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Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product).  As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along with copies of all labeling (see our full summary of the registration requirement here).  This registration must be renewed annually before midnight on December 31 (Eastern time) every year, and product lists must be updated bi-annually: by midnight June 30 and December 31 every year.

This means that operators of manufacturing establishments of newly deemed products (e.g., vapor, cigars, hookah, etc.) on the market as of August 8, 2016 that have made changes to their product offerings must update their product lists with FDA by tomorrow, June 30, 2018, or as soon as possible to avoid FDA enforcement (considering the likelihood that FURLS may crash, the sooner you start this process, the better). Specific examples of changes that need to be updated (in FURLS, if you used that system to register online) include (1) discontinuing products on your product list that you are no longer actively manufacturing, (2) adding new products that are now being manufactured (e.g., co-packers now manufacturing pre-August 8, 2016 products that were not on the co-packers’ initial product list), (3) adding a new manufacturing location for products already listed by another establishment, or (4) labeling changes (including rebranding) of existing products.

Note that if you are planning to update your labels to comply with FDA’s nicotine addiction warning and other labeling requirements (that go into effect on August 10, 2018) after June 30, you have until December 31, 2018 to update your product listing with the revised labels.

If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com) or Ben Wolf (202.434.4103, wolf@khlaw.com). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

 

 

The 3rd Annual Keller and Heckman E-Vapor and Tobacco Law Symposium will be held on January 29th-30th, 2019.

Registration for this program will be launching in late September 2018. 

Seminar Details
Dates:
January 29 – January 30, 2019

Location:
Miami Marriott Biscayne Bay 

Price:
$899 early rate
$1,099 regular rate

More information on speakers and a final agenda will be available soon. We look forward to seeing you at the program!

Take a look at highlights from this year’s conference:

For additional information, please contact:

Caryn Wick
Marketing Director
Keller and Heckman LLP
wick@khlaw.com

eSubmitter logo

Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco products such as e-liquid, vapor devices, cigars and hookah, is the requirement to submit to the Food and Drug Administration (FDA) a list of all ingredients that are “added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product….”  Unlike the Registration and Product Listing requirement, which only applies to domestic U.S. manufacturing establishments, ingredient listing is required for all finished deemed tobacco products marketed in the United States, regardless of where the product was produced.[1]

Upcoming Deadlines

When the Deeming Rule became effective on August 8, 2016, FDA’s initial compliance policy required large deemed tobacco product manufacturers (i.e., manufacturers earning over $5M in annual revenues or who have over 150 full-time employees) to submit ingredient lists to FDA for all of their finished products by February 8, 2017; small-scale manufacturers had until August 8, 2017.  Over the course of 2017 these deadlines were extended several times for various reasons; now, large-scale manufacturers have until May 8, 2018 and small-scale manufacturers have until November 8, 2018.[2]  While it is always possible FDA could further push the deadlines back, we think it is unlikely to do so for ingredient listing.

Information Required

The ingredient listing process can be complicated and time consuming, particularly for manufacturers of e-liquids and vapor devices, for whom FDA has provided little specific guidance, and that may have hundreds of SKUs or more.  Broadly speaking, ingredient listing reports require the following:

  • Contact information for the manufacturer/submitter and U.S. agent;
  • A product list (similar to the product list U.S. manufacturers had to prepare for establishment registration);
  • For each product, a list of “components”;
  • For each component, a list of “ingredients” (e.g., single chemical substances and complex purchased ingredients); and
  • Specific information regarding each ingredient (e.g., quantity, ingredient number, SKU number, supplier information for complex purchased ingredients, etc.).

For more detailed background on the information needed to prepare ingredient listing reports, see our previous postings.

Submission Process

Although companies can submit ingredient listing reports manually to the CTP Document Control Center using the paper Form 3742, FDA encourages electronic submission through the CTP Portal.  This should not be confused with the separate FDA Unified Registration and Listing System (FURLS), which is only for U.S. Establishment Registration and Product Listing.  Obtaining CTP Portal access typically takes a few weeks, so you should apply for an account as soon as possible if you do not yet have one.

Only files that are packaged using FDA’s eSubmitter software can be submitted through the CTP Portal (download eSubmitter here). The eSubmitter tool does not transmit data over the Internet, but resides locally on your computer along with any output files, allowing you to work on a submission offline, save, and continue later.  Once a submission is complete, eSubmitter “packages” (i.e., compiles) the submission into a format that can be securely submitted through the CTP Portal.

Preparing Reports in eSubmitter

The eSubmitter tool contains templates for various FDA required submissions, including health documents and ingredient listing reports, among other things.

Of note, on March 5, 2018, FDA Center for Tobacco Products published a new set of instructions which provides a step-by-step guide on using eSubmitter to list ingredients in tobacco products.  At the same time, eSubmitter was updated to include two new options for preparing ingredient listing reports, which are discussed in the new instructions.

The first new option (“Option (c)”) allows for the use of a single spreadsheet to input ingredient information for all of a company’s products, rather than using multiple spreadsheets (Option (b)). The Option (c) spreadsheets come in both e-liquid specific (download here) and any tobacco templates (download here).

The second new option to attach your own spreadsheet (“Option (d)”) permits manufacturers to create and submit their own ingredient listing files in any format they wish.  While FDA requests that a spreadsheet be generated, eSubmitter will support the submission of a number of file types: .pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .sgml, .mol, .xls, .xlsx, .csv or .txt.

New eSubmitter Spreadsheets

The new Option (c) spreadsheets require all the same information as before, but has several unique differences compared to the original, multiple-spreadsheet method.  For example, now combinations of flavors and other additives can be saved as “master recipes” that can be added to any e-liquid formulations that contain it, along with levels of nicotine, PG and VG, making it easier to list ingredients for e-liquids that differ only in concentration of nicotine or other ingredients.  In addition, the Option (c) spreadsheets simplifiy the process of inputting component information, making it easier to, for example, “link” different bottle sizes to a formulation without re-inputting all the ingredient information. The new spreadsheet is also less cumbersome to complete and, so far, appears not to have as many bugs that often made importing the original tobacco ingredient spreadsheets into eSubmitter an onerous process (see our May 2017 webinar here which demonstrates how to use the original, multiple-spreadsheet method in eSubmitter).

E-liquid manufacturers should also keep in mind that the Option (c) e-liquid spreadsheet can only be used for the e-liquid component of a product; information regarding the other components of the finished product (e.g., bottle, cap/dripper, label, packaging, etc.) will need to be entered separately (either manually in eSubmitter or with a separate spreadsheet).

Manufacturers of vapor devices and hardware components, many of whom have argued that the current “ingredient” listing requirement and process does not make sense for such products[3], will also need to report ingredients to FDA either manually in eSubmitter, using the original multiple spreadsheet method, the Option (c) spreadsheet for products other than e-liquids, or by developing and submitting their own files as attachments using Option (d).

*          *          *          *

While the new eSubmitter spreadsheet options could make submitting ingredients to FDA easier for some manufacturers, the process still presents a significant time commitment.  Companies should not hesitate to start the process sooner rather than later.

If you need assistance with ingredient listing or for more information regarding other regulatory obligations facing deemed tobacco product manufacturers, distributors, importers, or retailers, please contact Azim Chowdhury at chowdhury@khlaw.com or 202-434-4230.

 

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[1]              A finished tobacco product is defined in the Deeming Rule and FDA guidance as “a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. See FDA, Guidance for Industry (Revised)*: Listing of Tobacco Products, pg. 5 (Nov. 2017).

[2]           See FDA, Guidance for Industry (Revised)*: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Nov. 2017).

[3]           See e.g., comment to the FDA Ingredient Listing Guidance document submitted by Shenzhen E-Vapor Industry Association (SEVIA) in May 2017, available at https://www.regulations.gov/document?D=FDA-2009-D-0524-0034.

February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.

The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as amended by the Tobacco Control Act, which provides that FDA shall inspect each factory, warehouse, establishment, or vehicle in which tobacco products, including deemed tobacco products, are manufactured, processed, packed, or stored.  Pursuant to Sections 704 and 905 of the Act, FDA is directed to inspect every establishment at least once every two years.

Audit and Inspection Program

Keller and Heckman’s experienced team of attorneys and scientists will provide a comprehensive, on-site training and facility auditing program designed to help your company adequately prepare for an FDA inspection.  As part of the AIP, companies can expect:

  • An introductory presentation and memorandum detailing FDA’s inspection authority, what to expect during an inspection, and how to adequately prepare for – and respond to – an FDA inspection;
  • A full facility audit, consisting of a complete mock-inspection; and
  • A written post-inspection report detailing the overall readiness of the facility for an FDA inspection, including a list of specific recommendations and opportunities for improvement*

Keller and Heckman’s AIP program is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements.  The AIP will consider a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Supplemental Environmental and OSHA Compliance Components

In addition to FDA compliance, the AIP offers companies the option to include supplemental compliance training and auditing focusing on environmental and occupational health and safety regulations and requirements – efficiently leveraging the FDA mock inspection and full facility audit.

  • Environmental: The AIP program will offer companies the opportunity to add an additional training and compliance component focusing on federal and state environmental and waste management regulations. Specifically, nicotine-bearing products may be subject to regulation under the Federal Resource Conservation and Recovery Act (RCRA) when disposed.  State regulations governing dangerous or industrial wastes also could apply.  This component will provide an overview of how nicotine in tobacco-based products are regulated differently than when found in e-cigarettes and other vaping products, and will provide valuable information regarding companies’ obligations in responding to these additional requirements.  For more information on environmental requirements, see here.
  • Occupational Health and Safety: Participants in the AIP program will also have the opportunity to add an additional training and compliance component focusing on federal and state Occupational Safety and Health laws. OSHA recordkeeping requirements apply to all employers, except very small businesses.  Most other OSHA standards apply to all employers, regardless of size.  This component will provide companies with a review of existing policies and practices, and will recommend specific actions designed to bring companies into compliance with regulations in areas relevant to the industry, including: personal protective equipment, emergency plans, fire protection, and hazard communication (g., labeling and safety data sheets).

Pre-Registration

Pre-registration for the AIP is available immediately by filling out the form available here:

Tobacco and Vapor Product Manufacturing Establishment Audit and Mock Inspection Program Pre-Registration Form

The completed pre-registration form can be E-mailed to chowdhury@khlaw.com, faxed to (202) 434-4646, or mailed to:

Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street NW, Suite 500 West
Washington, D.C. 20001

Upon receipt of your pre-registration form, Keller and Heckman will provide your company with a formal written proposal and cost-estimate to conduct on-site training and mock inspection at your facility.  Scheduling is generally available on a first-come, first-serve basis.

*The written post-inspection report is covered by any existing attorney-client relationship between Keller and Heckman and the Company, and is generally not subject to discovery.  The recommendations set forth in the post-inspection report are for informational purposes only, and do not constitute any warranties or guarantees regarding the outcome of an actual FDA, EPA or OSHA inspection.  Keller and Heckman’s attorneys remain available and look forward to the opportunity to assist with any post-inspection activities or questions following completion of the written report.

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:
Requirement
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 here, here 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, chowdhury@khlaw.com). For more information on Keller and Heckman LLP’s Tobacco and E-Vapor practice in general, visit www.khlaw.com/evapor. 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]

Requirement
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; chowdhury@khlaw.com) and visit www.khlaw.com/evapor. 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.

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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 (CTPeSub@fda.hhs.gov) 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 http://www.dnb.com/.
  • 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, 
chowdhury@khlaw.com). For more information on our tobacco and e-vapor regulatory practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

Azim Chowdhury was interviewed in VB2B’s Winter Edition. Azim discussed current events in the e-vapor industry and what companies need to do in the face of rapid regulatory change.

  1. What are the different services Keller Heckman offers the business owners?

We are a regulatory law firm specializing in the U.S. Food and Drug Administration (FDA), European Union (EU), and global requirements for e-vapor products. Our expertise is in promoting, protecting, and defending products made by the spectrum of industries regulated by government agencies which, in the United States, now includes e-vapor products since FDA’s Deeming Regulation became effective on August 8, 2016. For over 50 years, Keller and Heckman has provided global legal counseling in the areas of regulatory law, litigation, and business transactions. With offices in Washington, D.C., Brussels, Paris, San Francisco, and Shanghai, the firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Further details regarding our services and personnel can be found at www.khlaw.com. With respect to e-vapor products specifically, our comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices, dietary supplements, and packaging before FDA and regulatory agencies around the world uniquely positions us to guide e-vapor companies through the Deeming Regulation and other requirements for various products. We currently represent e-liquid and device manufacturers and trade associations in matters of federal, state, and global regulatory compliance. We defend lawsuits, including class actions, against e-liquid companies. We are also currently representing the Right to be Smoke-Free Coalition and a number of industry trade associations in Federal district court in Washington, D.C., challenging aspects of the Deeming Regulation and the Tobacco Control Act. You can learn more about our e-vapor specific practice on our website at www.khlaw.com/evapor.

  1. Without exposing any confidential information or creating a conflict of interest, what types of companies in this industry do you represent? 

We represent a broad spectrum of e-vapor industry stakeholders, including ingredient suppliers, manufacturers (both e-liquid and devices), distributors and retailers, and trade associations of such companies located in the United States and around the world.

  1. What is the R2B foundation? How can businesses help support its cause?

In July 2015, a group of e-liquid companies came together to form the Right to be Smoke-Free Coalition—a non-profit, industry-led trade association of e-vapor businesses dedicated to promoting the interests of the industry, as well as for the right of vapers to be smoke-free. The specific goal of the Coalition is to legally challenge in court unconstitutional state and federal laws related to the vape industry. The first case that we took on for the Coalition was the unconstitutional e-liquid ban in Indiana. We are still fighting that battle in the 7th Circuit Court of Appeals. We are also challenging the approach FDA took in the Deeming Regulation in regulating vapor products.

Specifically, our position is that FDA’s treatment of vapor products, which is more onerous than cigarette products, violates the Administrative Procedure Act (APA), among other laws. Our main concern is that forcing all vapor products on the market today to go through the Premarket Tobacco Application (PMTA) process within 2 years (where each application is expected to cost hundreds of thousands if not millions of dollars), will result in a virtual ban of all products within 3 years. In short, this regulation will kill the industry. That is why we must come together now to fight this regulation and force FDA to take a more reasonable approach.

The FDA litigation is expected to cost between $1-2 million over the next couple of years (including appeals).  The Coalition is actively recruiting responsible vapor companies to join and contribute to the cause. The more reputable companies that join the Coalition, the less the financial burden will be for all members to fight these laws in court. In terms of contribution amounts, companies have donated between $5,000 and $50,000. But, any amount will help! You can join and contribute here: www.r2bsmokefree.org.

  1. What was going through your mind when you started R2B?

The original e-liquid companies that came together—Vapor Shark, Cosmic Fog Vapors, Mt Baker Vapor and NicQuid—recognized that there was a huge need for an industry-led coalition to challenge laws in court, particularly when the lobbying efforts to prevent such laws were unsuccessful. Indiana was the first example of this, but there are many other states with laws that may challenge, including California and Pennsylvania.

  1. What is your background of expertise? How many years have you been experienced in the field?

I have been practicing law for 10 years and am a Partner in Keller and Heckman’s food and drug law group, where I have been focusing on the e-vapor industry since 2009. Beyond my tobacco and e-vapor work, I advise domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, I assist companies in establishing clearances for food and drug additives and food-contact substances. I am also a frequent contributor to the Tobacco Reporter and the Food and Drug Law Institute’s (FDLI’s) Update magazine. I have edited and co-authored FDLI’s upcoming manual: Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. I have also previously served on the Editorial Advisory Board of the Food and Drug Law Journal.

  1. What types of law can your firm practice for potentially interested readers?

We practice in a wide variety of areas of potential interest to your readers including: Advertising & Promotion, Business Counseling and Transactional, Chemical Control (REACH, TSCA), Environmental, Litigation, Product Safety, Telecommunications, Workplace Safety and Health, among other areas. Our full practice list can be found here: http://www.khlaw.com/areas.aspx.

  1. How many partners does Keller Heckman currently have, how many on staff? 

We currently have 41 Partners, 24 of which practice in our food and drug law group. In addition to our legal staff, we have about 20 in-house scientists who work closely with the firm’s attorneys on matters of technical complexity (including e-liquid toxicity assessments, for example).

  1. What are some of the obstacles manufacturers and retailers have to overcome to manufacture finished American vapor products for retail sale in the USA, while now under federal regulation?

Since the Deeming Regulation became effective on August 8, 2016, e-liquid and e-vapor products are now regulated by FDA as tobacco products. That means they are subject to a host of regulatory requirements including establishment registration, product listing, ingredient reporting, health document submissions, warning requirements and, most critically, premarket review via the Premarket Tobacco Product Application (PMTA).  Products on the market on the August 8 effective date can take advantage of a two-year grace period before the PMTA deadline on August 8, 2018. But, new products cannot enter the market today (post-8/8/16) without first getting PMTA authorization.

  1. What are some of the requirements, and the timelines, for manufacturers who had their products on the market before August 8, 2016?

FDA’s full Deeming compliance calendar is available here: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM501016.pdf. For products that were on the market on August 8, 2016, here are the important deadlines:

  • Register facilities and submit product listings by December 31, 2016 for all U.S. establishments (this does not yet apply to foreign establishments, including Chinese manufacturers, but FDA has indicated it will propose a new rule to extend this requirement to foreign establishments).
  • Submit ingredient lists (i.e., product formulations) by February 8, 2017 (or by August 8, 2017) for small-scale manufacturers.
  • Submit health and safety studies (developed between June and December 2009) by February 8, 2017 (or by August 8, 2017 for small-scale manufacturers).
  • Submit PMTAs by August 8, 2018.
  • Have compliant labeling by May 10, 2018 (e.g., name and place of business, quantity of the contents, and “Sale only allowed in the United States” disclaimer), and the nicotine addiction warning by August 8, 2018.
  1. What are some of the scientific requirements of PMTA applications and how would you recommend manufacturers to go about obtaining such information about their products?

The Tobacco Control Act requires a PMTA to include the following:

  • full reports of all investigations of health risks;
  • a full statement of the components, ingredients, additives and properties, and principles of operation of the tobacco product;
  • a full description of methods of manufacturing and processing;
  • an explanation of how the product complies with any applicable tobacco product standards;
  • samples of the product and its components; and
  • specimens of proposed labeling.

FDA has issued a guidance document to assist manufacturers with preparing and submitting a PMTA, which is available here: http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf. The guidance details the information that should be submitted in order to meet the statutory criteria set forth above, and it further recommends the submission of particular additional materials (such as a cover letter and executive summary) that will assist FDA in the review of the submission. Of particular note, FDA has interpreted the provision regarding the “full reports of investigations of health risks” required under the Act to require submission of not only investigations that support the PMTA, but also any investigations that do not support, or are adverse to, the application. FDA further recommends that a PMTA provides information on both nonclinical and clinical investigations, including, but not limited to, any studies assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure, and consumer use profiles. In addition, FDA recommends that manufacturers provide information on (i) investigations concerning products with novel components, ingredients, additives or design features that are similar or related to those of the new tobacco product, and (ii) investigations concerning products that share novel components, ingredients, additives, or design features with the new tobacco product so that FDA may adequately assess the health risks of the product. The PMTA Guidance contains other detailed recommendations to assist manufacturers in making the required statutory showings, including general principles for scientific studies, product chemistry, nonclinical studies, and studies in adult human subjects.

  1. What would you say was the biggest hurdle you had to overcome throughout your venture as one of the partners of Keller Heckman?

The highlight of my career is actually not related to my food and drug or e-vapor practice, but to my pro bono work. A few years ago, I had the opportunity to assist a young boy and his family obtain asylum in the United States. It was a heartbreaking story—my clients had fled their home country of El Salvador because of the physical violence and threats of death they faced at the hands of the notorious, internationally-known criminal enterprise, the Mara Salvatrucha (MS-13). The gang had singled out my clients and an additional family member for refusing to join them, and actually murdered one of the brothers. Although asylum is rarely granted to the victims of gang-based violence abroad, the Executive Office of Immigration Review agreed that my clients’ case was distinguishable from other cases involving victims of gang violence. They are now productive U.S. residents and hope to become citizens.

  1. What’s the firm’s number one goal for the future?

Our goal is to continue to provide creative legal, scientific, and business solutions for our clients. We are here to help you grow your business, using both law and science.

  1. If you yourself could share one piece of advice with retailers what would it be?

Work with reputable suppliers who plan on doing their best to comply with the law itself (check IDs, no free samples, etc.) and help fund the litigation and lobbying efforts to change the law.

  1. If you had all of the vapor product manufacturers in America in one room, what would you say to them?

The industry must come together with one voice if it is going to survive. We are all on the same team.

     15. What are some new regulations or upcoming changes we can expect to see on the market in the  near future?

The Deeming Regulation is a “foundational” rule that gives FDA authority over deemed products, including e-vapor. There will be more regulations in the future covering, for example, advertising restrictions, Good Manufacturing Practices, online sales, and possible restrictions or prohibitions on the use of flavors. Those regulations would have to go through separate Notice and Comment Rulemaking processes and so are likely years away.

On April 19, 2016, the House Appropriations Committee voted to include a bipartisan amendment, sponsored by  Rep. Tom Cole (R – OK) and Rep. Sanford Bishop (D – GA), to the 2017 fiscal year Agricultural Appropriations bill that would amend the February 15, 2007 “grandfather date” for currently unregulated tobacco product categories, including nicotine-containing electronic vaping devices and the “e-liquid” used in them. The U.S. Food and Drug Administration (FDA) is expected to “deem” such e-vapor products subject to its authority under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), pending finalization of the so-called “Deeming Regulation” (FDA-2014-N-0189). The inclusion of the Cole-Bishop Amendment in the appropriations bill has been hailed as a victory for the e-vapor industry, but there remains a long road ahead before this budget amendment can effectively change the statutory grandfather date for deemed products.

In 2009, the Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FDCA) to give FDA authority to regulate the manufacture, distribution, and marketing of tobacco products. Although the new law defined “tobacco product” broadly to include, in pertinent part, anything made or derived from tobacco intended for human consumption, including any components, parts, and accessories of such products, it only gave FDA the immediate authority over certain types of tobacco products, e.g., cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own-tobacco. These four product types are the only product types currently regulated by the FDA under the Tobacco Control Act. In addition, the new law also gave FDA the ability to use its rulemaking procedures to promulgate a regulation that would “deem” other, currently unregulated, tobacco products under its tobacco authority. In April 2014, FDA published a Notice of Proposed Rulemaking for the Deeming Regulation which proposed to extend its regulatory authority to other tobacco products that were not initially captured by the Tobacco Control Act, including cigars, shisha/hookah, pipe tobacco, and e-cigarettes/e-liquid that contain nicotine derived from tobacco.

The Deeming Regulation, as proposed, would treat all deemed products in essentially the same manner as the currently regulated products under a one-size-fits-all regime, subjecting the newly covered products to the same requirements including, among other things, facility registration, product and ingredient disclosures, Harmful and Potentially Harmful Constituent (HPHC) testing and reporting and, critically, the premarket authorization requirements for “new” products. Under the Tobacco Control Act, any regulated tobacco product not marketed on or modified after the February 15, 2007 grandfather date is a “new” product that requires FDA marketing authorization – via either a Premarket Tobacco Application (PMTA) or Substantial Equivalence (SE) Report – before it can enter the market. For more on the Tobacco Control Act requirements that will apply to deemed products including e-vapor products, see “FDA Regulation of E-Cigarettes – Are You Prepared?”

In October 2015, having completed its review of the over 135,000 public comments received, FDA submitted its draft version of the final Deeming Regulation to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs. This is the final step in the rulemaking process. Subsequently, from November 2015 through January 2016, OMB met with industry stakeholders and members of the public health community to hear their concerns about the pending rule. The final rule is expected to be published this year, during the Obama administration according to Mitch Zeller, Director of FDA’s Center for Tobacco Products.

Given that there were virtually no e-vapor products on the market as of February 15, 2007, effectively all e-vapor products would be considered new tobacco products requiring premarket authorization. Further, because the SE process requires a manufacturer to compare their product to a “predicate” product (i.e., a grandfathered product, or a product authorized previously for sale through the SE process), if the grandfather date is not amended, the only pathway to market for e-vapor products would be through the PMTA process. For more on potential alternative grandfather dates for deemed products, see “The Grandfather Date – What are FDA’s Alternatives?”

The Cole-Bishop amendment to the 2017 Agricultural Appropriations bill would change the grandfather date specifically for deemed products from February 15, 2007 to the effective date of the Deeming Regulation (i.e., most likely sometime in 2016). If this amendment becomes law, any nicotine-containing e-vapor products on the market as of the effective date of the final rule would be grandfathered and, although such products would still have to comply with the rest of the Tobacco Control Act, could avoid the lengthy and expensive PMTA process. Grandfathered products could also serve as predicate products for future SE Reports for new products intended to be marketed after the new grandfather date.

In addition to changing the grandfather date for deemed products, the amendment also includes language that will:

-Require FDA to begin rulemaking to establish a product standard for e-vapor product batteries within 1 year of the effective date of the Deeming Regulation, and publish a final product standard for e-vapor product batteries within 2 years of the effective date of the Deeming Regulation.
-Cause an e-vapor product to be considered misbranded under the FDCA if it is advertised in a newspaper, magazine, periodical, or any other publication other than an adult publication (i.e., a publication with 15% or less of its readership from readers younger than 18 years of age, and read by fewer than 2 million persons under 18 years of age).
-Require retailers to sell e-vapor products in direct face-to-face exchanges without the use of any electronic or mechanical devices, such as a vending machine. This provision contains an exemption for mail-order sales (i.e., internet), and allows the use of vending machines or self-service displays if the machine or display is located in a facility where the retailer can ensure no persons under the age of 18 would be permitted to enter (i.e., adult-only facilities).
-Require publication, within 1 year of the effective date of the Deeming Regulation, a regulation that would require e-vapor products to be labeled with the phrases “Keep Out of Reach of Children,” and “Underage Sale Prohibited,” as well as feature an accurate statement of the nicotine content of the product.
-Requires retailers (e.g., vape shops) to register their establishment with FDA unless such retailer has already registered under any state or federal law.

What Next?
While it is certainly good news for the e-vapor industry, the Cole-Bishop amendment still has a long way to go before it becomes law. Both the House and the Senate will eventually have to vote on and pass the Agricultural Appropriations bill (with the amendment), which must ultimately be signed by the President. In addition, it is not yet clear when the bill will advance through Congress and make its way to the President, as recent budget bills have been passed in the final days of the previous fiscal year. It is very possible, if not probable, that the Deeming Regulation will be published before the Agricultural Appropriations bill becomes law, likely leading to additional showdowns between anti-tobacco and vaping advocates over the public health and economic impact of FDA’s rule, and the need to change the grandfather date for deemed products.

If you have any questions about the forthcoming Deeming Regulation and the premarket authorization requirements for new products, please contact us. For more information about our Tobacco and E-Vapor practice, click here.