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.

IPCPR, CAA, and CRA Joint Statement on Passage of FY 19 Agriculture Appropriations Bill

In better news, the International Premium Cigar & Pipe Retailers Association (“IPCPR”), Cigar Association of America (“CAA”), and Cigar Rights of America (“CRA”) were pleased to announce the adoption of language in the FY 2019 budget as approved by the U.S. House of Representatives Committee on Appropriations by a vote of 29 – 20 that works to protect premium cigars from overreaching and burdensome regulations, as proposed by the U.S. Food & Drug Administration.

The language addresses significant concerns that the premium cigar industry has maintained since the rule was proposed in 2014. According to Scott Pearce, IPCPR Executive Director, this language is proof positive these concerns are not only heard, but validated. “I think we’ve seen broad recognition on and off Capitol Hill that FDA’s regulatory regime for premium cigars has been deeply flawed since it was introduced four years ago,” said Pearce. “IPCPR and CRA applaud Congressmen Cole, Bishop and all of our supporters on Capitol Hill for finding a sensible legislative solution that provides premium tobacconists and manufacturers certainty. Congress never intended for the premium industry to endure the regulatory burdens imposed by the FDA. Today’s vote reinforces that.”

CAA President Craig Williamson extended his thanks to the Committee for adopting the amendment. Williamson added, “after working on two separate amendments for the past four years the groups realized that we are stronger working together to accomplish the same goal – the protection of the entire cigar industry.”

CRA Executive Director Glynn Loope stated, “This amendment once again sends a clear message that the regulations advanced by the FDA go well beyond the congressional intent of the Tobacco Control Act. We extend our appreciation to our legislative co-sponsors that have served as champions for this language, as well as proponents of regulatory reform as it applies to cigars with the President’s Administration.”

The language as adopted by the committee blends past efforts, by not only providing an exemption for defined premium and large cigars, but changing the “predicate date” for cigars and pipe tobacco from burdensome pre-market approval procedures to the time of the deeming rule issuance, from February 15, 2007 to April 25, 2014.