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Rapid response to:


US regulator adds to confusion around heated tobacco products

BMJ 2020; 370 doi: (Published 16 September 2020) Cite this as: BMJ 2020;370:m3528

Rapid Response:

There is nothing confusing about FDA's modified-risk orders for the iQOS heated tobacco product

Dear Editor

It is surprising that the authors of this commentary, Anna Gilmore and Sophie Braznell of Bath University, are confused. The legal framework for authorising modified risk claims under the US Tobacco Control Act is clear and logical and set out in section 911 of the Act [1]. Three types of claim are permitted, subject to FDA approval: [2]

I. the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
II. the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
III. the tobacco product or its smoke does not contain or is free of a substance;

Under II above, the reduced exposure claim, a company may be authorised to make a claim of reduced risk based on substantial reductions in exposure to toxicants, without necessarily having the data to show these reductions translate to reduced health burdens.  This is because it can take many years or decades for the health benefits of reduced exposures to emerge as measurable reduced impacts on health.  However, it is reasonable to assume that large reductions in exposures will lead to a reduction in the health burden. The drafters of the Act commendably recognised that it would be impractical for new products with significant benefits to public health to show epidemiological data that would take many years to gather and to show effects. However, they sought to provide consumers with meaningful risk information rather than deny them highly salient insights based on evidence of reduced exposures. Not to allow this would be to deny users valuable and potentially life-saving information and to violate principles of informed choice and user autonomy.

The process for granting a modified risk order for reduced exposure claims is set out in section 911(g)(2) of the Act. This provides defences against misleading use of such claims and ensures that exposure reductions are sufficient to be regarded as indicating reduced risk. This option requires that [3]:
+ the order is appropriate for the protection of public health;
+ the modified risk claims are limited to reduced exposures;
+ scientific evidence to show reduced harm cannot be made available without conducting long-term epidemiological studies, and;
+ the evidence that is available demonstrates a substantial reduction in morbidity and mortality among individual tobacco users is reasonably likely in subsequent studies.

The Act sets out “additional findings” that are required to use this approval pathway and “conditions of marketing” that can be applied to the qualify the order. [4] The whole package has to meet the population health standard. It can be subject to post-market surveillance and may be withdrawn if anything goes wrong [5], an inherently precautionary approach.

The report of the FDA’s Technical Project Lead for the iQOS evaluation shows clearly how these conditions were met. It should be required reading for anyone in the field who feels confused by the products, the science, the modified risk concept, the Tobacco Control Act or FDA’s role in making such assessments. [6] On page 11 of this document, FDA summarises as follows:

"With respect the exposure modification order request, the applicant has demonstrated that the products sold or distributed with the proposed modified risk information meet the standard under section 911(g)(2) of the FD&C Act, including that a measurable and
substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies, and issuance of an order is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products."

There is no mystery here and no need for confusion. Because heated tobacco products do not involve combustion, they do not create products of combustion and, as a result, the user is exposed to far lower levels of toxicants. Exposure studies clearly demonstrate exposure reductions in smokers switching to iQOS that are almost equivalent to quitting smoking. [7] It would be unethical to keep this information from consumers.

The real problem with the Tobacco Control Act is the opposite of that suggested by Gilmore and Braznell. The barriers to making reduced risk claims are so high that the process is, in practice, only open to giant tobacco companies willing and able to bear the burdens. PMI’s filing was reportedly over two million pages. [8] There has to be an easier way of explaining that use of products that do not involve combustion and inhalation of smoke are, beyond any reasonable doubt, far less harmful than smoking.

[1] Food, Drug and Cosmetics Act, Section 911 Modified Risk Tobacco Products (21 U.S.C. 387k). Often referred to as the Family Smoking Prevention and Tobacco Control Act or “Tobacco Control Act”.

[2] See section 911(b)(2)(A)(i):

[3] See the full text at Section 911(g)(2)(A)((i-iv)

[4] See the full text at Section 911(g)(2)(B & C)

[5] See the full text at Section 911(i) and 911(j)

[6] US Food and Drug Administration, Modified Risk Orders iQOS System Holder and Charger Decision Summary by the Technical Project Lead:

[7] See US Food and Drug Administration, Office of Science Center for Tobacco Products. Briefing Document for January 24-25, 2018 Meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) Modified Risk Tobacco Product Applications(MRTPAs) MR0000059-MR0000061 Philip Morris Products S.A. Page 24-28

[8] Campaign for Tobacco-Free Kids, Phillip Morris International's iQOS. Factsheet. 24 September 2020.

Competing interests: No competing interests

29 September 2020
Clive D Bates
Director, Counterfactual Consulting Limited
London SW12, United Kingdom