ROCKVILLE, Md. -- It has been nearly three years since the U.S. Food & Drug Administration's 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.
In the spirit of openness, CTP director Lawrence Deyton and Ann Simoneau, director of the Office of Compliance & Enforcement, met earlier this year with CSP in a rare face-to-face interview at FDA headquarters.
Deyton and Simoneau updated CSP on several 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.
[UPDATE: On February 29, U.S.District Judge Richard Leon ruled that the federal mandate to put the images on cigarette packs violates the Constitution's first-amendment guarantee of freedom of speech. The FDA has filed a notice of appeal seeking to overturn the decision (see Related Content below for previous CSP Daily News coverage).]
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 said 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 (RYO) 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 said, 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 said, "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 explained that the menthol report provided to CTP by the Tobacco Products Scientific Advisory Committee (TPSAC) 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 said. "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."
Retailer concerns include:
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 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.
Deyton said 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."
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 said. "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 said.
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 said, a letter affirming success bears limited value because it reflects compliance only for the time the inspection was done. He doesn't want such FDA-endorsed letters to be used inappropriately, he said.
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