Resources for Applicants Required to Submit by September 9, 2020
The United States District Court for the District of Maryland has granted FDA’s request for an extension of the premarket review submission deadline for certain tobacco products, which FDA requested due to the COVID-19 pandemic. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.
However, in accordance with the U.S. District Court for the District of Columbia ruling issued on Aug. 19, 2020, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline.
When Do I Need to Submit an Application for a Tobacco Product?
All new (i.e. non-grandfathered) tobacco products are required to obtain premarket authorization. If you are marketing a deemed tobacco product that is new and that was on the market as of August 8, 2016, you will need to submit a marketing application by September 9, 2020 as required by the Court, and as set forth in CTP’s compliance policy (see exception for premium cigars). If you want to market a new tobacco product that was not on the market as of August 8, 2016, you will need to submit a marketing application and receive authorization before marketing the product.
Products on the market as of February 15, 2007 are considered grandfathered tobacco products. A grandfathered product is not a new tobacco product and does not require an application. Learn about your product’s potential grandfather eligibility and submit a voluntary grandfather determination request.
A new tobacco product is:
- Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
- Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
Determine the Appropriate Pathway to Legally Market a New Tobacco Product
In order to submit a tobacco product application, it is first necessary to determine which pathway to market and distribute a tobacco product is most appropriate.
There are three pathways to legally market a new tobacco product:
- Premarket Tobacco Product Application (PMTA)
- Substantial Equivalence (SE)
- Exemption from Substantial Equivalence (EX REQ)
Each pathway page linked above includes information on how to prepare the application, as well as resources on the review process, previously issued order letters, review summaries, and other relevant resources for that type of application. In addition, we’ve highlighted some of the most important application resources for each pathway on this page under Tips and Resources for Tobacco Product Manufacturers below.
Tips and Resources for Tobacco Manufacturers
1. Premarket Tobacco Product Applications (most likely pathway for Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes and e-liquids)
To date, no valid grandfathered ENDS product has been identified and all premarket applications for ENDS products received by the FDA have been through the PMTA pathway. Tips and resources to help prepare a PMTA are provided below.
2. Substantial Equivalence (SE) and Exemption from Substantial Equivalence (EX REQ) (most likely pathways for Cigars, Pipe Tobacco, Hookah Tobacco)
Manufacturers of cigars, hookah tobacco, or pipe tobacco who wish to market a new tobacco product that may be similar to a tobacco product that is grandfathered, or to one previously found to be substantially equivalent, can consider the SE and EX REQ pathways. Tips and resources to help prepare an SE Report or EX REQ are provided below.
Note: FDA expects that many cigars, hookah tobacco, and pipe tobacco products may be eligible for grandfather status. Grandfathered tobacco products do not need to submit premarket applications to be legally marketed. Although a premarket application is not required, FDA encourages firms to voluntarily submit a standalone grandfathered submission. Learn about your product’s potential grandfather eligibility and submit a voluntary grandfather determination request.
How to Submit
To be timely submitted, applications for deemed new products on the market as of August 8, 2016 must be received by CTP by September 9, 2020. Although it is not always required*, FDA recommends electronic submissions in order to more efficiently transmit and receive applications. Given the file size of many applications, as well as the possibility of the system slowing due to many simultaneous users, FDA strongly encourages manufacturers to submit their applications ahead of the September 9, 2020 deadline. The Agency also encourages applicants who plan on submitting applications for a large number of products to contact the Agency to discuss their plans and method of submission.
What Happens After I Submit the Application?
Once the application is submitted, the FDA review process consists of three phases:
FDA may contact the applicant at several points during the review process, such as at the end of the acceptance review, the end of the notification (SE and EX REQ) or filing (PMTA), during substantive review, or to inform the applicant of a positive or negative marketing decision.
*In addition to the above phases, the PMTA review process includes a Phase 4 (postmarket reporting) that requires applicants to establish and maintain records and make reports, as necessary, to determine or facilitate a determination of whether there may be grounds to withdraw or temporarily suspend a marketing granted order.
Why Must I Comply?
On August 8, 2016, all deemed tobacco products (except for accessories of deemed tobacco products), including ENDS, cigars, hookah (waterpipe) tobacco, pipe tobacco, nicotine gels, and certain dissolvables became subject to the FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
All deemed new tobacco products need to have authorization from the FDA to be legally marketed. However, as an exercise of its enforcement discretion, the agency had deferred enforcement of the premarket authorization requirements for certain deemed new products on the market as of August 8, 2016.
On February 6, 2020, FDA began prioritizing enforcement against certain illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.
Beginning September 9, 2020 (previously May 12, 2020), FDA intends to prioritize enforcement against any ENDS product that continues to be sold and for which CTP has not received a product application from the manufacturer. Solely as a result of the coronavirus pandemic, the premarket review submission deadline for deemed tobacco products on the market as of August 8, 2016 was extended from May 12, 2020 to September 9, 2020. Accordingly, on April 29, 2020, FDA revised the January 2020 enforcement priorities guidance to update the May 12, 2020 date to September 9, 2020.
On Aug. 19, 2020, the U.S. District Court for the District of Columbia issued a ruling, in part, to prohibit FDA enforcement of the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the agency considers developing a streamlined substantial equivalence process specifically for premium cigars. Accordingly, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline.
Manufacturers that wish to market any of these products need to submit an application to FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health.
Companies that continue to manufacture, distribute, and sell unauthorized tobacco products risk FDA compliance and enforcement actions ranging from warning letters to injunction, seizure, and/or civil money penalty actions where warranted. Retailers and distributors are encouraged to communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
There are several requirements that a tobacco product manufacturer must fulfill in order to comply with the FDA’s tobacco regulations, including the premarket requirements. Learn more about manufacturer requirements, including other key submission dates.