PMTA FAQ

1. What is PMTA, and how does it work?

The Premarket Tobacco Product Application (“PMTA”) is a marketing authorization process run by the Food and Drug Administration (“FDA”) that new categories of tobacco products must go through before they can be sold in the United States.

PMTA traces its roots to the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the FDA regulatory authority over cigarettes and smokeless tobacco, and authorized the FDA to issue regulations, if the Agency thought it appropriate to do so, to bring any future tobacco products under the Agency’s authority and the provisions of the Act.

A core component of the Act is that it requires FDA authorization to market a new tobacco product. A “new” tobacco product is any product not marketed in the U.S. as of February 15, 2007. PMTA is one of the means of obtaining market authorization, and it is the process most every “new category” product must go through.

In its review of a PMTA submission, the FDA takes into account, among other things:

  • The increased or decreased likelihood that existing users of tobacco products will stop using such products if the product being submitted for PMTA is on the market;
  • The increased or decreased likelihood that those who do not use tobacco products will start using such products if the product being submitted for PMTA is on the market; and
  • The methods, facilities, and controls used to manufacture, process, and pack the product.

2. What are the steps in the PMTA process?

We see there being five steps to the PMTA process, but other manufacturers and the FDA itself may see this slightly differently:

  1. Determining What to Submit
  2. Compiling an Application
  3. FDA Administrative Review
  4. FDA Substantive Review
  5. Receiving a Marketing Order

We believe the outcome of successfully completing all of these steps will be continued product excellence and market access for products that meet the requirements.

3. What products must go through PMTA?

The PMTA process applies to all new tobacco products introduced after February 15, 2007, that are not addressed by the Substantial Equivalence (“SE”) or SE exemption paths.

This means that every “new category” product —such as vapor devices and liquids, tobacco-leaf free modern oral nicotine pouches and lozenges, and heat-not-burn products—must go through the PMTA process, because for almost all of them, there is no grandfathered predicate product to allow them to go through the FDA’s other clearance paths.

4. Can you continue to sell products while a PMTA is under review?

Yes. Products submitted for PMTA review by the September 9, 2020 deadline can remain on shelves for up to one year, assuming they were already on-market as of August 8, 2016. However, it is important to note that the FDA will perform its administrative review of a submission quite quickly and may issue a “refuse to accept” letter if the application does not have what the FDA needs to evaluate the product according to the Tobacco Control Act (TCA). What this would mean for the product is unclear, but could involve immediate removal from shelves.

Also worth noting that there are certain states that have additional restrictions on nicotine products, and we will continue to abide by all of those ordinances as well.

5. What happens once a PMTA marketing order is granted?

Manufacturers are granted a PMTA marketing order, not an approval or a “signoff” from the FDA. This is a key element of PMTA. This allows the company to market and sell the product, subject to specific post-market surveillance and reporting requirements, such as establishing and maintaining certain records, tracking how the product is being used, and filing reports with the FDA.

6. Is a PMTA marketing order permanent?

PMTA marketing orders are subject to review based upon the post-market surveillance information and reporting submitted to FDA. The FDA may withdraw or temporarily suspend a marketing order if the applicant fails to submit the required reports or if new data suggests that continued marketing of the product would not be appropriate for the protection of public health.

7. What will the PMTA process change about the industry?

Generally, we believe the PMTA process presents a great opportunity to level-set the U.S. industry for vapor and other new category products, and enable adult nicotine consumers (ANCs) to feel a renewed confidence in the products they buy at reputable retailers.

Reynolds believes that by level setting the market through the evidence-based PMTA process, the FDA and manufacturers like us can help address the serious issues facing the industry by ensuring responsibly manufactured and marketed new category products are the norm and not an exception.

More specifically, there are a handful of key changes we would anticipate:

  • There will be a clear understanding of the range of authorized, new category products available to adult nicotine consumers in the U.S.
  • Non-compliant manufacturers and marketers will be forced out of the ecosystem, and we will have an industry where all participants are held to the same sort of standards Reynolds has held itself to.
  • ANCs will continue to have access to a wide array of product formats, flavors, and strengths from reputable manufacturers.
  • ANCs will be able to feel confident that products sold at reputable retailers have gone through a detailed vetting process.
  • Retail partners and trade partners will benefit from streamlined supply chains and supplier relationships.
  • People working across the industry, including our own employees, will gain a deeper understanding of the PMTA process, its significance, and what to expect moving forward.
  • We will have a diverse new category focused industry with higher standards of care throughout the product lifecycle than are present today.

8. How were tobacco products regulated before the 2009 Tobacco Control Act (TCA)?

Prior to passage of the TCA, cigarettes and smokeless tobacco products were subject to various statutory, regulatory, and other legal requirements at the federal, state, and local levels. The FDA was the first government body vested with the comprehensive authority to regulate the sale, distribution, marketing, advertising, and use of cigarettes and smokeless tobacco products. The TCA also granted the FDA authority to expand its regulatory oversight over all products made or derived from tobacco (including vapor and modern oral products). This was accomplished through the so-called “deeming” regulations issued in May 2016.

9. What products has Reynolds submitted?

We have submitted or are in the process of submitting PMTAs for our Vuse Ciro, Vibe, Solo, and Alto branded vapor products, including for individual flavors, as well as for our VELO tobacco-leaf free pouches and lozenges and their flavor variants. We are very confident in our submissions and are hopeful that Reynolds’ applications will be successful.

10. What science did you submit with your applications?

There are a variety of ways a manufacturer could go about developing and providing this information, and we anticipate other manufacturers may choose to take a different approach.

The content of submissions is confidential and proprietary so we are unable to discuss them directly. However, to provide a high-level example, Reynolds’ process for Vuse products involved:

  • Surveying current tobacco users to understand product use behavior and demographics;
  • Conducting behavioral studies of current and non-users of tobacco to gauge consumer understanding of risks and interest in product use;
  • Performing statistical population modeling to project the effect of marketing these products on the population as a whole; and
  • Conducting clinical studies that looked at the abuse potential of Vuse products, which included examining nicotine pharmacokinetics, as well as several studies to examine the aerosol properties of the products and the temperature during use.

Reynolds’ process for VELO products involved:

  • Surveying current tobacco users to understand product use behavior and demographics;
  • Conducting behavioral studies of current and non-users of tobacco to gauge consumer understanding of risks and interest in product use;
  • Performing statistical population modeling to project the effect of marketing these products on the population as a whole; and
  • Conducting clinical studies that looked at the abuse potential of VELO products, which included examining nicotine pharmacokinetics, as well as conducting chemical analyses to examine the constituents and the stability of the products.

11. Will consumers have access to the same products or will some be removed from shelves as a result of the PMTA process?

The number of vapor and modern oral products on the market in the U.S. may initially decrease as regulators implement tighter restrictions and take enforcement action against brands that do not meet the requirements.

However, we expect adult nicotine consumers (ANCs) will continue to have access to a wide array of Vuse and VELO product formats, flavors and strengths, and will see no disruption to the current availability of Vuse and VELO products. Longer term, this process will level-set the U.S. industry for vapor and other new category nicotine products, and should enable ANCs to feel a renewed confidence in the products they buy at reputable retailers.

12. Does this process mean that an accepted product is safer than regular cigarettes?

No, relative risk is not the purpose of the PMTA process. The PMTA process requires the FDA to reach a determination that the product is appropriate for the protection of the public health. It is not a process to make a determination that one product is safer or better than any other product, including cigarettes.

13. How will I know if a Vuse or VELO product will no longer be available?

At this time, you can expect the availability of specific Vuse or VELO products in retail stores to remain the same as today, pending any changes to local, regional and state ordinances. We will continue to share more detailed information on product availability as we complete this process.

14. How will the PMTA process help ensure that tobacco products stay out of the hands of youth?

We hope that, over time, the PMTA process will enable higher standards of care throughout the entire industry. Reynolds has long set rigorous standards for how it develops and markets new category products and we hope this process makes those sort of standards more widespread as regulators implement these tighter restrictions and take enforcement action against brands that do not meet the requirements.

15. Will PMTA change anything about your product marketing standards?

Responsible marketing already underscores everything we execute at RJRVC, and we believe new category nicotine products can be produced, marketed and sold responsibly to adult nicotine consumers (ANCs) with only ANCs in mind. Our rigorous methods are designed to prevent youth access to information about, or access to, our products. They are effective, specific and ensure we adhere to applicable federal, state and local laws governing vapor products as well as our own standards across the product lifecycle, from conception to sale and everything in between.

Reynolds has not and does not make health or cessation claims in our product marketing, but there have been instances of players in the market pushing the boundaries, and the FDA has issued a number of warning letters. We are hopeful the PMTA process will reduce the number of marketers making unverified health claims as the FDA takes more aggressive action to address them.

16. What actions has the company taken to prevent youth access to tobacco products?

Reynolds utilizes multiple third-party data sources and technologies in an effort to prevent youth access to tobacco products and ensure our marketing programs are oriented towards adult nicotine consumers (ANCs) only. More specifically, the company:

  • Only uses mass media platforms with audiences that third-party survey data shows to be at least 85% adult.
  • Avoids imagery with youth appeal, only utilizes models who are 25 and older, and does not use testimonials from athletes or celebrities with special appeal to youth.
  • Verifies consumers are 21 years of age or older prior to purchase through an independent third-party.

In addition to the thorough marketing guidelines restricting how it markets its products, Reynolds has already instituted a tiered compliance program in all of its retailer contracts that includes penalties ranging from warning letters to contract termination for contracted retailers found to have illegally sold Vuse and VELO products to youth.

17. Where can I find updates on the status of an application?

Reynolds is among those encouraging the FDA to disclose a list of products submitted for PMTA review by the September 9, 2020 deadline.

Disclosing this information would help communicate to retailers and consumers which products are undergoing review and which are eligible to remain on the market, while also assisting federal- and state-level law enforcement to effectively remove illicit products from the market.

For Vuse and VELO products, we will be sharing updates as we have news to share right here on www.RJRVapor.com.

18. Do you expect there to be delays in the review process given the delayed deadline and COVID-19?

We cannot speak to the FDA’s internal review timing, although the agency has stated that some of their staff normally tasked with reviewing applications has been reassigned to COVID-19-related work. This was part of the rationale for delaying the deadline to September.

The extended deadline does however enable us to provide the FDA with additional data from studies that were in progress or that were delayed due to the impact of the COVID-19 pandemic, which we believe will make our applications even stronger.

19. Will you have to continue to file PMTA applications for new products in the future?

Yes. In the U.S. market, we will have to complete this same process before introducing any new products to our portfolios for which there is no grandfathered product to which to compare it to. The insights we have acquired thus far, and that we seek to continue building upon, will only increase our familiarity with the process and our expertise in submitting acceptable applications moving forward.

20. Where can I find more information about PMTA and the Tobacco Control Act?

The FDA has a number of informative resources on its PMTA page, which can be accessed here.