| February 1, 2017

Even as it suffers setbacks, Swedish Match’s MRTP application offers a path for other tobacco companies to follow.

By Timothy S. Donahue

Developing less risky alternatives to cigarettes is all the rage nowadays. Nearly every tobacco company has an alternative tobacco product that aims to be safer than smoking. However, only one company can be first in gaining approval from the U.S. Food and Drug Administration (FDA) to make the claim publicly.

Despite recent setbacks, Swedish Match (SM) remains far ahead of the pack. In June 2014, the firm filed a modified-risk tobacco product (MRTP) application for its General snus brand. It was the first such application to ever be accepted for review by the FDA. Snus is a moist tobacco product placed under the upper lip that does not involve spitting or chewing. In mid-December 2016, the FDA finally 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.

In another first, the FDA stated that it believed the SM application “could be amended to support issuance of modified risk orders.” However, it also informed the company that it would not be able to remove a warning that the products may cause gum disease and tooth loss. SM intends to meet with the FDA (a 45-day response deadline places a possible meeting in mid-February, although no date could be confirmed as of this writing), according to Jim Solyst, vice president for federal regulatory affairs for SM. The FDA requires SM fully address all remaining concerns within two years.

“What we will do is certainly have a conversation with the FDA, but the exact nature of those discussions have yet to be determined. We are more than willing to keep this process going, to respond to the letters we’ve received and the document they put out,” said Solyst. “We would need some additional information, some clarification as to what would be the path forward. Yes, we will have discussions. We believe it’s in all parties’ best interests that we keep this dialogue going.”

One challenge facing SM is that the FDA’s “conversations” with tobacco companies are not necessarily of the type that most people associate with that word. They are more like a dialogue through documents. When a tobacco company meets with the FDA’s Center for Tobacco Products (CTP), it’s a listening session where a company presents, the FDA listens, and at some point later the FDA makes a decision that is often unclear and more often without explanation. “The burden has always been on us, the applicant, to propose something,” says Solyst. “Then they comment on it.”

Risk reduction quantified

Jim Solyst

The actions on the MRTP applications have no impact on SM’s premarket tobacco product application (PMTA) authorizations issued for eight of its General snus products in November 2015. SM was the first—and, so far, only—tobacco company to receive product approvals under the PMTA process. In its PMTA, SM proposed that General snus should be considered to be protective of the public health, and the FDA agreed. In its response, the agency determined that the General snus products are protective of the public health and contain significantly lower levels of harmful constituents compared with over 97 percent of the smokeless products on the U.S. market.

“They even went further than we did,” says Solyst. “They quantified the risk reduction.” The MRTP response, however, was different. “The FDA stated that ‘No, this is not quite what we need. We’re not willing to remove the warning labels, and we want you to do your consumer perception in a different way.’ Going forward, part of our conversation with them would be, well, ‘Which way is that?’ Yes, it’s been a difficult process. They aren’t very clear on their expectations.”

Understanding the industry interest and complexity of its decision, the FDA did attempt to explain its scientific review process and what was considered in the actions taken against SM in its MRTP application. In a note on its website, the FDA states that to pursue an MRTP order, a company, among other things, is required to establish that submitted modified-risk data for a product is supported by scientific evidence that 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.”

In its MRTP applications, SM proposed to remove two warning statements required of smokeless tobacco products by the FDA: one stating that the product can cause gum disease and tooth loss, and the other stating the product can cause mouth cancer. In reviewing these requests, the FDA determined that “removing the warning statement about gum disease and tooth loss would imply that using these snus products cannot cause gum disease and tooth loss, as compared to other smokeless tobacco products,” according to its statement. Similarly, the FDA determined that removing the warning statement about mouth cancer would imply that using these snus products cannot cause mouth cancer. “Based on the available scientific evidence, we determined that the applicant’s proposal to remove this warning should be denied,” wrote the FDA. “There is sufficient evidence that the use of these products increases the risk of mouth cancer in users compared to nonusers.”

However, the FDA did state that evidence provided by SM may support other claims, such as a claim about the “reduced risk of mouth cancer provided on the product labeling, in advertising, or otherwise outside of a health warning. That claim would need to be carefully worded and adequately tested with consumers to ensure satisfaction of the MRTP requirements, including consumer comprehension.”

The FDA’s use of the word “imply,” however, is confusing. Is the agency attempting to determine how the general public may or may not interpret a statement without doing any reasonable research? Is the research of the wording a responsibility of the applicant? Solyst says he’s not sure. It’s hard to guess as to the FDA’s intent. “We believe that what they’re basically saying is that because there are the existing warning labels, they’re not going to remove them. They don’t address this specifically, but if you look back at the 2015 decision, the inference would be that had there not been a warning label at all, that’d be a different story,” says Solyst. “Because there is already a warning label, they’re not inclined to remove it no matter how much evidence we present.”

Public interpretation

Further muddying the waters, SM also asked to revise a third warning statement to say that General snus products present “substantially lower risks to health than cigarettes.” This seemed fair considering the FDA’s PMTA response that General snus products were 97 percent safer than similar products. Even the FDA’s review of the submitted scientific evidence for the MRTP concluded that “General snus products, as used by consumers in Sweden and Norway, may pose substantially lower health risks to individual smokers who switch completely to these products for some health outcomes, such as lung cancer or chronic obstructive pulmonary disease.”

Conversely, the FDA again claims that there is insufficient scientific evidence to support the claim, as would be implied by a generalized statement about health risks as compared to smoking. “However, as with the evidence related to mouth cancer, the evidence on relative health risks provided by Swedish Match may support a different explicit claim, such as one outside of a health warning providing information concerning the differences in specific health risks, if the claim is carefully constructed, and adequately tested,” wrote the FDA.

Why the FDA is trying to speculate at public interpretation is anyone’s guess. The agency may be losing sight of the bigger picture by being so vague and secretive. “We think that telling smokers that these products are 97 percent safer than similar products is the key message; this message is getting lost,” says Solyst, adding that maybe the FDA wants SM to take more of a relative risk approach. “Should our claims be that this product is significantly less risky than other products? That very well could be what they’re saying. The main message is, to us, that they’re not going to remove the current labels, but that doesn’t mean they wouldn’t consider other marketing claims. They seem to want us to continue this process. They gave us options, and one of those options was to present different claims. That’s why we need more information from them. What exactly do they mean by that; what evidence would be necessary to go that route?”

Spread the word

Looking back at its PMTA approval, Solyst says another frustration with the FDA is that the CTP didn’t really attempt to get the word out to the industry surrounding the significance of the first PMTA issued. The CTP decision was of global, and possibly even historical, significance. It was the first time any public health regulatory agency had made such a decision (allowing a new, safer tobacco product on the market). “We would have liked to have seen the FDA make more of it. Maybe they will, in the future, but that has been the frustration, which is: We agree with the decision; we just wish it was better known among tobacco users,” Solyst says. “We understand that this is an ongoing process, and we’re not discouraged. We think we have a harm reduction product that has already received one very positive decision from the FDA [in the PMTA], and we expect to continue this process and secure the first MRTP.”

While continuing and completing the MRTP is important to SM and its vision of a “world without cigarettes,” Solyst says the story is much bigger. As a leader in tobacco harm reduction and the only company to successfully navigate the PMTA course, SM has an obligation to the industry to establish the process of navigating the MRTP minefield. “We’re the only company who’s gotten this far. We feel we have to try to understand what exactly it is that they want. We’re not just acting as a company or as a product, but as a leader in the industry,” he says. “We feel this obligation to demonstrate how this [MRTP] can be done, and that it should be able to be done in an efficient manner. We felt the same way about the PMTA process. Now that we’re the only one with a PMTA, and we think we will do future PMTAs, we have that obligation to set a standard and continue the fight.”


Tags: , , ,

Category: Also in TR, Editorial Archives, Regulation

Comments are closed.