16 May Judge Rules in Cigar Industry Lawsuit Against FDA
Yesterday, Judge Amit Mehta issued an opinion on several issues raised in the IPCPR’s lawsuit against the FDA.
Notably, Judge Mehta struck down the requirement that retailers who blend pipe tobacco must register their establishments with and submit product listings to the FDA. This is a positive development for IPCPR members and significantly eases the compliance burden facing many premium tobacconists around the country.
However, Judge Mehta did not endorse other challenges to the FDA’s:
- Warning requirements for cigars and pipe tobacco;
- Regulations requiring payment of user fees by cigar and pipe tobacco manufacturers and importers (but not by those of e-cigarette companies); and
- Regulation of pipes as components or parts of tobacco products.
Scott Pearce, IPCPR Executive Director recognized that today’s ruling is yet another step in what has been a nearly two-year-long process of attacking the FDA’s regulatory scheme. “IPCPR is reviewing the overall decision and evaluating its impact on our members. We are pleased to see Judge Mehta recognized the unfair treatment of retailers who blend pipe tobacco and unfairness of expensively regulating premium cigars while reconsidering whether the Rule should reach them. However, we are disappointed that he did not grant relief against the FDA’s onerous warning requirements, the user fee scheme, and the regulation of wooden pipes, and our attorneys are exploring all legal options to secure this very necessary relief, including through an appeal. We are confident that the court system ultimately will vindicate the rights of our members.”
So what does this mean?
- At least until the FDA reevaluates the issue under the appropriate standards as required by the court, retailers who blend pipe tobacco in store need not register their shops with, and submit listings of blended products to, the FDA.
- As of now, the August 10, 2018, deadline for compliance with the FDA’s cigar and pipe tobacco packaging and advertising warning requirements remains in place
- Tobacco pipes remain regulated as “components” of tobacco products and subject to all applicable requirements and FDA compliance policies, including those relating to pre-market review of “new tobacco products.”
- Cigar and pipe tobacco manufacturers and importers will continue to pay user-fees.
The lawsuit is a joint effort by IPCPR, Cigar Rights of America and the Cigar Association of America. IPCPR, along with our legal team, will continue to provide updates as this process unfolds.
For questions concerning the lawsuit, please contact Daniel Trope, IPCPR Senior Director of Federal Government Affairs by emailing email@example.com.