FDA Extends Final Rule Compliance Deadlines By 90 Days

FDA Extends Final Rule Compliance Deadlines By 90 Days

The cigar industry has been given a 90-day extension to comply with future FDA rulings. Yesterday, the U.S. Food and Drug Administration announced that it is extending and deferring enforcement of all future compliance deadlines under its controversial Final Deeming Rule for three months.

The three-month extension applies only to deadlines set for May 10, 2017, or later, and includes all newly regulated tobacco products, among them premium cigars. It also pushes back the starting date for the joint cigar industry lawsuit, from August 30 to sometime in October.

The extension pertains to major deadlines such as manufacturer submission of future cigar warning label plans, registration and listing, health documents, Substantial Equivalence exemption request and applications, Premarket Tobacco Product Applications and Harmful and Potentially Harmful Constituent reports.

The deadline stay was the result of a compromise between the three major lobbying groups that represent the premium cigar industry—the Cigar Association of America, the Cigar Rights of America, and the International Premium Cigars and Pipe Retailers Association—and the U.S. Department of Justice, which is representing the U.S. Department of Health and Human Services, the overseer of the FDA, in multiple lawsuits that challenge the agency's Final Deeming Rule.

Members of the premium cigar industry had been hoping for an extension to FDA compliance. It came about via an unlikely source, after the Department of Justice asked Judge Amit P. Mehta of the U.S. District Court for the District of Columbia to push back the deadlines in the joint cigar industry lawsuit by three months "to allow new leadership personnel at the Department of Health and Human Services to more full consider the issues raised in this case and determine how best to proceed." The cigar industry attorneys agreed to this request, so long as the FDA agreed to delay all future compliance dates by three months.

Therefore, the trial for the joint cigar industry lawsuit, which had previously been pushed back to August 30, won't begin until sometime in October, depending on when Judge Mehta sets the date.

"The fact that it was the federal government that asked for the delay suggests that it is just as uncertain as to how FDA regulation should apply to premium cigars as all of us in the cigar industry," said Drew Newman, general counsel of J.C. Newman Cigar Co., based in Tampa, Florida.

The delay also means that the cigar industry lobbying groups have additional time to continue their efforts to help pass legislation that would exempt premium cigars from FDA regulation. Also, the extension offers smaller cigar companies, many of which may not be able to absorb the costs of compliance, a three-month reprieve.

"Hopefully this begins the process of a long-term dialogue with the new Department of Health and Human Services," said Glynn Loope, executive director of the Cigar Rights of America. "While this suspension of the rule is positive on the immediate demands of the regulations, it is also an opportunity for us to continue our message to Congress and the new administration as to the threat that these regulations pose to the industry." (Cigar enthusiasts can help by contacting their elected officials using this action tool at the CRA website.)

The FDA's decision to delay its deadlines affects one immediate provision: cigar warning plans. Originally, all retailers, manufacturers, distributors and importers were supposed to submit their warning plans to the FDA by May 10, but the new deadline is now August 10, 2017.

"We are very happy that the government has extended the implementation of FDA regulation by three months," said Newman. "Because there is so much uncertainty about FDA regulation throughout the premium cigar industry, this delay will give all of us some much needed time to continue to work together and address them."

The three-month extension means that the following provisions from the Final Deeming Rule, which were set to take effect on May 10, 2018, have been pushed back to August 10, 2018:

  • Rotational cigar warning statements on product packages and advertisements;
  • Point of sale warning statement requirement for cigars sold individually without packaging.

Moreover, the deadlines for the following premarket review requirements have also been pushed back:

  • Compliance period for manufacturers to submit a Substantial Equivalence Exemption Request (original deadline of August 8, 2017 is now November 8, 2017);
  • Compliance period for manufacturers to submit a Substantial Equivalence Application (original deadline of February 8, 2018 is now May 8, 2018);
  • Compliance period for manufacturers to submit a Premarket Tobacco Product Application (original deadline of August 8, 2018 is now November 8, 2018);

The deadlines for the following provisions from the FDA's Final Deeming Rule have also been extended:

  • Ingredient listing (original deadline of August 8, 2017 is now November 8, 2017. For small-scale manufacturers, the original deadline of February 8, 2018 is now May 8, 2018);
  • Harmful and Potentially Harmful Constituents (original deadline of August 8, 2019 is now November 8, 2019);
  • Tobacco products label information (original deadline of May 10, 2018 is now August 10, 2018).