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Ingredients_Listing_Flyer_1260749136

On Tuesday October 2, at 2PM EST, Azim Chowdhury and Ben Wolf will present a webinar, “Ingredients Listing: Walk Through” sponsored by the Smoke-Free Alternatives Trade Association (SFATA). Ingredient listing reports for small-scale tobacco product manufacturers are due by November 8, 2018. This program is recommended for manufacturers of deemed tobacco products, including e-liquids, their management, and staff who are responsible for regulatory compliance. Participants will learn how to prepare and submit ingredient listing reports to FDA. The floor will also open for questions regarding FDA compliance. For more information and to register, click here.

 

ingredient listing (002)2

The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing requirement, respectfully arguing, among other things, that the information required for non-consumable hardware products and components provides no meaningful information to FDA that would help it protect the public health.[1]  On April 13, 2018, just 25 days before the reporting deadline for large manufacturers of deemed tobacco products, FDA published a revised Guidance for Industry: Listing of Ingredients in Tobacco Products.  FDA now intends to enforce the ingredient listing requirement only with respect to those tobacco product components or parts that are made or derived from tobacco, or contain ingredients that are burned, aerosolized or ingested (i.e., consumed) during use.  Although the revised guidance is late – and comes after many companies have spent considerable time and funds to comply with the reporting requirement – it is welcome news for the industry.

The ingredient listing deadlines for the applicable components and parts of deemed finished tobacco products[2], however, have not changed – large manufacturers of such products still have only until May 8, 2018, while small-scale manufacturers[3] have until November 8, 2018.

Manufacturers of vapor devices and finished deemed tobacco product components and parts should keep in mind that FDA’s decision to exempt such products from ingredient listing does not change the fact that these products are still subject to FDA’s premarket authorization requirements.  It remains the case, for example, that any new vapor device intended for introduction into the U.S. market after August 8, 2016 requires Premarket Tobacco Product Application (PMTA) authorization (which requires ingredient information, along with a significant amount of additional data) before it can be marketed, and any devices on the market on August 8, 2016 have until August 8, 2022 before PMTAs are due, and can remain on the market after that date only if PMTAs for the products are accepted by FDA for review.

Components and Parts Subject to Ingredient Listing 

The revised guidance provides examples of “consumable” components and parts that still require ingredient listing including, but not limited to:

  • Cigar filler;
  • Cigar binder;
  • Cigar wrapper;
  • Pipe tobacco;
  • Waterpipe tobacco;
  • E-liquids;
  • Cigarette tobacco;
  • Cigarette paper;
  • Smokeless tobacco;
  • Roll-your-own (RYO) tobacco;
  • RYO rolling paper;
  • RYO tube; and
  • Cigarette filter that contains any ingredient that burns, aerosolizes, or is ingested during use (e.g., cigarette filter with menthol because the menthol will aerosolize during cigarette smoking).

Ingredients of tobacco product components and parts that are not made or derived from tobacco or consumed during use, e.g., pipes, hookah apparatus, vapor devices, etc., need not be submitted to FDA.  Examples of components or parts for which FDA does not intend to enforce the ingredient listing submission requirement at this time include, but are not limited to:

  • Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors;
  • System software;
  • Digital display, lights, and buttons to adjust settings;
  • Connection adapters;
  • Cartomizers;
  • Coils;
  • Wicks;
  • Tanks;
  • Mouthpieces;
  • Pipes;
  • Waterpipes;
  • Hoses;
  • Bowls;
  • Charcoal; and
  • Cigarette filter that does not contain any ingredient that is burned, aerosolized, or ingested during tobacco use.

Based on this, e-liquid manufacturers need only provide ingredient information on the liquid component of their products, not other non-consumable components such as bottles, drippers and packaging.  FDA expects to receive ingredient information for these non-consumable components and parts during its pre-market review of finished tobacco products (e.g., Premarket Tobacco Applications and Substantial Equivalence Reports).

Single Submissions for Multiple Products

With respect to consumable components and parts, the revised guidance also now makes clear that there are a number of situations where ingredients for multiple products may be listed together under a single submission, provided all of the different brands/subbrands and product sizes for the associated products in the submission are identified.  Examples of situations allowing a single ingredient listing for multiple products are provided in the guidance as follows:

  • Identical per weight composition of ingredients for tobacco products sold under multiple brands/subbrands:
    • Pipe tobacco with identical per weight composition of ingredients sold under 30 brands/subbrands;
    • E-liquids with identical per weight composition of ingredients sold under 200 brands/subbrands; and
    • Waterpipe (shisha) tobacco with identical per weight composition of ingredients sold under 15 brands/subbrands.
  • Identical per weight composition of ingredients for tobacco products sold in multiple product sizes:
    • E-liquid with identical per weight composition of ingredients sold in volumes of 30mL, 60mL, 90mL or sold in a range of product sizes (e.g., 20mL-100mL);
    • Pipe tobacco with identical per weight composition of ingredients sold in product sizes of 5g, 10g, 50g;
    • Waterpipe (shisha) tobacco with identical per weight composition of ingredients sold in product sizes of 100g, 200g, 500g; and
    • Pouched snus with identical per weight composition of ingredients sold in a can of 12 snus sachets or a can of 15 snus sachets.

For open-system e-liquids more specifically, the revised guidance indicates that manufacturers can satisfy the ingredient listing requirement by providing one listing that corresponds to multiple products if the manufacturer sells e-liquids that (1) are identical in chemical composition to one another or (2) are identical in chemical composition to one another except the quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine differ.8 For example:

  • E-liquids with identical nicotine concentrations (e.g., 0.5 mg/ml nicotine) but varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and all other ingredients having identical per weight composition.
  • E-liquids with identical PG/VG ratio (e.g., 50/50) but different nicotine concentrations (e.g., 0.5, 1.0 1.5 mg/ml) and all other ingredients having identical per weight composition.
  • E-liquids with varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and different nicotine concentrations (e.g., 0.5, 1, 2 mg/mL) with all other ingredients having identical per weight composition.

However, changes to relative ratios of ingredients or to the quality or type of an ingredient will require separate submissions.  For e-liquids, the revised guidance provides several examples of when separate submissions to correspond to each brand/subbrand of a product are required:

  • E-liquids that have identical PG/VG chemical structure, but the nicotine chemical structure is different (e.g., moving from free nicotine to nicotine salt), even with identical per weight composition of all other ingredients.
  • E-liquids that have identical PG/VG chemical structure and identical nicotine chemical structure but where the per weight composition of all other ingredients is different in any way (e.g., increased amount of cherry flavor #1 added when all other ingredient ratios stay the same).
  • E-liquids where the grade of the PG/VG is different in any way (e.g., percent purity changes).

For more detailed background on the ingredient listing information needed and submission process, see here.

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

 

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

[2]              The term “finished tobacco product” means a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. Components and parts that are sold separately from other tobacco products are finished tobacco products if they are sold in final packaging intended for consumer use.

[3]           The term small-scale tobacco product manufacturer means a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with.

eSubmitter logo

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

Upcoming Deadlines

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

Information Required

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

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

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

Submission Process

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

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

Preparing Reports in eSubmitter

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

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

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

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

New eSubmitter Spreadsheets

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

When are the Ingredient Listing Reports Due?

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

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

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

Who Submits Ingredient Listing Information?

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

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

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

What Products are Subject to Ingredient Listing?

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

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

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

How to Submit Ingredient Information

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

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

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

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

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

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

What Information Is Submitted With the List of Ingredients?

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

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

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

We discuss each item below.

1. Manufacturer/Importer Identification

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

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

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

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

3. Ingredient Identification

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

  • Tobacco
  • Substances
  • Compounds
  • Additives

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

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

a. Single Chemical Substance

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

Unique scientific names or codes, include:

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

b. Complex Purchased Ingredient

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

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

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

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

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

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

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

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

c. Reaction Products

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

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

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

On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP),[1] which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products[2]. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize and prevent additional risks associated with such products and apply to both domestic and foreign manufacturers of finished and bulk tobacco products.

A finished tobacco product is defined as a tobacco product, including any component or part, sealed in packaging, such as a pack of cigarettes, intended for consumers, while a bulk tobacco product is defined as a tobacco product that is not sealed in final packaging but is otherwise suitable for consumer use[3]. A tobacco product manufacturer is defined as any person(s), including a repacker or relabler, who manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished or bulk tobacco product for sale or distribution in the United States[4]. Of note, under the proposed rule, small tobacco product manufacturers, defined as a manufacturer that employs fewer than 350 employees[5], would not need to comply with the TPMP requirements until four (4) years after the effective date of the final rule. FDA notes that this is consistent with Section 906(e)(1)(B)(v) of the Food, Drug and Cosmetic (FD&C) Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA), and would provide small businesses with sufficient time to implement the proposed requirements[6]. Moreover, manufacturers would only be required to comply with requirements applicable to its finished and bulk tobacco product manufacturing operations. Thus, smaller tobacco product manufacturers (such as vape shops that engage in some but not all of the activities described in the proposed rule) would be able to tailor their procedures to suit their smaller operations while still complying with the TPMP requirements[7].

With respect to vape shops in particular, the proposed rule clarifies that such establishments that only sell ENDS products and components and parts would not be considered manufacturers and would not be subject to the requirements in the proposed TPMP rule unless they also engage in the manufacture, preproduction design validation, packing, and storage of finished or bulk tobacco products within the meaning of the rule[8]. While vape shop owners will certainly appreciate the compliance extension, it is not clear how many vape shop e-liquid manufacturers will survive the next four years, given the nearly insurmountable PMTA process and FDA’s continued enforcement focus on these small U.S. businesses with de minimis market share.

In addition, while the proposed rule clearly states that TPMPs will apply to foreign manufacturers to ensure that imported tobacco products comply with the TCA and applicable tobacco product standards, it is important to note that the rule does not require foreign manufacturing establishments, including China-based manufacturers largely responsible for producing counterfeit and otherwise illegal disposable ENDS, to register their establishments with or provide a product list to FDA. Section 905(b) of the TCA made this a requirement for domestic manufacturing establishments, but left it up to FDA to extend to foreign manufacturing establishments through the rulemaking process[9]. In other words, FDA is not using the proposed TPMP rule to execute its authority provided by Congress under Section 905(h) of the TCA to promulgate a regulation to extend the registration and product listing requirement to foreign establishments. This also means that foreign manufacturers will not be subject to regular, biennial inspections required for domestic establishments, although the agency has broad authority and ability to inspect foreign manufacturers pursuant to Sections 704 and 905 of the FD&C Act, and as part of the Premarket Tobacco Product Application (PMTA) review process under 21 C.F.R. § 1114.27.  

Summary of Proposed Rule

The proposed rule, which is expected to be codified at 21 C.F.R. Part 1120, establishes a framework of requirements that tobacco product manufacturers to follow, including:

  • Establishing tobacco product design and development controls to prevent or minimize certain risks;
  • Ensuring that finished and bulk tobacco products are manufactured in conformance with established specifications;
  • Minimizing the likelihood of the manufacture and distribution of nonconforming tobacco products;
  • Requiring investigation and identification of nonconforming tobacco products, including those that have been distributed, in order to institute appropriate corrective actions, such as conducting a recall as needed;
  • Taking appropriate measures to prevent contamination of tobacco products; and
  • Establishing traceability to account for all components or parts, ingredients, additives, and materials, as well as each batch of finished or bulk tobacco product, to aid in the investigation and identification of nonconforming tobacco products. 

Specifically, the proposed rule is divided into ten subparts, as follows:

1) Subpart A – General Provisions

Subpart A describes the purpose and scope of the proposed rule. As noted above, the proposed rule applies to both domestic and foreign manufacturers of finished and bulk tobacco products, requiring such manufacturers to adhere to the framework of requirements. 

2) Subpart B – Management System Requirements

Subpart B has three sections, as follows:

  • Organization and personnel, which requires establishing and maintaining an organizational structure with sufficient personnel and designated responsibilities, including management personnel with executive responsibility;
  • Tobacco product complaints, which requires establishing and maintaining procedures for handling the receipt, evaluation, and documentation of any complaints; and
  • Corrective and preventive actions (CAPA) are necessary to protect public health, which requires establishing and maintaining procedures for implementing such actions. 

3) Subpart C – Buildings, Facilities, and Equipment

Subpart C has four sections, as follows:

  • Personnel practices, which requires establishing and maintaining procedures related to personnel practices to reduce the risk of contamination with filth biological materials, chemical hazards, or other deleterious substances;
  • Buildings, facilities, and grounds, which requires ensuring that buildings and facilities are of suitable construction, design, and location to facilitate cleaning and sanitation, maintenance, and proper operation, as well as ensuring that grounds are maintained in a condition to prevent contamination;
  • Equipment, which provides requirements for the design, construction, and maintenance of equipment used in the manufacturing process, as well as requirements for testing, monitoring, and measuring such equipment; and
  • Environmental controls, which requires that systems be maintained and monitored to verify that environmental controls are adequate and functional. 

4) Subpart D – Design and Development Controls

Subpart D has two sections, as follows:

  • Design and development activities, which requires establishing and maintaining procedures to control the design and development of tobacco products, including the control of risks associated with the product, the manufacturing process, packaging, and storage, as well as procedures for design verification and validation, and requires developing a process for identifying, analyzing, and evaluating known and reasonably foreseeable risks associated with the tobacco product and its packaging and taking appropriate measures to reduce or eliminate risks; and
  • Master manufacturing record (MMR), which requires establishing and maintaining an MMR for each finished and bulk tobacco product manufactured for distribution, including tobacco product specifications, manufacturing methods and production process procedures, and all packaging, labeling, and labels approved for use with the product. 

5) Subpart E – Process Controls

Subpart E contains nine sections, as follows:

  • Purchasing controls, which requires establishing and maintaining procedures for ensuring that purchased or otherwise received products and services related to the manufacture of finished or bulk tobacco products are from qualified suppliers and conform to established specifications;
  • Acceptance activities, which requires establishing and maintaining procedures for incoming, in-process, and/or final acceptance activities, including acceptance criteria, to ensure that products meet established specifications;
  • Production processes and controls, which requires establishing and maintaining procedures for production processes, including process specifications and process controls, process validation, and manual methods and manufacturing material;
  • Laboratory controls, which requires demonstrating laboratory competency to perform laboratory activities associated with the manufacture of finished and bulk tobacco products and establishing and maintaining appropriate laboratory control procedures;
  • Production records, which requires establishing and maintaining procedures for ensuring that a production record is prepared for each batch of finished or bulk tobacco product to demonstrate conformity with the requirements established under the MMR;
  • Sampling, which requires establishing and maintaining an adequate sampling plan that uses representative samples based on a valid scientific rationale;
  • Nonconforming tobacco products, which requires establishing and maintaining procedures for the control and disposition of nonconforming tobacco products, including specific requirements for identification and segregation, investigation, and disposition and follow-up
  • Returned tobacco products, which requires establishing and maintaining procedures for the control and disposition of returned tobacco products, including specific requirements for identification, segregation, evaluation, and disposition; and
  • Reprocessing and rework, which provides specific requirements for the evaluation of the tobacco product to determine that it is appropriate for reprocessing or rework, authorization of the reprocessing or rework, and production processes, including process controls, to ensure that reprocessed and reworked tobacco product conforms to MMR specifications. 

6) Subpart F – Packaging and Labeling Controls

Subpart F contains four sections, as follows:

  • Packaging and labeling controls, which requires establishing and maintaining procedures for ensuring that the correct packaging and labeling are used to prevent mix-ups, ensuring that all packaging and labeling are approved for use by the manufacturer and comply with all requirements of the MMR as well as other applicable requirements promulgated by FDA, ensuring that packaging and labeling control procedures to ensure that labels are indelibly printed on or permanently affixed to finished and bulk tobacco product packages, and ensuring that the packaging, labeling, storage, and shipping cases do not contaminate or otherwise render the tobacco product adulterated or misbranded;
  • Repackaging and relabeling, which requires establishing and maintaining procedures for repackaging and relabeling operations;
  • Manufacturing code, which requires applying a manufacturing code that contains the manufacturing date and batch number to the packaging or label of all finished and bulk tobacco products; and
  • Warning plans, which requires establishing and maintaining procedures for implementing the requirements of such plans. 

7) Subpart G – Handling, Storage, and Distribution

Subpart G contains two sections, as follows:

  • Handling and storage, which requires establishing and maintaining procedures to ensure that tobacco products are handled and stored under appropriate conditions to prevent nonconforming products as well as mix-ups, deterioration, contamination, adulteration, and misbranding of tobacco products; and
  • Distribution, which requires establishing and maintaining procedures to ensure that tobacco products are distributed to the initial consignee under appropriate conditions and that only those finished and bulk tobacco products approved for release are distributed. 

8) Subpart H – Recordkeeping and Document Controls

Subpart H requires that all documents and records be maintained at the manufacturing establishment or another location that is readily accessible to responsible individuals of the manufacturer and to FDA and that they be written in English, or an English translation be made available upon request. Additionally, documents and records associated with a batch of finished or bulk tobacco product must be retained for a period of at least four years from the date of distribution of the batch or until the product reaches its expiration date, if one exists, whichever is later, while documents and records that are not associated with a batch of finished or bulk tobacco product must be retained for a period of at least four years from the date they were last in effect. 

9) Subpart I – Small Tobacco Product Manufacturers

Subpart I provides that small tobacco product manufacturers, defined as tobacco product manufacturers that employ fewer than 350 employees, are not required to comply with the proposed rule until four years after the effective date of the Final Rule. 

10) Subpart J – Exemptions and Variances

Finally, Subpart J contains five sections that set forth procedures and requirements for petitioning for a permanent or temporary exemption or variance from any of the proposed requirements. 

Next Steps

The proposed rule is open to public comments for 180 days, until 11:59 PM (Eastern) on September 6, 2023. As part of the rulemaking process, FDA will review all comments received, conduct a comment analysis, and decide whether to (i) proceed with the proposed rule; (ii) issue a modified proposed rule based on the comments received; or (iii) withdraw the proposed rule. Depending on how many comments are received, we anticipate it will take FDA at least two years to finalize the TPMP rule.

FDA will host a public hearing on April 12, 2023, to gather comments from stakeholders, including industry, the scientific community, advocacy groups, and the public. FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18, 2023, to seek recommendations from FDA’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations.

[1] 88 Fed. Reg. 15174 (March 10, 2023), available at: https://www.federalregister.gov/documents/2023/03/10/2023-04591/requirements-for-tobacco-product-manufacturing-practice. 

[2] See United States Food and Drug Administration, “FDA Proposes New Requirements for Tobacco Product Manufacturing Practices” (March 8, 2023), available at: https://www.fda.gov/news-events/press-announcements/fda-proposes-new-requirements-tobacco-product-manufacturing-practices. 

[3] 88 Fed. Reg. 15174, 15253 (March 10, 2023). 

[4] Id. at 15174, 15254. 

[5] The proposed rule indicates that, for purposes of this definition, the number of employees of a manufacturer includes those employees and personnel of each entity that controls, is controlled by, or is under common control with such manufacturer. Id. 

[6] Id. at 15174, 15237. 

[7] Id. at 15174, 15186. 

[8] Id.

[9] See United States Food and Drug Administration, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments: Guidance for Industry” (December 2017), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/registration-and-product-listing-owners-and-operators-domestic-tobacco-product-establishments. 

To be placed on the European Union market, tobacco and related products must comply with specific requirements and procedures, harmonized at the European level by Directive 2014/40/EU concerning the manufacture, presentation, and sale of tobacco and related products (hereinafter the “Tobacco Products Directive” or the “Directive”). This article provides a general overview of the requirements and procedures necessary to comply with the Tobacco Products Directive. This is the first of a series of articles that we will publish on marketing tobacco and related products in the EU. Future articles will address specific insights on (i) ingredients requirements and flavor bans, (ii) notification and reporting obligations under the Directive, (iii) labeling and packaging of tobacco products, and (iv) implementation of the Directive by the European Member States.

I. Scope of the Directive: Heated Tobacco Products Now Included

The Directive applies to electronic cigarettes, herbal products for smoking, and tobacco products. Under the Directive, “tobacco products” include pipe tobacco, roll-your-own tobacco, smokeless tobacco, cigarettes, cigars, cigarillos, waterpipe tobacco, and novel tobacco products. ‘Novel tobacco products’ is a new and open category introduced by the Directive, which encompasses all tobacco products not falling under the one previously mentioned and that are placed on the market after May 19, 2014. Following the Commission Delegated Directive (EU) 2022/2100, which became effective on November 23, 2022, novel tobacco products include ‘Heated Tobacco Products,’ which are defined as a product  “that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by user(s), and that, depending on its characteristics, is a smokeless tobacco product or a tobacco product for smoking.”

II. Notification and Reporting Obligations

Under the Tobacco Products Directive, prior to placing a product on the market, manufacturers and importers of tobacco products and e-cigarettes must submit to the Member State authorities specific information containing details on (i) ingredients, accompanied by relevant toxicological data, (ii) emissions resulting from the use of the products, (iii) studies and market research on smokers, ingredients and emissions, and (iv) on a yearly basis, information on the sales volumes of the products. Enhanced reporting obligations apply to cigarettes and roll-your-own tobacco products only if they contain additives on a priority list[1]. For electronic cigarettes, additional information includes components of the product, a description of the production process, and the nicotine doses and the nicotine uptake (i.e., the body absorption). The above information must be submitted through an electronic entry gate, common for all Member States of the European Union (also known as “the EU Common Entry Gate”).

III. Product Requirements

Emission levels and ingredients

The Tobacco Products Directive sets forth requirements on maximum emission levels, measurement methods, and standards (the latter for cigarettes only) and prohibits the use of ingredients that (i) are listed in the Directive,[2] (ii) have carcinogenic, mutagenic, or reprotoxic (CMR) properties, or (iii) pose a risk to human health (for tobacco products and electronic cigarettes). The use of flavorings is banned in cigarettes and roll-your-own tobacco. Importantly, the flavor ban will apply (as of October 23, 2023) to heated tobacco products as well, pursuant to recent Directive (EU) 2022/2100. Further to the above, the Directive also provides specific product requirements for electronic cigarettes, such as maximum nicotine levels (20 mg/mL), volume requirements for refill containers and cartridges, and mechanical requirements for electronic cigarettes and refill containers.

Labeling and packaging

The Directive also regulates certain aspects of the labeling, packaging, and presentation of tobacco products, electronic cigarettes, and herbal products for smoking. For each of these product categories, the mandatory health warnings required to be placed on the product packaging are provided in the Directive.

Traceability requirements

For tobacco products only, the Directive sets out a traceability system in order to address the issue of illicit trade[3]. Under the traceability system, (i) all unit packets of tobacco products must be marked with a unique identifier and a tamper-proof security feature enabling authorities and consumers to verify their authenticity, and (ii) economic operators in the supply chain must maintain records of the traceability of the products and transmit the related information to an independent provider of a repository, approved by the EU Commission, that stores therein the data transmitted. The competent authorities of the Member States and the Commission have access to the data stored in the repositories to ensure compliance with the tobacco products legislation.

Cross-border distance sales of tobacco products

Specific requirements (i.e., registration and verification obligations) apply to cross-border distance sales of tobacco products and electronic cigarettes. Cross-border distance sales may also be prohibited by Member States[4]. 

IV. Implementation of the Directive by the EU Member States

In general, EU Directives only set forth the objectives that all EU countries must achieve. However, it is up to the individual Member States to devise their own laws on how to achieve the objectives within the Directive. It follows that (i) Directives need to be implemented in each EU Member State to be enforceable and that (ii) the Directives may be, in practice, implemented differently in each Member State[5]. In this regard, we note that pursuant to the Tobacco Products Directive:

  • Member States may maintain or introduce further requirements in relation to the standardization of the packaging of tobacco products when justified on the grounds of public health;
  • Member States may also prohibit a certain category of tobacco or related products, provided again, the provisions are justified by the need to protect public health

V. Revision of the Tobacco Products Directive

The European Commission is currently reviewing the Tobacco Products Directive, aiming to address issues such as further enforcement of the current regime for cross-border distance sales, emerging novel tobacco products, regulatory challenges posed by heated tobacco products and electronic cigarettes, new herbal products entering the market, and options to increase tobacco manufacturers’ liability[6].  According to the European Commission’s Implementation Roadmap[7] of Europe’s Beating Cancer Plan, the Commission is expected to adopt a proposal for the revision of the Tobacco Products Directive in 2024.

VI. Conclusion

In summary, the Tobacco Products Directive establishes numerous and detailed provisions that manufacturers must take into consideration when placing electronic cigarettes and tobacco products on the European Union market. Given the numerous requirements, differences in Member State implementation of the Directive, upcoming flavor bans, and anticipated revisions to the Directive, companies must take a careful approach and monitor developments closely to ensure compliance and avoid enforcement.  

We will be covering EU regulation of tobacco products in detail at Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

[1] Decision (EU) 2016/787 laying down a priority list of additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations. This is a list containing the most commonly used additives, for which there are indications that they:  a) contribute to/increase the toxicity or addictiveness of the products, or b) result in a characterizing flavor, or c) facilitate inhalation or nicotine uptake, or d) leads to the formation/increase of CMR substances/their quantities.

[2] The list is provided by Article 7.6 of the Tobacco Products Directive.

[3] See Par. 5 (Traceability and security features) of the Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products of May 20, 2021 (the “2021 Commission Report”).

[4] According to the 2021 Commission Report, more than half of the Member States banned cross-border distance sales of tobacco and/or related products to consumers in their countries (Par. 6 Cross-border distance sales).

[5] We note that aspects not harmonized by the Directive may be regulated autonomously by the Member States. For example, the Directive (recital 47) mentions that it does not harmonize all aspects of electronic cigarettes or refill containers and that the responsibility for adopting rules on flavors remains with the Member States.

[6] See the 2021 Commission Report.

[7] Europe’s Beating Cancer Plan: Implementation Roadmap was published in November 2021 and is available here: https://health.ec.europa.eu/latest-updates/europes-beating-cancer-plan-implementation-roadmap-2021-11-17_en.

Yesterday, Janet Woodcock, M.D., the Principle Deputy Commissioner for the Office of the FDA Commissioner, released a statement regarding the Agency’s approach towards cannabidiol (CBD) and its application in the food and drug industry.

The statement provided that FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products.  The working group examined studies related to the CBD-based drug Epidiolex, as well as published scientific literature and information submitted to a public docket. Following review, the working group concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage potential long-term risks from frequent exposure. FDA is expecting to collaborate with Congress on this matter; however, the timeline for action remains unknown.

Woodcock, on behalf of FDA, stated: “[s]ome risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”

FDA also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

Keller and Heckman will continue to monitor and report on matters impacting the CBD industry.

We will be covering this topic in detail at Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here. To learn more about Keller and Heckman’s Cannabis, Hemp, and Cannabinoids (CBD) practice, see here.

From December 5-7, 2022, Keller and Heckman hosted a private conference with the China State Tobacco Monopoly Administration (STMA) on the topic of U.S. and global e-cigarette and tobacco product regulation. The event was approved by China’s Ministry of Science and Technology (MOST) and was attended by over 700 officials from STMA and its local subsidiaries across China. The event was co-sponsored by Gladen (Shanghai) International Trading Co., Ltd., a leading tobacco ingredient supplier in China.

China amended its tobacco monopoly law in 2021 to regulate e-cigarettes, officially placing e-cigarettes and raw materials (i.e., e-liquids as well as nicotine for use in e-cigarettes) under the “monopoly management” of STMA. Since then, STMA has issued dozens of regulations applicable to e-cigarettes intended for domestic sale as well as for export to overseas markets. Over 95% of all the world’s e-cigarette hardware is made in Shenzhen, China.

During the three-day intensive online training, which included several hours of live Q&A, Keller and Heckman attorneys provided detailed guidance on the regulation of e-cigarettes and tobacco products in the United States, European Union, and some Asia Pacific jurisdictions, particularly focusing on the U.S. regulatory framework for premarket authorization, good manufacturing practices, import and export requirements, state laws, as well as global market trends. Keller and Heckman attorneys Azim Chowdhury, David Ettinger, Eric Gu, Neelam Gill, Daniel McGee, and Elisa Giusto presented at the event, along with guest speaker Tim Phillips, Managing Director of ECigIntelligence.

David Ettinger, Managing Partner of Keller and Heckman’s Shanghai Office, and Eric Gu, will be discussing the situation in China at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on February 15-16, 2023. Register for the seminar here.

Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (FDA) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act.[1]

In 2020, the United States District Court for the District of Columbia (the “Court”) issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5, and remanding the final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency.[2] On August 19, 2020, the Court issued a ruling, in part, to prohibit FDA enforcement of the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the Agency considers developing a streamlined substantial equivalence process specifically for premium cigars.

Now, the Court has addressed the central issue of whether FDA should have ever deemed premium cigars to be subject to the Tobacco Control Act in the first place – ruling that doing so was arbitrary and capricious in violation of the Administrative Procedure Act (APA). The ruling does not apply to little cigars or cigarillos.[3]

By way of background, in 2014, the FDA promulgated the notice of proposed rulemaking (NPRM) for the long-awaited Deeming Rule. In the NPRM, FDA proposed two options defining the scope of the rule. Under “Option 1,” FDA would deem all products meeting the statutory definition of “tobacco product,” including premium cigars, to be subject to its regulatory authority, while under “Option 2,” FDA would exclude premium cigars from its regulatory authority.[4] FDA sought comments on these options, to “determine whether all cigars should be subject to deeming and what provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.”[5]

Of note, the Cigar Rights of America (CRA) in conjunction with the Cigar Association of America and the Premium Cigar Association, submitted comments to the NPRM regarding the usage patterns of premium cigar consumers, asserting the majority of premium cigar consumers are adults over 40 years old and only occasionally smoke the products, indicating that premium cigars do not pose the same type of public health concerns, including youth usage, as other tobacco products. The groups noted that the vast majority of premium cigar smokers are adults who rarely use premium cigars (71.2%), that only 3.3% reported ‘every day’ use, and 25.6% reported ‘someday’ use.

Notwithstanding such comments, FDA issued the final Deeming Rule, which became effective on August 8, 2016, and immediately deemed all products meeting the statutory definition of “tobacco product,” including premium cigars, to be subject to its regulatory authority (i.e., Option 1).[6] Specifically, FDA concluded that “there were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.”[7]

Following the publication of the final rule, the Cigar Association of America, the Premium Cigar Association, and the CRA (the Plaintiffs) collectively challenged the final rule, arguing that FDA’s decision to deem premium cigars and thereby subject them to the Tobacco Control Act requirements, including premarket authorization for new products, was arbitrary and capricious. The groups asserted:

  • FDA erroneously decided to deem premium cigars, based on an alleged lack of evidence in the administrative record of different usage patterns for premium cigar consumers, when in fact there was such evidence submitted by the CRA;
  • FDA erroneously concluded that there was significant youth usage of premium cigars further justifying regulation, based on a misinterpretation of one particular study; and
  • FDA failed to adequately conduct a cost-benefit analysis under the Regulatory Flexibility Act (RFA) of how regulating premium cigars would promote public health.[8]

In a Memorandum Opinion and Order issued on July 5, 2022, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia ruled that FDA’s decision to deem premium cigars was indeed arbitrary and capricious.[9] Specifically, the Court found that there was pertinent record evidence on premium cigar usage, but that FDA failed to adequately consider the submitted comments and data, despite signaling during rulemaking (i.e., the presentation of the two options) that evidence of different usage patterns and public health impacts would be a central consideration in deciding whether to exclude premium cigars from the scope of the final rule.[10] In short, Judge Mehta found FDA ignored relevant data about the population health risks of premium cigar use.

Before issuing a final ruling vacating the Deeming Rule for premium cigars, or remanding the rule back to FDA for further consideration, for example, the Court has asked the parties to submit briefs proposing potential remedies by July 26, 2022. We will continue to monitor this case, so stay tuned for updates.

[1] See Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 79 Federal Register 23,141 (Apr. 25, 2014).

[2] See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020).

[3] One issue for the Court to confirm in a final decision is how to define “premium cigar.” For the purposes of the August 2020 decision on premarket authorization requirements, for example, a premium cigar was defined as a cigar that meets all of the following eight criteria: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units.

[4] Id. at 23,143–23,145.

[5] Id. at 23,143.

[6] See final rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Federal Register 28,973 (May 10, 2016) (codified at 21 C.F.R. §§ 1100, 1140, 1143).

[7] Id. at 29,020.

[8] See Cigar Association of America et al. v. United States Food and Drug Administration et al., Case No. 1:16-cv-01460-APM (D.D.C.) (July 5, 2022), 4–5.

[9] Id. at 1.

[10] Id. at 5–6, 14–15.

[11] Id. at 15–16.

[12] Id. at 18.

FDA Premarket Tobacco Product Application (PMTA) Pathway

Under FDA’s premarket tobacco product application (PMTA) pathway, manufacturers or importers of tobacco products must demonstrate to the U.S. Food and Drug Administration (FDA) that the marketing of a new tobacco product would be appropriate for the protection of the public health (APPH). See Section 910(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA). This statutory threshold standard requires that FDA consider the risks and benefits of the product to the population as a whole, including users and non-users of tobacco products. The Agency’s risk-benefit analysis includes evaluating the impact of the product, both the likelihood that existing users will stop using such products and the likelihood that non-users, particularly youth and vulnerable populations, will start using such products. In its evaluation of whether a product is appropriate for the protection of the public health, the Agency reviews a product’s components, ingredients, additives, constituents, health risks, the manufacturing process, and the product’s packaging and labeling. If FDA concludes that the benefits outweigh the risks, it may authorize the product for marketing, which the Agency notes is different from the approvals that it issues for drugs or medical device products. Under the provisions of Section 910 of the FD&C Act, an issuance of a marketing granted order allows the introduction into interstate commerce of the tobacco products.

As of March 24, 2022, FDA announced that it has now taken action on approximately 99% of the almost 6.7 million electronic nicotine delivery system (ENDS) products submitted for premarket authorization. As previously reported, the vast majority of these applications for non-tobacco flavored ENDS have either been refused filing or have been denied. As to its next order of business, FDA has signaled that it will be issuing decisions on applications for popular ENDS products, noting that these products have the potential to substantially impact public health, positive or negative, given their large market share.

FDA Issues Marketing Granted Orders to Logic Technology Development LLC

On March 24, 2022, FDA authorized several tobacco-flavored electronic nicotine delivery system (ENDS) products from Logic Technology Development LLC (Logic), including various e-cigarette devices and tobacco-flavored cartridges/capsules. The Agency noted that several other products from Logic were issued marketing denial orders and must be removed from the market or be subject to enforcement action. Further, additional PMTAs remain under review (e.g., menthol products).

Last October, FDA issued its first authorization for an e-cigarette device and tobacco-flavored cartridges produced by the R.J. Reynolds Vapor Company under the brand name Vuse. The Agency notes that its authorization for the sale of such products (e.g., Logic or Vuse ENDS products that received marketing granted orders) does not mean that these products are safe, nor are they considered “FDA approved.” Instead, FDA has concluded after its review that the likely benefit for adult smokers who use such products and significantly reduce their cigarette use outweighs the risk to youth. The company must follow post-market requirements to reduce youth access and youth exposure to their marketing.

Logic PMTAs

The Agency issued premarket tobacco product marketing granted orders[1] for the following Logic products:

  • Logic Vapeleaf Regular Cartridge/Capsule Package – a blister pack of 5 capsules
  • Logic Vapeleaf Cartridge/Capsule Package – a closed e-liquid cartridge containing an atomizer and U-plugs on either end of the cartridge
  • Logic Vapeleaf Tobacco Vapor System – a closed e-cigarette device
  • Logic Pro Tobacco e-Liquid Package – a tobacco flavored closed e-liquid product
  • Logic Pro Capsule Tank System – a closed e-cigarette device
  • Log Pro Capsule Tank System – a closed e-cigarette system battery unit/USB charger
  • Logic Power Tobacco e-Liquid Package – a closed e-liquid cartridge containing tobacco flavored e-liquid
  • Logic Power Rechargeable Kit – a closed e-cigarette with battery unit/USB charger

The Vapeleaf sub-brand products are electronic cigarette products, while the Logic Pro sub-brand products are rechargeable ENDS devices with a traditional screw-in atomizer supplement.

In its decision summaries[2] and order letters, FDA has noted that in making the APPH assessment for noncombustible tobacco products such as ENDS products, the Agency weighs the negative public health impact (i.e., youth initiation and use of the product) against the potential positive public health impact (i.e., decrease of adult traditional combustible cigarette users). The Agency explained that Logic’s products were authorized only after the Agency concluded that Logic had demonstrated that the products were appropriate for the protection of public health. FDA based its conclusions on the following:

  • Data demonstrating that the marketing of Logic products may help addicted smokers transition from combustible cigarette use. Specifically, current smokers were more likely to decrease their use of traditional combustible cigarettes, from an average of 13–16 cigarettes per day (Day 1) to 1–2 cigarettes per day (by Day 59).
  • Data showing that, in comparison to traditional combustible cigarettes, ENDS products produced fewer or lower levels of toxins (e.g., carbon monoxide).
  • Data demonstrating that non-smokers, particularly youth, were unlikely to start using ENDs products. However, FDA noted that Logic is still subject to strict post-marketing requirements and must comply with the applicable statutory or regulatory requirements to minimize the potential for youth access and exposure. In addition, Logic is still subject to the Agency’s enforcement discretion (i.e., if Logic fails to comply with any applicable requirements or if there is a notable increase in the number of non-smokers who begin to use the authorized products, the Agency may suspend or withdraw the marketing order).
  • Logic’s PMTA marketing materials indicated that to decrease the potential for youth use of its products, Logic (1) eliminated all social media accounts as of September 28, 2020; (2) does not pay social media or other influencers to market or promote Logic’s products; (3) does not employ social media bots to market products; (4) only uses models over the age of 30 in its marketing materials; (5) does not use characterizing words that appeal to youth (e.g., sweet, fruity, candy, juicy, etc.); (6) does not use cartoon imagery or images of foods marketed to youth; (7) requires adult consumers to confirm that they are current tobacco or vapor users; and (8) requires mandatory age verification when purchasing Logic products.
  • Microbial stability data supporting the stability of the products over 12 months.

The Agency highlighted that the risk for the use of tobacco-flavored ENDS products by youth is lower than for flavored ENDS products. Accordingly, a PMTA applicant has a higher burden to establish that the product meets the APPH standard. Notably, the above products which have received a marketing granted order are tobacco-flavored ENDS products.

As regulated tobacco products, Logic’s authorized ENDS products are subject to the requirements of the FD&C Act, which include submission of annual registrations, ingredient and product listing requirements, reporting of harmful and potentially harmful constituents, packaging, labeling, and advertisement requirements. Should any information submitted in the PMTAs (e.g., marketing and advertising of products) change and have an effect (e.g., expanding opportunities to reach youth), those changes may, in turn, affect FDA’s APPH analysis of the products and the marketing granted order.

FDA Issues Marketing Denial Orders to Fontem US, LLC

On April 8, 2022, the Agency issued marketing denial orders (MDOs) to Fontem US, LLC (Fontem) for several of the company’s ENDS products under the ‘myblu’ brand. In reviewing Fontem’s PMTAs, FDA determined that the applications lacked sufficient evidence to show that permitting the marketing of the myblu products would meet the Agency’s APPH standard.

The Agency has noted that it is not typical practice to disclose whether a company has submitted a PMTA or its intent to commercially market a new product that has never been marketed. However, FDA has indicated that the Fontem products listed below are confirmed by the manufacturer to currently be on the U.S. commercial market. In addition, the products subject to the April 8, 2022 MDOs are listed on the publicly available ‘Deemed New Tobacco Product Applications Lists,’ which indicate products for which PMTAs were timely submitted by September 9, 2021. The following Fontem ENDs products are subject to an MDO:[3]

  • myblu Device Kit
  • myblu Intense Tobacco Chill 2.5%
  • myblu Intense Tobacco Chill 4.0%
  • myblu Intense Tobacco 2.4%
  • myblu Intense Tobacco 3.6%
  • myblu Gold Leaf 1.2%
  • myblu Gold Leaf 2.4%

FDA has also indicated that it issued several MDOs for Fontem products that were not on the publicly available Deemed New Tobacco Product Applications Lists; thus, FDA cannot release those product names. Tobacco products subject to an MDO (or negative action regarding its PMTA submission such as a Refuse to Accept or Refuse to File) may not be offered for sale, distributed, or marketed in the U.S., and if already on the market, they must be removed.

Notably, the Agency has noted in its announcement of Fontem’s MDOs, that its “highest enforcement priorities are ENDS products for which no application is pending, including, for example, those with an MDO or those for which no application [has been]… submitted.”

[1] See Logic Technology Development LLC’s marketing granted orders; available at: https://www.fda.gov/media/157143/download.

[2] See FDA’s decision summaries for Logic Technology Development LLC’s marketing granted orders; available at: https://www.fda.gov/media/157144/download.

[3] See FDA, Center for Tobacco Products April 8, 2022 press release re the Agency’s issuance of marketing denial orders to Fontem US, LLC for several of the company’s ENDS products; available at: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-denial-orders-fontem-us-myblu-products?utm_campaign=ctp-pmta&utm_content=CTPStatement&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms.