On Sept. 9, premarket review applications for many new tobacco products, including e-cigarettes, certain cigars, and hookah products, currently on the market are due to FDA for review. FDA staff have been working tirelessly on preparations to meet this challenge in an efficient, reliable and transparent manner.
The Deeming Rule and FDA’s Premarket Review Requirement for Deemed Tobacco Products
Prior to Aug. 8, 2016, e-cigarettes, cigars and hookah products were not regulated by FDA. That’s because the original grant of authority from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.
That all changed with FDA’s historic “Deeming Rule” that helps implement the Tobacco Control Act and allows FDA to protect the public health and protect future generations from the dangers of tobacco use. On Aug. 8, 2016, when the deeming rule took effect, many of the regulatory and statutory requirements that had been in place for manufacturers of cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco since 2009, became applicable to e-cigarettes and all other electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, nicotine gels, hookah tobacco, and any future tobacco products.
Before the deeming rule, there were no federal protections on, among other things, retailers selling these tobacco products to youth. The deeming rule changed that and its continued implementation has allowed FDA to make great strides in protecting public health through tobacco regulation—for example, manufacturers of these tobacco products must register their establishments and list their products with FDA, products may not be marketed with direct or indirect claims of reduced risk unless substantiated by FDA and they receive FDA authorization to do so, and retailers are prohibited from selling these tobacco products to youth.
Importantly deemed tobacco products are now subject to the requirements in the Tobacco Control Act that already apply to cigarettes and smokeless tobacco products. This includes the requirement that a “new tobacco product” must receive premarket authorization from the FDA prior to marketing.
For deemed products that met the definition of a new tobacco product and were on the market as of Aug. 8, 2016 (when the deeming rule took effect), FDA issued a compliance policy; this, in effect, provided more time for manufacturers of these products to submit their applications for authorization. The deadline for the submission of applications for these products is now approaching. As the result of a court order (and a subsequent extension due to the unique circumstances of the COVID-19 pandemic), applications for deemed new tobacco products on the market at that time are due to FDA by Sept. 9, 2020. The court order also provided a one-year period during which products with timely filed applications might remain on the market pending FDA review.
Since the deeming rule took effect, FDA has been taking measures to prepare for the large volume of applications the agency anticipates receiving, particularly from manufacturers of e-liquids, e-cigarettes and other ENDS products.
Expectations for Applications Coming in by Sept. 9
All new tobacco products are required to obtain premarket authorization through one of three pathways: Premarket Tobacco Product Applications (PMTA), Substantial Equivalence (SE) Reports, or Requests for Exemption from Demonstrating Substantial Equivalence (EX REQ). Those deemed new tobacco products still on the market that do not have premarket applications submitted by Sept. 9, 2020, will be subject to FDA compliance and enforcement actions.
However, there may be some deemed tobacco products that are eligible for “grandfathered status” because they were commercially marketed in the United States as of Feb. 15, 2007. These deemed tobacco products are not “new tobacco products” and therefore do not need to submit premarket applications (unless the products were since modified). We expect that many cigar, hookah tobacco, and pipe tobacco products may fall in this category, and we encourage manufacturers to request a determination from FDA on their products’ grandfathered status. For deemed tobacco products that are not eligible for grandfathered status, manufacturers may decide that their product is sufficiently similar to a previously authorized or grandfathered product and find that the SE or EX REQ pathway is the most appropriate pathway for their applications.
To date, no ENDS product has received marketing authorization from the FDA and FDA has not issued a grandfathered status determination for an ENDS product. All premarket applications for ENDS products accepted by the FDA have been submitted through the PMTA pathway, and we expect most applications for ENDS products submitted on or before Sept. 9 to be submitted through the PMTA pathway.
Although we do not know how many applications will be submitted by the September deadline, we do know that there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced. However, FDA has been planning and preparing to receive the expected influx of applications for years. Our preparations are intended to help ensure that our approach to product review protects public health and is fair, consistent, efficient, and as transparent as possible.
We have been encouraging companies to submit their applications as early as possible. To date, FDA has received applications for around 2,000 deemed products – of which around 40 percent have already been resolved.
Preparations to Receive Premarket Review Applications
FDA has been working tirelessly to ensure that we are as prepared as possible to receive, process, and review the applications in a timely manner. To help accomplish this, we have been laying the groundwork for many years.
Since Congress authorized FDA to regulate tobacco products in 2009, CTP’s staff has increased from just a handful to over 950 today. During that time, we have built product review expertise and refined our premarket review processes, enhanced our technical capabilities, issued rules and guidances, met with stakeholders to get a better understanding of tobacco products and applicants’ needs for information about the process, invested in tobacco product research, and provided resources to help industry prepare and submit premarket applications.
Mitch Zeller – FDA Center for Tobacco Products – August 31, 2020.
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