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FDA committee rejects most label claims for ‘reduced-risk’ cigarette

The FDA’s Tobacco Products Scientific Advisory Committee recently ruled that several of the claims made by Philip Morris for the intention of using in its marketing and labelling its IQOS cigarette were invalid.

IQOS is a tobacco filtered, non-combusted heatstick that heats tobacco instead of burning it and does not emit carbon-based solid particles, releases less toxicants than traditional cigarettes and thus, presents less risk of harm, according to company representatives who spoke during the 2-day hearing.

Philip Morris’ proposal is considered one of the first tests of FDA commissioner Scott Gottlieb’s initiative to limit the amount of nicotine in cigarettes. This week’s votes had nothing to do with whether or not the product hits the market.

The committee rejected Philip Morris’ claims that:

• “Switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.”
• “Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.”

The panel unanimously agreed that the proposed modified risk labeling and advertising would not accurately educate consumers on the risks of IQOS.

Officials from Philip Morris had claimed that if IQOS came to the market, it would commence a wind of change involving the world’s deadly addiction to cigarettes: “If you decide that using IQOS would be a better choice than continuing to smoke ... you may ultimately find that we can change the status quo in a rapid, unprecedented way,” Moira Gilchrist, PhD, vice president of scientific and public communications at Philip Morris International said.

The committee agreed that IQOS lowered one’s body exposure to what the FDA called “harmful or potentially harmful chemicals” by an 8-1 vote, but voted 5-2 against the assertion that the lowered exposure was “reasonably likely to translate to a measurable and substantial reduction in morbidity and mortality.,” with one abstention.

On the question of the “likelihood that U.S. smokers would completely switch to use of the IQOS system, ” two members deemed there was a medium likelihood, while seven said it was a low likelihood. In determining the “likelihood that U.S. smokers would become long-term dual users of IQOS and combusted cigarettes,” three members said there was a high likelihood, five members said there was a low likelihood and one member said there was a low likelihood.

The committee was also split on the likelihood that U.S. never-smokers, particularly youth, would become established users of the IQOS system, with four deeming a low likelihood, one expecting a medium likelihood, two voting there was a high likelihood, while two abstained.

Philip Morris representatives had presented evidence from both human and animal studies involving IQOS that they said showed significant improvements in several components of lung health, including amount of cellular tissue, progression to emphysema, inflammation and clotting.

IQOS also emitted significantly less toxicants than traditional cigarettes and was not likely to be misused, the company said, which also promised to conduct postmarketing research that would watch for abuse.

“The totality of the evidence shows that IQOS presents less risk for harm and tobacco-related disease than cigarettes,” Manuel C. Peitsch, PhD, chief scientific officer at Philip Morris International said.

Gilchrist said that IQOS would lead to “major population benefits over time.”

“The likelihood and magnitude of IQOS benefitting the population as a whole is much greater than the opposite,” she added.

However, at several points during the hearing, FDA employees researchers pointed out concerns or limitations to the tobacco company’s data.

“Based on the studies that were submitted [by Phillip Morris] ... it is unclear if the effects that were observed in these treatment groups can translate to potential risk reduction to noncancer related effects,” Mayo Wright, an FDA pharmacologist said.

“I would have liked to have seen some description of the pretesting or of the comprehension items or some attempt to validate them ... but that information was not in the application, and there was no control group,” Alexander Persoskie, PhD, a social scientist within the FDA’s Center for Tobacco Products responded.

“We recognize that no single study can demonstrate in a premarket assessment that a tobacco product presents less risk of harm than cigarettes,” Gilchrist said during a rebuttal period. “The strength of our assessment approach is that we’ve conducted multiple, multidisciplinary studies to develop evidence across the entire causal chain of events that links to smoking to disease.All of our studies, including clinical trials with smokers, have consistently and coherently demonstrated that switching completely to IQOS can reduce the risk of tobacco-related disease.”

Philip Morris was unable to answer some questions from the committee about how IQOS would impact those less than 18 years of age, the population group most likely to start smoking, since it does not conduct tests on that age group. That did not sit well with one special interest group that works with children.

“A quick caution from our point of view. We’ve been here before with light and low tar cigarettes. We shouldn’t make the same mistake again,” Matthew Meyers, representing Campaign for Tobacco Free Kids, said during the public comment period. “Philip Morris has truly not met the burden of demonstrating that its product will not be targeted to youngsters.”

Other remarks made during the public comment section, covering a broad spectrum of medical, business and legal interests, seemed largely supportive of the IQOS application.

“I have encountered patients repeatedly in practice who have tried to quit and they just can’t do it. Up until now, all I could offer was nicotine replacement or medication ... and for some of [my patients] these are not effective ... IQOS ... would be such a great tool to have in my toolbox,” Erika Bliss, MD, who said she was a practicing primary care physician for nearly 20 years and a former smoker. “The research is very compelling.”

“Women have a far more difficult time than men quitting combustible cigarettes,” Julie Gunlock, senior fellow, Independent Women’s Forum, said. “[Studies show] women need treatments other than nicotine replacements ... Many women, I suspect, would urge this committee to approve new and innovative e-cigarette products like IQOS.”

Research on the benefits of combustible cigarettes vs. alternative cigarettes has been been mixed over the past few years.

One survey of 808 teenagers showed that those who used e-cigarettes within the past month were more likely to smoke cigarettes in the future. Conversely, another study concluded “the risks for youth posed by e-cigarettes likely fall far short of those feared by the products’ opponents.”

There is also debate on whether or not e-cigarettes should be used as a cessation tool.

A survey released in 2017 found that 82% of family physicians do not recommend e-cigarettes to get a patient to stop smoking. Of the 18% of responding physicians that said they do, it was mainly because e-cigarettes can “serve as a bridge for smokers to quit smoking cigarettes, and e-cigarettes are the lesser of two evils.”

Philip Morris International's proposal now goes onto the full FDA for its consideration and vote. A date for that final vote could not be determined prior to publication.

"Philip Morris International appreciates the open, positive dialogue and the serious consideration the Tobacco Products Scientific Advisory Committee [showed] ... discussing the complex science presented in our Modified-Risk Tobacco Product application," a Philip Morris spokesperson told Healio Family Medicine. "We are encouraged by the recognition of the risk reduction potential of IQOS that clearly emerged from the statements of the committee members."
 
"We are confident in our ability to address the valid questions raised by the Committee with the FDA as the review process for our application continues,” he added. – by Janel Miller

Editor's Note: This story has been updated to include additional comments from Philip Morris International.

Further reading:

FDA.gov. “2018 TPSAC Meeting Materials and Information.” https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm583080.htm. Accessed Jan. 24, 2018.

Disclosure: Healio Family Medicine was unable to determine relevant financial disclosures prior to publication.