On July 11, a federal judge issued an important ruling that dramatically advances submission deadlines for premarket review of tobacco products.  As a function of that ruling, the deadline for applications for FDA premarket review of “deemed” tobacco products (including cigars, pipe tobacco and electronic nicotine delivery systems (ENDS)) is now May 11, 2020.

By way of background, the Family Smoking Prevention and Tobacco Control Act (the law that gives the FDA jurisdiction over tobacco products) requires FDA marketing authorization for all “new tobacco products.”  A “new tobacco product” is defined as:  (1) any product introduced after February 15, 2007, or (2) any product that has changed in any way since then.  “Grandfathered” products (those that were sold before February 15, 2007, and that have not been changed, are exempt from this process. 

When the FDA issued the deeming regulations in 2016, it set deadlines in 2018 for these submissions.  Then, in the summer of 2017, the FDA extended these deadlines, making the deadline for combusted products in 2021 and non-combusted products in 2022.  Late last year and early this year, the FDA indicated that it was considering revisiting these deadlines, citing an “epidemic” of youth usage of tobacco products.

The ultimate change to the deadlines was prompted by a lawsuit filed in March 2018 by a number of public health organizations challenging the revised deadlines established by the FDA in 2017.  The case is American Academy of Pediatrics, et al. v. Food & Drug Administration, et al., No. 8:18-cv-00883 (D. Md.).  The plaintiffs asserted that the FDA’s extension of deadlines was not allowed under the Tobacco Control Act and this extension was an abdication of the FDA’s duty to administer and enforce the Tobacco Control Act. The plaintiffs also asserted that the FDA did not go through the appropriate administrative procedures in issuing the extension, and that the decision was not based in reasoned decision-making.

Although the plaintiffs’ standing to pursue these claims was dubious, the court allowed their claims to go forward.  Indeed a similar group of plaintiffs was found to lack standing in their effort to defend the Deeming Regulations in another case.  See Cigar Ass’n of Am. v. U.S. Food & Drug Admin., 323 F.R.D. 54 (D.D.C. 2017).  There, the court found a lack of standing where the plaintiffs relied on advocacy, informational, and educational disadvantages if the Deeming Regulations were vacated.

The Maryland court ultimately invalidated the 2017 compliance policy.  The Court reasoned that the compliance policy violated the Tobacco Control Act and impermissibly modified the Deeming Regulations’ original deadlines without going through notice and comment.  The Court was clearly influenced by its view of the “epidemic” of youth consumption of ENDS.  The court ordered a new deadline of May 11, 2020, which is more than one year earlier than the FDA deadline for combusted products and more than two years earlier than the FDA deadline for non-combusted products.  The court also ordered that products for which applications have can remain on the market for a period of one year.  After that, the products are subject to FDA enforcement action.  It is not clear how the FDA could conceivably act within a year on the thousands of premarket review applications that are likely to be filed. 

Although it is possible that there could be future changes to the deadline based on litigation or other developments, it is prudent to assume that nothing will change and that the deadline will remain May 11, 2020.  Stay tuned for further developments and please let us know if we can help with your premarket review submissions for deemed tobacco products.