The modified-risk tobacco product (MRTP) authorization comes with challenges. The brand needs to communicate its message to adult smokers without allowing youth to misconstrue the risks of using nicotine products. That is the conundrum faced by the two companies who currently have MRTP authorizations from the U.S. Food and Drug Administration (FDA).
During the Global Tobacco & Nicotine Forum (GTNF) held in September, Robyn Gougelet, director of health policy and regulatory strategy at Pinney Associates, moderated a panel representing 100 percent of the companies that have earned an MRTP designation: Swedish Match and Philip Morris International (PMI). Currently, three other products are under MRTP review by the FDA: 22nd Century’s low-nicotine cigarettes, Camel brand snus and Copenhagen snuff.
The panelists agreed that the MRTP authorization is complicated for consumers to understand. Consumers may think a product is safe or “FDA approved,” and this is not true. So, manufacturers are challenged to find a way to explain what the MRTP order means without confusing the consumer. The message must also be conveyed in a way that does not entice youth to try the products. The panelists said that none of the organizations they represent have perfected the process of communicating the MRTP’s complicated messaging. However, “helping people to understand how this process works is imperative,” said Gougelet.
Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor in the Department of Health Management and Policy at the University of Michigan School of Public Health, said that tobacco companies have to navigate a difficult path in collecting youth data. Douglas said he could not offer any advice on how tobacco companies should proceed, and he was “unclear on [any] best approach” to collect the youth data. “In the end, there has to be careful attention given to what is happening with youth use of products and the dynamics of youth use,” he said. “It also has to be done in real time … the data on youth use, it moves month-to-month.”
In a note on its website, the FDA states that to receive an MRTP order, a company must establish that submitted modified-risk data for a product is supported by scientific evidence, which shows “the product (as actually used by consumers) can significantly reduce the harm and risk of tobacco-related disease to individual tobacco users as well as benefit the health of the population.” Gougelet says that companies struggle with helping consumers understand the claims being made as well as the potential risks.
Tryggve Ljung, vice president of scientific affairs at Swedish Match, which received an MRTP authorization for its General brand snus products last year, says that while he understands why the Swedish Match claim reads like it does—it’s very evidence based—he fails to grasp how the message can be effective from a communications viewpoint.
In June of 2014, Swedish Match filed an MRTP application for its General snus brand. It was the first such application to ever be accepted for review by the FDA. In mid-December 2016, the FDA responded to the 135,000-page document. The regulatory agency decided to defer any decisions on whether to allow the company to claim the products cause less harm than cigarettes or whether to allow removal of a warning that the products may cause mouth cancer.
Then, on Oct. 22, 2019, the FDA announced for the first time that it had authorized the marketing of products through its MRTP pathway. The authorization order allowed Swedish Match to market these specific products with the claim, “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
The FDA stated that it had made this authorization after reviewing scientific evidence submitted by the company that supports the claim. To help prevent youth access and exposure, the agency also placed stringent advertising and promotion restrictions on the products, including a requirement to restrict advertising to adults.
“It has helped to transform the company and the market,” Ljung told attendees. “It was a learning experience for both us and the FDA … it’s changing the industry.”
There are two types of MRTP orders the FDA may issue: a “risk modification” order or an “exposure modification” order. PMI’s IQOS tobacco-heating system was the second product to receive an MRTP and the first tobacco product to receive “exposure modification” orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population.
Moira Gilchrist, vice president of strategic and scientific communications at PMI, says the important aspect of the MRTP order is that it allows for exposure reduction communication, information PMI believes can help guide consumer choices toward less risky products.
“The IQOS authorization was a validation for what we set out upon as a viable path … IQOS has the potential to not only benefit health across the United States but also around the world,” explained Gilchrist. “The decision was an important milestone for our industry overall. Now we have a really clear example of evidence-based decision making that was done in an inclusive and transparent way and really clearly recognizes a continuum of risk.”
Gougelet said that the MRTP review is one of the most transparent regulatory processes. A company’s MRTP application is available for the public to review. The application also goes before the FDA’s Tobacco Products Scientific Advisory Committee, a panel created to provide advice, information and recommendations to the FDA commissioner on matters related to the regulation of tobacco products. “It is important for everyone to remember it didn’t end with a ‘yes’ decision. There is continual oversight,” she explains. “In order to remain on the market, we have to be able to show that the product is appropriate for public health through its entire life cycle.”
The MRTP authorization requires the company to conduct post-market surveillance and studies to determine whether the MRTP orders continue to be appropriate, including assessing the potential for increased use among youth. Ljung said that Swedish Match has been carrying out its post-market study, but “it’s too early to say” what the data shows about consumer understanding of the MRTP authorization. Gilchrist said that PMI has submitted its plans for post-market surveillance to the FDA. She added that even though the company has not seen any data to support an uptick in youth use in other countries where IQOS is available, “we still think about it every minute of every day.”
Gilchrist added that people in public health were caught by surprise by the FDA’s decision to approve an MRTP application, especially the Swedish Match decision (because it was the first). She said she can understand why public health groups are cynical about large tobacco companies, but there is a general misunderstanding about how these products can help adult smokers and the guardrails the FDA put in place to prevent youth use and to stay abreast of developments to prevent it from happening. “Why this visceral reaction to hard work by scientists to figure out if a product is a benefit to public health?” she asked.
Douglas suspects U.S. tobacco control organizations view any FDA campaign placing e-cigarettes or heated-tobacco products in competition with combustible cigarettes as support for tobacco companies. “If the industry favors it, it immediately becomes suspect,” he says. “There are strong feelings about distrust on both sides.”
Another worry for both regulators and tobacco companies is that the “public in general, not to mention the medical community, suffers from a significant misunderstanding” of nicotine, according to Douglas. This is supported by a recent study from Rutgers University, published in the Journal of General Internal Medicine, that concluded that most specialists from fields that treat lifelong smokers believe that nicotine contributes to cancer, heart disease and chronic obstructive pulmonary disease.
“As long as people are under the misconception [of] the effects that nicotine has physically and pharmacologically and the role it plays in different products … it is going to, to put it bluntly, is going to screw up this whole process,” he said.