FDA grants its first Modified Risk Order, for Swedish Snus

Earlier this week, the FDA issued its first “modified risk tobacco product” (MRTP) order, allowing Swedish Match to make the following claim in its advertising: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

Eric Lindblom, Director, Tobacco Control and Food & Drug Law at Georgetown Law, sent me these comments, which I am passing along with his permission.  They continue to show a willingness of the FDA to trust the tobacco companies.  I am also disappointed that there was not a more explicit engagement with the public comments that we and other public health authorities submitted.

Here are Eric’s comments:

The final order letter seems to include the exact same advertising restrictions placed on IQOS via the PMTA order – basically requiring age and ID verification and the like to prevent social media and electronic advertising from reaching youth, and requiring disclosures of Swedish Match’s sponsorship of any partners, influencers, bloggers or brand ambassadors who push the product on behalf of the company. 

However, it also states:

“Limiting youth initiation of the products and, relatedly, youth exposure to advertising and marketing materials for the products are important factors in the population health benefit analysis. Accordingly, FDA also recommends limiting youth-exposure to any of the tobacco products’ labeling, advertising, marketing, and/or promotion appearing in print media publications.” [emphasis added]

And later states:

“To help ensure that your products, as actually used by consumers, continue to benefit the health of the population as a whole, we strongly recommend that you take measures to limit youth initiation and use of the products, beyond limiting advertising and promotion as required in this order. For example, we strongly recommend you adopt the following measures related to all digital sales of your products:

For any digital sales – whether conducted by you, on your behalf, or at your direction – establish, maintain, and monitor use of independent age- and identity-verification service(s) that compare customer information against independent, competent, and reliable data sources, such as public records, to prevent the sale of the products to individuals who are under the federal minimum legal age to purchase tobacco products.” [Emphases added]

But it simply does not make sense for FDA to only recommend these extra protective measures, it should have required them.

Similarly, FDA requires Swedish Match to provide reports of any plans or actions it might take in the future to restrict youth access or limit youth-exposure to the products labeling, advertising, marketing and/or promotion.  Instead, FDA should have, at least, specifically required SM to show in those future reports that it actually had developed and implemented effective plans to restrict youth access or limit youth-exposure to the products labeling, advertising, marketing and/or promotion.   Better yet, FDA should have required SM to develop such plans as part of its application and then formalized those plans into MRTP order requirements and restrictions.

To protect the public health even more effectively – without interfering with the ability of the MRTP snus to secure harm reduction – FDA should have also included other restrictions and requirements in the MRTP final order to try to prevent and reduce possible harmful uses of the MRTP snus.  For example, at a minimum, FDA should have included in the final order a  requirement that the MRTP snus and their ads have clear warnings on the label, and/or in instructions for use inside each snus package, that make it clear that the snus should be used only as a complete substitute for smoking or for other more-harmful tobacco products – and that any other use will increase user harms and risks.

A couple more things, prompted by my reading the Decision Summary’s executive summary:

FDA’s conclusions about how youth and adults might respond to the marketing of the snus with the reduced-risk claim are based almost entirely on a single experimental (not actual use) Perception and Behavioral Intentions (PBI) study submitted by Swedish Match.  That seems odd given that most research has to replicated before its findings are considered solid; research is often biased based on who conducts it or who is paying for it, and the decision summary refers to the study as having been conducted by the applicant (see, e.g., p. 29); and there is a long history of tobacco industry misdeeds relating to research.  But none of those three problems or concerns appear to be mentioned in the FDA Decision Summary.  It’s also not clear why FDA did not require at least some small-scale, short-term actual use study with current adult smokers (and perhaps other adult tobacco product users) to gain additional insights.

In addition, the Decision Summary’s executive summary states that some of the favorable, MRTP-supporting findings of the PBI study were not statistically significant.  While listing not statistically significant findings is common in research studies, given that FDA is not a researcher reporting results but a regulatory agency evaluating research to decide whether to allow an addictive, harmful tobacco product to be marketed with reduced risk claims, one could imagine a prudent FDA policy of not citing statistically insignificant research findings to support its permissive MRTP findings.

Moreover, when the FDA executive summary discusses how the different impacts on consumers might cause increased or reduced harms, it concludes that “the new evidence [from the PBI study] supports that the population health benefits gained by cigarette smokers (and potentially other smokeless tobacco users) switching to these products will not be outweighed by the risks of initiating new tobacco use” (given that using snus is still more harmful and risky than not using any tobacco product at all, or compared to using NRTs).  But that equation leaves out the possible new health harms and risks from smokers’ dual use with the snus preventing or delaying smoking cessation, from smokers’ complete switching to snus preventing or delaying total cessation, or from users of more-harmful smokeless products switching to the snus or to dual use instead of total cessation.  And I could not find any significant, direct discussion of those possible harm-increasing uses of the snus in the Decision Summary, either, although there is some discussion of dual use with smoking.

Along these lines, the Decision Summary (but not the executive summary) notes that FDA has concluded that “there is insufficient information to conclude that smokers who use snus in conjunction with smoking will realize any reductions in risk of tobacco‐related disease.”  [Page 28-29] But there does not appear to be any finding as to whether such dual use might be more harmful than just smoking. In addition, the PBI study did not specifically evaluate whether smokers or others would  perceive dual use with snus to be more or less harmful than just smoking The study did include some findings that indicated that the reduced-risk claim could increase the number consumers thinking that dual use was more harmful, but those findings also indicated that the MRTP claim would still leave significant numbers thinking that they could daily smoke quite a few cigarettes while engaging in dual use and still secure harm reductions (which is not accurate). [Page 36]  But FDA focused on just the positive side of that data.  In fact, in the conclusion of the Decision Summary, FDA clearly thinks it is sufficient to find, based on the study, that “most consumers do not infer that partial substitution is associated with a reduction in risk” without considering or discussing the possible harms from the rest of the consumers inferring just that. [37]

The FDA decision summary has lots of references to FDA having considered all comments from interested persons submitted to the snus MRTP docket.  But there does not appear to be any text discussing any such comments.  For example, the decision summary states:  “FDA considered all significant comments when making the final determination. Specific comments are addressed in the Social Science review.”  But the decision summary includes no Social Science review section (as the IQOS PMTA decision summary did) and the decision summary’s references to the Social Science review do not mention any specific submitted comments.

Overall, the problems with the FDA MRTP order for the Swedish Snus appear to parallel the problems with FDA’s previous permissive PMTA orders for the Swedish Snus and for the Philip Morris IQOS products.  A related paper on those PMTA orders is now available as a pre-publication comments draft on the O’Neill Institute website: https://oneill.law.georgetown.edu/wp-content/uploads/Comments-Draft-Lindblom-FDA-PMTA-Article-10-24-19.pdf.

Eric N. Lindblom, JD

Director, Tobacco Control and Food & Drug Law

O'Neill Institute for National and Global Health Law

Georgetown University Law Center

Washington, DC 20001

(202) 661-6688 | [email protected]

Publications (SSRN)   MyBibliography (PubMed)

www.oneillinstitute.org