Evidence map›Paper›PMID 33811155›Full record

ArticleTobacco control2022

FDA's reduced exposure marketing order for IQOS: why it is not a reliable global model.

Lauren Kass Lempert, Stella Bialous, Stanton Glantz

Abstract readEditorial
In one paragraph

Article in Tobacco control, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. How Media Stories in Low- and Middle-Income Countries Discussed the U.S. Food and Drug Administration's Modified Risk Tobacco Product Order for IQOS.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2023
    Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Lauren Kass LempertCenter for Tobacco Control Research & Education, UCSF, San Francisco, California, USA Lauren.Lempert@ucsf.edu.ORCID 0000-0001-5421-0263
Stella BialousDepartment of Social and Behavioral Sciences, School of Nursing, UCSF, San Francisco, California, USA.
Stanton GlantzCenter for Tobacco Control Research & Education, UCSF, San Francisco, California, USA.ORCID 0000-0003-4620-6672

Funding

PROJECT 5: IMPACT OF CHANGING TOBACCO PRODUCT USE ON HEALTHCARE COSTS FOR GENERAL AND VULNERABLE POPULATIONSU54HL147127 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LING, PAMELA MAY · 2018 to 2022
$20.4M
NHLBI NIH HHS U54 HL147127
6 · The paper itself

Abstract

The US Food and Drug Administration (FDA) issued orders in July 2020 authorising Philip Morris Products S.A. to market its heated tobacco product (HTP) IQOS inside the USA with claims that it reduces exposure to some dangerous substances. FDA's 'reduced-exposure' orders explicitly prohibit the marketing of IQOS with claims that IQOS will reduce harm or the risk of tobacco-related diseases. Under US law, FDA's IQOS orders are problematic because FDA disregarded valid scientific evidence that IQOS increases exposure to other dangerous toxins and that Philip Morris Products S.A. failed to demonstrate that consumers understand the difference between reduced-exposure and reduced-harm claims. Unfortunately, both 'reduced-exposure' and 'reduced-harm' are classified as 'modified risk tobacco products' under US law. Exploiting this confusion, Philip Morris International used the FDA decision as the basis for marketing and public relations campaigns outside the USA to press governments to reverse policies that ban or regulate the sales and marketing of HTPs, including IQOS. Parties to the WHO Framework Convention on Tobacco Control should reject tobacco companies' unsubstantiated explicit or implied claims of reduced harm associated with HTPs and resist Philip Morris International's and other companies' calls to relax HTP regulations based on the FDA's actions. Instead, parties should adopt policies aligned with the Framework Convention on Tobacco Control when dealing with HTPs and other novel tobacco products.

Indexed as

MarketingTobacco ProductsGovernmentHumansPolicyUnited StatesUnited States Food and Drug Administrationadvertising and promotionglobal healthnon-cigarette tobacco productspublic policytobacco industry

Identifiers

PMID33811155
PMCPMC8486889

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.