Perspective: FDA’s Progress on Tobacco Product Application Review and Related Enforcement
By Mitch Zeller, Director of the FDA’s Center for Tobacco Products (CTP)
September 9, 2021
Following updates provided in May and February, as well as our initial perspective published in August 2020, this piece describes the current status of our review of applications for “deemed” new tobacco products submitted by Sept. 9, 2020. Previously, we also created a webpage with general information and resources related to the submission of tobacco product applications for these products.
FDA’s premarket review of tobacco products is an essential tool for ensuring that products on the market meet a set of legal standards set forth by Congress to protect public health, and that products that do not meet the legal standards are not marketed. Although different tobacco products have different levels of risk, all tobacco products are inherently dangerous. Whether they receive a marketing authorization or not—there are no safe tobacco products. People who do not currently use tobacco products, especially young people, should not start.
The Family Smoking Prevention and Tobacco Control Act provided FDA with immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the agency, by regulation, deems to be subject to the law. When FDA’s historic “Deeming Rule” took effect in 2016, many of the regulatory and statutory requirements that had been in place for manufacturers of the originally regulated tobacco products since passage of the law in 2009, became applicable to the deemed products, including e-cigarettes and all other electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, nicotine gels, hookah tobacco, and any future products meeting the statutory definition of “tobacco product.” The applicable statutory provisions include the requirement that deemed products that meet the definition of a new tobacco product must receive premarket authorization from the FDA to be legally marketed.
In the deeming rule and subsequent guidance documents, FDA stated that it intended to defer enforcing the premarket review requirements, for a period of time, with respect to “deemed” new tobacco products that were on the market as of Aug. 8, 2016 (the effective date of the deeming rule). This policy did not extend to deemed new tobacco products that entered the market after the rule’s effective date. Under a federal court order, manufacturers of deemed new tobacco products that were on the market as of the deeming rule’s effective date were required to submit premarket review applications by Sept. 9, 2020. Following the court order, FDA accelerated its planning and preparation to receive a large number of applications by the premarket application deadline. FDA received thousands of submissions representing more than 6.5 million products by the deadline of Sept. 9, 2020. Per the court order, products for which applications were submitted by the deadline could generally remain on the market for up to a year from the date of the application—or until Sept. 9, 2021, at the latest—pending FDA review, although FDA retains enforcement discretion.
Over the last year, the agency has worked to review premarket applications for millions of products. The vast majority of the applications are for ENDS products. When reviewing premarket tobacco product applications (PMTAs) for ENDS products, FDA’s job is to assess the scientific evidence presented by the applicant and determine if permitting the marketing of the new tobacco product would be “appropriate for the protection of the public health” – the standard laid out by the statute. The agency makes this determination by following the direction Congress provided in the law to assess the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account the increased or decreased likelihood that existing users of tobacco products will stop using such products, as well as the increased or decreased likelihood that those who do not use tobacco products will start using such products. In making this determination, the impact of such products on youth initiation and use is a critical consideration.
FDA has made significant progress in reviewing premarket applications over the last year. This perspective piece provides an update on our work and information about what to expect after Sept. 9, 2021.
As previously described, there are multiple phases in the review process which may differ by application pathway. The sections that follow describe where we are regarding each phase.
Receipt and Processing
Earlier this year, we completed the receipt and processing stage for all deemed new tobacco product applications submitted by the deadline via any of the three pathways to market: Substantial Equivalence (SE) Reports, Exemption from Substantial Equivalence Requests (EX REQ), and Premarket Tobacco Product Applications (PMTA).
Acceptance and Filing
As of September 2021, we have completed acceptance review for all applications submitted by the Sept. 9, 2020 deadline. More specifically:
- For the SE pathway, we have accepted applications for more than 5,200 products and issued Refuse-To-Accept (RTA) letters for applications for roughly 1,900 products.
- For the EX REQ pathway, we have accepted applications for more than 240 products and issued RTA letters for applications for about 100 products.
- For the PMTA pathway, we have accepted applications for more than 6.5 million deemed products and issued RTA letters for applications for more than 200,000 products.
As of Sept. 8, we have completed filing review for about 90 percent of applications submitted via the PMTA pathway by the Sept. 9, 2020 deadline. Many of the accepted applications ultimately received a Refuse-To-File (RTF) letter at the filing stage of the review process because the application did not include required information. For example, companies received RTF letters for not including required content such as ingredient listings, labels for each product to be marketed, or adequate environmental assessments. One such RTF letter was issued on Aug. 9 to a single company for PMTAs associated with approximately 4.5 million products because their PMTAs lacked an adequate Environmental Assessment.
Review and Actions
As of Sept. 8, with respect to applications submitted by the September 9, 2020 deadline, FDA has issued SE marketing orders covering more than 120 products and EX REQ marketing orders covering more than 230 products.
On Aug. 26, we issued the first marketing denial orders (MDOs) for ENDS products after determining the applications for about 55,000 flavored ENDS products lacked sufficient evidence that these products have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are flavored ENDS and they included flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal. In total, the agency has issued 132 MDOs for over 946,000 flavored ENDS products after reviewing those applications and concluding that they failed to provide sufficient evidence that those products will benefit adult smokers to an extent sufficient to justify their documented risks to youth.
The FDA’s review of new tobacco products before they can be legally marketed is required by statute and ensures that new products meet the standard Congress set in the law to protect the public health. In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency reviewed each flavored ENDS application to determine whether it provided sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers to overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable. Because the Agency found the necessary, product-specific evidence absent in each of these applications, the FDA issued MDOs.
To date, FDA has taken action on a substantial majority—around 93 percent—of the applications submitted by the Sept. 9, 2020 deadline.
Marketing orders and other information about tobacco product application decisions are generally posted on our Tobacco Product Marketing Orders webpage and organized by pathway. Due to legal requirements to redact confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone, the full decision summary and order letters may not be posted to the website until a later date.
In addition to the applications on which we’ve already taken actions, FDA continues review on thousands of applications for tobacco products across all product classifications. FDA intends to continue to devote significant resources to responding to the remaining pending applications expeditiously and will issue our decisions on a rolling basis.
We have also updated our Metrics & Reporting page with the complete set of metrics for all review phases of all pathways, which provide aggregate numbers showing our progress within each phase of application review. We will continue to update these metrics every other month.
Update on Compliance and Enforcement
While our review of premarket applications is ongoing, we remain vigilant in overseeing the market and continue to prioritize the use of our enforcement resources to curb the unlawful marketing of tobacco products.
As such, FDA has been closely monitoring retailer, manufacturer, importer, and distributor compliance with the premarket authorization requirement. Since January 2021, we have issued a total of 170 warning letters to firms that collectively have listed more than 17 million ENDS products with the FDA and that did not submit premarket applications for these products by Sept. 9, 2020. Among those warning letters, FDA issued a warning letter in July to a single company that did not submit an application and has more than 15 million products listed with FDA.
FDA requests that firms that receive warning letters respond to the agency within a specified time period, typically 15 working days, and provide an explanation of the steps they will take to address any violations and their plan for maintaining compliance with the law. Failure to address any violations may lead to regulatory action, including injunctions, seizure, and civil money penalties.
What Happens on Sept. 10 and Beyond?
A small percentage of the more than 6.5 million products that were the subject of timely-submitted applications still remain under review after Sept. 9, 2021. We continue to work expeditiously on the remaining applications, many of which are in the final stages of review, and will issue our decisions on a rolling basis.
Consistent with FDA’s January 2020 (revised April 2020) enforcement guidance, we will continue to make enforcement decisions on a case-by-case basis according to our enforcement priorities and individual circumstances, recognizing that we are unable, as a practical matter, to take enforcement action against every illegally marketed tobacco product, and that we need to make the best use of Agency resources. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion, as recognized in the court’s order regarding the Sept. 9, 2020 premarket application deadline.
As described in FDA’s enforcement guidance, we have identified flavored products that appeal to youth as enforcement priorities. Available data, including from the National Youth Tobacco Survey, suggest that tobacco-flavored ENDS products, unlike products with other characterizing flavors, are used by relatively few youth. Products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. If such products are not removed from the market, the Agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating regulatory action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond.
FDA regulates the manufacturing, marketing, and distribution of tobacco products to protect public health. Premarket review of new tobacco products before they can be legally marketed is one of the most important responsibilities of the FDA’s Center for Tobacco Products (CTP). We will continue to assess whether applicants meet the applicable statutory standard to market their new products.
The large number of applications submitted by the Sept. 9, 2020 deadline was unprecedented. However, over the last year, we’ve taken action on a significant number of the applications we received by Sept. 9, 2020. After the Sept. 9, 2020 deadline, FDA received additional applications for more than 1 million products. We will continue working to review all pending and incoming applications.
FDA remains committed to providing continued regular updates to the public about our premarket review as well as compliance and enforcement actions related to deemed tobacco products. For the latest information, please check our metrics and reporting and the products list pages regularly and sign up for email updates from CTP.