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 On October 28, 2016, the FDA Center for Tobacco Products (CTP) released a revised Draft Guidance document regarding
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.
What Information Is Submitted With the List of Ingredients?
The information you should expect to submit to FDA is summarized as follows:
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:
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.
c. 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.
d. 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.
e. 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.