The FDA has finally released more information about the PMTA application process. Better yet, it’s in an easy to understand format for even the newest of business owners. Here’s a breakdown of some of the most frequently asked questions.
Questions on FDA’s New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
What are the costs associated with submitting an application?
The costs associated with submitting an application to market a tobacco product can vary greatly and depend on a number of factors, such as the pathway to market being applied for, the type of tobacco product and the availability of data on the specific product or other similar products. Generally, high costs may come from needing to conduct original research and testing to inform the application, as well as staff time spent compiling it. For further information on the different premarket pathways, please refer to the Tobacco Product Review & Evaluation webpage.
On page 94 (Table 14) of the “deeming” Regulatory Impact Analysis (RIA), the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:
- an SE exemption report = around $1,500
- an SE report = anywhere from around $3,500 to around $22,700
- a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others
In general, and especially over time as manufacturers become more experienced and relevant research develops, the FDA expects many efficiencies to lower the average costs of premarket review. For example, we expect that manufacturers’ costs will be dramatically lowered by the bundling of applications for similar products; by reliance on Tobacco Product Master Files; and by bridging of data from one product to another. Due to these and other efficiencies, the FDA expects submission costs to vary across products and to diminish broadly over time, thus resulting in lower average costs per product, as reflected in the cost estimates that accompanied the rule.
Recognizing that some of the costs associated with this process may be challenging to small businesses, the FDA is taking several steps to ease this process. Those steps include:
- issuing final guidance on Tobacco Product Master Files (which can help applicants use existing information, rather than developing their own, when submitting premarket applications),
- issuing draft guidance on submitting PMTAs for ENDS products (which, when final, will reflect the agency’s current thinking on what information the FDA recommends an applicant submits and how the FDA intends to review PMTAs),
- issuing two Small Entity Compliance Guides for deeming and user fees,
- revising and updating several other previously issued guidances to include the newly-regulated products,
- posting training videos and live webinars to the website to assist industry, and
- providing a final “deeming” rule web hub to help industry navigate the new regulations.
I am a vape shop with hundreds of different e-liquids. Do I need to submit an application for each flavor/ingredient variant or nicotine strength? Can I bundle similar products into one, or just a few, applications?
Each tobacco product application is a unique situation. However, generally speaking, a manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA. Where the same information applies to multiple products, it should be noted.
FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product.
How does a manufacturer know if they need to conduct clinical trials?
For assistance, manufacturers of newly regulated products can reference the FDA’s Applications for Premarket Review of New Tobacco Products draft guidance from 2011 and the recently-issued Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS) draft guidance. The PMTA ENDS draft guidance discusses circumstances when a new clinical trial might be helpful and when it might be less necessary. As these are both draft guidances, FDA will review the comments and feedback submitted before issuing final guidances. Once final, they will represent the agency’s current thinking on this topic.
What is the grandfather date?
Congress wrote and passed the Tobacco Control Act, which states that any tobacco product on the market as of February 15, 2007 is eligible for grandfather status (this includes products that were in test markets).
Otherwise, any products introduced or modified after that date are considered “new” tobacco products and must submit a premarket application to the FDA through one of the three available pathways.
Are there any e-cigarettes that are grandfathered and could be used as a predicate for a Substantial Equivalence application?
It’s possible that an ENDS product exists that may have been on the market in the United States as of February 15, 2007 and could be used as a valid predicate. However, the burden of identifying a predicate falls to the applicant, so a manufacturer would have to prove such a product is grandfathered.
The FDA expects that most ENDS products that companies submit for market authorization will utilize the PMTA pathway, which does not require a comparison to a predicate product.
Why can’t the FDA just change grandfather date as it relates to newly regulated products?
Only an Act of Congress can change the grandfather date.
In the proposed rule, the FDA stated it lacks the legal authority to change the grandfather date and specifically asked for the public to comment on this legal interpretation. The agency received a large number of comments in response to this statement, but none provided a legal theory that would support changing the date.
How can a vape shop be considered a manufacturer?
Vape shops that mix, prepare, or combine liquid nicotine and other components of tobacco products meet the definition of a “tobacco product manufacturer” under the law, and are therefore subject to the same legal requirements as all other tobacco product manufacturers.
If a vape store is not mixing, preparing or combining any products then that store may be considered a retailer, not a manufacturer. Certain requirements apply only to manufacturers, such as requirements relating to establishment registration, product listings, and premarket applications. You can visit the new Manufacturer hub and new Retailer hub for additional information.
Can I mix or make my own e-liquids at home or do I need to register as a tobacco product manufacturer?
If you are mixing these components of a tobacco product and then selling them to other individuals or companies, you would be considered both a retailer and a manufacturer, and subject to all applicable requirements under the law.
Who has to pay user fees and what are the deadlines?
A final rule on user fees that accompanied publication of the final “deeming” rule explains that FDA can only assess user fees on tobacco products that fall within the six classes specified in the law. Cigars and pipe tobacco are the only newly-regulated products that fall within these six classes.
Beginning August 8, 2016, the total amount of user fees will be allocated across cigars, pipe tobacco, cigarettes, snuff, chewing tobacco, and roll-your-own tobacco. Accordingly, assessments on individual manufacturers or importers that currently pay user fees will likely either decrease or remain the same depending on the classes and volume of tobacco products they produce. As outlined in the FD&C Act, the total assessments for user fees are as follows:
- For fiscal year 2016, $599 million
- For fiscal year 2017, $635 million
- For fiscal year 2018, $672 million
- For fiscal year 2019 and each subsequent fiscal year, $712 million
Domestic manufacturers and importers of cigars and pipe tobacco will be subject to quarterly assessments beginning in Q1 of FY17 (from October-December.) Additionally, they have to report certain information monthly beginning August 20, 2016 (including, for this first submission, a retroactive monthly report from October 2015 – July 2016.)
See the small entity compliance guidance on these user fee requirements for more details on what information to submit in the monthly reports, how to submit it, and more.
Will adding warning labels to my product already on the market make it a “new” product, requiring me to submit an application for pre-market review?
If the only change to a product’s label is the addition of a required warning statement in compliance with the deeming rule, including any modifications to the label necessary to accommodate the warning, it is unlikely to render the product distinct, and premarket review would not be required. If, however, the label is modified in any other way, and if those changes rendered the product distinct, premarket review would be required.
Is the FDA banning e-cigarettes?
No, the FDA has not banned any class of tobacco products, including e-cigarettes. We expect that many products will remain on the market while manufacturers apply for authorization to market their products.
I am an importer of tobacco products – what requirements apply to me?
Importers who import finished tobacco products for sale or distribution in the U.S. are considered tobacco product manufacturers. Examples of requirements applicable to importers of newly deemed, finished tobacco products include:
- Reporting ingredients, and harmful and potentially harmful constituents;
- Submitting an application for premarket review and receiving authorization from FDA before marketing new tobacco products;
- Complying with health warning requirements on product packages and advertisements; and
- Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by FDA.
Additionally, importers who own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a newly regulated tobacco product need to register the establishment and submit product listing to FDA by December 31, 2016.
Adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission. Visit out new Manufacturer hub for more information.
What is the “registration and product listing” process and timeframe to comply?
Owners and operators of domestic manufacturing establishments engaged in the manufacturing of tobacco products are required to register with FDA and submit product listings.
Every person who owns or operates any establishment in the U.S. engaged in the manufacture, preparation, compounding, or processing of a newly regulated tobacco product must register with the FDA certain information. This information includes:
- Place(s) of business; and
- All establishments engaged in these activities owned or operated by that person.
At this time, FDA intends to enforce the tobacco product registration and listing requirements with respect to finished tobacco products. Such registration information must be submitted annually on or before December 31st of each year. Additionally, every owner or operator upon first engaging in the manufacturing of a tobacco product in any domestic establishment must immediately register, and registered owners and operators must immediately register any new establishment that begins manufacturing tobacco products.
All registrants must also submit a list of all tobacco products manufactured for commercial distribution, along with certain accompanying information (including all labeling). Complete product list information must be submitted at the time of first registration; certain changes in the product list must then be submitted biannually.
Please refer to the guidance for further details about the process. Additionally, the FDA has posted a Step-by-Step Instruction guide for users accessing the FDA Unified Registration and Listing Systems (FURLS).
The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?
The definition of “tobacco product” includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities. FDA will review these products on a case-by-case basis.
I’m a supplier who sells to a manufacturer. I don’t sell directly to consumers. Do I need to register with the FDA and submit premarket applications?
If you are solely a supplier and your product is sold only to another company for further manufacture into a finished tobacco product, at this time, FDA does not intend to enforce certain provisions of the law with respect to your product. For example, FDA does not intend to enforce the requirements that you register your manufacturing establishment and list your products, submit premarket applications or submit ingredient listing or health documents with respect to newly deemed products that are sold or distributed solely for further manufacturing into finished tobacco products.
I have an e-liquid line coming out next week. Will I be able to sell it next week?
New e-liquids entering the market after August 8, 2016 are in violation of the law and may be subject to enforcement if marketed without authorization.
To legally sell a new e-liquid, a manufacturer must submit an application through one of the three available premarket pathways for each tobacco product and receive marketing authorization from FDA.
Smoking premium cigars and pipes are a niche hobby. Shouldn’t they be regulated differently from mainstream tobacco products like cigarettes and chewing tobacco?
After thorough review of the comments to the proposed rule and the scientific evidence, FDA believes it is appropriate to subject all tobacco products to its tobacco control authorities to best protect the public health.
What is the Center for Tobacco Products (CTP)? How did it come about?
The Family Smoking Prevention and Tobacco Control Act, signed into law in June 2009, granted the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. FDA then established CTP to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use.
What are the mission and goals of the Center for Tobacco Products (CTP)?
Tobacco use continues to be the leading cause of preventable death and disease in the United States. To help make tobacco-related death and disease a part of America’s past, not its future, CTP is committed to educating the public about the harms of tobacco products, keeping tobacco products out of the hands of America’s youth, and dramatically reducing the appeal of these deadly products. Everything we do is designed to reduce the impact of tobacco on public health, including the FDA’s three key goals:
- Prevent Americans—especially youth—from starting to use tobacco
- Encourage current users to quit
- Decrease the harms of tobacco product use
What is the Center for Tobacco Products (CTP) authorized to do?
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) allowed FDA to establish CTP and granted CTP the authority to:
- Require tobacco product manufacturers register with FDA
- Establish standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness
- Establish limits on sale and distribution of tobacco products
- Require premarket review for new and modified risk tobacco products to protect the public health
FDA regulates safe and effective products—but how does tobacco fit in?
FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco. FDA evaluates tobacco products based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole, including users and nonusers.
The law requires FDA to apply a public health approach when developing regulation that considers the net effect on tobacco-related behavior changes within the entire population, not just an individual user, for initiation, cessation, and re-initiation of tobacco use.
There is no known safe tobacco product. FDA does not have the authority to ban any class of tobacco products, such as cigarettes. We do, however, have the authority to dramatically reduce the harm of all tobacco products, and we will use that authority to continue improving public health.
Is there a way to find out the harmful ingredients in different tobacco products?
FDA is required by law to publicly display information about harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke that cause harm, or could cause harm, to users and non-users, in a way that is understandable and not misleading. The regulation includes listing the amount of each chemical present in specific brands and sub-brands of tobacco products.
FDA will make HPHC information available once the Agency is confident that the list is accurate, understandable, and not misleading to the public. FDA is still evaluating the data it has received from manufacturers, including verifying its accuracy. In addition, FDA is conducting scientific studies to assess consumer understanding of how the Agency presents information about HPHCs. Upon completion of these important activities, FDA intends to publish the HPHC information, so that consumers can make more informed decisions about tobacco products.
Can you provide me with a list of ingredients in a certain tobacco product?
Section 915 of the Federal Food, Drug, and Cosmetic Act requires FDA to issue regulations requiring the testing and reporting of tobacco product constituents, ingredients, and additives that FDA determines should be tested to protect the public health. Once FDA issues a proposed rule related to Section 915, it will be available for public comment. You can track the status of the proposed rule through the Unified Agenda, which semi-annually lists all of the Agency’s projected publication dates. Additionally, for more information about the FDA rulemaking process, visit the FDA’s Rules and Regulations page.
Which tobacco product/brand is the healthiest option?
No matter what they taste, smell, or look like, all tobacco products can be harmful to your health. The Family Smoking Prevention and Tobacco Control Act grants FDA the authority, and responsibility, to reduce the harm of tobacco products. The most effective way to achieve the greatest reduction in tobacco-related death and disease is to stop using all tobacco products. However, FDA understands there is a potential market for tobacco products that could present less health risks to consumers. These items are called modified risk tobacco products (MRTPs), and they are tobacco products that are sold or distributed for use to reduce harm or risk of tobacco-related disease associated with commercially marketed tobacco products. FDA can issue an order authorizing the marketing of a product claiming reduced harm or risk, only if the evidence submitted in the application includes, among other things, data showing that the product will or is expected to benefit the health of the population as a whole. Furthermore, if a proposed MRTP is a new tobacco product (not yet on the market), a person or entity seeking to bring that MRTP to market is subject to premarket requirements (e.g., substantial equivalence, exemption from substantial equivalence, or a premarket tobacco application) in addition to MRTP requirements. To learn more, see FDA’s Modified Risk Tobacco Products webpage.
How do I report a violation of the Family Smoking Prevention and Tobacco Control Act, such as selling tobacco products to a minor?
To report a potential violation of the Family Smoking Prevention and Tobacco Control Act, you can call Center for Tobacco Products’ Call Center at (877) CTP-1373 or send an email to AskCTP@fda.hhs.gov.
In addition, you may also use the downloadable Potential Tobacco Product Violations Reporting form.
Why was an FDA inspector just in my store?
Retailers play an important role in protecting the health of America’s youth by not selling, marketing, or advertising tobacco products to underage children and adolescents. FDA conducts compliance check inspections of tobacco product retailers to determine a retailer’s compliance with federal laws and regulations.
FDA generally issues Warning Letters for first-time violations and civil money penalties for violations found on subsequent inspections. Results from compliance check inspections are available on the FDA’s website.
What should I do if I receive a Warning Letter?
FDA generally sends Warning Letters to retailers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws and regulations that FDA enforces. First, review the letter carefully to see what charges are listed. You should respond in writing to the letter within 15 working days. Include the following in your response to the Warning Letter:
- An explanation of the steps you will take to correct the violation(s) and prevent future violations (e.g., retrain your employees, remove the problematic items)
- Your current contact information, including telephone number and email address
Promptly and adequately correct the violations listed and be sure that you comply with all applicable laws and regulations. The Warning Letter includes contact information, so if you have any questions, reach out to us for more information. You may also visit the FDA’s Warning Letters Overview page for further resources.
What documents do I need to submit to the Center for Tobacco Products?
Tobacco product manufacturers or importers are required to submit certain information to FDA, including:
- Tobacco health documents
- Establishment registration and product listing
- Listing of ingredients in tobacco products
- Reporting of harmful and potentially harmful constituents in tobacco products and tobacco smoke
For more details about the requirements and submission process, visit the FDA’s Manufacturing webpage.
How can I get my new or innovative product approved by FDA?
FDA does not “approve” tobacco products, but the Family Smoking Prevention and Tobacco Control Act provides legal ways for new tobacco products to be marketed. If FDA determines a new tobacco product meets the relevant legal requirements, the FDA will issue a written notification permitting the marketing of the new tobacco product. Tobacco manufacturers may use one of the three Pathways to Market to seek to legally market new tobacco products. These include:
- Premarket tobacco products—This pathway requires the applicant to demonstrate that FDA permitting the marketing of the new tobacco product would be appropriate for the protection of the public health.
- Substantial equivalence—This pathway may be appropriate for a new tobacco product that demonstrates it has the same characteristics as a predicate tobacco product, or has different characteristics, but does not raise different questions of public health from a predicate product.
- Exemption from substantial equivalence—This pathway may be appropriate for new tobacco products with certain minor modifications to additives of a legally marketed tobacco product.