It’s been nearly three years since the FDA Center for Tobacco Products (CTP) began its journey as the regulating body of tobacco. And while the road hasn’t always been smooth, tobacco stakeholders have generally accepted the agency’s approach—at times also accepting that it means agreeing to disagree.
As retiring Altria CEO Michael Szymanczyk said matter-of-factly during a recent earnings call, “There have already been some places where you may see industry disagreement with conclusions that have been drawn or regulations that have been issued by the FDA. But I think that’s always to be expected in a regulatory environment.”
Meanwhile, the agency has made it almost a policy to listen to stakeholders, as David Howard, spokesman for Reynolds American Inc., confirms. He tells CSP that his company has met with CTP director Lawrence Deyton and other execs at CTP, and experienced “lots of good information sharing.”
“I think the relationship is going as well as can be expected, given the monumental task that’s under way here,” Howard says.
As for that monumental task, Howard explains, “There’s always lots of questions, because it’s all very new to everybody and both sides have a big learning curve in all of this. But we’re very optimistic that things can move in a very good direction.”
Doctor-turned-regulator Deyton shares Howard’s optimism.
“You know the saying: ‘We may not always agree, but we don’t need to be disagreeable,’ ” he says. “But the better we can trust each other to be open and honest and straightforward about what’s working and what isn’t working—that’s my goal.” In the spirit of openness, Deyton and Ann Simoneau, director of the Office of Compliance and Enforcement, met with CSP in a rare face-to-face interview at FDA headquarters.
Deciding Deliberately
Across the oversized conference-room table, Deyton doesn’t seem like someone who wields the power that he does. He smiles often and warmly, and offers answers in a thoughtful way. He says his methodical manners aren’t for everyone and he understands retailers, manufacturers, distributors and importers want decisions and certainty, but that CTP also need “a level of certainty” about its actions. “And our ability to give that certainty, I can’t predict how long that takes,” he says. “I think ultimately [stakeholders are] going to want to know that when FDA says something, that we’ve listened, and we’ve made decisions based on the science and we’re doing our best. … I cannot predict what time that’s going to take for each individual question that we are going to need to answer.” Those answers currently revolve around graphic warning labels, menthol, modified risk and what will become of other tobacco products the agency doesn’t currently oversee. And Deyton and Simoneau updated CSP on those issues:
- Graphic warnings: In June 2011, the agency issued a final rule on graphic health warnings for cigarette packs, cartons and advertisements, set to take effect Sept. 22, 2012. A federal district court lawsuit, filed by five tobacco manufacturers, challenged the constitutionality of the graphic warning images. That resulted in a temporary injunction against the implementation of the new warnings, which the FDA appealed. CTP declined further comment on the case, pending legal outcomes.
- Modified risk: A modified-risk product is “any tobacco product sold or distributed for use to lower the harm or risk of tobacco-related disease associated with other tobacco products.” So far, the Institute of Medicine has released its recommendations on the design and conduct of studies, which the FDA may take into consideration in the assessment and ongoing review of modified-risk tobacco products. Deyton says he intends to meet the April deadline required by the statute to issue advice, guidance or a rule.
- Other tobacco products: While CTP has direct authority over cigarettes, cigarette tobacco, roll-your-own and smokeless tobacco, the law gives it authority to assert jurisdiction over other products for public health good. “We have signaled our intent to develop a regulatory strategy,” Deyton says, and that any of the CTP’s thinking will be put out for feedback and comment in draft form first. While there is also no timeline about when that would appear, he says, “That notice of proposed rulemaking or whatever that action is a signal—it’s a plea, frankly—from us to stakeholders to read it carefully and give us their honest feedback about it.”
- Menthol: Deyton explains that the menthol report provided to CTP by the Tobacco Products Scientific Advisory Committee was a requirement of the Tobacco Control Act and “just that, advisory.” That report, released in March 2011, concluded that the “removal of menthol cigarettes from the marketplace would benefit public health in the United States.”
The CTP has been examining both that report and an industry perspective, while also conducting its own independent review of the available science on the public health impact of menthol. It is currently examining the peer review comments on the FDA scientific review. “So that process is going ahead,” he says. “Once we evaluate the peer review comments, we will post the final FDA report for public comment in the Federal Register, and we’ll publish the peer review comments.
“If and when FDA proposes any regulatory action, we have to put forth whatever scientific evidence that FDA believes supports any actions that we might propose in the future.”
While the industry has fretted about the potential outcome, it has expressed an understanding of the process. During a recent earnings call, Lorillard CEO Murray Kessler used adjectives such as “cautious” and “transparent” to describe the FDA’s efforts on menthol. He also predicted the process to be a long one but said he was glad the agency was conducting its own review.
For his own part, Szymanczyk of Altria used the word “appropriate” to describe how the agency is moving forward, and said it was “moving right along relative to the legislative imperatives that it’s been given.” Meanwhile, Deyton says no timeline for the next step is currently available; however, “We know it’s a big public concern, so it’s not sitting on the back burner.”
Inspection Introspection
For retailers, another FDA effort causing concerns is the tobacco compliance inspections the administration has implemented. Lyle Beckwith, NACS’ senior vice president of government relations, concurs that lines of communication have been open, but results haven’t always reflected the conversations. “Our meetings to date haven’t produced a meeting of the minds the way I would have hoped that they would, but they continue,” he says.
Some retailer concerns center around training programs, public reporting and certificates of passing inspections.
- Retailer training: The CTP had outlined two schedules for violations found during the inspections, one for retailers who have an approved training program and another, more severe one for those who don’t. But one concern around that, according to Beckwith, is that the FDA isn’t approving training programs, and has instead put forth “very ambiguous” elements of an approved training program in a draft guidance.
“We are encouraging merchants to use We Card,” he says, “because we know that they have kept up with all the FDA regulations. … But what troubles me is [CTP’s] numerous repetitive statements that they will not approve a training program— they will only put forth the elements of what should be in an approved training program. And if a program has those elements, then why can they not approve it and take the uncertainty out of it?”
Meanwhile, CTP has reached out for public comment on that draft guidance and is operating under the less onerous of the two violation schedules. “We put a lot of effort into the guidance, and we listened to a lot to the comments and feedback that we got from lots of stakeholders in getting that out,” Deyton says. “We’ve heard very clearly that it’s something that retailers are looking forward to hearing from us on.”
Simoneau says the CTP is reviewing the comments, “and we’re ultimately going to issue a final guidance that retailers can use when they develop their training program for their staff.”
There is no timeline for when a final guidance or rule will be issued, and Simoneau says reviews and clearances make it difficult to speculate on one. “But for the time being,” she says, “we recommend that retailers look at the elements and the criteria that we recommend they contain in their retail training programs and include that in their materials for their staff.
“Think of a retailer doing business [and] how many different factors that might impact and influence your store vs. another store. And I think each retailer needs to assess its own specific needs, but the ultimate goal is to comply with the law and make sure their staff is not continuing to sell these deadly products to kids.”
Deyton says the agency could have opted for a final guidance or a final rule, rather than the draft guidance: “We’re all still learning to work with each other. … We, with calculation, started out with the least concrete so that we could get feedback and hear what’s working and what’s not, so that as we get more and more concrete, we’re absorbing the feedback from retailers, from other sectors of industry, etc., so that we’re reflecting what will really work at the front line.”
Meanwhile, Deyton points out that under the less onerous schedule, first violations receive a warning letter, rather than a penalty. “Let’s use each inspection as a teachable moment, particularly if that first inspection shows a problem,” he says. “And let’s make sure we have materials that will help and support that retailer learning what to do and how to do it.”
- Public reporting: Anyone can report witnessing a tobacco compliance violation, which has caused concern among retailers about the caliber of the complaints—such as whether they might come from someone with a grudge or someone not trained to truly know what a violation is.
“I don’t just take somebody’s word for it,” Simoneau says. “We have to do our own independent investigation and surveillance and inspection. … You would have had to have committed the violation in the presence of my investigators.” Retailers hit with a public complaint are treated “no differently” than retailers getting a random inspection. “If you do everything correctly, you never even know,” she says.
- Certificate of passing: The agency has come under scrutiny for deciding not to provide letters to retailers who pass tobacco compliance inspections, while at the same time issuing letters of noncompliance.
From his perspective, Deyton says, a letter affirming success bears limited value because it reflects compliance only for the time the inspection was done. “Both that warning letter, as well as knowing that you passed an inspection, is as good as the date that it was done,” he says. “And I can imagine from a retailer’s perspective ... it’s a job for them to keep all of their staff informed and doing the right thing. And so one wants to keep that vigilance up.”
He doesn’t want such FDA-endorsed letters to be used inappropriately, he says, but retailers, local agencies or trade organizations can toot their own horns.
“Frankly, if I were a retailer … I would make a billboard out of [it]—that I was inspected on this date and this store passed,” he says. “They don’t need FDA to do that.” Simoneau points out that the information of who passed inspections is available on CTP’s website, searchable by date, name, neighborhood and ZIP code.
Behind the Why
Deyton is no doubt methodical, reluctant to rush to a decision without a lengthy window for communication, science and consideration of the effect a regulation or policy will have.
In short, it is important that he resolve the “why” before advancing a policy. It’s no different than the fact that Deyton is still a physician with a clinic once a week. “That’s how I spend a lot of my time with individual patients, saying why and how I came to this recommendation or conclusion,” he says.
That notion of “why” also is something he realizes is important to constituents in his role as director of CTP. “It’s not a dissimilar process, and it’s just respecting all stakeholders enough to listen and then say ... here was how we weighed the various suggestions and evidence, and this was why we made the decision,” he says. “You may not agree with it, but at least you know why.”
He hopes providing the “why” and listening to stakeholders will help achieve his much-coveted goal of establishing trust.
On the flip side, he says he’s heard from many retailers, and knows they want to do “the right thing.” He recounts an anonymous call from a retailer to the CTP’s hotline in his first few weeks. “They said, ‘Thank you for taking those candyflavored cigarettes off the market. I don’t like selling them, and I’m glad that I don’t have to anymore.’ So to me that was sort of an ‘a-ha’ moment, that the whole retail community is a great partner here.”
As for the CTP’s seemingly deliberative approach in its efforts affecting retailers, Deyton says simply that “the juice is worth the squeeze.”
“The concept of good back and forth, collecting knowledge and information and getting feedback, certainly is a philosophy I endorse,” he says. “If we are opening ourselves up to ask for and then receive good input and comment, those draft guidances, guidances, proposed rules and final rules will represent and be reflective of the suggestions of various stakeholders, and then we’ve done our job.
“The success of this is all about relationships. And the retailers of the nation are hugely important to the success of this law—and we know they want to do the right thing.”
When the next version of a guidance or rule comes out, he says, “I want the retail community to look at it and go, ‘I had a piece of that. I had a piece of forming that, and that will work for me.’ ”
Faces of the FDA
Lawrence Deyton
Lawrence Deyton joined the FDA as the director of CTP on Sept. 16, 2009. Prior to that, he was chief public health and environmental hazards officer for the Veterans Health Administration and served in various capacities at VA national headquarters in Washington, D.C., for about 12 years before joining the FDA. He is a clinical professor of medicine at George Washington University School of Medicine and an attending physician at the Washington, D.C., VA Medical Center, where he helps deliver medical care to veterans in a weekly clinic. Deyton says, “I love to practice medicine, and I love helping to deliver medical care to veterans. It is an honor to serve the men and women who have served our nation.”
Ann Simoneau
Ann Simoneau is the director of the Office of Compliance and Enforcement in the Center for Tobacco Products. She joined the agency in 2001 and has worked in FDA’s New England District Office; the Center for Drug Evaluation and Research’s Division of Drug Marketing, Advertising and Communications; and the Center for Devices and Radiological Health’s Office of Compliance. Prior to working for the FDA, she was a practicing litigation attorney in Boston for several years. Simoneau has received a bachelor of science degree in pharmacy from Massachusetts College of Pharmacy, a law degree from Boston University School of Law, and an MBA from Suffolk University, Sawyer Business School.
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