Cigar Trade Groups Fight to Keep Substantial Equivalence Extension

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Cigar Trade Groups Fight to Keep Substantial Equivalence Extension

On July 2, 2019, the ongoing legal battle between the cigar industry and the U.S. Food and Drug Administration (FDA) reached a new level when the cigar industry trade organizations that originally filed the lawsuit against the FDA filed a new motion urging a Washington, D.C.-based federal court to maintain the compliance deadlines previously set by the FDA.

While it may sound odd that those in the cigar industry would advocate for the FDA, the alternative could be costly. In May 2019, several public health groups urged the courts to force the FDA to review deemed tobacco products at a faster rate than previously required. This process, known as Substantial Equivalence (SE), has been the focus of much legislation and legal discussion in terms of the tobacco industry’s push back against regulation. Along with premarket tobacco applications (PMTA), Standard Equivalence is another way tobacco manufacturers can get their products on the market if they were introduced after the predicate date of Feb. 15, 2007. A manufacturer can file a Standard Equivalence report to demonstrate to the FDA how a certain tobacco product has similar characteristics to a predicate tobacco product and that it doesn’t raise any new questions in terms of its affect on a person’s health.

When the FDA’s Deeming Rule went into affect in May 2016, the deadline of May 2018 was set for Substantial Equivalence reports to be filed. With the change of administration and changes at the FDA, that deadline was extended to Aug. 8, 2021. Several public health groups, including the American Academy of Pediatrics, challenged this extension in court, focusing on how the delay of this requirement would allow e-cigarettes to remain on the market, adding to the “epidemic” of an increase in e-cigarette and vaping among minors in America. U.S. District Judge Paul Grimm of Maryland ruled in favor of the health groups, ordering the FDA to come up with a new plan to review deemed tobacco products at a much faster rate than the 2021 extension [read more here]. The decision, while based on e-cigarettes, impacted all deemed tobacco products, including premium cigars.

Now, the three cigar industry trade organizations–Cigar Rights of America (CRA), Cigar Association of America (CAA) and the Premium Cigar Association (formerly known as the International Premium Cigar & Pipe Association) are pushing back, urging the court to throw out Judge Grimm’s decision and instead stick to the extension implemented by former FDA Commissioner Scott Gottlieb. The trade organizations are fighting against the influence of the public health groups and the previous agreement between the cigar trade groups and the FDA that hinged on delaying the Substantial Equivalence requirement.

With two other FDA/cigar industry cases currently being argued in the D.C. courts, the trade groups are seeking to keep all things related to the lawsuit confined to D.C. Judge Amit P. Mehta will hear oral arguments related to the two other lawsuits at the end of July 2019.

For all the latest legislation and FDA news impacting the tobacco industry, click here.