The U.S. Food and Drug Administration (FDA) recently released an updated module, “Tobacco Registration and Listing Module Next Generation (TRLM NG)” to its FDA Unified Registration and Listing (FURLS) Tobacco Registration and Listing Module (TRLM) (FURLS TRLM). TRLM NG was developed to better assist industry stakeholders submitting information and to improve system usability.

Section 905(b) of the Family Smoking Prevention and Tobacco Control Act requires the owners and operators of domestic establishments that manufacture, prepare, compound, or process finished tobacco products[i], including deemed tobacco products, to register with FDA and submit product listings. Here, the phrase “manufacture, preparation, compounding, or processing” includes repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product. U.S. tobacco product importers do not register with FDA unless they are also engaged in a manufacturing activity in the United States.

Registered tobacco manufacturers are required to register and/or renew annually with FDA by December 31 each year through TRLM NG module or by paper submission. Changes to product lists to reflect new products being manufactured, products no longer being manufactured, or changes to labeling/packaging, advertising, or consumer information, must be made twice each year – by June 30 and December 31. This means that any labels that have changed to include FDA’s required nicotine warning statement, for example, will need to be updated in TRLM NG.  Paper submissions (i.e., FDA Form 3741 or Form 3741a) must be mailed to CTP’s Document Control Center.

The updated module, TRLM NG, provides the following substantive updates and improvements for industry:

  • Users can manage multiple active and draft registrations in a single account (e., owner, operator, authorized third party, other roles/ registrations under one single account);
  • Improved dashboard capabilities which include a summarized view of registration status and associated establishments;
  • Resources provided to assist users through the listing process;
  • Faster processing and loading speed for searching, filtering, and exporting products and material files listings;
  • A single screen view of product actions with the option to add, edit, and upload, as well as make changes in bulk, to process requests at a faster rate; and
  • Autoscaling capability to handle large data volumes and number of users.

New Users

As noted above, Users will need to register if they did not have a preexisting FURLS TRLM account and the following are applicable:

  • Your tobacco manufacturing establishment (s) is located within the United States; and
  • Your establishment (s) is involved with any of the listed operations: blending, manufacturing, labeling, relabeling, reconstituting/reconstituting tobacco, packaging, repackaging, saucing (or casing) storing, and testing.

Existing Users with a FURLS TRLM Account

On August 31, 2020 FDA sent transition emails to users that already had FURLS TRLM accounts. The transition email contained instructions for activating a user’s TRLM NG account and resetting their passwords. Users do not need to re-enter their registration and product listing information as data that has already been submitted to FDA has automatically transferred/migrated to TRLM NG. TRLM NG has the following roles within the updated system: Primary User and Additional User. These User roles are defined as:

Primary User – The User having the listed email, name, and phone number listed in FURLS TRLM. The Primary User account information will migrate from FURLS TRLM to TRLM NG and will need to create a TRLM NG password. This User account will receive the transition email that was sent on August 31, 2020.

Additional User – Any Additional Users will not be automatically listed in FURLS TRLM NG. Each Additional User will need to create their own TRLM NG account with their name, email, phone number and password to log into TRLM NG.

Primary Users will be the only user to have access to the registrations migrated from legacy TRLM (FURLS TRLM). The Primary User will be able to grant an Additional User access to a specific registration by entering the TRLM NG Username (email) and selecting a role for the User on the specific registration.

If a company cannot access its August 31, 2020 transition email, FDA has advised that the company may first want to check your “junk/spam’ folders. If you continue to have technical difficulties, please contact TRLM NG Helpdesk at CTP-TRLM-NG-Helpdesk@fda.hhs.gov.

For additional assistance, Users may also reference Tobacco Registration and Product Listing Next Generation (TRLM NG) Instructions, TRLM NG User Guide, TRLM NG Training Video, and TRLM NG Frequently Asked Questions (FAQs).

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). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapr. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

[i]  Establishments that do not manufacture “finished” tobacco products should not register with FDA.  FDA considers a tobacco product as finished if the tobacco product, including all components and parts, is sealed in a final packaging intended for consumer use (e.g., filters or filter tubs sold separately to consumers or part of kits).

As a reminder, the registration requirement for domestic U.S. tobacco product manufacturing establishments, including manufacturers of deemed products such as e-liquids and cigars, is a biannual obligation that requires each such establishment to “update” their Registration and Product Listing information with FDA by December 31 every year (product listing information must also be updated by June 30 every year). See Section 905(b) of the Food, Drug, and Cosmetic Act (FDCA) as amended by the Family Smoking and Tobacco Control Act, 21 U.S.C. 387e(b).

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.  By December 31, 2018, all domestic manufacturers of tobacco products will need to log in to their FURLS accounts and confirm that the registration information in the system is correct (or make any necessary changes), and domestic manufacturers of deemed products who updated their product labels after June 30, 2018 to comply with the nicotine addiction warning and other labeling requirements (which became effective on August 10, 2018), will need to upload their new labels and associate them with the correct products.  Domestic manufacturers who have otherwise changed the list of products they manufacture or the label or labeling, advertising, or consumer information for their products will also need to update their product list and associated information.

Although FURLS was recently updated with a more user-friendly interface, the system is notorious for running slowly and glitches during high use periods should be expected (especially if users are attempting to upload many large files).  We encourage anyone who needs to update files in FURLS to develop a plan and to start updates as soon as possible ahead of the deadline.

Tobacco products that are produced in an establishment that is not registered are considered misbranded per FDCA § 903(a)(6) (21 U.S.C. 387c(a)(6)); the sale of a misbranded product is a prohibited act under FDCA § 301(a). In addition, failure to update a tobacco product list or to register a facility are violations of FDCA § 301(p) (21 U.S.C. 331(p)) and can lead to enforcement actions such as fines, seizures, or injunctions.

If you have any questions or need assistance updating your Registration and Listing, please contact Azim Chowdhury at chowdhury@khlaw.com or 202-434-4230 or Ben Wolf at wolf@khlaw.com or 202-434-4103.

Just five days before the September 30, 2017 registration deadline for U.S. manufacturing establishments, on Tuesday, September 26, 2017, the Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, tweeted that due to “website connectivity problems” with the FDA Unified Registration and Listing System (FURLS), FDA would be “implementing a short term extension to allow firms to register”. On September 28, 2017, FDA officially announced via e-mail  that it was revising its guidance once again to extend the Registration and Product Listing deadline for U.S. manufacturing establishments to October 12, 2017. This applies to U.S. manufacturers of deemed products on the market as of August 8, 2016, but of course does not apply to foreign manufacturing establishments or U.S. importers, distributors or retailers not engaged in manufacturing, packaging or labeling activities.

FDA also indicated that if you continue to have technical issues with FURLS you should send an email to CTPRegistrationandListing@fda.hhs.gov with “IT Questions” in the subject line. In the body of the email provide:

  • Name of the Owner or Operator of the establishment;
  • Name and Address of the establishment;
  • Contact phone number; and
  • The best time for FDA to call the contact.
If IT issues prevent you from completing your registration and product listing by October 12, 2017 let FDA know as soon as possible so that they can work with you to address any technical problems.

FDA also recently issued a separate alert noting that establishments affected by Hurricanes Harvey or Irma may also be eligible for a separate extension, determined on a case-by-case basis. If you would like to be considered for such an extension, send an email with the information bulleted above to CTPRegistrationandListing@fda.hhs.gov and the subject line “Natural Disaster”. We also recommend providing a brief description of how the recent natural disasters have impacted your ability to register on time.

On September 15, 2017 FDA published a Revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. Keller and Heckman’s analysis of this revised Guidance, including a summary of how to register and who must register can be found in our previous Client Alert.

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.

Just two weeks before the September 30, 2017 registration deadline for U.S. tobacco product manufacturing establishments, on Friday, September 15, 2017, the U.S. Food and Drug Administration (FDA) published a Revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments .See our original Client Alert summarizing the registration requirements here.

Has the Deadline Changed?

No. Registrations and product listings are still due by September 30, 2017 for U.S. manufacturing establishments. This applies to deemed tobacco products marketed as of August 8, 2016, the effective date of the Deeming Regulation.

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 document (e.g.,ingredient reportshealth 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 3741a and mailing all of the necessary materials to CTP’s Document Control Center.

View FDA’s latest Webinar “Using the Tobacco Registration and Listing Module of FURLS – Tips and Recent Enhancements” here (published September 18, 2017).

Who Registers their Establishments and Submits Product Listing Information?

The revised guidance clarifies that owners and operators of domestic U.S. establishments engaged in manufacturing regulated tobacco products are required to register and provide a product list to FDA. This requirement does not extend to foreign establishments (e.g., e-vapor device manufacturers in China) or U.S. importers, distributors or retailers who merely distribute and sell products, but are not engaged in any manufacturing activity (e.g., manufacture, preparation, compounding, or processing, including bottling, packaging and labeling). FDA also encourages establishment owners to act as the agent for all operators and to register all establishments it owns and to submit the associated product listing, in order to reduce redundant submissions. If you have any questions about how to best structure your registration and product listing for your particular business, please let us know.

What Products Need to be Listed?

Despite the fact that the Form 3741a and the template FURLS product listing spreadsheet provided by FDA allow companies to indicate whether a particular product is for “Consumer Use” or “Further Manufacturing”, FDA’s revised guidance clarifies that the listing requirement only applies to finished tobacco products sealed in final packaging intended for consumers use. This includes components and parts sold directly to consumers in final sealed packaging. For example, an e-liquid sold in a sealed bottle for use by consumers in an open-system device would be a finished tobacco product, but an e-liquid intended to be filled into a closed system cigalike would be for further manufacturing, and should not be listed.
 
What Information Should be Submitted as Part of Establishment Registration and Product Listing?

Registration Information
The following information is needed to register manufacturing establishments:
  • The name and full address of each establishment engaged in manufacturing the registrant owns or operates, as of the date of registration.
  • The name and places of business of the owner or operator. In the case of a partnership, include the name of each partner. In the case of a corporation, include the name of each corporate officer and director, and the State of incorporation.

Optional information includes an email address and a Data Universal Numbering System (D-U-N-S) number or other unique identifier (codes) for the place of business of the owner, the place of business of the operator, and the location of the establishment.

Product Listing Information

For the product list, FDA’s template product listing spreadsheet (available in FURLS) should be used, particularly if you are processing the registration online through FURLS. The spreadsheet identifies the information that must be submitted for each product, e.g., product identification number (SKU), intended use (consumer use), product category (ENDS), subcategory (e-liquid), open/closed system, flavor, and advertising, labeling and consumer information. Please note that each unique product must be identified on your product list including, for example, e-liquids under the same brand or flavor that vary in terms of package (e.g., bottle) size, nicotine strength and/or Propylene Glycol (PG)/Vegetable Glycerin (VG) ratio.

Do I need to submit labels for all my product variations?

In addition, the product listing must include labeling information, but FDA’s revised guidance clarifies that e-liquid manufacturers in particular need not submit labels for all product variations. Specifically, the guidance states (on page 9):

However, FDA recognizes that product listing for some tobacco products may result in numerous labeling submissions that the manufacturer must prepare and submit. For example, variations in package size, nicotine strength, Propylene Glycol (PG)/Vegetable Glycerin (VG) ratio, and flavor can result in thousands of individual product labeling submissions. 

In order to reduce the amount of uploaded labeling submissions, FDA does not, at this time, intend to enforce the requirements that owners and operators submit the labeling for each individual listed tobacco product if the registrant submits the information that represents the labeling for a selected line of products. In deciding whether a registrant’s submitted information falls within this compliance policy, FDA may consider whether the tobacco products’ labeling is essentially identical (e.g., the same formatting, fonts, colors, background text, and images) and whether the variations are limited to package size, nicotine strength, PG/VG ratio, and flavor. However, we recommend that zero nicotine formulas of a product, or product line, be grouped separately from products with nicotine. 

Rather, as described in Appendix A to the revised guidance, registrants may submit a separate “package label plan”, which is a model/generic product label with placeholder text for the specific variations, along with a “product variation index” which lists all the variations for a specific product, e.g. package size, nicotine strength, PG/VG ratio and flavor. The product variation index must list all combinations of the variations that will be using the model label. The examples from FDA’s revised guidance are copied below.

The Package Label Plans, including the Model/Generic Labels and Product Variation Indices can be uploaded in FURLS by creating a single PDF containing the label and the index. Once uploaded into FURLS you will be given the option of associating the file with all applicable products.

Example A – Sample Model Label (Package Label Plan) for nicotine containing products from the revised FDA guidance:
Example A – Product Variation Index
Example B – Sample Model Label (Package Label Plan) for 0 mg nicotine products from the revised FDA guidance:

Example B – Product Variation Index

What about advertisements and “consumer information”?

 

Finally, we note that despite previously implying that this information was optional, FDA’s revised guidance states that if product advertising exists, a representative sampling of such advertisements must be provided with the product listing. FDA interprets “a representative sampling of advertisements” to mean typical advertising material that reflects the full range of promotional statements made for the tobacco product. For example, if more than one magazine advertisement is used, but the promotional content is essentially identical, only one need be submitted.

FDA’s revised guidance further notes that, in addition, the product listing must include “a copy of all consumer information” to the extent the information is not advertising and has not already been provided as a form of product labeling. Consumer information does not include information directed at wholesalers, distributors or retailers where such information is not available to consumers (e.g., product specifications intended for manufacturing purposes, photos of components or parts not intended for individual sale, or communications between companies), but may include items like consumer brochures.

If you are interested in obtaining additional guidance on this topic 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/evaporFollow 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.
Examples
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,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.

What can we expect in 2021 and beyond?

We are excited to announce that Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium is going virtual! The 2021 symposium will be taking place virtually February 9 – 11, 2021. Mark your calendars now!

Registration for this seminar will open in early December. Additional information, including a detailed agenda, will be available soon.

Course Details:
Three-Day Seminar:
February 9 – February 11, 2021

Registration Fee:
Early-bird rate: $649
Regular rate: $849

For questions concerning the 2021 E-Vapor and Tobacco Law Symposium, please contact:
Sara A. Woldai, CMP
Manager, Marketing Meetings & Events
Keller and Heckman LLP
woldai@khlaw.com

On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021) for filing Premarket Tobacco Product Applications (“PMTAs”) due to continuing delays experienced by manufacturers in preparing the applications caused by the COVID-19 pandemic.

The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017. Attached to the petition were 20 declarations demonstrating that many small vapor companies, without an extension, will either have to file incomplete PMTAs or not submit applications at all, thus forcing them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes.

The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the September 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use. In particular, each manufacturer would need to show that it:

  • Has fewer than 50 employees and/or 10MM in annual revenue
  • Only manufactures open system products (g., e-liquids) and does not produce products used in cartridge or pod-based systems
  • Has taken steps to prohibit access by and sales to underage consumers for its brick-and-mortar stores and/or retail websites
  • Will only market to adults and not rely on kid-friendly advertising (g., using age-gated social media accounts)
  • Is otherwise in compliance with TCA and Deeming Rule requirements (g., facility registration, product listings, etc.)
  • Has already made progress in completing PMTAs prior to the September 9, 2020 deadline, but has been materially delayed in one or more tasks due to COVID-19

The court had previously granted a similar request by FDA for a 120-day extension at the beginning of the COVID-19 outbreak, which extended the court’s initial May 2020 deadline to September 9, 2020. The FDA justified the need for the extension based on the extensive impact that the spread of coronavirus was having on U.S. workers and businesses, and particularly on the ability of vapor product manufacturers to complete tasks necessary to file compliant PMTAs. The agency cited to: (i) laboratory testing delays; (ii) the inability of consultants to complete required Environmental Assessments; (iii) suppliers who were unable to provide products (e.g., devices) for testing; (iv) travel restrictions associated with China where key PMTA information is located; and (v) stay-at-home orders forcing employees to work remotely.

The petition and accompanying declarations request an additional 180-day extension given that the COVID-19 conditions justifying the first court extension still exist today and show no signs of improving. Many small manufacturers are still: (i) unable to secure lab testing and consulting services; (ii) obtain PMTA-related information from suppliers (e.g., where flavor producers have not been able to complete Tobacco Product Master Files); (iii) retain or dedicate a sufficient number of employees to work on the applications; and (iv) overcome a steep decline in revenues that would otherwise be used to complete the PMTAs. To prevent a mass exit from the marketplace of small manufacturers and their products, the petition also points to Executive Order 13924, in which President Trump directs agencies like the FDA to grant temporary extensions from regulatory requirements and otherwise exercise enforcement discretion to promote job creation and economic growth during the coronavirus outbreak.

Also critical to the petition’s extension proposal is that it is limited to manufacturers of open system vapor products. FDA has concluded, based on extensive data collected as part of the 2019 National Youth Tobacco Survey (“NYTS”), that flavored, cartridge or pod-based systems are driving underage use, and that open systems should remain on the marketplace to help adult smokers transition away from more dangerous cigarettes. The proposed extension would therefore not be available to larger manufacturers who make products that may attract young consumers. This approach is consistent with FDA’s repeated statements over the years that the agency must balance concerns about minors having access to vapor products with potential health benefits to adults of using less risky, non-combustible options.

Since the petition was filed just over a week ago, nearly 6,000 public comments have been submitted to FDA’s docket (FDA-2020-P-1797) (here). Additional comments can be filed here.

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and “Cinnamon” Nicotine Toothpicks.  FDA’s warning letter focused on the following, specific violations: (1) selling a tobacco product to a minor through the company’s website;  (2) selling unauthorized modified risk tobacco products; and (3) failing to include required nicotine addiction warning statements on both packaging and advertising. In making the illegal sales finding, FDA cited the fact that a person younger than 18 years of age was able to purchase Peppermint Ice Nicotine Toothpicks from the company’s website. The company’s website also contained some advertising claims that came under scrutiny as modified risk claims because they represented that the product presents a lower risk of tobacco-related disease or is less harmful than other commercially marketed tobacco products (such as its website claims, “Nicotine Satisfaction without smoke damage to your lungs” and “Smart Toothpicks – A catalyst to promote a healthier way of life… in a flavorful way!”). The products were also found to be misbranded because both the website and the product packaging were missing the required nicotine addiction warning statement.
  • This action provides an illustration of the Agency’s interpretation of “tobacco product,” which FDA defines broadly as any product made or derived from tobacco that is intended for human consumption. The Agency takes the position that this definition includes novel, non-tobacco products that contain nicotine derived from tobacco, such as nicotine-infused toothpicks. Referring to the nicotine-infused toothpicks as “dissolvable tobacco products,” the Agency concluded that the products are “covered tobacco products” under 21 C.F.R. § 1140.3, and thus subject to the same FDA requirements as other deemed products, including sales restrictions to minors and marketing authorization requirements.
  • This action also signifies the extensive reach of FDA’s regulatory authority, and highlights to others in the growing novel nicotine products industry that FDA remains focused on holding retailers and manufacturers accountable for marketing and sales practices that can lead to increased youth appeal of tobacco products.  In fact, FDA has gone on record to state that it is increasingly focused on “novel nicotine-containing products” as one such way to facilitate youth access and nicotine addiction. Accordingly, others in the industry would be prudent to heed this warning and ensure full compliance with FDA regulations, including heightened age verification for online sales and reviewing product advertising and any use of non-tobacco flavors appealing to minors.

Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California.  Details and Registration information can be found here.

On January 8, 2020 FDA published its latest compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Pursuant to the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of premarket review requirements for the following products:

  • Any flavored, cartridge-based ENDS product (other than a tobacco or menthol-flavored ENDS product);
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

Importantly, FDA also intends to prioritize enforcement of any ENDS product (on the market as of August 8, 2016[1]) that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application). The May 12, 2020 deadline was initially established by a federal district court in Maryland; that decision is now pending appeal in the Fourth Circuit.

With respect to the flavored cartridge/pod-system ban, the definition of “cartridge-based ENDS” in the guidance is somewhat unique and does not fall squarely within meaning of “open” and “closed” systems in industry parlance:

Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system. [Footnote: An example of products that would not be captured by this definition include completely self-contained, disposable products.]

Manufacturers should note that because a cartridge/pod may be “sealed or unsealed” this definition appears to cover devices that use refillable pods. As discussed below, manufacturers of such devices, particularly small and easily-concealable devices, should not assume that their products are safe from immediate enforcement because they are open-systems or sold without flavored e-liquid.

While FDA has identified non-tobacco and non-menthol flavored cartridge-based ENDS (such as the JUUL) as the primary source of rising underage use, the Agency is also targeting (a) manufacturers of all types of ENDS that are not adequately preventing minor access, and (b) any ENDS products (open or closed systems, including e-liquids sold in vape shops) that, in FDA’s view, are targeted to minors or likely to promote ENDS use by minors. FDA’s broad approach could put a significant portion of the vapor industry at risk of immediate enforcement.

When determining whether an ENDS manufacturer is taking or has taken adequate measures to prevent minors’ access to its products, the Agency will consider, for example:

  1. Whether adequate programs to monitor retailer compliance with age-verification and sales restrictions are being implemented;
  2. Whether retailers face manufacturer-established penalties for failing to comply with age verification and sales restrictions, and whether there is a policy of notifying FDA of retailer violations;
  3. If the manufacturer is also a retailer, whether programs have been implemented to ensure age-verification (g., check ID at the door, adult-only access, etc.);
  4. For online sales, whether the manufacturer uses adequate age-verification technology or requires that online retailers use such technology to prevent minor access and underage sales; and
  5. Whether a manufacturer limits or requires retailers to limit the quantity of ENDS products that a customer may purchase in a given period of time (e., no bulk purchases).

When determining whether an ENDS product is targeted to minors or is marketed in a manner that is likely to promote ENDS use by minors, the Agency will consider, for example:

  • Whether the labeling and/or advertising of a product resembles kid-friendly foods and drinks or resemble other non-ENDS products that are appealing to youth. Here FDA highlights the numerous warning letters issued to e-liquid manufacturers since 2018. Those warning letters alleged that the e-liquid products were misbranded and misleading because the labeling and/or advertising of the products (e., color schemes, label images, brand names, etc.) inappropriately imitated specific food products that are generally marketed toward and/or appealing to children, including cereals (e.g., Cinnamon Toast Crunch, Lucky Charms, Fruit Loops, Franken Berry), candies and snacks (e.g., Life Savers, Sour Patch Kids, Gummy Worms, War Heads, Pocky Sticks, Goobers, Tree Top Apple Juice), and desserts (e.g., Unicorn Cakes, Nilla Wafers, Reddi Wip).
  • Whether marketing materials utilize youth appealing cartoon or animated characters or use popular children’s characters and titles;
  • Whether paid social media influencers are used; and
  • Whether a product is promoted for being easily concealable (from parents and teachers, for example). In this regard, FDA makes clear in the guidance that the following types of devices and device features present a unique concern for youth, even if adults may prefer these as well:
    1. Small size that allows for easy concealability and features that facilitate the ease of use (draw activation, prefilled cartridges or pods, and USB rechargeability);
    2. Small size that allow for use in school, quick concealment, product use in a social setting without others’ awareness, and products’ ability to be concealed with other equipment;
    3. Products with no settings to change and very little assembly required; and
    4. Products with features such as pre-filled cartridges, draw activated batteries, and that can be recharged via a USB port, charging adapters or cell phone.

While FDA carved out “self-contained disposable products” from the definition of cartridge-based ENDS as noted above, such products, particularly flavored high-nicotine salt disposables (as opposed to low nicotine cigalikes) could also be targeted by FDA for these reasons.

In short, while FDA’s focus is on flavored cartridge and pod-systems, ENDS companies should be aware that FDA’s guidance is broad enough to capture a wide variety of open and closed-system products that may be viewed by FDA as accessible to youth, marketed to youth or easily used and/or concealed by youth.

Other Deemed Products

With respect to other deemed tobacco products, including cigars and hookah, FDA indicated that available data does not support utilizing limited Agency resources for increased enforcement in advance of the May 12, 2020 premarket application deadline. FDA will make enforcement decisions on a case-by-case basis and intends to prioritize enforcement based on the likelihood of youth use and initiation. Factors the Agency may consider include:

  • What FDA understands about the number of youth currently using the product or category of product;
  • Trends in the numbers of youth use (since 2016);
  • Whether the product contains added flavors;
  • What FDA understands about how the product is typically sold and how likely to impact access and use by minors;
  • What FDA understands about the frequency and other demographics of use by minors.

Based on these factors, given what FDA understands to be their comparatively lower youth usage rates, FDA’s lowest priority among other deemed products include relatively expensive, large hand-rolled cigars that do not have flavors (e.g., fruit, candy, or mint). FDA further states in the guidance that it is actively working towards a proposed rule that would ban the use of characterizing flavors in cigars.

Keep your business in compliance! Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California. Details and Registration information can be found here.

[1]   All deemed tobacco products, including ENDS, intended to be introduced to the U.S. market for the first time after August 8, 2016 still require FDA premarket authorization “up front” and do not qualify for the compliance policy.

Ahead of the Food and Drug Law Institute’s (FDLI) annual Tobacco and Nicotine Products Regulation and Policy Conference in Washington, DC, on October 23, 2019, Keller and Heckman attorneys Ben Wolf and Kathryn Skaggs presented on FDA’s “Pathways to Market” for new tobacco products during the pre-conference seminar, Introduction to Tobacco and Nicotine Law and Regulation. The presentation slides are available here.

Registration is now open for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020, in Irvine, CA.  For more information, click here.