The Long and Winding Road Toward Substantial Equivalence

    Nine years later and still no rules for the road


    Finally, in April 2019, the FDA issued its proposed rule governing the “content and format of substantial equivalence reports,” which was the first time the industry was given a glimpse of what the “rules of the road” for an SE report would look like. At nearly the same time as comments on this proposed rule were due, Judge Paul W. Grimm, a district judge for the United States District Court for the District of Maryland, vacated the guidance document that extended the SE report deadline and instead imposed a deadline of May 2020 for SE reports.

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    What’s next?
    With the proposed SE rule, the industry admittedly has more guidance than it previously had. The proposed SE rule, however, still leaves unanswered numerous questions concerning the content of SE reports, especially for cigars. As CAA noted in its extensive comments on the proposed SE rule, it takes a one-size-fits-all approach to SE reports, failing to appreciate the differences between product categories and that cigars are a heterogeneous product category. Among others, the cigar industry will have to deal with the following hurdles in preparing SE reports:

    • The FDA has failed to define any design parameters for cigars.
    • The FDA does not appreciate that, with respect to many cigars, harmful and potentially harmful constituent (HPHC) testing will be of little to no value, as there are no reliable and reproducible methodologies for this testing.
    • The FDA has not informed the cigar industry what HPHCs to test for.
    • The FDA has not finalized the rulemaking on whether and how premium cigars could be exempt from regulation.

    These substantive issues related to the content of SE reports are putting aside the more significant timing issue, as the deadline for submission of SE reports has now been accelerated by a staggering 14 months, from the original date of August 2021 to May 2020.
    This significantly accelerated deadline creates substantial hurdles for the industry. Even assuming that the proposed SE rule is released by the end of 2019, this does not leave sufficient time for companies to necessarily prepare the “quality” SE reports the FDA is looking for. This deadline also ignores many practical issues that the industry will face, such as the fact that, even if the FDA told cigar manufacturers how and what HPHCs to test for, labs are currently at full capacity as they separately handle testing for premarket tobacco product applications for e-cigarette products.

    So, nine years later, the SE process is still in a state of disarray. To the extent that the FDA had started to make any meaningful progress on outlining the “rules of the road,” that progress has been trampled on by way of an irresponsibly accelerated deadline.
    CAA will continue to fight on behalf of the entire cigar industry to make the SE report process fair, achievable and practical.

    1. As of the writing of this article, neither the FDA nor the courts had extended the SE deadline for cigars and pipe tobacco.
    2. This decision is currently subject to numerous legal challenges.

    This story first appeared in the September/October 2020 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    – Contributed by Craig Williamson, President, Cigar Association of America (CAA)