90-Day Countdown Begins for FDA Deeming Rule Startup
WILLIAMSBURG, Va. — Just days after the Food and Drug Administration (FDA) released its long-awaited final deeming rule — which extends the agency's authority to electronic cigarettes, cigars and other tobacco products — the regulatory process and future of these products was top of mind at the Tobacco Merchants Association's (TMA) 101st Annual Meeting and Conference, taking place this week.
"We are at a historic point in the evolution of the tobacco industry," TMA President Farrell Delman said at the event, being held at the Kingsmill Resort and Spa in Williamsburg from May 9-11.
During this year's conference, Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), took to the podium as a featured speaker to discuss details of the deeming rule. Coincidentally, his May 10th speech coincided with the same day the final deeming rule was published in the Federal Register. Publication means the 90-day countdown begins and its effective date will be Aug. 8.
As Zeller explained, the deeming rule includes both automatic and additional provisions. The automatic provisions include registration and reporting requirements, health warnings, and a prohibition of descriptions such as "light," "low" and "mild." The additional provisions include a ban on the sale of the products to anyone under the age of 18, photo age verification for anyone under age 27, a ban on vending machine sales unless in an adult-only establishment, and a ban on free samples.
On the issue of health warnings, Zeller said companies have 24 months to stop manufacturing products without the warnings, plus an additional month for those products without warnings to work their way out of the supply chain.
Industry Sticking Points
One key question the FDA considered before finalizing the deeming rule, which it first proposed in April 2014, was whether or not to exempt premium cigars. In the end, premium cigars are covered by the new regulations.
During the TMA Conference's "Cigar Panel" discussion, Barry Schaevitz, partner at Fox Rothschild, said his initial reaction to the inclusion of premium cigars was surprise. The cigar industry first met with the FDA several years ago, he recounted, and the agency seemed to understand the differences between cigars and the differences along the continuum of risk.
"We scoured all the comments" and the CTP could not find any public health justifications to carve out premium cigars, Zeller said.
Another key point of contention with the deeming rule has been the grandfather, or predicate, date. The final rule sets the date as Feb. 15, 2007 — the same date that applies to cigarettes, smokeless tobacco and roll-your-own products spelled out in the Family Smoking Prevention and Tobacco Control Act of 2009.
According to Zeller, the agency did not see a basis for changing that date, nor did it receive any public comments describing a legal basis for a change.
Now that the FDA has taken the first step in regulating these newly deemed tobacco products, the agency will be offering some help to the industry to comply. The CTP has established a deeming rule landing page with information and resources, and it will host an extensive series of webinars. Some of the upcoming webinars will be presented in two stages: taped presentations by subject experts at the CTP, followed later by a live webinar, Zeller explained.
Even though it is early and the industry is still digesting what this all means, some attendees of the TMA Conference expressed skepticism that the FDA will be able to meet the product application timelines spelled out in the deeming rule.
Acknowledging the backlog of substantial equivalent (SE) applications the agency faced during the first years of the Tobacco Control Act, Zeller noted that when the CTP opened its doors the first day of fiscal year 2010 — after the Control Act was signed into law — the center only had two employees. Additionally, of the 3,500 SE applications filed the first time around, roughly 3,000 were filed in the last five days before the deadline.
"A lot has changed and we've learned a lot," Zeller said.
Still, in spite of Zeller's presentation, it was apparent that not all TMA Conference attendees are on board with the deeming, what it means for harm reduction, and whether companies will be able to comply with the new regulations.
James Dillard, senior vice president, R&D and regulatory affairs and chief innovation officer at Altria Client Services Inc., reminded the industry that this is not the first time they've had similar concerns. "In 2009, we heard it was the end of tobacco. But since 2009, the industry has been able to move forward, the industry has been able to innovate," he said during a panel discussion entitled "Better Aligning Industry with Public Health."
Dillard, for one, believes the deeming rule now provides the industry with clarity and a level playing field.
"I know we are all sitting here today and nobody is happy, but I think we felt that way when the statute came out [in 2009]," Dillard said. Having the rules, knowing the rules, having a level playing field and having an agency that is willing to work with the industry are positive steps, he added.
With just five days to digest the rule prior to the conference, Craig Williamson, president of the Cigar Association of America Inc., said "everyone needs to slow down, take a breath and figure out timing and what we need to do."
During the conference's "Cigar Panel," he described a sense of relief when the deeming rule was finalized May 5. Now, the biggest concern for cigar manufacturers, Williamson said, should be what they have to do to comply in the next 90 days, and then going forward in the next two years.
"It's kind of scary, but I really think we can get through this," Williamson added. "We are trying to get our members as prepared as possible to get through this. It will be a bumpy ride, but we will get through this."
Tobacco industry players should also keep in mind that the CTP is still in the very early stage of its regulatory life. Therefore, communication between the industry and the CTP is crucial, noted John Pinney, CEO of Pinney Associates, who moderated "The Future of Nicotine" panel.
"The idea that the industry engages with the Center for Tobacco Products aggressively will help turn the regulatory process for the better," Pinney said. "Be patient, but also be assertive, with interacting with the Center for Tobacco Products."