FDA’s Finalized Deeming Regulation Will Not Be End of Rulemaking

LAS VEGAS — One year ago, the Food and Drug Administration (FDA) released its proposed deeming regulation that would give it the authority over electronic cigarettes, cigars, pipe tobacco and certain dissolvable products that are not smokeless tobacco.

In the intervening 12 months, the agency's Center for Tobacco Products (CTP) received and sifted through more than 135,000 public comments on the proposal. And now, a final rule could be revealed by the end of June, according to Mitch Zeller, director of the CTP.

Zeller took the stage at the 2015 NATO Show Thursday morning in Las Vegas. It was the second time he addressed the association at its annual show since taking over the director role in March 2013, demonstrating the importance he places on the agency and the tobacco industry working together to responsibly regulate tobacco products.

He was joined on a panel entitled "Business 'As Usual' Under FDA Regulation" by industry executives Jim Dillard, senior vice president of regulatory affairs at The Altria Group Inc., and Daniel McGee, general counsel at General Cigar Co.

According to Zeller, there are two key discussions taking place at the FDA. One discussion takes aim at keeping tobacco products out of the hands of minors — a top priority for all stakeholders — while the second conversation centers around looking at nicotine differently. As he noted, the majority of adult cigarette smokers started as minors and by the time they were adults, the addiction had taken hold. Nicotine creates and sustains the addiction, but does not cause death. 

"It's not the drug, it's the delivery method," Zeller said. "E-cigarettes have become the poster child for this debate, so it's about time to look at nicotine differently. We need to recognize that there is a continuum of nicotine-containing products." On one end of the spectrum are combustible cigarettes and on the other are nicotine replacement therapy products.

Rules in the Making

With the June target for a final deeming rule around the corner, the industry waits to see what shape the regulations will take. However, Dillard cautioned that changes can happen between the proposed rule and the final form.

He is worried the proposal is "a bit overbroad" as there are multiple categories with different characteristics "lumped together."

Dillard also pointed out the segments covered by the deeming regulation are very diverse, but the agency must apply a level playing field. For example, when it comes to compliance and user fees. 

On the cigar side of the business, McGee raised concerns with the definition of premium cigars in the deeming regulation and the grandfather date for predicated products, which proposed stands at Feb. 15, 2007 — the same date as tobacco products the FDA already regulates.

"Premium cigars, in contrast to machine-made cigars, are a very distinct [animal]," McGee said, noting premium cigars are a much smaller segment so the regulations should not be "one size fits all" when it comes to cigars.

He also hopes the FDA allows sufficient time for compliance once the deeming regulation is finalized.

Zeller explained, though, that finalizing the deeming regulation will not bring an end to new rules governing tobacco products. The deeming regulation is "a foundation jurisdictional step" and the industry should expect other regulations to follow. "We should all expect that when deeming is final and in effect, there will be other rulemaking," he said. 

As the FDA moves forward, Zeller said research will go "a long way in shaping future regulations." Research enables all stakeholders to understand and start to answer questions for a new generation of products. The two main questions are: who is using the products and how are they being used.

Education & Today's Youth

Zeller's history with the FDA dates back further than his role as director of the CTP. He previously worked with the agency, leading the first — although unsuccessful — effort to bring tobacco regulation under the purview of the FDA during the 1990s while the Master Settlement Agreement negotiations were taking place. 

In 2000, efforts were coming on the heels of "Joe Camel" and the idea that smoking was cool. There were leaders and followers when it came to cigarette use, he said. Fast forward 15 years and the picture is very different. "The kids we are looking at today don't see smoking as cool, but as a coping mechanism," Zeller pointed out.

That makes them harder to reach, according to the CTP director. To that end, the agency has launched an education campaign aimed at the general "at-risk market," with further efforts in the works to reach several subgroups: multicultural, rural, American Indian/Alaskan Native and LGBT youth.

"To state the obvious, the marketplace is changing at a head-spinning rate," Zeller said. "Retailers' role in complying with the law and helping us keep tobacco products out of the hands of kids is critical."

More on the CTP Front

During the NATO Show panel, Zeller also outlined other agency-related activities on the tobacco front:

• Product Standards: The CTP is working internally on a strategy to use its authority in the interest of public health that will withstand legal challenges. The director called this "one of the most, if not the most, powerful tool" the center has.
• Substantial Equivalence (SE):  The center received 4,710 SE applications, with provisional reports (those submitted before March 22, 2011) accounting for the lion's share. Provisional reports allow companies to continue marketing the product until the FDA rules on the SE application. Ninety-seven percent have reached acceptance review, which is the first step.
• Modified Risk Tobacco Products (MRTP): In August, Swedish Match became the first — and only company — to file an MRTP application to date. 
• Retailer Compliance Checks: The center has conducted more than 400,000 retailer compliance checks in 56 states and territories. It has issued more than 23,800 warning letters and more than 3,000 civil money penalties. 

"I remain mystified over those that do not follow the law," Zeller said, adding that some retailers have received two and three warning letters. "I applaud those retailers who follow the law and take it seriously."