FDA’s Final Deeming Regulations Covers all “Tobacco Products”

May 10, 2016

By David B. Clissold

On May 10, 2016, FDA published in the Federal Register the final “deeming regulation” asserting control over all tobacco products, even products that do not yet exist, meeting the broad statutory definition of a “tobacco product.” Under the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), a “tobacco product” is defined in relevant part as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product . . . .” As discussed in our post describing the proposed deeming regulation, the Tobacco Control Act gave FDA the immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, any other “tobacco product” could be regulated by FDA only if the agency issued regulations “deeming” such other products to be subject to the Tobacco Control Act. The final rule does exactly that, deeming electronic cigarettes (“e-cigarettes”), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvable tobacco products, among other products, to be within FDA’s regulatory authority. (And almost immediately after publishing the final rule, Nicopure Labs, Inc., which distributes vaping devices and manufactures and distributes nicotine- and non-nicotine-containing “e-liquid” filed suit against FDA challenging the regulations as unlawful.)

In the proposed rule, FDA presented an option that would have exempted premium cigars from FDA regulation. The final rule rejected that possibility and treats all cigars the same. Although the proposed rule requested comment on how the concept of a “continuum of risk” could be applied to the regulation of various tobacco products, FDA proceeded to regulate these diverse products with all the subtlety of a sledgehammer. Among the requirements going into effect on August 8, 2016, all manufacturers of any tobacco product will be required to:

  • Register and list every product (domestic manufacturers only). Foreign manufacturers will be required to register and list too, but this will require a separate regulation with its own effective date.
  • Obtain premarket authorization (SE, SE exempt, or PMTA; see our discussion of the tobacco product pathways to market here) for any product introduced after August 8, 2016.

For products marketed before August 8, 2016 and not “grandfathered,” the premarket authorization requirements are subject to certain “compliance periods.” Under an FDA compliance policy announced in the final rule, enforcement of the premarket authorization requirement will be delayed depending on the type of premarket authorization submitted:

  • August 8, 2017: Deadline for manufacturer to submit and FDA to accept an SE exemption request.
  • February 8, 2018: Deadline for a manufacturer to submit and FDA to accept an SE report.
  • August 8, 2018: Deadline for a manufacturer to submit and FDA to accept a PMTA. 

If the manufacturer submits and FDA accepts one of the submissions by the deadline stated above, FDA will not take enforcement action against that product for one year. However, at the end of that period, even if FDA has not completed its review, the product will be subject to enforcement action unless FDA determines that “substantial progress” is being made towards completion. These deadlines are departures from the proposed rule, which provided 24 months for the submission of an SE report or PMTA, and foreclosed the possibility of enforcement action until after FDA had acted upon the submission.

Another deadline looming for cigar and pipe tobacco manufacturers is August 20, 2016, which is the date by which such manufacturers must submit certain information to FDA for the purpose of calculating user fees. This issue was addressed in a companion final rule and compliance guide.

Requirements for all manufacturers to list the ingredients in every tobacco product, submit certain “health documents,” and for cigar manufacturers or importers to submit a “warning plan” to FDA, all take effect in 2017. By August 8, 2018, cigar manufacturers must include specified warnings on all packaging and advertisements. The required reporting of harmful or potentially harmful constituents (“HPHC”) takes effect on August 8, 2019, although FDA promised additional HPHC guidance before then.

With respect to e-cigarettes (examples of a tobacco product category that FDA defines more broadly as “electronic nicotine delivery systems,” or “ENDS”), FDA issued a draft guidance entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” This draft guidance outlines all of the information that FDA considered important for a manufacturer to include in a PMTA for an ENDS. FDA also seems to believe that ENDS manufacturers in particular can make great use of “tobacco product master files” for certain components (e.g., the “e-liquid” in an ENDS), which are the subject of their own guidance. Further, ENDS “retailers who mix or prepare their own e-liquids or create or modify aerosolizing apparatus from various components” are classified as “manufacturers” by FDA, and are thus subject to all of the restrictions on all tobacco product manufacturers (e.g., the premarket submission requirements).

Although FDA expressed great confidence in its ability to review the avalanche of premarket submissions that it is about to receive, its recent history might suggest some degree of skepticism. FDA gave itself one year to review these new submissions, but even if FDA has not completed its review by the end of that one-year period, the product could nevertheless be subject to enforcement action. The only incentive for FDA to act on such submissions within a year is apparently to meet its own, as yet unspecified, “performance goals.” FDA also indicated that it intends to issue a proposed product standard to regulate the use of “characterizing flavors” in tobacco products. The landscape for the newly deemed tobacco products, particularly ENDS and cigars, is about to become very different from what we know today.

Categories: Tobacco