Reduced Risk Claims Research Articles

From "Additive-Free" to "Tobacco & Water": Assessing the Impact of Marketing Claim Changes on Natural American Spirit and L&M Cigarettes.

The 2017 agreement between the U.S. Food and Drug Administration and the makers of Natural America Spirit (NAS) cigarettes restricted the use of "additive-free" (AF) in brand marketing, which the company replaced with "tobacco ingredients: tobacco & water" (TW), a phrase subsequently adopted by L&M. We tested how participants' perceptions differed when exposed to AF versus TW claims on NAS and L&M packs. A between-subjects experiment was embedded within an online survey in August 2022 (n = 2526). Participants were randomized to view one of three packs (NAS AF pack, NAS TW pack, L&M TW pack). Logistic regressions assessed differences (by pack exposure) in perceived pack attractiveness and relative chemical and harm perceptions compared to other cigarettes. Interactions by smoking status were explored. No significant differences were observed between the NAS AF and NAS TW packs on perceived attractiveness or relative harm, although never smokers had higher odds of having lower relative chemicals perceptions in response to the NAS AF versus NAS TW pack (OR = 1.81). Compared to participants who saw the NAS TW pack, those who saw the L&M TW pack tended to have lower odds of perceiving the pack as attractive, believing that the product had fewer chemicals than other products, or believing the product was less harmful than other products compared to the NAS TW pack. Results suggest the more implicit "tobacco ingredients: tobacco & water" claim functions similarly to "additive-free" and as an unauthorized modified risk claim. NAS brand image also appears to contribute to higher perceived pack attractiveness and lower perceptions of chemicals and harm. Additional marketing regulations and corrective campaigns may be needed to reduce risk-related misperceptions about NAS cigarettes. Our findings show that replacing "additive-free" claims with "tobacco ingredients: tobacco & water" did not sufficiently address the illegal use of unauthorized modified risk claims by the makers of NAS cigarettes. Further regulatory action restricting the TW claim could potentially reduce inaccurate lower harm perceptions about NAS cigarettes. Educational campaigns may also be needed to mitigate NAS's history of marketing that implies reduced harm, given that the effects of implicit reduced risk claims like TW have a greater effect on pack perceptions for NAS than L&M.

Discussion of Heated Tobacco Products on Twitter Following IQOS's Modified-Risk Tobacco Product Authorization and US Import Ban: Content Analysis.

Understanding public opinions about emerging tobacco products is important to inform future interventions and regulatory decisions. Heated tobacco products (HTPs) are an emerging tobacco product category promoted by the tobacco industry as a "better alternative" to combustible cigarettes. Philip Morris International's IQOS is leading the global HTP market and recently has been subject to important policy events, including the US Food and Drug Administration's (FDA) modified-risk tobacco product (MRTP) authorization (July 2020) and the US import ban (November 2021). Although limited in their legal implications outside the United States, these policy events have been quoted in global news outlets and Philip Morris International's promotional communications, showing how they may potentially impact global tobacco regulation. Given the impending return of IQOS to the US market, understanding how the policy events were received through social media discourse will provide valuable insights to inform global tobacco control policy. This study aims to examine HTP-related social media discourse around important policy events. We analyzed HTP-related posts on Twitter during the time period that included IQOS's MRTP authorization in the United States and the US import ban, examining personal testimonial, news/information, and direct marketing/retail tweets separately. We also examined how the tweets discussed health and policy. A total of 10,454 public English tweets (posted from June 2020 to December 2021) were collected using HTP-related keywords. We randomly sampled 2796 (26.7%) tweets and conducted a content analysis. We used pairwise co-occurrence analyses to evaluate connections across themes. Tweet volumes peaked around IQOS-related policy events. Among all tweets, personal testimonials were the most common (1613/2796, 57.7%), followed by news/information (862/2796, 30.8%) and direct marketing/retail (321/2796, 11%). Among personal testimonials, more tweets were positive (495/1613, 30.7%) than negative (372/1613, 23.1%), often comparing the health risks of HTPs with cigarettes (402/1613, 24.9%) or vaping products (252/1613, 15.6%). Approximately 10% (31/321) of the direct marketing/retail tweets promoted international delivery, suggesting cross-border promotion. More than a quarter of tweets (809/2796, 28.9%) discussed US and global policy, including misinterpretation about IQOS being a "safer" tobacco product after the US FDA's MRTP authorization. Neutral testimonials mentioning the IQOS brand (634/1613, 39.3%) and discussing policy (378/1613, 23.4%) showed the largest pairwise co-occurrence. Results suggest the need for careful communication about the meaning of MRTP authorizations and relative risks of tobacco products. Many tweets expressed HTP-favorable opinions referring to reduced health risks, even though the US FDA has denied marketing of the HTP with reduced risk claims. The popularity of social media as an information source with global reach poses unique challenges in health communication and health policies. While many countries restrict tobacco marketing via the web, our results suggest that retailers may circumvent such regulations by operating overseas.

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.

In 2020, the U.S. Food and Drug Administration authorized the marketing of IQOS as a modified risk tobacco product (MRTP) with reduced exposure information (reduces exposure to harmful chemicals compared to cigarettes) but prohibited Philip Morris International from making reduced risk claims (reduces risk of disease compared to cigarettes). We aimed to assess how news media in low- and middle-income countries (LMICs) discussed this authorization and whether articles discussed IQOS as a reduced exposure versus reduced risk product. News articles published between July 7, 2020 and January 7, 2021 were obtained by searching Tobacco Watcher (www.tobaccowatcher.org), a surveillance platform for tobacco-related news. Articles were eligible if they were published in an LMIC and mentioned the IQOS MRTP order. Non-English language articles were professionally translated. Articles were double coded to identify country of origin, reduced risk and reduced exposure language, discussions of potential impacts of the authorization on regulations in LMICs, and quotes from tobacco industry and public health stakeholders. We identified 50 eligible articles published in 20 LMICs. Twenty-six (52%) and 40 (80%) included reduced risk and reduced exposure language, respectively. Twenty-two (44%) discussed potential impacts of the MRTP order on regulations in LMICs. Thirty (60%) included quotes from tobacco industry representatives, 6 (12%) included quotes from public health or medical professionals, and 2 (4%) included both. News articles in LMICs frequently misreported the MRTP order by using reduced risk language. The authorization is potentially being used to shape perspectives on tobacco regulations in LMICs. Tobacco control experts need to more frequently share their perspectives with the news media. News articles from LMICs frequently misrepresented the IQOS MRTP order by using reduced risk language (reduces harm compared to cigarettes) rather than only using reduced exposure language (reduces exposure to harmful chemicals compared to cigarettes). Many articles referred to IQOS as a "better alternative" to cigarettes without specifically referencing reduced risk. Few articles included perspectives from public health or medical professionals, while most included tobacco industry quotes, suggesting that tobacco control experts need to more frequently engage with the news media. These findings also highlight how the U.S. FDA's actions can potentially shape perspectives on tobacco product regulations in LMICs.

United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America.

ABSTRACTPhilip Morris International has used the July 7, 2020 United States Food and Drug Administration’s (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US’s unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International’s global public relations campaign largely ignored the FDA’s rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers – including tobacco users and Philip Morris International’s customers – to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

Health Claims, Marketing Appeals, and Warnings on Popular Brands of Waterpipe Tobacco Packaging Sold in the United States.

Waterpipe tobacco (WT) smoking is associated with misperceptions of harm, especially among users. WT packaging contains imagery, flavor descriptors, and text claims that may contribute to misperceptions. The study goal was to characterize visual and text elements of WT packaging. Using data from the U.S. Population Assessment on Tobacco and Health Study Wave 2 (October 2014-October 2015), we identified the 10 most popular WT brands. For each brand, we identified available flavors, including flavor collections with unique packaging elements. We randomly selected 10 flavors per brand for purchase (March-April 2018). We conducted descriptive content analysis to code all textual and visual design elements of each package. Over half (54%) of WT packages had modified risk tobacco product (MRTP) claims prohibited by federal law, including substance-free MRTP claims (43%) and the descriptor "natural" (11%). No MRTP reduced exposure or reduced risk claims were found. Over a quarter (26%) of packaging including one or more of terms that may imply reduced harm including "fresh," "premium," "quality," and "pure." All packages included a text-only warning, yet none appeared on the primary display panel. Almost all packaging (99%) included imagery, with 72% including flavor imagery. The majority of packages (72%) included a smoking cue. The most popular marketing appeals were "well-made" (57%), "enjoyable" (55%), and "patriotic" (47%). Prohibited MRTP claims, other descriptors, and flavor imagery are common on WT packaging, despite federal law. Future research is needed to evaluate if this marketing contributes to misperceptions of reduced harm. Tobacco packaging is used to convey health-related messages, both explicitly and implicitly; however, information about WT packaging is virtually nonexistent. We conducted a content analysis of WT packaging from the 10 most popular US brands. Over half (54%) of packages had prohibited MRTP claims and over a quarter (26%) included one or more descriptors that may be perceived as implying reduced harm. Use of imagery, including smoking cues, was common. The widespread use of prohibited MRTP claims, other descriptors, and imagery on WT packaging may contribute to misperceptions of reduced harm.

Evidence of compensation among waterpipe smokers using harm reduction components

ObjectivesWe examined two waterpipe tobacco smoking components advertised to reduce harm to determine if they result in lower levels of biomarkers of acute exposure.MethodsWe conducted a crossover study of 34...

An Overview of iQOS® as a New Heat-Not-Burn Tobacco Product and Its Potential Effects on Human Health and the Environment.

Tobacco smoke from regular cigarettes contains a number of harmful chemicals such as nicotine, arsenic, benzene, carbon monoxide, heavy metals, and tobacco-derived nitrosamines. About 1% of over 7000 chemical substances formed by burning tobacco are identified as the leading causes or possible risk factors of smoking-related diseases such as lung cancer, cardiovascular diseases, and emphysema. The concept of heating tobacco without combustion and smoke has been designed for more than two decades. The products developed with this idea, known as "Heat-Not-Burn" tobacco cigarettes, were first introduced in the late 1980s but did not achieve commercial success. However, the tobacco giants have been trying to remarket tobacco heating systems with new technological and modified features for over 10 years. I-Quit-Ordinary-Smoking (iQOS®) is one of the latest heat-not-burn tobacco products, first launched in Japan and Italy. The company then made a submission to the Food and Drug Administration as a modified-risk tobacco product application to sell its own tobacco-heating device iQOS® under its Marlboro® brand in the USA with reduced-risk claims in 2016, but it was rejected. This device is, however, now sold in more than four dozen countries. There are some striking claims that iQOS®, which is described as a novel hybrid product between traditional cigarettes and electronic cigarettes, offers an alternative way to substantially reduce the amount of harmful components compared with traditional cigarettes by its new technology in which tobacco is heated up to 350°C instead of being burnt. It is claimed to produce vapour containing nearly 90% less toxic substances than cigarette smoke and not be a source of second-hand smoking negatively affecting indoor air quality. The purpose of this article is to objectively review the potential effects of iQOS® on human health and the environment by searching and integrating the published research findings.

Light and mild redux: heated tobacco products’ reduced exposure claims are likely to be misunderstood as reduced risk claims

IntroductionHeated tobacco products (HTPs) are being marketed in several countries around the world with claims that they are less harmful than combusted cigarettes, based on assertions that they expose users...

American Spirit Pack Descriptors and Perceptions of Harm: A Crowdsourced Comparison of Modified Packs.

In 2015, the Food and Drug Administration issued warnings to three tobacco manufacturers who label their cigarettes as "additive-free" and/or "natural" on the grounds that they make unauthorized reduced risk claims. The goal of this study was to examine US adults' perceptions of three American Spirit (AS) pack descriptors ("Made with Organic Tobacco," "100% Additive-Free," and "100% US Grown Tobacco") to assess if they communicate reduced risk. In September 2012, three cross-sectional surveys were posted on Amazon Mechanical Turk. Adult participants evaluated the relative harm of a Marlboro Red pack versus three different AS packs with the descriptors "Made with Organic Tobacco," "100% Additive-Free," or "100% US Grown Tobacco" (Survey 1; n = 461); a Marlboro Red pack versus these AS packs modified to exclude descriptors (Survey 2; n = 857); and unmodified versus modified AS pack images (Survey 3; n = 1001). The majority of Survey 1 participants rated the unmodified AS packs as less harmful than the Marlboro Red pack; 35.4%-58.8% of Survey 2 participants also rated the modified (no claims) packs as less harmful than Marlboro Red. In these surveys, prior use of AS cigarettes was associated with reduced perceptions of risk (adjusted odds ratio [AOR] 1.59-2.40). "Made with Organic Tobacco" and "100% Additive-Free" were associated with reduced perceptions of risk when comparing the modified versus the unmodified AS packs (Survey 3). Data suggest that these AS pack descriptors communicate reduced harm messages to consumers. Findings have implications for regulatory actions related to product labeling and packaging. These findings provide additional evidence that the "Made with Organic Tobacco," "100% Additive-Free," and "100% US Grown" descriptors, as well as other aspects of the AS pack design, communicate reduced harm to non-, current, and former smokers. Additionally, they provide support for the importance of FDA's 2015 warning to Santa Fe Natural Tobacco Company on "100% Additive Free" as an unauthorized modified risk claim.

E-Cigarette Marketing Online: A Systematic Content Analysis of Manufacturers and Retailers

Abstract Purpose: To identify the current atmosphere of online sales of Electronic Nicotine Delivery Systems (ENDS) in regards to key health-related and legal claims being made and to analyze the legal framework for regulating such claims. Methods: In December 2014, a systematic search protocol was employed with 3 popular search engines using six terms: 1) e-cigarettes, 2) e-cigs, 3) e-juice, 4) e-liquid, 5) e-hookah, and 6) vape pen. Websites from ENDS manufacturers and retailers were eligible for inclusion, and excluded review sites, blogs, or other non-commercial sites. Three pages of content were examined for each search term. In Phase I, included sites were independently coded for several health-related and legal themes, including: Modified or Reduced Risk, Cessation, Smoke anywhere, Health Benefits, Cleanliness, Environmentally Friendly, and Modern. In Phase II, gathered qualitative data was further coded for primary (explicit) and secondary (implicit) claims. Results: The final web search (n = 115) identified eligible sites and these were divided into two categories Manufacturers (n = 78) and Retailers (n = 32). Between both groups, the most common claims were Modified or reduced risk claims (63.6%), Cessation claims (41.8%), and Claims regarding one's ability to get around clean indoor air laws (42.7%) for Manufacturers and Retailers, combined. Overall, Manufacturers were more likely to make any health or legal claim than Retailers. Conclusions: The unregulated marketing of ENDS has led to a proliferation of health-related claims. Applying a legal/regulatory perspective, this research reveals the different types of health-related claims being made by ENDS manufacturers and retailers on their websites. For claims that are misleading or deceptive, the specifics content and context of each claim may influence whether the FDA has the current regulatory authority to address it. This research demonstrates that the FDA should complete the proposed “deeming” rule and develop a comprehensive regulatory scheme to addresses health-related claims by ENDS manufacturers and retailers.

Smoking behaviour and toxin exposure during six weeks use of a potential reduced exposure product: Omni

Objective: To determine smoking behaviour, acceptability, and toxin exposure when smokers switch to the potential reduced exposure product—Omni cigarette. Design: 12 week randomised, crossover study of Omni versus own cigarettes....

Smoker and ex-smoker reactions to cigarettes claiming reduced risk

Context: The tobacco industry is introducing modified tobacco products claiming to reduce the risk of smoking (potential reduced exposure products, PREPs). If PREPs are perceived as safe, they may deter...