FDA Clarifies Premarket Path for Ecigarette Products

June 20, 2019

The US Food and Drug Administration (FDA or the Agency) on June 11 issued the final guidance: “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems” (the ENDS Guidance), which is intended to assist persons submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) pursuant to 21 USC § 387j.[1] This final ENDS Guidance is substantially similar to the draft guidance that was issued in May 2016.

The main takeaways from this ENDS Guidance are:

  • The final ENDS Guidance is essentially unchanged from the draft; companies that have taken measures consistent with the draft guidance will generally be in compliance with the final ENDS Guidance.[2]
  • ENDS on the US market as of August 8, 2016, must submit a PMTA or an application to obtain an FDA substantial equivalence order by August 2022 to stay on market.

The ENDS Guidance explains

  • the types of products that are subject to FDA regulation;
  • when a PMTA must be submitted and what information must be included in the application;
  • FDA’s general procedures for review of an ENDS PMTA; and
  • the type of information that should be submitted in an ENDS PMTA to show that permitting the proposed ENDS to be marketed would be appropriate for the protection of the public health.

Types of ENDS Products Subject to Regulation

Generally, the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA, 21 USC §§ 387-387u) amended the Federal Food Drug and Cosmetics Act (FD&C Act) to provide FDA with authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Secretary of Health and Human Services (HHS) deems to be subject to the law. In 2016, FDA published a final rule (Deeming Rule) to deem all products meeting the statutory definition of “tobacco product” in the FD&C Act (21 USC § 321(rr)), except accessories of newly deemed tobacco products, to be subject to chapter IX of the FD&C Act.[3] In the Deeming Rule, FDA clarified that all ENDS are subject to FDA authority. ENDS products include both the e-liquid and aerosolizing apparatus used as an ENDS, whether sold as a unit or separately.[4]

Under the TCA, manufacturers of ENDS and their components are subject to a number of regulatory requirements. Most notably, all newly deemed products, including ENDS, are subject to premarket requirements (21 USC §§ 387j, 387e). ENDS on the US market as of August 8, 2016, must submit an application to obtain an FDA new product or substantial equivalence order by August 2022 to stay on market; and any new ENDS (or existing ENDS that are significantly modified) must obtain a new product order before entering the US market.

When to Submit a PMTA and What to Include

To introduce a new or modified tobacco product, including an ENDS, an applicant must submit a PMTA to FDA providing information on the product sufficient to allow the Agency to determine that an order authorizing the product’s market introduction is appropriate for the protection of the public health. Before marketing a product in the United States, written notification must be received from FDA permitting the marketing of the new tobacco product.

A PMTA must include all information specified in 21 USC § 387j(b)(1), including health risks associated with the ENDS, a concise but complete description of the new tobacco product, the nicotine strength, an overview of the product’s formulation, conditions for using the product or instructions for use, and design, and examples of proposed labeling. FDA may refuse to file (i.e., accept and/or approve) a submission if it is an incomplete application.

Review of ENDS PMTAs

The time it takes to review a PMTA depends on the complexity of the product. FDA will review an ENDS PMTA consistent with the requirements of 21 USC § 387j(c). FDA must act on a PMTA “as promptly as possible, but in no event later than 180 days after the receipt of an application.”[5] As part of the review process, FDA will assess the product’s marketing, conduct inspections of manufacturing facilities, and determine whether the application should be sent to the Tobacco Products Scientific Advisory Committee. If the Agency concludes that a PMTA meets the requirement for marketing, it will issue a marketing order for the introduction of the product into interstate commerce. Postmarket reporting, if appropriate, will be included in the Marketing Authorization letter.

Public Health Considerations

To determine whether a proposed ENDS would be appropriate for the protection of the public health, FDA will consider factors such as whether the ENDS will increase or decrease the likelihood that

  • existing users of tobacco products will stop using such products; and
  • those who do not use tobacco products will start using such products.[6]


If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Kathleen M. Sanzo
Alexandre H. Gapihan

[2] ENDS Guidance at 2.

[3] See 81. Fed. Reg. 28973 (May 10, 2016).

[4] ENDS Guidance at 3.

[5] 21 U.S.C. § 387j(c)(1)(A).

[6] ENDS Guidance at 11.