With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk 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 products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.
The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.
“The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.
“In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”
The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that the agency deems the products to be safe for use by consumers.
Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.
The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.
Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.
Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.
In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.
“As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.
During the meeting, representatives from Swedish Match and committee members discussed a range of scientific, technical and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented evidence and research demonstrating low levels of use by unintended populations.
General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).
“We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”
The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.
Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.
On Nov. 30, 2023, the U.S. Food and Drug Administration filed for scientific review modified-risk tobacco product (MRTP) renewal applications submitted by Swedish Match USA for General Snus smokeless tobacco products, including:
General Loose;
General Dry Mint Portion Original Mini;
General Portion Original Large;
General Classic Blend Portion White Large, 12 count;
General Mint Portion White Large;
General Nordic Mint Portion White Large, 12 count;
General Portion White Large; and
General Wintergreen Portion White Large.
In 2019, the FDA issued modified-risk granted orders for eight smokeless tobacco products made by Swedish Match USA. These orders expire in 2024. To continue marketing the MRTPs after the authorized five-year term, the company submitted an MRTP renewal application to the FDA.
Starting Dec. 1, the public may submit comments on these applications on regulations.gov.
On Dec. 18, 2017, the FDA filed for substantive scientific review of six MRTP applications from R.J. Reynolds Tobacco Company for the following smokeless tobacco products: Camel Snus Frost, Camel Snus Frost Large, Camel Snus Mellow, Camel Snus Mint, Camel Snus Robust and Camel Snus Winterchill.
On Oct. 25, 2022, R.J. Reynolds Tobacco Company requested to withdraw these applications from FDA review.
The U.S. Food and Drug Administration has issued a modified-risk granted order authorizing Philip Morris Products to market the IQOS 3 system holder and charger with the following reduced-exposure information:
The IQOS system heats tobacco but does not burn it.
This significantly reduces the production of harmful and potentially harmful chemicals.
Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
This reduced-exposure information is the same as the information previously authorized by FDA in July 2020 for an earlier version of the device.
Today’s action follows the FDA’s review of a new modified-risk tobacco product (MRTP) application submitted by the company for the IQOS 3 system holder and charger. This MRTP application primarily cross-referenced the supplemental premarket tobacco product application for this device, which was authorized for legal sale and distribution in the United States in December 2020, as well as the MRTP application for the previous version of the device.
The IQOS 3 device is similar in design to the previous version (with mainly aesthetic changes), uses the same tobacco source, and the company requested to use the same exposure reduction claim as authorized for the previous version of the device. Given these similarities, FDA largely relied on its past evaluations of the IQOS 3 device and previous version of the device in determining that the IQOS 3 device meets the authorization criteria to be marketed as an MRTP.
Headquartered in Switzerland, Philip Morris is currently banned from importing the product into the United States following an adverse ruling in a patent dispute with BAT’s Reynolds American subsidiary.
In an interview with Bloomberg, PMI CEO Jack Olczak said the company plans to manufacture IQOS in the U.S. to get around the import ban.
The U.S. Food and Drug Administration’s Center for Tobacco Products has introduced a new webpage on its site entitled “Deemed New Tobacco Product Application Lists.” The webpage lists and features 17 MS Excel files that include over 6 million deemed new tobacco products for which a premarket application was submitted to the FDA by Sept. 9, 2020.
A court order provided for a one-year period during which time such products might remain on the market pending FDA review. If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the below lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
“It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute or sell without risking FDA enforcement,” the FDA wrote on its website.
Companies that submitted their application by the Sept. 9, 2020, deadline can keep their products on the market for one year pending FDA review.
If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
The publication of the list likely signals the start of enforcement. The FDA has already issued 111 warning letters to vapor companies in 2021.
Stakeholders in the nicotine business have been anticipating the FDA list for months. In September 2020, the FDA stated that it would publish a list of vapor companies that had submitted PMTAs by the Sept. 9, 2020, deadline. The news came just one week after several retail groups submitted a letter to the agency asking for a published list of applicants.
The U.S. Food and Drug Administration (FDA) on July 7 issued exposure modification orders to Philip Morris Products’ (PMP) IQOS heat-not-burn device system (holder and charger) and three Marlboro Heatstick variants.
The FDA previously authorized the marketing of IQOS without modified risk information in April 2019 via the premarket tobacco application pathway.
In its most recent ruling. the FDA determined that IQOS does not currently meet the standard for marketing with reduced-risk claims but can be marketed with a reduced-exposure claim.
Specifically, the FDA is allowing the company to claim:
The IQOS system heats tobacco but does not burn it.
This significantly reduces the production of harmful and potentially harmful chemicals.
Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
“Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
“Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.”
In its announcement, the FDA stressed that is marketing authorization doesn’t mean the reviewed products are safe or “FDA approved.”
The FDA’s marketing order requires PMP to conduct post-market surveillance and studies to determine the impact of these orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.
These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use.
“The FDA’s decision is a historic public health milestone,” said Andre Calantzopoulos, CEO of Philip Morris International. “Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”
“The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”
“We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product,” said Billy Gifford, CEO of Philip Morris USA’s parent company, Altria Group, which will be marketing the product in the U.S. “This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers.”
In a note to investors, Morgan Stanley described the FDA’s order as a positive development because it provides greater flexibility for IQOS to be marketed as relatively less harmful than cigarettes.
“The inability to make relative lower harm claims is a constraint to broader IQOS adoption in the U.S.,” wrote Morgan Stanley analyst Pamela Kaufman.
“Over time, PM can continue to submit additional information towards a full MRTP approval. The modified exposure designation combined with pending PMTA approval for IQOS 3 should accelerate MO’s [Altria’s] U.S. expansion strategy for IQOS. The FDA’s recognition of IQOS’s benefits relative to cigarettes may also enhance IQOS’ perception with international health agencies, helping its growth prospects,” Kaufman said.
Anti-smoking activists were less enthusiastic. In a joint statement, the Campaign for Tobacco-Free Kids, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Truth Initiative, said the FDA marketing order would put consumers at risk.
“With today’s action, the FDA has created a real danger that kids and adults will falsely believe IQOS has been proven to present a lower health risk and that kids will be exposed to marketing that portrays IQOS, a highly addictive tobacco product, as an appealing, cool alternative to cigarettes, in much the same way as e-cigarettes,” the anti-tobacco groups wrote in their statement.
R.J. Reynolds Tobacco Co. (RJRT) has submitted Modified Risk Tobacco Product (MRTP) applications to the U.S. Food and Drug Administration (FDA) covering six styles of Camel Snus, its premium pouched, smokeless tobacco product introduced in 2006 and marketed nationwide in the U.S.
To support the applications, R.J. Reynolds has provided the FDA more than 450,000 pages of documentation. As the submission guidelines advise, the documentation covers results and discussion from an extensive suite of scientific studies, including:
Chemistry, pre-clinical and clinical toxicology, as well as epidemiology
Consumer perception and understanding studies of the proposed MRTP
Likelihoods of use studies based on the proposed MRTP claims
Population-level modeling under a scenario in which the MRTP claims are authorized for dissemination to adult smokers
R.J. Reynolds now awaits FDA’s review of the applications to determine whether they are accepted for substantive review.
The company says it looks forward to working with the agency as the process moves forward.
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.”
