FDA and Cigar Trade Associations Take on Substantial Equivalence

Justice Department and Cigar Trade Associations Take on Substantial Equivalence

Substantial equivalence, the process by which manufacturers of covered tobacco products including cigars, pipe tobacco, and e-cigarettes submit different products for U.S. Food and Drug Administration (FDA) review in order to keep them on the market, has been in the news in recent months. After the FDA extended the deadline for manufacturers to file substantial equivalence applications to 2021, health advocacy groups filed a lawsuit, claiming the FDA had neglected its duty to protect public health by invoking the substantial equivalence application within the regulation of covered tobacco products, leading to the rise of e-cigarette and vaping among minors.

In July, a Maryland judge ruled in favor of the the health groups, agreeing that the delay in substantial equivalence gave the e-cigarette industry in particular a way to keep their selling and marketing their products without going through the necessary premarket requirements [read more here]. Through the case’s focus was on e-cigarettes, the substantial equivalence requirement impacts all covered tobacco products, including cigars and pipe tobacco. Cigar trade associations filed a lawsuit challenging the Maryland case that moved up the substantial equivalence to May 2020, but U.S. District Court Judge Amit P. Mehta ruled against the cigar industry, deciding they had not effectively proven what was required to overturn the decision [read more here].

Now, the Department of Justice has filed a notice of appeal on behalf of the FDA in the Maryland case, Academy of Pediatrics, et. al v. United States Food and Drug Administration, et al. The appeal challenges Judge Paul Grimm’s decision, claiming it violates the principles of separation of powers and interferes with the executive branch’s authority and regulation.

On another legal front, the cigar trade associations that filed the lawsuit against the FDA–the Cigar Association of America (CRA), Premium Cigar Association (PCA), and the Cigar Rights of America (CRA)–have updated their lawsuit and its various complaints against the FDA and the Deeming Rule. Part of the updated complaint includes the substantial equivalence process, which the cigar trade associations argues will be hard for many manufacturers to comply with if they don’t have predicate products to compare their post-2007 products to. The amended complaints also takes on the many compliance date changes, including the one brought on by the Maryland decision, the lack of finalized guidance for premium cigars, the high costs associated with compliance, and user fees, among other subject matters.

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