Prohibitionist or harm reductionist?
Since Mitch Zeller’s appointment as director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) in 2013, the question has been debated by manufacturers, retailers, anti-tobacco groups and harm-reduction advocates alike.
It’s understandable. On one hand, Zeller played a key role in developing the tobacco control-oriented American Legacy Foundation (which has since been rebranded as the Truth Initiative). On the other hand, he’s repeatedly touted the potential upside alternatives such as electronic cigarettes could have on public health.
So far, there’s been very little regulatory action to indicate where the Zeller-led CTP will fall in this debate. At the time this story went to print, the public was still waiting on two potentially landmark pieces of regulation: the FDA’s official ruling on Swedish Match’s modified-risk application; and the final deeming rule for products like electronic cigarettes, cigars and pipe tobacco.
“The FDA has a chance to demonstrate to American tobacco users that it is supportive of tobacco harm reduction when it makes these decisions,” says Brad Rodu, a professor of medicine and holder of the endowed chair in tobacco harm-reduction research at the University of Louisville in Kentucky.
Or not.
Many vape supporters have decried the FDA’s proposed deeming regulations as a prohibition, due to the costly Pre-Market Tobacco Product Application (PMTA) requirement. Others fear the CTP will follow the guidance of the TPSAC (Tobacco Products Scientific Advisory Committee) panel, which voted down Swedish Match’s application to market its General Snus products as modified risk in April 2015.
These issues definitely hit close to home for tobacco retailers.
“It makes a difference,” says Ray Johnson, operations manager for Las Vegas-based Speedee Mart, of modified risk. “There’s so much propaganda about e-cigarettes and smokeless being more dangerous than combustible cigarettes. If something is safer than a cigarette, you should be able to say so.”
To be fair, Zeller is not the sole “decider” when it comes to tobacco regulation: He’s working with a team at the CTP, not to mention the Obama-led White House, which was reviewing the final deeming regulations at press time.
Mitch Zeller, however, is the face of tobacco regulation in the United States. As such, he’s the person the industry has zeroed in on, asking the important question: prohibitionist, harm reductionist or somewhere in between? And, more important, what does his position mean for tobacco retailers?
Let’s look at the facts.
Position: Tobacco Control
Many equate “tobacco control” with “anti-tobacco.” But that’s not entirely how groups such as the Truth Initiative and the Campaign for Tobacco-Free Kids describe themselves.
“We advocate for proven strategies that prevent kids from using tobacco, help tobacco users quit and protect everyone from secondhand smoke,” says Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, Washington, D.C.
Meanwhile, Truth Initiative CEO and president Robin Koval describes the Washington, D.C.-based organization as being “dedicated to achieving a culture where all youth and young adults reject tobacco.”
Given Zeller’s history with Truth Initiative, it’s not shocking that some of his public comments are completely in line with tobacco control.
“Product regulation is a powerful component of a comprehensive strategy to reduce death and disease from tobacco use,” Zeller said upon his CTP appointment in 2013. “We will marshal the science to support new policies to help combat the leading cause of preventable disease and death in the United States.”
Regulate he has. Koval cites the CTP’s Advanced Notice of Proposed Rule Making on menthol cigarettes, first-ever No Tobacco Sale Orders to tobacco retailers, grants to scientific institutes for tobacco regulatory science, and launch of “The Real Cost” youth prevention campaign as being “critically important” to tobacco control.
Myers also cites the recent Not Substantially Equivalent (NSE) orders against R.J. Reynolds Tobacco Co. and warnings to cigarette manufacturers (including ITG Brands LLC, Santa Fe Natural Tobacco Co. Inc. and Sherman’s 1400 Broadway NYC Ltd.) “to stop deceptive marketing with health-related terms such as ‘natural’ and ‘additive-free.’ ”
But Zeller has not given tobacco-control groups everything they’ve asked for. Truth Initiative, Tobacco-Free Kids and groups such as the American Cancer Society and American Lung Association have a long list of issues they’d like the FDA to tackle, including:
- Graphic warning labels
- Banning menthol
- Product standards
- Banning Internet sales
Additionally, while the harm-reduction side feels Zeller overreached on the proposed deeming regulations, those within tobacco control feel he didn’t go far enough. Complaints center around what the proposed regulations didn’t include: self-service bans, open-system bans, childproof-packaging requirements and flavor bans.
Continued: Position: Tobacco Harm Reduction
Position: Tobacco Harm Reduction
In theory, tobacco control and tobacco harm reduction are on the same side: public health. For example, Michael Siegel, a professor of Community Health Sciences at Boston University’s School of Public Health and an avid supporter of electronic cigarettes, testified against Big Tobacco in the landmark Engle v. Liggett lawsuit.
Siegel and other harm reductionists would tell you they take a more inclusive position than tobacco control groups.
“I have always defined tobacco harm reduction as giving smokers options other than absolute absence,” Rodu explains.
In an ideal world, harm-reduction advocates would like to walk lockstep with Zeller and the CTP, seeing the agency set product standards, enforce sales bans to minors, study (without politicizing) new products such as electronic cigarettes, and educating the public.
“Their role should not just be as a regulator, but an information source,” says Gregory Conley, president of the American Vaping Association, Hoboken, N.J.
For all the comments that seem to align Zeller with tobacco-control groups, he’s made just as many—if not more—comments that put him on the side of harm reduction.
“People are dying from the tobacco-related diseases from the smoke particles, not the nicotine,” Zeller said in a June 2014 Legacy-hosted webinar. “It’s time we take an honest look at the role of nicotine.”
The problem, according to Conley, is such comments are “just talk.”
“The only thing that matters,” he continues, “is what gets out on those pieces of paper when the regulations are released.”
Jim Solyst, vice president of federal regulatory affairs for Stockholm-based Swedish Match, said there are some positive indicators about Zeller’s attitudes on modified risk.
“At the end of the TPSAC meeting, Zeller referred to us as ‘trailblazers,’ ” Solyst said in a July 2015 interview with CSP, adding that the company has had continued contact with the CTP regarding its modified-risk application.
Still, the agency is taking its time on a product researchers such as Rodu consider a “scientific slam dunk” for harm reduction given the decades of evidence from Sweden about the minimal risks and positive role snus can play in smoking cessation. According to a European Commission report, Sweden’s smoking rate had dropped to 11% in 2014 (the lowest in the world) and with it the number of smoking-related deaths.
“Any other product, you’d be in trouble for not telling the truth about it,” says Johnson of Speedee Mart. “These products, you get in trouble for telling the truth.”
Then there’s deeming.
It’s been covered time and time again: The proposed regulations assert that any product not on the market by the February 2007 grandfather date established in the Tobacco Control Act will not be eligible for the Substantial Equivalence (SE) pathway.
The only option for staying on the market is submitting a PMTA—a process that critics say is financially prohibitive, undercuts innovation and preserves Big Tobacco’s dominance as the segment rapidly expands from cigarettes to a panoply of products.
“Technically, it bans all nicotine vaping products unless you go out and spend what I think will be $20 million to submit a PMTA that the FDA’s actually going to accept and consider,” says Bill Godshall, executive director of Pittsburgh-based Smokefree Pennsylvania. “Not approve, just consider.”
“The deeming proposal is not regulation,” Conley adds. “It’s prohibition for all but a very small handful of products made either by Big Tobacco companies or companies with multimillion-dollar Wall Street investments.”
“It bans it,” Godshall says of the deeming proposal. “It sends tobacco harm reduction underground.”
Continued: Retail Realities
Retail Realities
While retailers might not be terribly concerned about where Zeller falls on the tobacco control/tobacco harm reduction spectrum, they have discussed how CTP actions under Zeller have positively or negatively affected business.
Interestingly enough, the proposed deeming regulations were considered largely positive among the traditional retail community, thanks to the lack of bans on flavors, advertising or self-service displays.
And while harm reductionists fear the PMTA requirement will force many companies out of business, retailers such as Johnson argue it also ensures vape shops “operate on a fair playing field” with c-stores and tobacco shops.
Product application rulings are another retail “win.” Since Zeller has taken over, the CTP has issued the first of many SE rulings—when speaking at the April 2015 NATO Show, Zeller said there was no longer a backlog of SE applications—and its first PMTA approvals for eight new Swedish Match snus products in November of last year.
On the negative side, there’s the September 2015 NSE order. This effectively outlawed four Reynolds cigarette brands, giving retailers a 30-day window to remove the products from their shelves and stores or risk receiving an FDA violation letter.
“If it’s a one-time deal, it’s not a big thing,” Johnson says of the NSE order. “If this is going to be a routine, then it’s a big issue.”
Perhaps it’s not just about retail-friendly or less-retail-friendly regulatory actions. When discussing Zeller and the CTP, trade groups and retailers point to the agency’s transparency and willingness to communicate.
“The FDA’s Center for Tobacco Products and director Mitch Zeller have encouraged tobacco industry members to ‘have a seat at the table,’ ” says Thomas Briant, executive director of the National Association of Tobacco Outlets NATO‑, Minneapolis, pointing to the fact that 2016 marks the third consecutive year Zeller has spoken at the NATO Show. “Zeller appreciates the opportunity to reach out to all stakeholders on both sides of tobacco issues and obtain as much input as possible in drafting tobacco regulations.”
Indeed, Zeller has repeatedly used such opportunities to compliment tobacco retailers.
“I applaud industry efforts on compliance,” he said while appearing at last year’s NACS Show. “Coming to events like this, it’s reassuring to see how seriously you take your responsibility to comply with the law.”
This transparency and willingness to engage often stands in stark contrast to the state and local regulatory bodies that retailers are dealing with.
“Whether you agree with them all the time or not, I like to believe that the folks at the FDA at least attempt to ground their decisions in facts, research and the scientific method, as opposed to a shotgun approach of heated rhetoric and unsubstantiated outcomes we often see at the local level,” says Anne Flint, senior category manager of tobacco for Framingham, Mass.-based Cumberland Farms.
Clarity Is Coming
If there’s one thing retailers, tobacco control groups and harm-reduction advocates agree on, it’s that the regulatory process has not moved fast enough. Yes, Zeller has made progress—but it’s now going on two years since Swedish Match applied for modified-risk status and the FDA released its proposed deeming regulations.
These rulings aren’t just important for Swedish Match or vaping manufacturers: They’ll also provide the first concrete indications of which direction Zeller and the CTP are leaning.
Prohibitionist, harm reductionist or somewhere in between? For better or worse, we’ll have an answer soon.
Zeller himself would likely answer “neither.” That he is on the side of science, on the side of public health, as dictated by the language of the Tobacco Control Act.
When discussing menthol during a 2013 FDA telebriefing, Zeller said, “Any decision on my watch will be based on rigorous science and the potential to produce the greatest advances in public health.”
Perhaps the greatest indication of his actual stance is the way Zeller has seemingly mastered the art of balancing the two very extreme positions.
“I’ve participated in many discussions about the potential benefits of these new technologies, as well as the risk and harm they could cause,” Zeller said in the 2014 Legacy webinar. “The reality is, it’s going to be some of both.”
Zeller’s History with Tobacco
1988
Mitch Zeller takes his first official government job: counsel to the Human Resources and Intergovernmental Relations Subcommittee of the House of Representatives Government Operations Committee.
1993
Zeller is named associate commissioner and director of FDA’s Office of Tobacco Programs. Zeller helped craft the agency’s 1996 tobacco regulations and represented the FDA before Congress, federal and state agencies.
2000
Zeller moves to the American Legacy Foundation, serving as executive vice president of marketing and communications, strategic partnerships and government affairs during the Legacy-created Truth Campaign’s first year on the air.
2002
Consulting firm Pinney Associates brings Zeller on as senior vice president. Here, he advised on domestic and global public health policy issues related to tobacco products and pharmaceuticals.
2013
Zeller returns to the FDA as director of the Center for Tobacco Products (CTP), the FDA center responsible for the implementation of the Family Smoking Prevention and Tobacco Control Act.
Source: U.S. Food and Drug Administration website
Zeller’s Actions
How Mitch Zeller’s regulatory actions affect retailers:
GREAT FOR RETAILERS
- Premarket Tobacco Product Application (PMTA) Approvals Status: First PMTA approved (November 2015)
- Substantial Equivalence (SE) Approvals Status: First SE applications approved (June 2013)
- Modifıed Risk Status: Waiting on offıcial ruling (February 2016)
- Deeming Regulations Status: Waiting on fınalized deeming regulations (February 2016)
- Not Substantially Equivalent (NSE) Stop-Sale Orders Status: First NSE order issued (September 2015)
- Graphic Warning Label Requirements Status: Researching how to draft a proposed rule that will stand up in court (June 2014)
- Menthol Cigarette Regulations Status: Advanced Notice of Proposed Rulemaking (ANPRM) issued (July 2013)
HORRIBLE FOR RETAILERS
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