The Long and Winding Road Toward Substantial Equivalence

    Nine years later and still no rules for the road

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    The following article was written before the Aug. 19, 2020 court ruling delaying the Deeming Rule and Substantial Equivalence process as it applies to premium cigars.

    In September 2019, the Cigar Association of America (CAA) wrote the piece below on substantial equivalence (SE) and the difficulties confronting the cigar industry in attempting to comply with onerous yet unclear requirements. On the eve of having to file thousands of SE reports, nothing has changed—other than a brief extension of the May 2020 deadline due to the global COVID-19 pandemic. The industry still has no “rules of the road” and no final SE rule. The U.S. Food and Drug Administration (FDA) has still not provided clarity on critical questions regarding the SE process, and companies are confronting vexing decisions on how to submit SE reports and where to place their limited resources.

    In addition, we remain in the midst of a global pandemic, and so far, the FDA has refused an additional extension so that the industry does not have to decide between finalizing quality SE reports and the health and safety of its employees. The FDA appears more interested in preserving an artificial deadline for many products the agency says are its “lowest priority” than in addressing pandemic health concerns. CAA petitioned the regulatory agency to extend the May 12, 2020, deadline due the pandemic for “no less than 90 days,” given the uncertainty of the situation. The FDA did grant an extension on the assumption the pandemic would abate over the summer. That, unfortunately, has not happened. Both to protect the public health and to provide the final SE rule, the FDA should again extend the deadline.

    Since 2011, the tobacco industry—first cigarettes and smokeless tobacco and now cigars and pipe tobacco—has sought to navigate the uncharted waters of the FDA’s SE process. After nine years, and with filing deadlines looming, the FDA has yet to provide promised “rules of the road” that outline an SE process that is practical and sensible—and that takes into account the very different nature of various products.

    Background and History
    Before a “new” tobacco product (one not on the market as of Feb. 15, 2007) may be introduced for commercial distribution in the United States, the product must undergo premarket review by the FDA. One of the premarket review pathways is through the submission of a substantial equivalence report (SE report) that demonstrates the product is “substantially equivalent” to a predicate tobacco product. While this SE pathway, on the surface, may appear manageable, the FDA’s lack of clarity and guidance with respect to the SE process has left this pathway riddled with confusion and inconsistency from 2011—when provisional SE reports for cigarettes and smokeless tobacco products were due—through today.

    Under the 2009 Family Smoking Prevention and Tobacco Control Act, the filing of a provisional SE report for originally regulated products allowed the product to remain on the market while being reviewed by the FDA. Nearly 3,600 provisional SE reports were filed by the statutory deadline of March 2011 with no guidance from the FDA other than a brief and insubstantial guidance document posted less than three months before these reports were due. Because of this lack of guidance, these provisional reports lingered for seven years, when, without explanation, the FDA removed about 1,500 of them from review, allowing them to remain on the market.

    Upon the final deeming rule going into effect, the deadline for submission of SE reports for products on the market as of Aug. 8, 2016, was February 2018, but this deadline was ultimately extended to August 8, 2021. This extension was to give the FDA time to put in place the so-called “rules of the road” for manufacturers to follow in filing the SE reports for cigars and pipe tobacco.

    In October 2018, the FDA held a public meeting in an attempt to “improve public understanding and to seek feedback on the policies and processes for the submission and review of tobacco product marketing applications.” This meeting, while helpful, still did little to shed light on what cigar SE reports would need to contain. The industry was still without sufficient information from the FDA, only walking away with “appendix” documents for various products, crafted on perceived “deficiencies” in reports filed with the FDA—yet virtually no SE reports for cigars had been filed with the FDA at that point in time.