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premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco productcan be legally marketed in the United States. Under section 910 of the FD&C Act, persons wanting to market a new tobacco product (one that was not commercially marketed in the United States as of (i.e., on) February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007) must first obtain an order to do so (referred to in this guidance as a marketing order) under section 910(c)(1)(A)(i) unless a report pursuant to section 905(j) of the FD&C Act has been submitted for the new tobacco product and FDA has issued an order under section 910(a)(2) that the new tobacco product is substantially equivalent to a tobacco product commercially marketed in the United States as of (i.e., on) February 15, 2007 (the 905(j) pathway), or the new tobacco product is exempt from the substantial equivalence requirements.When a new product is not found to be substantially equivalent to an appropriate predicate product or exempt from the substantial equivalence requirements, you must submit a PMTA under section 910(b) and receive a marketing order under section 910(c)(1)(A)(i) prior to marketing the product.
All deemed products that meet the definition of a “new tobacco product,” including ENDS, are subject to the requirements of premarket review in sections 910(a)(2) of the FD&C Act. Given the expected difficulty in identifying valid ENDS predicate products (products commercially marketed on February 15, 2007, or previously determined to be substantially equivalent to an appropriate predicate product) for use in the substantial equivalence pathway, FDA expects to receive PMTA submissions from manufacturers of deemed ENDS products. Section 910(b)(1) of the FD&C Act contains the requirements for a PMTA submission.
Guideline for PMTA
Applying to legally market a tobacco product in compliance with FDA regulations may feel complicat- ed and confusing, especially for first time applicants. While there are three main ways to bring a new tobacco product to market, a premarket tobacco application (PMTA) is the most likely pathway by which manufacturers of e-cigarettes and other electronic nicotine delivery systems (ENDS) will apply to market their products. To help manufacturers navigate the PMTA process, FDA has finalized a guidance on how to complete it as correctly, efficiently, and cost-effectively as possible.
Prior to finalizing this guidance, FDA had issued a draft guidance for ENDS manufacturers in May 2016. While the final version is very similar to the draft, there are a few significant changes that are important to know before submitting a PMTA. These changes have been primarily made to further explain the types of information that may help FDA determine if marketing a proposed new tobacco product would be appropriate for the protection of public health. Some of the changes in the updated guidance include:
Some of the changes in the updated guidance include:
A revised list of the harmful or potentially harmful constituents (HPHC) that are recommended for analysis of an ENDS product;
The types of short-term testing that may be conducted to support an ENDS PMTA;
Other recommended design considerations for some ENDS and their parts. PMTA for ENDS guidance asks that manufacturers consider including instructions to consumers for responding to accidental nicotine exposure, as well as a prominently displaying a nicotine exposure warning on product packaging. In addition to these instructions, FDA recommends applicants provide a plan for tamper-resistant packaging, including how to tell if the packaging has been tampered with or damaged.
The guidance has information about battery specifications, examples of battery testing certifi- cates, and potential safety features.
FDA understands that many ENDS manufacturers are small business owners who may have con- cerns about the costs of submitting PMTA. In August 2016, when all ENDS products were brought under FDA’s regulatory jurisdiction, some rumored estimated costs would have been prohibitive for many small businesses. FDA’s estimates, however, are significantly lower than these theoret- ical numbers; total costs for meeting all PMTA requirements will vary from product to product.
Although there is no set cost for preparing a complete PMTA, FDA recognizes manufacturers’ concerns about affordability and has provided some measures in the guidance that could potentially reduce cost. These steps include:
“Bridging”, which allows a PMTA applicant to forego costly research studies if they can refer to existing data or studies previously conducted by themselves or another party.
Using published literature reviews, including meta-analyses, or independent analyses of publicly available data to help support a PMTA rather than paying for new analyses.
Referencing tobacco product master files (TPMFs), which may increase efficiency and reduce costs for complying with premarket requirements.
FDA understands the labor, time, and financial commitment involved in applying to market an ENDS product, and has taken manufacturers into consideration when writing this guidance. Because FDA’s new comprehensive tobacco regulatory plan places nicotine at the heart of tobacco control efforts, the agency aims to authorize new tobacco products that will provide adults, who are addicted to nicotine, with less harmful alternatives to smoking cigarettes, while keeping any form of nicotine out of the hands of children. ENDS manufacturers are encouraged to create innovative, potentially less harmful tobacco products that can efficiently deliver satisfying levels of nicotine to addicted adult smokers, with less of the known toxicity than combustible products.