Over the past several weeks, the Premium Cigar Association (PCA) has received numerous questions from members about the U.S. Food and Drug Administration’s (FDA’s) current compliance policy for the premarket review requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) as applied to deemed tobacco products, particularly premium cigars and pipe tobacco. The following update summarizes the current situation and PCA’s understandings. As the policy remains subject to potential modification, the PCA plans to issue further updates in the coming days and weeks, as appropriate.
- A July 2019 order from the U.S. District Court for the District of Maryland significantly altered FDA’s compliance policy for implementation of the premarket review requirements of section 910 of the FFDCA for deemed tobacco products including premium cigars.
- In brief, the July 2019 Order moved the deadline for submitting marketing applications to FDA for certain deemed tobacco products. In the case of combusted deemed tobacco products, the July 2019 Order moved the deadline from August 8, 2021 to May 12, 2020.
- This deadline applies to marketing applications for deemed tobacco products that: (i) qualify as “new tobacco products” (i.e., those that were not commercially marketed in the United States as of February 15, 2007, or have been physically modified since); (ii) were on the U.S. market on August 8, 2016 (i.e., the date the deeming regulation took effect); and (iii) do not already have FDA-issued marketing authorizations.
- Note that this deadline does not apply to “grandfathered” products (i.e., those products that were commercially marketed in the United States as of February 15, 2007) that by law do not require FDA review, deemed “new tobacco products” that were not on the U.S. market on August 8, 2016 (which today require actual premarket authorizations), or deemed “new tobacco products” for which FDA has already issued marketing authorizations. In addition, note that: (i) changing the label or brand name of a “grandfathered” product does not render it a “new tobacco product”; and (ii) while FDA issues “grandfathered” determinations in response to voluntarily submitted requests from industry, the law does not require obtaining such a determination to market a “grandfathered” product.
- Under the July 2019 Order, FDA must receive a marketing application for a product covered by the current compliance policy by May 12, 2020. Otherwise, FDA would have the discretion to enforce the premarket review requirements for that product consistent with its stated enforcement priorities. Note that in January 2020, FDA released guidance explaining, in part, that “FDA intends to prioritize enforcement based on the likelihood of youth use or initiation to make the most efficient use of its resources” and that “FDA’s lowest priority among these products will include relatively expensive, large hand-rolled cigars that do not have flavors.
- Submitting an application by May 12, 2020, will ensure that a product covered by the current compliance policy may remain marketed without an otherwise-required authorization for up to one year during FDA’s review of the application.
NOTE: FDA’s current compliance policy as modified by the July 2019 Order remains subject to potential change.
- First, there remain several pending court cases, including an appeal of the July 2019 Order and broader challenges to FDA’s implementation of the deeming rule brought by PCA and other industry groups, that could result in significant changes, including an extension of the current May 12, 2020 deadline.
- Second, the impacts of the COVID-19 pandemic on FDA’s implementation of the July 2019 Order and, in particular, the current May 12, 2020 deadline, remain unclear. We understand that members of industry have requested that FDA extend the deadline based on the various and evolving impacts of the pandemic on applicants, their supply chains, and their vendors (e.g., laboratories, contract research organizations, environmental consultants). We understand that FDA leadership continue to evaluate these requests and the evolving situation.
In addition, PCA and other industry groups continue to advocate for relief related to the required contents of marketing applications for premium cigars as well as the circumstances under which FDA will require submission of such applications.