On Friday July 28, 2017, the U.S. Food and Drug Administration (FDA) announced its new "comprehensive regulatory plan to shift trajectory of tobacco-related disease, death" that refocuses the Agency's implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule. FDA's new strategy appears to be moving away from its "one-size-fits-all" approach to tobacco product regulation by recognizing that a "continuum of risk" of tobacco and nicotine-containing products exists. While FDA has indicated that its long-term plan is to, among other things, potentially lower nicotine in cigarettes to non-addictive levels, it also made major changes to its compliance policy for recently "deemed" tobacco products that immediately impacts manufacturers of e-vapor, e-liquid, cigars, hookah and pipe tobacco products.
Background: FDA Compliance Policy for Deemed Tobacco Products
The Deeming Rule became effective on August 8, 2016, extending FDA's tobacco product authority over newly deemed products and subjecting manufacturers to the requirements in the Tobacco Control Act, including adulteration and misbranding prohibitions, establishment registration and product listing for manufacturing facilities located in the United States, ingredient reporting, testing for Harmful and Potentially Harmful Constituents (HPHCs), a ban on unauthorized modified or reduced-risk claims and, most significantly, premarket authorization for any new products first marketed or modified after the February 15, 2007 "grandfather date".
In the Deeming Rule, FDA proposed a "compliance policy" delaying enforcement of the premarket authorization requirements for deemed products already on the market when the rule went into effect. More specifically, for non-grandfathered deemed products on the market on August 8, 2016, manufacturers initially had either two years (i.e., by August 8, 2018) to submit a Premarket Tobacco Product Application (PMTA) or 18 months (i.e., by February 8, 2018) to submit a Substantial Equivalence (SE) Report. Products intended to be introduced to the market or existing products modified in any way after August 8, 2016 are not subject to the compliance policy and would first need to obtain FDA authorization before they can be marketed (enforcement of this requirement, however, has not been a priority for FDA to date).
Moreover, even if a company could submit a timely PMTA or SE Report that FDA accepted for review, the "sunset provision" in the compliance policy only allowed that product to be marketed for an additional 12 months (i.e., until August 8, 2019 for PMTAs) while the agency reviewed the application (FDA could extend this on a case-by-case basis). If FDA was unable to complete its review by then, the product would have to be removed from the market, and could only be re-introduced if the Agency ever granted marketing authorization.
Due to the copious amounts of data and associated expenses needed for a PMTA, which potentially includes clinical and epidemiological studies to demonstrate that a product is "appropriate for the protection of the public health", this resulted in a particularly dire situation for the vapor industry - which faced effectively being banned - because there are no known grandfathered e-vapor or e-liquid products and, therefore, no way to make use of the less arduous SE pathway. Indeed, through September 2016, FDA had refused to accept 362 PMTAs submitted, presumably, without the data needed to even begin the substantive review process. (To date, only Swedish Match's PMTAs for its snus smokeless tobacco products have survived the review process, and those applications included a substantial amount of clinical and long-term epidemiological data from Sweden.)
Earlier this year, in light of multiple lawsuits filed by the industry, the PMTA deadline (as well as all other forthcoming TCA compliance deadlines for deemed products) was delayed by three months to November 8, 2018 "to allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final [Deeming Rule]."
The new leadership, led by FDA Commissioner Dr. Scott Gottlieb, has now announced FDA's revised compliance policy for deemed products. Under the new timelines, the February 15, 2007 grandfather date remains in place, but the deadlines for "applications" (i.e., SE Reports or PMTAs) for deemed products on the market have been delayed. Specifically, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, are due by August 8, 2021, and applications for non-combustibles, such as e-vapor and e-liquid products, are due by August 8, 2022. In his remarks, Dr. Gottlieb also indicated that FDA would be revising the sunset policy so that existing products under review remain on the market.
How Will This Impact Your Vape Business?
While the PMTA delay provides much needed breathing room on the most complicated and expensive requirement - and saves the vapor industry from a de facto ban - it is important for vape businesses to understand that none of the other fast approaching TCA deadlines have been impacted by FDA's new policy.
Specifically, the Agency noted in its press release that its new policy will not (1) apply to provisions of the Deeming Rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors, or (2) affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., "light," "low," or "mild," or similar descriptors. The table below summarizes the major compliance deadlines for e-vapor product manufacturers:
|Requirement||Deadline for Large-Scale Manufacturers||Deadline for Small-Scale Manufacturers|
|Free sample ban, age restriction, photo-ID check, use of modified/reduced risk claims and descriptors, adulteration and misbranding prohibitions||August 8, 2016|
|Introduction of new, deemed products without FDA premarket authorization (products on the market before this date are subject to the new compliance policy deadlines)||August 8, 2016|
|Registration of U.S. manufacturing establishments and submission of List of Products manufactured in such establishments [does not apply to foreign establishments]||September 30, 2017|
|Submission of Health Document Notification||February 8, 2017||November 8, 2017|
|Submission of Ingredient Listing Reports||November 8, 2017||May 8, 2017|
|Submission of Harmful and Potentially Harmful Constituents (HPHCs) reports||November 8, 2019|
|Nicotine Addiction Warning on Labels and Advertisements||August 10, 2018 (distribution of products without the required warning must cease by September 10, 2018)|
|PMTA or SE Report for deemed combustible products ( e.g. cigars or hookah) on market on August 8, 2016||August 8, 2021|
|PMTA or SE Report for deemed non-combustible products (e.g., vapor products) on August 8, 2016||August 8, 2022|
To learn more about the U.S. manufacturing establishment registration & product listing, health document submission, and ingredient listing requirements, see here, here and here. If you have any questions about how to complete these submissions, please let us know.
Beyond the immediate PMTA delay, FDA broadly announced that it is working to develop foundational rules and guidance, including rules and guidance to clarify the requirements for the SE Reporting process, PMTAs, and Modified Risk Tobacco Product (MRTPs) applications and the standards of review. Specifically, FDA:
- Plans to issue product standards for vapor products to protect against known public health risks;
- Will issue new "foundational rules" and guidance to modify the product review process and clarify the requirements for the SE Reporting process, PMTAs, and Modified Risk Tobacco Product (MRTPs) applications;
- Will study the effects of flavors (including menthol), both on young people and adult smokers looking for a less harmful alternative;
- Will begin a public dialogue through an Advanced Notice of Proposed Rulemaking (ANPRM) on the impact of reducing nicotine in cigarettes to non-addictive levels (FDA stressed that, at this time, it is only contemplating a reduction in nicotine in cigarettes and not for other tobacco (i.e., vapor) products); and
- Will issue an ANPRM soliciting comments and data relating to the use and public health impacts of premium cigars.