Last month, six health groups filed a motion to intervene in lawsuits filed in opposition to the U.S. Food & Drug Administration’s (FDA) deeming regulations. Last week, both FDA and the cigar trade associations responsible for one of the lawsuits responded.
The plaintiffs—the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR)—are opposing the motion to intervene. In a brief filed with the court, the plaintiffs argued the health groups have no right to decide whether the government will keep all or parts of the rule.
It also highlighted the fact that the motion to intervene itself was largely copy and pasted from another lawsuit, specifically one that had to do with e-cigarettes, and as such some parts of the health groups arguments aren’t relevant in this case.
The health groups are:
- American Academy of Pediatrics
- American Cancer Society Cancer Action Network
- American Heart Association
- American Lung Association
- Campaign for Tobacco-Free Kids
- Truth Initiative
As for FDA, it said it took no position as to whether the health groups’ motion should be granted. However, it did ask the court to consider delaying a decision as FDA argued it’s unclear what parts of the original complaint will be litigated.
That stance is due to an announcement last month that FDA would delay the deadline for substantial equivalence filings until 2021, as well as reconsider the rule itself; something that angered the health groups who argued FDA would not be fully committed to defending the rule as part of the lawsuit. As such, the health groups filed a motion that would allow them to act as co-defendants.
FDA argued that two lawsuits, including one brought by 1502 Cigars, were stayed, effectively an indefinite suspension, following the substantial equivalence delay. It speculated that the announcement could alter the legal strategy from the cigar trade groups.
It also formally stated that the late July announcement only affected the substantial equivalence and PMTA deadlines, not any other deadlines:[ref]PMTA is not relevant for cigar makers.[/ref]
For example, the FDA stated that its approach would “not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., ‘light,’ ‘low,’ or ‘mild,’ or similar descriptors.” Id. It likewise stated that this approach would “not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.