PMTA

WARNING: This product contains nicotine.Nicotine is an addictive chemical.

What’s PMTA?

A 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.

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.

What’s PMTA?

Guideline for PMTA:

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