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.

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.

Azim Chowdhury and Eric Gotting, partners at Keller and Heckman, will discuss the recent decision in the case American Academy of Pediatrics et al. vs. FDA, which struck down the extended premarket review compliance policy for deemed tobacco products.  Find out what the decision will mean to your business, both short and long term.

All vapor and deemed tobacco product industry stakeholders should attend.

See our previous blog posts on this case here and here.

Conference Call Details:

Date: TODAY– Friday, May 17, 2019

Time: 1:00 pm EDT

Registration fee: $50; Smoke-Free Alternatives Trade Association (SFATA) members FREE

Register: Click here to register.

If you are in the Vape Industry, you cannot afford to miss today’s call.

Following a series of actions over the last several months, on November 15, 2018, the U.S. Food and Drug Administration (“FDA”) announced new steps aimed at protecting youth from tobacco, including, among other things, preventing access to flavored electronic nicotine delivery system (“ENDS”) sold in certain retail locations, and potentially banning menthol in combustible tobacco products.[1]  Spurred by the release of new data from the 2018 National Youth Tobacco Survey (“NYTS”) showing a rise in e-cigarette use among youth over the past year, FDA Commissioner Scott Gottlieb, M.D., announced a number of steps to prevent youth access to, and use of, tobacco products, including: (i) directing the Center for Tobacco Products (“CTP”) to revisit FDA’s premarket review compliance policy for flavored ENDS, other than tobacco, mint and menthol flavors, sold in retail outlets that are not adult (18+) only; (ii) directing CTP to publish additional information regarding best practices for age-restricting online sales; (iii) issuing a Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars; (iv) issuing a Proposed Rulemaking to ban, through appropriate means, all flavors in cigars; and (v) advancing a policy that aggressively pursues the removal of ENDS products that appear to too kid-friendly.

National Youth Tobacco Survey Data

On November 15, 2018, the FDA and the U.S. Centers for Disease Control and Prevention (“CDC”) released new findings from the 2018 National Youth Tobacco Survey showing that more than 3.6 million middle and high school students were “current e-cigarette users” – defined as having used e-cigarettes once in the past thirty days – in 2018, which FDA described as a “dramatic increase of more than 1.5 million students since last year.”[2]  As background, the NYTS “is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”[3]

According to the FDA news release, “the number of U.S. high school students who reported being current e-cigarette users increased 78 percent between 2017 and 2018 to 3.05 million (or 20.8 percent).”[4]  Further, “among middle school students, numbers rose 48 percent [from the previous year] to 570,000 (or 4.9 percent) [of total middle school students].”  What is more, the NYTS data showed that high school students who reported being current e-cigarette users reported using these products more frequently.  Indeed, “[i]n the last year, the proportion of those [high school students] using the product more regularly (on 20 or more of the past 30 days) increased from 20 percent to 27.7 percent[.]”[5]  The study authors suggest that rising e-cigarette use in the last year is likely attributable “to the recent popularity of certain types of e-cigarettes, such as JUUL,” noting that these and similar products “have a high nicotine content and come in appealing fruit and candy flavors.”[6]

In his statement, FDA Commissioner Scott Gottlieb, M.D. explained that “[w]e still believe that non-combustible forms of nicotine delivery, such as e-cigarettes, may be less harmful alternatives for currently addicted adult smokers who still seek nicotine[,]” but clarified that “FDA will not allow” the opportunity presented by e-cigarettes “to come at the expense of addicting a whole new generation of kids to nicotine.”[7]  CDC Director, Robert R. Redfield, M.D., echoed these concerns stating that “[t]he markedly accelerating rate of e-cigarette use among U.S. youth within the past year is a cause for grave concern” and noting that it is “critical that we implement proven strategies to protect our Nation’s youth from this preventable health risk.”[8]

FDA Announces New Policy Framework to Combat Rising Youth Use of Tobacco Products, Including ENDS

In response to the NYTS data, FDA announced a new policy framework designed to address rising youth use of tobacco products, including ENDS.

Limiting Sales of Flavored ENDS (Other Than Tobacco, Mint and Menthol) to Adults-Only Retailers  

First, FDA announced that all flavored ENDS products (other than tobacco, mint, and menthol flavors, or non-flavored products) will be required to be sold in age-restricted, in-person locations, or else potentially be subjected to a revised Premarket Tobacco Product Application (“PMTA”) deadline.  This policy revision would apply to all ENDS products, including e-liquids, cartridge-based systems and cigalikes, in flavors except tobacco, mint, and menthol, sold in physical locations where people under age 18 are permitted.[9]  This policy revision would not apply to ENDS products sold exclusively in age-restricted locations (e.g., a stand-alone tobacco retailer (such as a vape shop)) that adequately prevent persons under age 18 from entering the store at any time; or, a section of an establishment that adequately prevents entry of persons under age 18 and prevents persons under age 18 from viewing or accessing flavored ENDS products.[10]  As noted, this policy revision does not apply to ENDS products with tobacco, mint, or menthol flavors, as well as to non-flavored ENDS products, sold in any location.

In other words, vape shops that restrict access to adults (18+) only will be able to continue to sell a wide variety of flavored e-liquids/ENDS.  ENDS products sold in locations that are not adults-only, however, will be limited to only tobacco, mint and menthol flavored products; other flavors (e.g., cherry, vanilla, crème, tropical, melon, etc.) sold in such locations, while not “banned” per se, will be subject to a revised compliance policy that could move the PMTA deadline earlier than the current August 8, 2022 deadline for ENDS products on the market as of August 8, 2016.

The Commissioner also noted that FDA plans to continue to aggressively pursue removing ENDS products marketed to children and/or appealing to youth from the market.  These marketing practices may include “using popular children’s cartoon or animated characters” or “names of products favored by kids like brands of candy or soda.”[11]

Heightened Age Verification for Online Sales

Second, FDA announced that it would seek to curtail the sale of flavored ENDS products (other than tobacco, mint and menthol) that are sold online without “heightened age verification” processes.  To advance this goal, FDA plans to identify and publish a list of best practices for online retailers.

Earlier this week, in addition to promising to cease selling flavored products (other than tobacco, mint and menthol) in all brick-and-mortar retailers, JUUL announced its own comprehensive online age-verification process:

Flavored Cigars and Menthol Cigarettes

Third, FDA announced that flavored cigars will no longer be subject to the extended compliance date for premarket authorization (which currently sets the premarket application deadline for cigars on the market on August 8, 2016 to be August 8, 2021).  However, this policy does not apply to the entire product category, as certain flavored cigars are considered “grandfathered” and exempt from premarket review if they were on the market as of February 15, 2007.[12]  To address this gap in regulatory authority, FDA plans to propose a product standard that would ban all flavored cigars.

Fourth, FDA announced plans to publish a Proposed Rule in the Federal Register that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.

Implications for the ENDS Product Category

FDA’s approach to addressing rising youth use of certain flavored (e.g., non-tobacco, mint, and menthol flavored) cartridge-based e-cigarette products may be effective, but is also potentially subject to legal challenge.  Section 906(d)(3) of the Tobacco Control Act expressly states that “no restrictions under [906(d)(1)] may — (i) prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets.”  Nevertheless, a prohibition on the sale of flavored ENDS at retail outlets (e.g., convenience stores) appears to be precisely what FDA plan to accomplish, albeit through indirect means.

In particular, FDA’s announcement is framed as a withdrawal of an “enforcement discretion” policy, previously applicable to certain flavored ENDS products.  Arguably, the practical effect of this compliance policy revision is a prohibition on the sale of a tobacco product in face-to-face transactions by a specific category of retail outlets (e.g., generally accessible convenience stores).  That said, FDA will likely argue that it is simply reverting to the state of the law at the time of the Deeming Rule.  Further, FDA is likely to justify its policy by noting that it expressly allows sales of flavored ENDS products at all retail outlets, provided that the retail outlet has an “adults-only” section where flavored ENDS products are not visible to youth who may otherwise be in the store.  This action aligns with the requirements currently applicable to the distribution of samples of smokeless tobacco products in “qualified adult[s]-only” facilities.[13]

In any case, only time will tell whether FDA’s actions to address the rise in youth use of tobacco products, including flavored ENDS products, will be effective at curtailing youth access.  In the interim, e-liquid manufacturers will increasingly rely on specialty tobacco product retailers (e.g., “vape shops”) and age-verified online channels to distribute their products to adults.

If you have any questions regarding FDA’s recent announcements contact Azim Chowdhury (chowdhury@khlaw.com) and be sure to register for Keller and Heckman’s 3rd Annual Tobacco and E-Vapor Law Symposium in Miami, Florida on January 29-30, 2019 here.

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[1] U.S. Food & Drug Admin., FDA Statement, Statement From FDA Commissioner Scott Gottlieb, M.D., on Proposed New Steps to Protect Youth by Preventing Access to Flavored Tobacco Products and Banning Menthol in Cigarettes (Nov. 15, 2018) (hereinafter, the “FDA Nov. 15, 2018 Statement”), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM625884.htm?utm_campaign=111518_Statement_FDA%20Commissioner%20statement%20on%20proposals%20to%20address%20youth%20tobacco%20use&utm_medium=email&utm_source=Eloqua.

[2] U.S. Food & Drug Admin., FDA News Release, Results from 2018 National Youth Tobacco Survey Show Dramatic Increase in E-Cigarette Use Among Youth Over Past Year (Nov. 15, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625917.htm?utm_campaign=111518_PR_New%20federal%20findings%20show%20dramatic%20increase%20in%20youth%20e-cigarette%20use&utm_medium=email&utm_source=Eloqua.

[3] Id., supra n.2.

[4] Id.

[5] Id.

[6] Id.

[7] Id.

[8] Id.

[9] FDA Nov. 15, 2018 Statement, supra n.1.

[10] Id.

[11] FDA Nov. 15, 2018 Statement, supra n.1.

[12] Family Smoking Prevention and Tobacco Control Act, Pub. L. 111-31, 123 Stat. 1776 (June 22, 2009) (hereinafter, the “Tobacco Control Act”), at § 910(a)(1)(A) (defining a new tobacco product” as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007”).

[13] Tobacco Control Act, supra n.11, at § 102(d)(2)(A).

The U.S. Food and Drug Administration (FDA) is expected to announce today detailed plans to curtail the growing number of youth who are using certain types of e-cigarette products. Below is a summary of the Agency’s recent actions and compliance deadlines.

September 12, 2018 Letters to Vuse, Blu, JUUL, MarkTen XL, and Logic

  • On September 12, FDA sent letters to the manufacturers of five Electronic Nicotine Delivery System (ENDS) products (Vuse [British America Tobacco], Blu [Imperial Brands], JUUL [JUUL Labs], MarkTen [Altria] and Logic [Japan Tobacco]) “requiring them to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of their products.”  These cartridge-based (closed system) products account for 97% of the closed-system cartridge-based e-cigarette market.
  • FDA indicated that it believes e-cigarette use by youth “is reaching epidemic proportions”.  FDA Commissioner Dr. Scott Gottlieb asked the five manufacturers to “come back to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their products by minors, or [FDA will] revisit the FDA’s exercise of enforcement discretion for [flavored ENDS] products currently on the market.”  Dr. Gottlieb continued, “This may require those brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements.”
  • In an October 31 Statement,  Commissioner Gottlieb announced that he had met with the five manufacturers and heard their comments and proposals on how each company would address sales to minors, and how each company thought FDA should regulate to address the same issue.  Altria subsequently announced that it would cease sales of its MarkTen cartridge-based products, as well as its flavored cigalike products other than tobacco and menthol; Fontem Ventures indicated it will tighten its age-verification process and raise the age for online sales to 21;  and JUUL has announced that it will only permit the sale of flavored products (e.g., cucumber, mango, crème and fruit) through its age-verified online-store, while restricting brick-and-mortar retailers to only tobacco, mint and menthol-flavored pods. JUUL further announced it would be increasing retailer compliance efforts, reduce its social media presence, and develop technology to further reduce the use of its products by youth.

October 12, 2018 Letters to 21 Manufacturers Regarding Potentially Unauthorized New Tobacco Products

  • On October 12, FDA “sent letters to 21 e-cigarette companies . . . seeking information about whether more than 40 products . . . are being illegally marketed and outside the agency’s current compliance policy.”  These letters asked manufacturers to provide documentation within 30 days of receipt demonstrating that the identified products were on the market on August 8, 2016 and have not been modified since that date.
  • This effort is a clear indication that FDA intends to ramp up its enforcement of the marketing authorization provisions and that ENDS products introduced to the market after August 8, 2016 can expect enforcement.

October 22 – 23, 2018 FDA Public Meeting on Tobacco Product Application Review

  • FDA held a meeting (video available) to discuss FDA’s review of premarket applications.
  • Topics included:
    • Substantial Equivalence (and requests for exemption);
    • Premarket Tobacco Product Applications (PMTAs);
    • Modified Risk Tobacco Product Applications (MRTPAs);
    • Pre-submission meetings;
    • Tobacco Product Master Files (TPMFs);
    • Resources available;
    • Environmental Assessments; and
    • Newly Deemed Tobacco Products

November 8, 2018 Ingredient Listing for Small-Scale Tobacco Product Manufacturers

  • Ingredient Listing submissions were due to FDA on November 8 for small-scale manufacturers of Newly Deemed Tobacco Products.  Ingredient listing is a requirement for all tobacco products marketed in the United States, regardless of where manufactured.  For more on ingredient listing, see our most recent blog posts here and here (all ingredient listing related posts are here).
  • For small-scale manufacturers impacted by recent natural disasters, FDA has extended the deadline to submit until May 8, 2019.
  • In a revised guidance published in April 2018, FDA clarified that it now intends to enforce the ingredient listing requirement only with respect to those tobacco product components or parts, such as e-liquids, that are made or derived from tobacco, or contain ingredients that are burned, aerosolized or ingested (i.e., consumed) during use.

December 5, 2018 Public Hearing Announced to Discuss FDA’s Efforts to Eliminate Youth Electronic Cigarette Use

  • As previously reported on Keller and Heckman’s Daily Intake blog, On November 2, 2018 FDA announced a public hearing scheduled for December 5, 2018 to discuss continued efforts to curb e-cigarette use and to aid cessation amongst youth. Topics of interest noted in Dr. Gottlieb’s press release focus on cessation and include:
    • Potential role of drug therapies to support cessation of e-cigarettes and traditional tobacco products use (including cigarettes and smokeless tobacco) amongst youth;
    • Behavioral interventions to aid in cessation;
    • Development of cessation drugs;
    • Development of methods, study designs, and measures for evaluating drugs for use in youth cessation; and
    • Funding opportunities for research on youth use, attitudes, and cessation.

Modification to FDA’s Unified Registration and Listing System Tobacco Registration and Listing Module

  • In early November, FDA updated its FDA Unified Registration and Listing (FURLS) Tobacco Registration and Listing Module (TRLM) to be more user friendly.  The information required for registering a facility and providing product lists does not appear to have changed, but the process should be simpler and more user-friendly.
  • As a reminder, facility registrations must be renewed annually by December 31. 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 by June 30 and December 31 every year.  This means that any labels that have changed to include FDA’s required nicotine warning statement, for example, will need to be updated in FURLS.

Impending FDA Actions

  • In recent weeks, FDA has announced through the press that it is considering banning, or otherwise severely limiting, the sales of flavored (except tobacco and menthol), cartridge-based e-liquids in convenience stores and gas stations, and that it is considering proposing a rule to ban menthol in cigarettes as well as characterizing flavors in other combusted tobacco products (e.g., cigars).

We will report further as additional details of any marketing or other restrictions are released.