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Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications

On December 14, 2016, we denied Swedish Match North America Inc.’s request to remove one of the required warning statements for eight General snus products. We also provided recommendations related to the applicant’s other requests and an opportunity for the company to amend their modified risk tobacco product (MRTP) applications. Below, we explain the scientific review process and what was considered in taking these actions.

The Tobacco Control Act defines an MRTP as any tobacco product sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. MRTP information may communicate to consumers that the product is less harmful or presents a lower risk of tobacco-related disease than other commercially marketed tobacco products, reduces exposure to a substance, or does not contain or is free of a substance. To pursue an MRTP order, companies must, among other things, establish that modified risk information for their product is supported by scientific evidence. For FDA to make a determination that a product is modified risk, the applicant must demonstrate that the product, 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, taking into account both users of tobacco products and people who do not currently use tobacco products.

In its applications, Swedish Match proposed to remove two warning statements required of smokeless tobacco products: 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, we 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. However, the scientific evidence shows that these products, as actually used by consumers in Sweden and Norway, are linked to increased risks of certain outcomes classified as gum disease or tooth loss, or precursors to gum disease and tooth loss. In addition, there is little biologically plausible reason to expect that outcomes related specifically to gum and teeth of users resulting from the use of the eight products would differ from those outcomes resulting from the use of other smokeless tobacco products. Thus, these products can cause gum disease and tooth loss. Based on the available scientific evidence, we determined that the applicant’s proposal to remove this warning should be denied.

Similarly, we determined that removing the warning statement about mouth cancer would imply that using these snus products cannot cause mouth cancer. While these products contain significantly lower levels of certain harmful carcinogens than other smokeless tobacco products in the U.S. market, they still contain elevated levels of chemicals known to cause cancer, including mouth cancer. There is sufficient evidence that the use of these products increases the risk of mouth cancer in users compared to non-users.

Also, although the few epidemiological studies conducted on Swedish snus products are inconsistent, the most recently published study found a three-fold increase in the risk of oral cancer associated with the use of Swedish snus products. Based on the totality of the evidence, FDA has determined that the products can cause mouth cancer and does not support removal of the warning statement related to mouth cancer. However, the evidence provided by Swedish Match 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. To be clear, such a claim would need to be carefully worded and adequately tested with consumers to ensure satisfaction of the MRTP requirements, including consumer comprehension

Swedish Match also asked to revise a third warning statement to say that these products present “substantially lower risks to health than cigarettes.” On this point, the evidence submitted by the applicant relied largely on how the products have been used in Sweden and Norway, where snus products have cultural significance as traditional products and have been commonly used as a method for quitting smoking.

The FDA’s review of the available scientific evidence concluded that the 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. However, the scientific evidence is insufficient to support that substantial reductions would be observed across the full range of risks posed by tobacco products (e.g., negative effects during pregnancy), as would be implied by a generalized statement about health risks as compared to smoking.

In evaluating the potential effects of an MRTP on public health, the FDA is required by our statute to consider the potential impacts, such as: how the modified risk product may affect the likelihood users who would have otherwise quit tobacco use will instead switch to the MRTPs or use MRTPs along with other tobacco products; the likelihood that non-users of tobacco products will start using an MRTP; and the risks and benefits compared to the use of products for smoking cessation approved by the FDA to treat nicotine dependence. We also review whether the proposed modified risk information is understandable to the public.

In this case, the scientific evidence was not sufficient to demonstrate that consumers would understand the modified risk information proposed by the applicant in the context of total health, particularly when this information is provided in a warning label. Furthermore, the evidence was insufficient to show that revising the warning as proposed would benefit the health of the U.S. population as a whole. 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.

We’ve made available on the FDA’s website materials related to our review of the applications including the Technical Project Lead Review (PDF), which summarizes the basis for the actions. In these materials, we describe several ways these applications may be amended with respect to the mouth cancer and comparison to cigarette claims, including changing the claims, conducting additional studies, and supplementing the data. We hope that this information will be helpful to Swedish Match, and to others considering submitting MRTP applications, in understanding what we are looking for and the level of evidence needed to support a proposed modified risk product.

FDA asked that the applicant request a meeting to discuss further evidence, indicate that they intend to amend their applications, or withdraw the applications within 45 days. If they decide to amend their applications, we requested that the company fully address our remaining concerns within two years. If Swedish Match does not respond, we may consider the applications to have been withdrawn by the applicant.

These MRTP actions do not affect the company’s ability to sell the eight General snus tobacco products without modified risk information. Rather, it means that we are not authorizing the distribution of the products as modified risk products at this time.

The FDA is committed to making sure that all tobacco products marketed, distributed, and sold to the public meet the requirements of the Tobacco Control Act.

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