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.

 

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.

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/evaporFollow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

On August 29, 2023, a three-judge panel on the U.S. Court of Appeals for the District of Columbia Circuit unanimously ruled against FDA on the Agency’s review of Fontem LLC’s “unflavored” (i.e., tobacco-flavored) myblu electronic nicotine delivery system (ENDS) products, vacating FDA’s marketing denial orders (MDOs) for these products. For Fontem’s non-tobacco flavored myblu ENDS, however, the Court upheld FDA’s denial, deferring to the Agency’s general concerns surrounding “substantial risks of flavored products to youth.”

Under the Tobacco Control Act (TCA), a Premarket Tobacco Product Application (PMTA) applicant must demonstrate that the ENDS product is “appropriate for the protection of the public health” (APPH). Specifically, the TCA directs FDA to assess the public health impact of a new tobacco product “with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account – (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.” 21 U.S.C. § 387j(c)(4). 

In April 2020, Fontem submitted PMTAs for its myblu Device Kit, as well as a variety of non-tobacco flavored and tobacco-flavored myblu liquid pods:

  • Tobacco-flavored myblu ENDS products:
    • 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%
  • Non-tobacco flavored myblu ENDS products (not publicly disclosed due to potential confidential commercial information (CCI) issues)

Following a nearly two-year review period of the application, which included an FDA-issued, 22-item deficiency letter identifying FDA’s concerns and requesting additional information, FDA denied the applications for all of the above products in April 2022. Note: Although the Court characterizes “unflavored” ENDS as vaping products with “the same flavor as more traditional tobacco products—menthol or tobacco,” [Opinion at 4] the appeal did not cover FDA’s denial of the myblu menthol liquid pod, which recently received an MDO in July 2023. The DC Circuit opinion, which refers to tobacco and menthol-flavored ENDS as “unflavored,” reflects the common misperception that ENDS products, like traditional tobacco-leaf containing products, are inherently tobacco-flavored. In reality, however, ENDS products do not contain any tobacco, and the base ingredients (PG, VG) used in e-liquids do not impart a tobacco or any characterizing favor. Rather, all favors in ENDS, including tobacco favor, must be separately added to the e-liquid. To avoid further confusion, we refer to “tobacco-flavored” products accordingly in this post.

In vacating the MDO for the unflavored myblu ENDS products, the DC Circuit criticized FDA for its failure to perform a “holistic public health analysis” required by the TCA. Specifically, the Court held that the Agency cannot deny PMTAs for tobacco-flavored ENDS based on “highly technical” deficiencies or “for failing to provide very specific information about the physical properties of [the] products” without conducting the required statutory balancing of an application on public health grounds. As provided in the FDA press release concerning the Fontem myblu MDOs, the deficiencies were related to discrete items such as the stability studies, manufacturing-related concerns, or product design features.  

For these specific deficiencies related to the tobacco-flavored myblu products, the Court stated that if any technical or product-related “highly granular deficiencies” are essential to the public health standard and application, then the Agency must “require fine-grained requirements of all tobacco products” by “promulgating tobacco product standards or manufacturing regulations. Otherwise, the Agency must consider the overall public health consequences of the product.” Opinion at 23-24. The opinion goes on to state:

Congress established a comprehensive and interlocking scheme for the regulation and approval of tobacco products, defining the considerations the FDA must use to evaluate whether a product is appropriate for the protection of the public health and providing for a regulatory process that accounts for the competing interests regarding the production, marketing, and safety of tobacco products. Cf. FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 159–60 (2000) (emphasizing Congress had for decades “creat[ed] a distinct regulatory scheme for tobacco products”). The FDA cannot simply ignore Congress’s detailed directives when denying tobacco marketing applications.

Opinion at 24 (emphasis added).

The Court also took issue with FDA’s review process for the tobacco-flavored applications. At one point, the Court even stated that FDA’s deficiency letter suggested that providing the missing information “would be sufficient for the agency to approve Fontem’s products,” or for requesting a specific item and faulting Fontem for not providing another item that was not previously requested (such as quality control information for a different facility). Opinion at 22. By doing so, the Court criticized the Agency for acting arbitrarily and capriciously by “shifting the regulatory goalposts without explanation.” Opinion at 23. According to the DC Circuit, “[t]he lack of consistency and notice to regulated entities is another unlawful consequence of the agency’s departure from the holistic public health inquiry.” Id. at 24.  

The DC Circuit, however, upheld the denial of the non-tobacco flavored myblu products. In doing so, the Court reasoned that, for the flavored products, FDA “focused on the question central to the public health inquiry”— i.e., whether Fontem was able to show that the benefits of its flavored products to adult smokers outweighed the substantial risks of flavored products to youth. Because the primary study Fontem conducted failed, in FDA’s judgment, to show that its flavored products had any added benefit for adult smokers relative to unflavored products, the Court concluded that FDA acted consistent with the public health balancing required by the statute and denied Fontem’s petition.  

This recent ruling appears to emphasize a holistic public health review for tobacco-flavored (and menthol-flavored) products with consideration of all public health factors. At the same time, the decision upholds a comparative efficacy approach – which does not consider all the public health elements – for flavored ENDS products. Thus, the decision offers a bifurcated take on the statutory APPH analysis, emphasizing different factors based on the flavor classification of the product.

This decision may also impact another high-profile MDO challenge in the DC circuit: Juul Labs Inc. FDA issued an MDO in June 2022 denying PMTAs for Juul’s tobacco and menthol pods (3% and 5% nicotine), as well as the device. FDA alleged Juul’s PMTA contained insufficient and conflicting data regarding genotoxicity and potentially harmful chemicals. Juul countered that FDA had not reviewed up to 6,000 pages of its PMTA that addressed FDA’s concerns. The DC Circuit granted an emergency stay of MDO. FDA then issued its own administrative stay acknowledging “unique” scientific issues that warrant additional review. Juul filed a 21 CFR § 10.75 request for supervisory review detailing substantive and procedural errors in the MDO. FDA administratively stayed the MDO and is re-reviewing its denial (and the DC circuit MDO challenge is being held in abeyance in the meantime). As everyone waits to see whether FDA will rescind the MDO, this decision from the DC Circuit may impact FDA’s review. If the Agency does not rescind the MDO, Juul will likely proceed with an appeal, in which this Fontem decision will now serve as precedent.  

We will discuss this and other important FDA litigation at Keller and Heckman’s 2024 Annual E-Vapor and Tobacco Law Symposium. Be sure to save the date: January 29-30, 2024, in Las Vegas, Nevada. Details and registration information can be found here.

On August 9, 2023, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia issued a final Memorandum Opinion in Cigar Association of America et al. v. United States Food and Drug Administration et al., vacating the decision of the Food and Drug Administration (FDA) to deem premium cigars subject to the agency’s regulatory authority under the Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA)[1].

The decision concludes a seven-year conflict between the cigar industry and FDA. As previously reported, FDA issued a Final Rule on August 8, 2016, deeming all products meeting the statutory definition of a “tobacco product” to be subject to its regulatory authority, including premium cigars (“Deeming Rule”). In the preceding rulemaking phase, the Cigar Association of America (CAA), the Cigar Rights of America (CRA), and the Premium Cigar Association (PCA) had submitted comments to FDA regarding the usage patterns of premium cigar consumers, asserting that premium cigars did not pose the same type of public health concerns as other tobacco products. Nonetheless, in the Federal Register notice for the Deeming Rule, FDA asserted that no data had been provided to support different usage patterns and public health concerns. 

The CAA, CRA, and PCA subsequently challenged the Final Rule in federal court. In July of 2022, the Court held that FDA’s decision to deem premium cigars was arbitrary and capricious, insofar as that FDA failed to consider data before it concerning the use of premium cigars and the health effects of such use and requested further briefing from the parties on potential remedies. Since then, Plaintiffs have requested that the Court vacate the Deeming Rule, while FDA has requested that the Court remand the decision without vacating it, a remedy that is typically reserved only for exceptional circumstances. Relevant case law dictates that a court must consider two factors: first, the seriousness of the rule’s deficiencies; and second, the disruptive consequences of vacating the rule. 

With regard to the first factor, FDA argued that the Deeming Rule had minimal deficiencies that could be cured by (1) addressing existing record evidence on remand and (2) elaborating further on other rationales supporting the deeming of premium cigars, including concerns about secondhand smoke and usage among young adults. The Court rejected both arguments, finding that FDA’s decision to ignore relevant data in the first instance was a significant enough error to support vacatur, and that FDA could not separate other potential rationales for deeming premium cigars from the fundamental failure to consider relevant data on usage patterns and health effects. 

As to the second factor, FDA argued (1) that vacating the Deeming Rule would leave premium cigars entirely unregulated at the federal level, including in terms of sales to youths and false or misleading advertising; (2) that maintaining the status quo would not impose significant burdens on manufacturers of premium cigars; and (3) that vacatur would invite litigation about FDA’s user fee scheme, which funds the regulation of all tobacco products. The Court acknowledged the importance of these concerns, but ultimately found that none of the consequences, alone or in combination, were disruptive enough to warrant remand without vacatur. The Court specifically noted that while premium cigars may not be regulated at the federal level, all 50 states prohibit the sale of premium cigars to individuals under 18 years of age, with the majority of states prohibiting sales to individuals under 21 years of age, and that FDA itself had noted that premium cigars were the agency’s lowest enforcement priority relative to other tobacco products used with greater frequency by youths. 

Upon consideration of the two factors, the Court found that FDA had not carried its burden to establish extraordinary circumstances that might displace the default remedy of vacatur. Thus, the Court has vacated the Deeming Rule insofar as it applies to premium cigars, as requested by the Plaintiffs. Significantly, the Court defined premium cigars as those that (1) are wrapped in whole tobacco leaf; (2) contain a 100% leaf tobacco binder; (3) contain at least 50% (of the filler by weight) long filter tobacco; (4) are handmade or hand rolled; (5) have no filter, nontobacco tip, or nontobacco mouthpiece; (6) do not have a characterizing flavor other than tobacco; (7) contain only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weigh more than six pounds per 1,000 units. 

The Department of Justice now has an opportunity to appeal this decision to the U.S. Court of Appeals for the DC Circuit, so stay tuned for further updates.


[1] 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.) (August 9, 2023). 

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

  • Delta-8 Tetrahydrocannabinol (Delta-8 THC) is an isomer of Delta-9 THC, the intoxicating component of certain cannabis plants. It is naturally occurring at very low levels in hemp and can be synthetically manufactured by chemical conversion of cannabidiol (CBD) extracted from hemp. We have discussed a September 14, 2021 consumer update, “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC,” that was issued by FDA after an uptick in adverse event reports, findings of Delta-8 THC products marketed to children, and contamination concerns from potentially unsafe manufacturing methods. FDA’s first warning letters for products labeled as containing Delta-8 THC were announced on May 4, 2022, as discussed here
  • On July 5, 2023, in a coordinated effort with the Federal Trade Commission (FTC), FDA announced the issuance of six warning letters for adulterated food violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and unfair or deceptive marketing violations of the FTC Act related to adding Delta-8 THC to conventional foods. The products at issue in the new warning letters are candy (e.g., sour worms and gummy bears), chips, cookies, and other snack foods that FDA says intentionally mimic well-known snack food brands (i.e., Doritos, Oreos, Cheetos, Jolly Rancher, and Nerds) by using similar brand names, logos, or pictures on packaging that consumers, especially children, may confuse with traditional snack foods. FDA is also concerned that adults could unintentionally consume these products or take a higher dose than expected and suffer serious consequences, and notes this risk is especially dangerous for those who are driving, working, or have other responsibilities. 
  • All Delta-8 THC products at issue were found by the agencies’ review of the companies’ websites where customers could place orders for the products. Safety concerns raised by FDA and FTC suggest that enforcement against these kinds of products containing Delta-8 THC will remain a priority. Keller and Heckman will continue to monitor and report on regulatory developments related to cannabis-derived ingredients.

As we previously reported, the Reagan-Udall Report evaluated FDA’s Center for Tobacco Products (CTP) and reported that stakeholders were concerned over, among other things, a lack of clear guidance and transparency regarding regulations, the premarket review process, and enforcement priorities. On February 24, 2023, CTP responded to the report and committed to addressing all 15 of the recommendations outlined therein as expeditiously as possible.

On April 25, 2023, a group of 23 academics and public health experts sent a letter to FDA Commissioner Robert Califf, MD, proposing recommendations for a more efficient, transparent, and fair tobacco and nicotine regulatory regime following the Reagan-Udall Foundation report[1].

Cancer Moonshot logo

The experts’ response, titled “Reagan-Udall Foundation evaluation of FDA’s tobacco program- a response” (hereinafter the “Letter”), recommends a four-part strategic framework for FDA to (re)shape its tobacco program considering President Biden’s “Cancer Moonshot” goal to cut the death rate from cancer by at least 50% over the next 25 years. The Letter details four pillars to support its recommendations: Education, Efficiency, Enforcement, and Engagement.

I. The Four Pillars

(1) To Degrade the Attractiveness and Addictiveness of Cigarettes and other Combustible Tobacco Products

The Letter notes that even though cigarette smoking causes 480,000 deaths per year and leaves 16 million living with smoking-related diseases, FDA’s regulation for these combustible tobacco products is light compared to the much safer non-combustible nicotine product alternatives. The Letter suggests that FDA should target regulatory controls on more harmful combustibles and make the regulatory process of non-combustible products more efficient. The Letter proposes FDA utilize its authority under sections 907[2] and 906[3] of the Tobacco Control Act to better regulate the ingredients, emissions, toxicants, packaging, and marketing of combustible cigarettes.

(2) To Promote Transition Pathways to Smoke-Free Status

The Letter suggests FDA should allow consumers to transition to a smoking cessation or smoke-free status with options to choose from a variety of alternatives to cigarettes. The Letter proposes FDA use its education and communication resources to address consumer misunderstanding.

(3) To Control Risks Arising from the Ongoing Use of Smoke-Free Nicotine Products

The Letter explains that once a smoker transitions to smoke-free nicotine products, there are still controllable risks for the user that will need to be monitored. Monitoring these risks should come in the form of regulating the product itself to reduce any electrical, thermal, or mechanical risks, for example, from e-cigarettes. Meanwhile, regulations targeting youth use should focus on marketing, branding, packaging, and point-of-sale restrictions rather than product design.

(4) To Protect Young People from Tobacco-Related Health and Welfare Risks

Lastly, the Letter acknowledges the risk of youth access to smoking, vaping, or nicotine in any form. The Letter states that strategies should address the reality that there will be a subset of youth who engage in transient experimentation. For some youth, vaping could be a diversion from smoking cigarettes. The Letter recommends FDA acknowledge that when prevention fails, it is preferable for youth to use a safer non-combustible nicotine product than cigarettes.

II. Balancing Risks

The Letter agrees with the Reagan-Udall assessment that FDA’s interpretation of the “Appropriate for the Protection of Public Health (APPH)” standard is unclear and inconsistent. It is unclear how the agency intends to balance the benefits of nicotine products for their harm reduction potential with the concerns about youth uptake of nicotine. The Letter proposes that FDA consider a variety of factors to help reconcile these trade-offs. The factors call for FDA to consider both the interests of adult smokers and adolescent vapers who would otherwise become smokers.

III. Supporting Measures

a. Education

The Letter discusses widespread misperceptions about the relative risks of smoking, vaping, and smokeless tobacco. These misperceptions may make smokers reluctant to switch from traditional cigarettes to e-cigarettes. The Letter also states that public health officials’ claims targeted towards youth, specifically around EVALI or gateway claims, adversely influence risk perceptions. The Letter recommends that CTP conduct mass communication and educational activity to rectify these misperceptions.

b. Efficiency

The Letter provides recommendations for simplifying the Premarket Tobacco Product Application (PMTA) process to reduce barriers to entry for novel and reduced-risk nicotine products and to reduce smoking. A few recommendations are highlighted below:

  • Develop and communicate clear and transparent strategies for APPH determinations
  • Create expedited pathways for evaluations for products that are similar and already established in the market to avoid repetition
  • Create ‘soft standards’ to expedite the technical evaluation process by allowing commonly accepted scientific findings; additional evidence would be required for products that did not meet the soft standards

c. Enforcement

The Letter stresses the need to have a balanced regulatory approach that is fair, transparent, and proportionate. The Letter recommends that FDA prioritize enforcement as follows:

  • Illicit supply chains and illegal supply networks;
  • Enforcing ID checks at point-of-sale; and
  • Removal of products that would be unlikely to be authorized, for which no pre-market authorization application has been made, or where an application for authorization has been made and rejected.

d. Engagement

The Letter recommends FDA use its authority to bring together experts, activists, and academics, to play the role of “honest broker” in assessing research findings on controversial subjects. The Letter also recommends that FDA make its research and assessments publicly available.


[1] The Reagan-Udall Foundation is an independent 501(c)(3) created by Congress to advance the mission of FDA. FDA Commissioner Califf commissioned the Foundation to conduct a comprehensive evaluation of the Agency’s Center for Tobacco Products (CTP). Reagan-Udall published its final operational evaluation in December 2022. See The Reagan Udall Foundation- A Critical Evaluation of FDA’s Center for Tobacco Products.

[2] See 21 U.S.C. § 387(g), Tobacco Product Standards https://bit.ly/3JZt3zS.

[3] See 21 U.S.C. § 387(f), General Provisions Respecting Control of Tobacco Products https://bit.ly/3zmea5F.

I.      Reagan-Udall Report

In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations.” As such, Commissioner Califf was “prompt[ed] . . . to take a closer look at how [FDA does] business.” To this end, Commissioner Califf commissioned external agency experts to conduct a comprehensive evaluation of the Agency’s Center for Tobacco Products (CTP), given the growing concerns from a chorus of industry and public health stakeholders about CTP’s approach to the regulation and enforcement of tobacco products. In Commissioner Califf’s statement, he noted that CTP has “greater challenges . . . ahead as we . . . navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health.” The external agency experts selected to conduct the comprehensive evaluation of CTP was The Reagan-Udall Foundation (Reagan-Udall or the Foundation)[1]. Reagan-Udall formally began its operational evaluation of CTP in September 2022.

A.      The Report

In December 2022, Reagan-Udall published their final operational evaluation (Reagan-Udall Report or Report) of CTP, titled, Operational Evaluation Of Certain Components Of FDA’s Tobacco Program (hereinafter the “Report”). The Report includes fifteen recommendations across four program areas: Regulations and Guidance, Application Review, Compliance and Enforcement, and Communication with the Public and Other Stakeholders. Id. at 2. The Foundation’s recommendations for each program area are detailed in the following sections.

1.      Regulations and Guidance

The Report notes that CTP has been active since its creation, “issuing numerous advance notices of proposed rulemaking, proposed rules, final rules, and guidance documents.” However, the Foundation heard from stakeholders that they felt that “certain foundational requirements are still lacking.” Id. at 17. The two primary concerns among the stakeholders were the “lack of clarity regarding how the Agency is applying the [Appropriate for the Protection of the Public Health] standard” and the need for “more specific guidance on the factors CTP weighs while evaluating applications.” Id. Stakeholders provided a laundry list of areas where they would like “more specific guidance,” including modified risk tobacco products; standards for the maximum yields of specific toxicants; testing, reporting, and possible disclosure of tobacco product constituents, ingredients, and additives; nicotine levels in combustible tobacco products; and science needed to support product applications. Id.  

The Report particularly notes that “regulations and product standards [are] time-consuming and resource-intensive,” while guidance documents take less time to craft and can be used to “convey FDA’s expectations for matters where a binding regulation may not be needed or where the Agency’s thinking is evolving and is not yet ripe for inclusion in a binding regulation.” Id. However, the Report goes on to warn that CTP’s process for regulations and guidance development and publication is, at “the outset,” insufficiently informed, “about the needs of CTP staff and various stakeholders.” Id. As such, CTP needs to “strengthen the quality and usefulness of its policy development function by gathering more input from staff and the public at the front end of the process.” Id.

To this end, the Report made one recommendation—albeit with several additional caveats. The Report recommends that CTP “should evaluate and redesign the current policy development program to create a more effective approach to achieving the regulatory review and enforcement goals that the Center establishes.” Id. In particular, the policy development program should:

  • Collaboratively develop, publish, and maintain a comprehensive policy agenda listing foundational and other regulations and guidances needed to implement the Tobacco Control Act, including timeframes for development.
  • Create an elevated CTP Office of Policy, incorporating the current Office of Regulations functions, with broader responsibility and authority to provide strategic policy leadership and direction across all Center functions.
  • Use regulations strategically to prescribe categorical principles and standards to reduce the need for case-by-case determinations in application reviews and compliance and enforcement matters.
  • Review and expand the use of existing guidance to provide clarity, predictability, and transparency concerning scientific standards for application review, and update the guidance as the science and CTP’s application of that science evolves. Id. at 17-18.

2.      Application Review

The Report Panel heard from stakeholders that the Agency’s review process needed a “new approach.” Id. at 18. The Report goes on to note that some application processes are “perceived” as working well, such as the SE pathways, while others, such as the PMTAs, are generally perceived by stakeholders to be “ineffective and problematic.” Id. Concerns among stakeholders ranged from discontent with inadequate guidance and the “unsustainable” need for PMTA filings on every new product, especially considering that “thousands of product variations exist” and stakeholders’ belief that applications are handled inconsistently. Id. at 18-19. The Report specifically noted that the Panel did not receive “significant feedback concerning the SE or EX REQ pathways.” Id. at 19.

The Report continues by describing that because of the litigation surrounding the Deeming Rule’s finalization in 2016 —discussed in earlier chapters—CTP was “unable to issue PMTA regulations describing the requirements for submissions in advance of the deadline for application submission.” Id. As a consequence, CTP’s ability to review applications was compromised. Id.

To address these concerns, the Report made two sweeping recommendations that advance the general goal of “accelerat[ing], intensif[ing] and expand[ing] [CTP’s] efforts to establish regulatory policies and scientific standards for application review.” Id. at 20.

First, CTP “should develop a more clear and predictable framework for high-quality PMTA and MRTP application submission and reviews…” Id. at 19:

  • Prioritizing timely development and completion of policies and scientific standards necessary for high-quality submissions.
  • Simplifying, standardizing, documenting, and publicly disseminating review procedures.
  • Further developing operations management capabilities.
  • Clarifying supervisory roles and responsibilities for ensuring review quality and developing a process for the review team to timely identify novel or complex scientific issues that merit senior management attention or consultation with specialized subject matter experts.
  • Providing more details in public summaries of Marketing Granted Orders and summaries at regular intervals of deidentified reasons why Marketing Denial Orders were issued to provide applicants more insight into CTP’s regulatory decision-making process. Id.

Secondly, CTP should “[c]onsider clarifying in formal policy the Center’s plans for triaging its substantive reviews to conserve resources when there are certain critical sections of the application that can be indicative of whether all sections of the application merit review.” Id.

3.      Compliance and Enforcement

The Report spent a considerable length discussing and offered a number of recommendations concerning the current regulatory and enforcement environment. Id. at 21-22. The Report details that while the FDA has been busy addressing individuals who do not comply with the requirements of the TCA, “millions of [tobacco] products have entered the market without pre-market authorization and remain on the market today.” Id. at 21.

The Report continues to say that while companies have and continue to evade enforcement via a number of practices, CTP’s current inability to independently bring injunction or seizure cases[2] creates an ultimately cumbersome and disjointed process. Id. at 22. While CTP can impose civil money penalties for TCA violations, the Report notes that this process is “cumbersome,” and the penalties may be “insufficiently low.” Id.

The Report’s final observations regarding CTP’s compliance and enforcement actions were critical of the Agency’s lack of transparent communication “regarding the reasons it has failed to clear the market of illegal products” and the seeming misalignment of CTP’s Office of Compliance and Enforcement’s actions with CTP’s largest enforcement priority— “illegal products on the market.” Id. at 23.

The Report makes five recommendations:

  • FDA should seek higher-level Administration involvement to establish an interagency task force to make enforcement of the tobacco laws a government-wide priority, particularly to address the marketing of illegal products and the risks of youth use.
  • The Agency should consider whether statutory changes to provide streamlined processes for tobacco enforcement, including increased consequences for TCA violations, should be pursued.
  • In addition to pursuing formal enforcement through DOJ, FDA should explore alternative approaches to achieving compliance.
  • CTP should enhance its use of public communications to provide greater transparency about the Agency’s approach to compliance and enforcement, including prominently posting and maintaining a list of legally marketed products to facilitate voluntary compliance and discourage the sale of illegal products by manufacturers, distributors, wholesalers, and retailers.
  • The Center should ensure that the workplan and goals for the Office of Compliance reflect any new priorities that the Center adopts as a result of its evaluation of additional enforcement approaches. Id.

4.      Communication with the Public and Other Stakeholders

A significant theme of the Report is the need for CTP to engage with the public and stakeholders. The Report notes that CTP’s role is not only protection via regulation but also via educating the public, “especially young people.”[3] The Foundation heard from many stakeholders who wanted clarifying communication from CTP regarding vaping, harm reduction, and the relative risk of tobacco products, particularly as it pertains to “help[ing] adult consumers make informed decisions.”[4] Stakeholders also expressed discontent regarding CTP’s lack of “clear communication about its plans to address products marketed without the required PMTA.” Id. at 26.

To advance CTP’s communication with the public and stakeholders, the Report made three recommendations:

  • CTP should obtain public input during the development of the Strategic Plan and communicate with stakeholders and the public about the Center’s strategic objectives as well as key messages, and metrics for measuring plan effectiveness.
  • The Center should solicit broad public input as it continues to develop its tobacco public education campaigns, which are critical to the public health mission.
  • CTP should improve the overall transparency of the tobacco program, particularly with respect to the regulatory process and its scientific underpinnings. Id. at 26-27.

B.      CTP’s Response to the Reagan-Udall Foundation Evaluation Report

On February 24, 2023, Brian King, the Director of FDA’s Center for Tobacco Products, released a press release titled, An All-Center Approach: CTP’s Response to the Reagan-Udall Foundation Evaluation Report (the “CTP Response”). CTP’s response broadly summarizes the center’s review of the Report’s recommendations and details CTP’s responses and next steps. In conjunction with the press release, CTP also launched a new website titled, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP, which provides more details about CTP’s plans for addressing the recommendations.

1.      Cross-Cutting Responses

Effective as of the press release’s publication, CTP is initiating the development of a comprehensive 5-year strategic plan. A central tenet of the plan will be a focus on advancing health equity as a means of addressing “tobacco-related disparities across CTP’s programmatic portfolio.”

Additionally, taking a cue from stakeholder comments, CTP plans on being “transparent about . . . key activities” by appointing “internal transparency liaisons within each CTP Office” and sharing routine updates on the strategic plan’s development. CTP anticipates issuing interim strategic goals by Summer 2023 and a final strategic plan to the public by December 2023.

2.      Responses to Science and Application Review Recommendations 

According to the press release, CTP has started developing a more efficient framework for high-quality tobacco product application reviews in response to the Report’s observation and recommendation. Part of this effort will include posting scientific policy memos and reviewer guides and holding more frequent meetings of the Tobacco Products Scientific Advisory Committee (TPSAC)[5]. CTP also recently announced that the Office of Science has appointed a new Director, Dr. Matthew Farrelly.  

3.      Responses to Regulations and Guidance Recommendations

CTP announced that effective immediately, CTP was initiating a new hiring process to create a new policy unit within the Office of the Center Director. This new unit would “be responsible for providing overall policy coordination across CTP.” Additionally, in a node to the Report’s heavy focus on transparency, CTP plans to “develop, publish, and maintain a comprehensive policy agenda of rules and guidances that are in development or planned for development at the center.” CTP noted that an initial policy agenda was expected by the end of 2023, with reports made annually thereinafter.

4.      Responses to Compliance and Enforcement Recommendations

In the release, CTP touted the number of warning letters, permanent injunction filings, and the Center’s first-ever civil money penalty complaints. However, drawing on the Report’s observation that FDA does not have independent litigation authority, the release notes that FDA will be convening a summit of officials from the Department of Health and Human Services (HHS), FDA, and DOJ. Moreover, CTP plans to consider if statutory changes are needed for CTP to enforce the law fully and if alternative approaches to achieve compliance (i.e., outside DOJ assistance) are possible.

CTP also plans to create a new website that will contain all “enforcement activities for products that are illegally marketed without FDA authorization,” as well as create a searchable database for tobacco products that have an FDA marketing order. Additionally, CTP plans to be in contact with trade groups and other industry stakeholders in order to “keep them apprised of the development of new enforcement priorities and updates, and enhance FDA’s Tobacco Product Marketing Order webpage.”

5.      Responses to Public Education Campaigns Recommendations

While in their response, CTP draws attention to current public education campaigns they are conducting, they do recognize that “there are always opportunities for continued improvement.” Without describing specifics, CTP plans to “explore new ways for soliciting and considering public input on our campaign program” and will “develop, publish, and promote resources that describe the mechanisms we currently use to solicit and consider public input on our campaigns to ensure relevant stakeholders are aware.”[6]


[1] The Reagan-Udall Foundation, formally known at the Reagan-Udall Foundation for the Food and Drug Administration, is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” About Us, Reagan-Udall Found. for the Food & Drug Admin., https://reaganudall.org/about-us (last visited Mar. 8, 2023).

[2] The Report states, “[t]he U.S. Department of Justice (DOJ) is charged with bringing injunction or seizure cases on behalf of FDA.” Id. at 22.

[3] The Report stresses that the CTP “could use its communications function more strategically to achieve its overall public health goals.” Id. at 26.

[4] In the additional discussion regarding the recommendations, the Report noted that stakeholders’ “[v]iews on CTP’s public education campaigns varied.” Id. at 26-27.

[5] The Tobacco Products Scientific Advisory Committee (TPSAC) advises the Agency’s Commissioner on responsibilities as they relate to the regulating tobacco products. See Tobacco Products Scientific Advisory Committee, U.S. Food & Drug Admin. (Sept. 26, 2022), https://www.fda.gov/advisory-committees/committees-and-meeting-materials/tobacco-products-scientific-advisory-committee.

[6] CTP Response.

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