number or UPC);
  • The quality of the specified ingredient (such as the percent purity or a published standard);
  • Expected function of the specified ingredient (e.g. e-liquid flavoring or vaping device mouthpiece); and
  • Identification number used within your company to reference the complex ingredient (e.g. the ingredient SKU).

With respect to e-liquids, for example, the flavorings used in most products are complex purchased ingredients because they are mixtures of multiple chemicals. If an e-liquid manufacturer is simply purchasing a flavor from a flavor supplier without providing any particular specifications or assisting in designing the flavor, that ingredient would likely be considered “off the shelf”. On the other hand, flavors that are uniquely created to an e-liquid manufacturer’s specifications using particular molecules or chemicals, for instance, may be considered complex purchased ingredients made to specifications.  

For e-vapor device manufacturers, components of devices (which we consider “ingredients”) are often made to the manufacturer’s specifications by suppliers to fit unique product designs.

If the complex ingredient is made to your specifications, you must provide:

  • Complete name of ingredient manufacturer;
  • Uniquely identifying item name and/or number (e.g. ingredient manufacturer’s UPC or SKU);
  • Information to uniquely identify each ingredient you specified be used (identify these ingredients in the same way as you would other ingredients);
  • The quality of the specified ingredient (such as the percent purity or a published standard);
  • Expected function of the specified ingredient (e.g. e-liquid flavoring);
  • Identification number used within your company to reference the complex ingredient (e.g. SKU);
  • Any additional specifications for the complex ingredient, such as release specifications, acceptance criteria, or a sample certificate of analysis.
Finally, if you use multiple suppliers interchangeably for the same ingredient, provide sufficient information to link the ingredients that you consider interchangeable.

c. Reaction Products

If you know or intend to form an ingredient through chemical reaction during tobacco product manufacturing, you will need to include the resultant material in your ingredient listing. Under this scenario, you should identify:
  • The reaction product, in the same manner used for single chemical substances;
  • Which ingredients combined to form the reaction product; and
  • The expected function of the reaction product.
 d. Changes In Additives

We note that Sections 904(c)(2) and (c)(3) of the TCA require manufacturers to report changes in additives to all tobacco products, including deemed products. Specifically, if you:

  • increase or decrease an existing additive, report the change to FDA within 60 days.
  • add or increase an additive that FDA has designated in regulations as a tobacco additive that is not a human or animal carcinogen and is not otherwise harmful to health under intended conditions of use, report the change to FDA within 60 days.
  • add a new tobacco additive or increase the quantity of an existing tobacco additive, report the change to FDA at least 90 days prior to making the change.
As a practical matter, however, changes cannot be made to additives in deemed products already on the market (by August 8, 2016) without first obtaining FDA PMTA authorization. 
If you are interested in obtaining additional guidance regarding submission of ingredient listing reports to FDA, contact Azim Chowdhury (+1 202.434.4230, For more information on our tobacco and e-vapor regulatory practice in general, visit Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

UPDATE: On December 9, 2016, FDA issued a revised guidance for industry, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments,” extending the December 31, 2016 deadline for registration and product listing for U.S. manufacturers by six months by June 30, 2017. According to FDA, the guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule must register and list immediately with the FDA. The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.

Please note that this does not change the fact that no new deemed tobacco products can be introduced into the U.S. market after August 8, 2016 without first obtaining FDA Premarket Tobacco Product marketing authorization (products marketed on August 8, 2016 can take advantage of the 2 year grace period before the PMTA deadline on August 8, 2018, pursuant to FDA’s compliance policy)

Section 905(b) of the Tobacco Control Act requires every person who owns or operates any “establishment” in the United States that manufactures, prepares, compounds, or processes a “tobacco product” to register with FDA by December 31 of each year. Now that the Deeming Regulation is effective, e-vapor products, including their components and parts (e.g., e-liquids that contain tobacco-derived nicotine), are considered regulated tobacco products. If you own or operate a facility in the United States that manufactures, prepares, compounds, or processes an e-vapor product, which includes repackaging or otherwise changing the container, wrapper, or labeling of such product package, then you must register with FDA by the end of the year. (See also: E-Vapor Industry Challenges Deeming Regulation.)

At the time of registration, registrants must also submit to FDA a detailed list of all products that are being manufactured, prepared, compounded, or processed for commercial distribution, along with copies of consumer information, all product labeling, and a representative sampling of advertisements. Registrants must also file a biannual report of certain changes to their product lists.

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 other regulatory documents (e.g., ingredient reports, health document submissions, etc.). To obtain a FURLS account and to view more instructions and webinars see here.

Alternatively, you may file your Establishment Registration manually by filling out and Form FDA 3741 and mailing all of the necessary materials to CTP’s Document Control Center, or by packaging the files electronically using FDA’s eSubmitter software and submitting that package through the CTP Portal.

Establishment Registration
Domestic manufacturers of finished tobacco products must register their facilities.
Deemed tobacco products, including e-liquids, that are intended or reasonably expected to be used with nicotine or tobacco, are now regulated by FDA, and are thus subject to the Establishment Registration and Product Listing requirements of the Tobacco Control Act.
Section 905(b) (21 U.S.C. 387e(b)) of the Act requires that domestic businesses engaged in the preparation, manufacture, compounding, repackaging, relabeling or processing of finished tobacco products register their establishment(s) on or before December 31 of each year.
In FDA’s Registration and Product Listing guidance document, released in July, 2016, FDA states it only intends to enforce the registration and listing requirements with respect to domestic manufacturers of “finished tobacco products.” A finished tobacco product is defined as a “tobacco product, including all components and parts, sealed in final packaging intended for consumer use” (and do not include “products that are sold or distributed solely for further manufacturing”).
Only Domestic Establishments 
Per Section 900(20) (21 U.S.C. 287(20)) of the TCA, a tobacco product manufacturer means “any person, including any repacker or relabeler, (A) who manufactures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a finished tobacco product for sale or distribution in the United States.” FDA’s guidance document states, however, that an importer who does not own or operate “domestic establishments engaged in manufacturing tobacco products” is not subject to the registration and listing requirements. Accordingly, only domestic U.S. establishments engaged in the manufacture, compounding, repackaging, relabeling or processing of finished tobacco products are required to register their facilities and provide product information. This means e-liquid and e-vapor device manufacturers, including vape shops that mix, bottle, assemble or label their own products, located in the United States must register their manufacturing establishments with FDA by the end of the year.  As noted, this requirement does not currently apply to foreign manufacturing establishments.
Therefore, if you are both a domestic manufacturer and produce finished tobacco products, you must register your U.S. manufacturing facility as directed by FDA by December 31, 2016. Registration instructions are provided below. The information required by FDA includes:
  • The name and address of establishments engaged in manufacturing and owned by the registrant as of the date of registration;
  • The name and place of business of the owner or operator; and
  • If filing electronically, FDA also recommends providing an email address and DUNS number.
Tobacco products that are produced in an establishment that is not registered under Section 905 will be deemed misbranded per Section 903(a)(6) (21 U.S.C. 387c(a)(6)), which can lead to enforcement actions against the manufacturer such as fines, seizures, or injunctions.
Product Listing
When you register your domestic facility, you must also list the tobacco products you manufacture and provide information regarding those products. 
In conjunction with registration, Section 905(i)(1) requires manufacturers to submit a complete list of tobacco products being manufactured for distribution. A manufacturer’s tobacco product list must be accompanied by certain product information. At this time, the principal requirement is that the product list must include all labeling for each product, as well as “a representative sampling of advertisements” for each product. FDA’s guidance document states that FDA interprets “representative sampling” to mean “typical advertising material that reflects the full range of promotional statements made for the tobacco product.” If manufacturer’s have additional consumer information that is not submitted as either advertising or labeling, manufactures should submit this consumer information as well. This means that when you register your manufacturing facilities, the list of products produced at such facility must be accompanied by copies of labels and advertising materials (e.g., any ads for your products in VAPE Magazine, for example) for each product.
FDA’s Registration and Listing guidance states that “each product included in a product listing [should] be clearly identified and distinguished.”  If two products are different, for example if they contain different components or parts, the products should be listed separately. FDA requires that the listed products be identified by category, unique name, and identification number such as a SKU or UPC, as needed. For examples of the information required for a product listing, see pages 8 and 9 of FDA’s Form 3741.
Finally, under Section 905(i)(3), changes that occur to a manufacturer’s most recent product list must be submitted biannually, during June and December. As FDA’s guidance explains, these changes include: tobacco products introduced for commercial distribution; tobacco products for which manufacturing was discontinued; tobacco products that for which manufacturing was previously discontinued but which has since resumed; and “any material change” to information previously submitted in a product list.
FDA’s website for manufacturers provides the following examples of completed registration and listing forms for various types of tobacco products:
Parties interested in obtaining additional guidance regarding submission of registration and listing information to the FDA should contact Azim Chowdhury (+1 202.434.4230, For more information on our tobacco and e-vapor regulatory practice in general, visit . Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.