heated tobacco product regulation under us law and the fctc

Heated acttobacco is marketing new \"heating tobacco products \"(HTPs)
Composed of batteries
Power stand, charger and cigarette plug or cigarette support. The non-
According to tobacco control laws in many countries, tobacco HTP components evade effective regulation because they are packaged and sold separately from Tobacco
Contains components.
In the United States, HTPs cannot be sold unless the Food and Drug Administration determines that it allows HTPs to sell \"suitable to protect public health.
Philip Morris International (PMI)
Seeking permission to sell its iqos htp in the United States with \"improved risk tobacco products (MRTP)
Claims it reduces access to harmful substances and is less harmful than other tobacco products.
However, PMI did not submit enough scientific evidence required by US law to prove that the product is far less harmful to users than other tobacco products, and its label does not mislead consumers, or its marketing
Claims with or without MRTP-
It will benefit the health of the entire population.
Parties to the WHO Framework Convention on Tobacco Control (FCTC)
Measures must be taken to reduce tobacco use and nicotine addiction to prevent false or misleading labeling, advertising and promotion of tobacco products;
The introduction of new HTPs must be evaluated based on these objectives.
All components of HTPs should be at least as tightly regulated as existing tobacco products, including restrictions on labeling, advertising, promotion and sponsorship, sales to minors, price and tax policies, and smoke-free measures
There is nothing in US law or FCTC that prevents the authorities from banning HTPs.
Iqos htp is an integrated tobacco product designed to maintain nicotine addiction. IQOS consists of three integrated components that are critical to its normal operation: Stand (
Heating tobacco material by electronically controlled heating of blades), a charger (
Recharge to the holder after each use)
And a cigarette stick (
\"Stic\" or \"heets \")(figure 1).
As PMI acknowledges, these three components together constitute IQOS7;
Without the tobacco stick, the stand and charger do not have separate functions, and without the stand and charger, the tobacco stick cannot produce nicotine aerosol.
PMI said in its MRTP application that the hot rods were \"designed to work with the supports to produce aerosol [s\"emphasis added]’.
Figure 1 shows the IQOS schematic diagram of its components (A)
Schematic diagram of the bracket (B)
, And schematic cross
Section diagram of cigarette sticks (C)(
Executive Summary).
7PMI is using these three-
Component design packages and sells tobacco cigarettes separately from other IQOS components that do not contain tobacco, thus avoiding existing tobacco control labels, marketing and tax laws in some countries.
For example, in Canada, many chain convenience stores sell IQOS tables, but do not sell the device itself, and the clerk notifies the customer to contact the IQOS representative to arrange the purchase of the device.
In Korea, 10 pm I sells its IQOS holders, and the Chargers and associated accessories in the package do not contain tables marked as \"iqos\" only, does not involve health warnings required on the packaging of tobacco or tobacco products.
PMI is sold in separate packaging from marl road or other cigarette brand brands that include health warnings and comply with the tobacco product packaging and labeling act.
The product description of IQOS in the MRTPA of PMI is heavily edited, but it is stated that the IQOS holder contains the electronic chip (firmware)
Other functions used to \"control temperature\", \"detect porpoise\" and control the user\'s nicotine intake. (Module 3.
1. Product description)
PMI testified at the tpac meeting on January 2018 that IQOS devices were able to capture data, such as the number of puffs taken, but indicated that this information would be used for diagnostic purposes if the device was returned.
In addition, PMI testified to tpac that the Bluetooth feature of IQOS is used to deliver information to consumers such as \"you haven\'t used an IQOS device today\" and reminded them to re-order tobacco hot bars
11 IQOS measures puff of users-by-
11 12 puff heating profile integrates the Bluetooth function of IQOS with mobile phones and computers, 13 and automatically remind consumers to keep using the device and re-order the tobacco glue 11 it is recommended that it calibrate the delivery of nicotine to ensure that not only is it \"satisfied\", but that it is possible for PMI to customize the dose, the delivery speed and continuous use of nicotine maximize the addictive potential of individual users.
12 14 15 how the definition of tobacco products under the US HTPs regulation affects its regulation.
16. TCA defines \"tobacco products\" as \"any tobacco products intended for human consumption, including any ingredients, parts or accessories of tobacco products . . . . . . [emphasis added]’. (Section101(a))4 IQOS (
Heating rods, brackets and Chargers included)
Fully in line with the FDA\'s definition of \"tobacco products;
PMI for its IQOS products (
Including three components
It is a \"tobacco product\" stipulated in US law 7 and is subject to most regulations related to tobacco products (
For example, pre-listing review (Section 910)4)
Free samples are prohibited.
17. FDA\'s presumption rule of jurisdiction over tobacco products other than cigarettes and non-smoking tobacco defines \"ingredients or parts\", including materials designed or expected to change or affect the performance of tobacco products, all tobacco products, including HTPs and its components and components, that comply with the definition of \"tobacco products\" and expand the regulatory authority of the FDA.
19 certain provisions of the rule (
It is forbidden to sell and vending machines to customers under the age of 18)
20 applies only to \"covered tobacco products that do not include any non-tobacco-made or derived ingredients or parts \".
The vulnerability created by the FDA in the Deeming rule contradicts the clear definition of \"tobacco products\" in tca4. this definition includes \"any ingredient, part or attachment \".
The vulnerability creates an opportunity for companies to sell IQOS devices to young people in violation of the law\'s intent.
In addition, federal cigarette label and advertising Act21 (FCLAA)
Define \"cigarettes\" as \"any roll of tobacco wrapped in paper or any substance that does not contain tobacco\" and incorporate this definition in accordance with the regulations implemented by TCA.
Because these hot rods also meet the definition of \"cigarettes\", additional restrictions applicable to cigarettes but not to other tobacco products (
For example, a cigarette warning is required and advertising is prohibited in electronic communication media
Should be suitable for heating rods.
Before being allowed to sell new tobacco products in the United States, manufacturers must first obtain a pre-market authorization from the FDA through a pre-market tobacco product application (PMTA)
Equal substance \'(SE)
Order or exemption for SE. (Section910(a)(2))4 (
At present, a generation of HTPs cannot obtain a less stringent SE route, because the United States did not sell HTPs with similar features before February 15, 2007 ,(Section 910(a)(3))
24 and HTPs are not \"minor modifications\" of any product sold in the US before February 15, 2007 \". (Section905(j)(3))24)
It is the responsibility of the PMTA applicant to certify that the product is \"suitable for the protection of public health\" and that the product is based on \"risks and benefits\" that take into account the increased or reduced likelihood of existing users stopping the use of tobacco products, for the entire population including users and non-users, and
Users will start using them. (Section910(c)(4))
4 This strict standard basically requires the applicant to prove that, in general, allowing the sale of new products may reduce tobaccorelated harms’.
25 In addition, the FDA is required to reject any PMTA of a product that is recommended to be labeled \"any particular false or misleading. (Section910(c)(2)(C))
Further fulfilling its mission to protect the health of the public, the US district court held that tobacco companies deliberately used labels and marketed 26 27 to deceive and mislead consumers about the harm of their products and in the \"search\" section. (Section2)
In particular, the US Food and Drug Administration has the right to \"ensure effective supervision of efforts by the tobacco industry to develop, introduce and promote tobacco products that are less harmful \". (Section3(4))
4tca defines MRTP as \"selling or distributing any tobacco product used to reduce tobacco hazards or risks\"
Diseases related to commercial sales of products. ’ (Section 911(b)(1))
4 obtain orders allowing the sale of modified tobacco products
The manufacturer must submit an application for a risk claim (MRTPA)
Proving to the FDA that products actually used by consumers will \"significantly reduce the harm and risk of tobacco\"
Taking into account users and non-users, diseases related to individual tobacco users and \"health benefits to the entire population\"
Users of tobacco products. (Section911(g)(1))
4 products that cannot accept risks-
FDA may issue a change order-
The amendment order if the applicant proves that doing so is \"conducive to the promotion of public health \", and labels and advertisements are limited to a reduction in the level of substances that indicate that the product or its smoke does not or contains reduced substances or that are exposed to tobacco smoke. (Section911(g)(2)(A))
4 In addition, for exposure-
To amend the order, the applicant must prove :(1)
Compared with similar types of tobacco products on the current market, the products actually used by consumers will not expose them to higher levels of other harmful substances, and its use will reduce the overall incidence and mortality of users; and (2)
Based on tests perceived by actual consumers, the proposed labeling and marketing will not mislead consumers into believing that the product is less harmful or less at risk of disease than other tobacco products sold commercially. (Section911(g)(2)(B))
4 In addition, for these two risks
Modification and exposure
To modify the order, FDA must ensure that \"any advertising and labeling of modified risk products enables the public to understand information about the risk of modification, and understand the relative importance of this information in overall health and tobaccorelated harms. (Section911(h)(1))
4. The housing association authorizes states to enact stricter laws than the requirements of the housing association, including measures prohibiting sales, distribution, possession, contact, advertising and promotion, or the use of tobacco products by individuals of any age. (Section916)
In December 2016, PMI submitted millions-
Page MRTPA, which applied to FDA for permission to sell IQOS in the United States, was modified twice-risk claims (
Switching from cigarette to IQOS system completely reduces the risk of tobacco
Related diseases and \"completely switching to IQOS is less harmful than continuing smoking \")
Modified one. Risk claim (
\"Completely switching from cigarettes to the IQOS system significantly reduces the risk of physical exposure to harmful and potentially harmful chemicals \").
On January 2018, PMI submitted its iqos mrtpa to tpac, which found that PMI\'s MRTPA failed to provide sufficient scientific evidence to support its revised risk claim.
On March 2017, PMI submitted a PMTA28 seeking authorization to sell IQOS in the United States, regardless of whether or not IQOS is declared for sale in MRTP, authorization is required.
Therefore, if the FDA refuses the IQOS application for PMI to submit MRTP claims to the market, the FDA can still submit PMI applications to the US market without any such claims. PMI’s harm-
The principle of reducing the claim is that the inhalation of complex combustion compounds in tobacco smoke can lead to adverse health outcomes, since the IQOS device is allegedly heated, but it doesn\'t burn proprietary smoke sticks to produce inhaled nicotine --
It contains aerosol, which is less harmful than cigarette smoke.
Contrary to these statements, harmful chemicals are produced during the pyrolysis phase. 29US law (Section 911(g)(1))
4 before making a MRTP claim to PMI, apply pressure to PMI to demonstrate that IQOS is appropriate to protect public health, rather than to show the harm of the product to the FDA or the public.
A careful reading of the pmi mrtpa, however, suggests that it does not meet this burden.
PMI\'s own data show that the risk of human injury using IQOS continues to decrease compared to traditional cigarettes, and 30 31 IQOS is associated with lung and immune regulatory injuries, not significantly different from traditional cigarettes, 32 33 the use of IQOS may be related to liver toxicity and accidental organ toxicity that are not associated with conventional cigarettes 34 35, and the use of IQOS does not necessarily avoid cardiovascular adverse effects of conventional cigarettes smoking.
36 37 In addition, data collected independently of the PMI showed that IQOS did not continuously reduce access to harmful or potentially harmful chemicals.
In addition, Reuters released a report on December 2017, noting violations in the pmi iqos study.
43 44 at its meeting on January 2018, tpac voted that PMI\'s MRTPA failed to provide scientific evidence in support of its revised risk claim.
Evidence provided in pmi mrtpa also failed to demonstrate the net public health benefits required for PMTA orders (Section 910(c)(4))
4 and MRTP orders. (Section911(g)(1))
4 PMI does not indicate that IQOS will be beneficial to the health of the entire population considering both users and non-users
Users of tobacco products.
45 46 PMI is particularly worrying that it does not consider youth, youth or other non-
Users may use IQOS, 10 47 48 to initiate tobacco use, or whether it is possible for users to use IQOS at the same time as other tobacco products, rather than \"switch completely \".
Based on the evidence provided in PMI\'s MRTPA, tpac found that the likelihood of US smokers switching completely to IQOS use was low.
13. TCA also asked PMI\'s MRTPA to include scientific research to demonstrate that consumers will understand the proposed advertisements and labels and will not be misled to believe that the product is less harmful than the actual one.
However, the evidence provided by PMI suggests that the IQOS tag or advertising does not ensure the consumer\'s accurate perception of risk and that smokers do not understand that they need to switch completely to IQOS to achieve the so-called benefits, and consumers may think
Reduced risk claims
The risk claim makes it inherently misleading.
27. 50. 51 independent studies also show that misconceptions among adults and adolescents have decreased --
Even without a clear low risk statement, the risk statement conveys a lower risk.
52 tpac also found that PMI failed to demonstrate that consumers were able to accurately understand the IQOS risks communicated in the MRTP tag and advertising proposed by PMI.
13. if PMI cannot modify its application to prove that marketing IQOS is actually \"appropriate to protect public health\" and that its proposed label is not misleading, the regulation requires FDA to reject the application for PMI, PMI does not allow marketing of IQOS, whether or not any related changes are maderisk claims.
FDA\'s decision on pmi iqos applications will affect how other governments regulate HTPs and related reductions
Risk claims around the world.
In fact, PMI pointed out in its 2018 annual report that we are still concerned about our desire to see the launch of IQOS in the United States, and future FDA actions may affect the way other governments regulate.
In December 2016, PMI submitted millions-
Page MRTPA, which applied to FDA for permission to sell IQOS in the United States, was modified twice-risk claims (
Switching from cigarette to IQOS system completely reduces the risk of tobacco
Related diseases and \"completely switching to IQOS is less harmful than continuing smoking \")
Modified one. Risk claim (
\"Completely switching from cigarettes to the IQOS system significantly reduces the risk of physical exposure to harmful and potentially harmful chemicals \").
On January 2018, PMI submitted its iqos mrtpa to tpac, which found that PMI\'s MRTPA failed to provide sufficient scientific evidence to support its revised risk claim.
On March 2017, PMI submitted a PMTA28 seeking authorization to sell IQOS in the United States, regardless of whether or not IQOS is declared for sale in MRTP, authorization is required.
Therefore, if the FDA refuses the IQOS application for PMI to submit MRTP claims to the market, the FDA can still submit PMI applications to the US market without any such claims. PMI’s harm-
The principle of reducing the claim is that the inhalation of complex combustion compounds in tobacco smoke can lead to adverse health outcomes, since the IQOS device is allegedly heated, but it doesn\'t burn proprietary smoke sticks to produce inhaled nicotine --
It contains aerosol, which is less harmful than cigarette smoke.
Contrary to these statements, harmful chemicals are produced during the pyrolysis phase. 29US law (Section 911(g)(1))
4 before making a MRTP claim to PMI, apply pressure to PMI to demonstrate that IQOS is appropriate to protect public health, rather than to show the harm of the product to the FDA or the public.
A careful reading of the pmi mrtpa, however, suggests that it does not meet this burden.
PMI\'s own data show that the risk of injury to people using IQOS continues to decrease compared to traditional cigarettes, and 30 31 IQOS is associated with lung and immune regulation injuries, use with conventional cigarettes without obvious 32 33IQOS may be associated with liver toxicity and accidental organ toxicity that are not associated with conventional cigarettes 34 35, the use of IQOS does not necessarily avoid the adverse cardiovascular effects of conventional cigarettes.
36 37 In addition, data collected independently of the PMI showed that IQOS did not continuously reduce access to harmful or potentially harmful chemicals.
In addition, Reuters released a report on December 2017, noting violations in the pmi iqos study.
43 44 at its meeting on January 2018, tpac voted that PMI\'s MRTPA failed to provide scientific evidence in support of its revised risk claim.
Evidence provided in pmi mrtpa also failed to demonstrate the net public health benefits required for PMTA orders (Section 910(c)(4))
4 and MRTP orders. (Section911(g)(1))
4 PMI does not indicate that IQOS will be beneficial to the health of the entire population considering both users and non-users
Users of tobacco products.
45 46 PMI is particularly worrying that it does not consider youth, youth or other non-
Users may use IQOS, 10 47 48 to initiate tobacco use, or whether it is possible for users to use IQOS at the same time as other tobacco products, rather than \"switch completely \".
Based on the evidence provided in PMI\'s MRTPA, tpac found that the likelihood of US smokers switching completely to IQOS use was low.
13. TCA also asked PMI\'s MRTPA to include scientific research to demonstrate that consumers will understand the proposed advertisements and labels and will not be misled to believe that the product is less harmful than the actual one.
However, the evidence provided by PMI suggests that the IQOS tag or advertising does not ensure the consumer\'s accurate perception of risk and that smokers do not understand that they need to switch completely to IQOS to achieve the so-called benefits, and consumers may think
Reduced risk claims
The risk claim makes it inherently misleading.
27. 50. 51 independent studies also show that misconceptions among adults and adolescents have decreased --
Even without a clear low risk statement, the risk statement conveys a lower risk.
52 tpac also found that PMI failed to demonstrate that consumers were able to accurately understand the IQOS risks communicated in the MRTP tag and advertising proposed by PMI.
13. if PMI cannot modify its application to prove that marketing IQOS is actually \"appropriate to protect public health\" and that its proposed label is not misleading, the regulation requires FDA to reject the application for PMI, PMI does not allow marketing of IQOS, whether or not any related changes are maderisk claims.
FDA\'s decision on pmi iqos applications will affect how other governments regulate HTPs and related reductions
Risk claims around the world.
In fact, PMI pointed out in its 2018 annual report that we are still concerned about our desire to see the launch of IQOS in the United States, and future FDA actions may affect the way other governments regulate.
53 national HTPs regulations of the parties to the Framework Convention on Climate Change the objective of the framework convention on climate change is to protect contemporary and future generations from devastating health, society, tobacco consumption and exposure to the environment of tobacco smoke and economic consequences, and reduce the \"continued and substantial prevalence of tobacco use \". (Article3)
5 181 parties to the Framework Convention on Tobacco Control undertake to implement legislation and other measures to prevent and reduce tobacco consumption, nicotine addiction and exposure to tobacco smoke ,(Article 5)
5 inform everyone of \"health consequences, addictive nature and fatal threats caused by tobacco consumption\" to prevent \"any form\" from starting and reducing consumption of tobacco products ,(Article 4)
5. Prevent and reduce \"nicotine addiction\" other than tobacco consumption \". (Article5)
The climate convention provides strong and broad support for parties to take measures to protect the public from HTPs hazards.
Although FCTC (
Negotiations between 1999 and 2003)
HTPs were not specifically discussed and there was no intention of limiting to traditional cigarettes, non-smoking tobacco and other tobacco products that were being sold at the time.
The objective of the Framework Convention is clearly to protect \"future generations\" and the present ,(Article 3)
It is expected to launch new products after the end of the treaty negotiations in 2003.
Article 2 of the Framework Convention encourages parties to implement measures beyond the requirements of the framework convention. (Article2)
Five countries can choose a variety of methods that meet the objectives of the climate convention to regulate HTPs.
Specification of HTPs for tobacco products tsfctc article 1 definition of \"tobacco products\" as \"products made entirely or partially from tobacco leaves as manufactured for smoking, sucking, chewing or snuggling(Article1)
5 unlike the definition provided by US law, FCTC\'s definition of \"tobacco products\" does not explicitly include \"any component, part or attachment of tobacco products \".
However, since HTPs are integrated products made in part from tobacco for smoking or sucking, some countries may interpret their laws as treating HTPs as tobacco products.
It is worth noting that PMI said in its own document and marketing statement that its \"I qos system\" is a comprehensive tobacco product.
PMI pointed out that the smoke branch of IQOS is \"specifically designed to work with the holder\" and alternately called IQOS \"IQOS \", that is, the IQOS system composed of cigarettes and supports and the \"tobacco heating system \".
On its website, PMI sells three major IQOS components as a single tobacco product, the IQOS \"tobacco heating system.
54 several statements issued by the Convention Secretariat confirm that HTPs is considered a \"tobacco product\" under the Tobacco Products convention \".
55 meeting of the parties in 2016 (COP)
The governing body of the treaty said, \"all new and emerging tobacco products should be regulated by the WHO Framework Convention on Tobacco Control.
This should include products such as vaporizers and any other new equipment that can be used for tobacco consumption that do not belong to e-cigarettes.
WHO information sheet on HTPs 56 A 2017 states that \"all forms of tobacco use, including HTPs, are harmful \", it is also recommended that \"HTPs should comply with the agreement that applies to all other tobacco to who fctc.
On September 2017, the Secretariat of the Framework Convention on Tobacco Control, in introducing new tobacco products such as HTPs, pointed out that, parties have an obligation to deal with these and \"other new tobacco products that may appear in the same way are regulated in accordance with the Framework Convention on Tobacco Control.
55 accordingly, parties shall include HTPs in all restrictions currently applicable to other tobacco products, including, but not limited to, regulation of product content and disclosure, packaging and labeling requirements, full bans (
Or strict restrictions)
Regarding product advertising, promotion and sponsorship, prevention of exposure to product smoke/aerosol, prohibition of sales to minors and price and tax measures.
In March 2017, Israel became the first country to regulate IQOS as a tobacco product and apply all tobacco product restrictions to IQOS. In March 2018, the Israeli finance committee approved the Israeli tobacco tax on IQOS.
59 The easiest and most effective way to prohibit HTPs from handling HTPs according to FCTC is to prohibit the introduction of HTPs supported by FCTC targets, including protecting future generations from the devastating consequences of tobacco consumption on health ,(Article 3)
5 prevent the start of production of \"any form\" of tobacco products (Article 4)
Prevent and reduce \"nicotine addiction \". (Article5)
Five historical arguments against the ban on smoking (
This will lead to addictive smokers looking for nicotine elsewhere and creating a black market)
60 does not apply to products such as banning HTPs that have not yet been introduced or have not yet become a small part of the nicotine market.
By introducing IQOS or other HTPs, tobacco companies may increase tobacco consumption, increase nicotine addiction, and increase the initiation of adolescents and non-adolescents
62-year-old smokers have disrupted efforts to eliminate tobacco pollution and significantly reduce tobacco use, and 63-year-old smokers have created a new market for tobacco products that are difficult to control once established.
PMI has introduced IQOS in some markets where it differs from cigarettes under the existing regulatory framework, allowing it to promote IQOS and conduct intensive publicityto-
A marketing that switches current smokers to IQOS, which is not allowed by FCTC in these countries --
Consistent legislation on tobacco control.
The fact that 9 60 IQOS can be programmed to maximize the potential for addiction (Discussed above)
Particularly worrying.
Latest experience in e-commerce
Cigarettes indicate that the introduction of new highly addictive tobacco products where cigarettes are available may increase the initiation and encouragement of dual use, especially among young people, and in violation of the Framework Convention on Tobacco Control
Some FCTC parties have effectively banned HTPs.
In 2015, for example, Singapore banned emerging tobacco products, including e-commerce.
Cigarettes and equipment that smoke or imitate smoking.
Nicotine is a predetermined poison in Australia, so unless \"for human therapeutic use \"(
Cigarettes are ancestral).
68 definitions in national implementation legislation the statutory systems of 181 parties to the framework convention vary, and legal mechanisms for drafting, revising or interpreting laws will be directed to each country.
Because many parties have enacted national legislation to implement FCTC before the current generation of HTPs is listed, the laws of some countries use the definition of \"tobacco products\" related to HTPs.
Eliminating the possibility of any ambiguity or misconception will make it more difficult for tobacco companies to claim that there is a loophole that will exempt HTPs or any HTP components from the constraints of tobacco control laws.
As mentioned above, tobacco companies are trying to take advantage of this ambiguity by dismantling their integrated tobacco products and selling tobacco-free ingredients in separate packaging and even in separate stores to escape labeling and advertising.
Parties to the Framework Convention on Tobacco Control should ensure that all tobacco control measures contained in the Framework Convention on Tobacco Control apply to all components of the HTP system, whether sold as a single system or as an independent
Similar to the case where the IQOS stand and charger are sold separately from the IQOS smoke branch, the hookah pipe is typically sold separately from hookah tobacco.
In response to the potential problems this poses with respect to regulatory warning labels, the Conference of the parties issued a decision in November 2016 highlighting the need for all parties to fully implement all aspects of the climate convention in all aspects of water pipe use
69 we have found a country, Turkey, whose labeling law explicitly requires the placement of health warnings on hookah and water pipe tobacco packaging.
70 countries should interpret their definition as including HTPs (
New tobacco products)
, If it is necessary to avoid ambiguity, modify their definition, for example, \"tobacco products\" means products made entirely or partially from tobacco for inhalation, smoking, sucking, chew, snuggle or in any other way (
See, for example, the definition of \"tobacco products\" found in Thailand, the Philippines, Cambodia, Oman and Uganda).
71. Alternatively, states may add language to clarify their existing definitions of tobacco products, including ingredients such as the US definition, and ensure that all regulations applicable to tobacco products also apply to their ingredients.
The conference of the parties should make an opinion to recommend parties that implement all FCTC regulatory measures applicable to tobacco products for HTPs and prohibit the tobacco industry from trying to evade them.
Countries can also clarify and expand the definition of \"smoking\" in their laws.
The FCTC Article 8 guide recommends that \"smoking\" be defined as \"possession or control of lit tobacco products whether smoking is active inhalation or outgoing \". (Article8)
Six countries adopting this language should change the definition in order to explicitly include HTPs.
This can be achieved by explicitly adding HTPs to the definition of smoking.
The conference of the parties should issue a decision recommending that all parties ensure that their definition of \"smoke\" includes HTPs and other new tobacco products that may arise.
Article fctc for packaging, advertising and marketing requires parties to take measures to prohibit the promotion of packaging and labeling of tobacco products in any false and misleading manner, deception may have a false impression of its features, health effects, hazards or emissions, include any metaphor or other sign that directly or indirectly causes a false impression that a particular tobacco product is less harmful than other tobacco products.
72 FCTC defines \"tobacco advertising and promotion\" as \"any form of commercial communication, advice or action that directly or indirectly promotes the purpose, effect or possible effect of tobacco products or tobacco use\"(Article1(c))
5 terms of advertising, promotion and sponsorship of FCTC (Article 13(2))
5. Urge all parties to ban all advertising, promotion and sponsorship of tobacco products in an all-round way to reduce the consumption of tobacco products.
Article 13 guidelines for implementation (Article 13)
6 it is emphasized that this \"full prohibition\" applies without exception to all acts that may have promotional effects and commercial communications, including indirect advertising.
For example, in addition to traditional media and Internet advertising, the limitations of 13 \"advertising, promotion and sponsorship\" include the display of tobacco products at the point of sale, packaging and product features (
Including color, logo, picture, material)
Brand extension and corporate social responsibility activities. (Article13)
Article 6 guidelines are particularly relevant to current IQOS promotions, including their \"smoke-
Free Future activity 73 and its product features and marketing that appeal to teenagers, including packaging using colors, logos and materials that mimic the iphone, and selling IQOS in stores that mimic the Apple computer store.
9 10 61 62 it is important to recognize that any advertising or promotion of IQOS, in particular including the promotion of any other IQOS component that the holder, individually or for marketing purposes, is separate from the essential cigarette support, promote tobacco in the sense of FCTC, as it is not only possible to promote tobacco products or use, but its specific purpose is to promote the use of IQOS cigarette sticks (
Hot bar or table).
Except when used together, neither the IQOS holder nor the IQOS tobacco stick has any utility.
According to this reasoning, in April 2018, Lithuanian tobacco regulators imposed a fine on PMI subsidiaries for advertising on IQOS devices, according to the view that the device can only be used for smoking, determine that the device is subject to the same advertising restrictions as other tobacco products 74.
As of May 2018, PMI is promoting IQOS as a substitute for less harm to cigarettes.
9. 50. 60. 76 since these claims have not been confirmed by scientific evidence, they have violated the prohibitions of Articles 11 and 13 of the Tobacco Control Commission. PMI’s ‘smoke-
The \"Free Future\" campaign appears to be aimed at changing the use of tobacco rather than treating tobacco dependence or promoting the end of tobacco.
63. 2018 on February, who issued a statement condemning bat\'s promotional statement to its glo HTP, implying that who supported glo as a harmless alternative to traditional cigarettes, he said there was no evidence that HTPs were less harmful than traditional tobacco products.
13 countries that cannot issue a comprehensive ban (4)
State that the party shall at least prohibit, by any false means, propaganda of all forms of tobacco advertising, promotion and sponsorship of tobacco products, misleading or deceptive, or may have a false impression of its features, health effects, hazards, or emissions. (Article13(4))
Under this regulation, countries should prohibit any form of advertising or promotion of IQOS by PMI.
In the absence of such a ban, countries should at least not allow PMI to market IQOS with unproven express or implied claims that it is safer than conventional cigarettes, including changing consumers\' perception of product harm by using deceptive packaging or color.
78-83 since the scientific evidence does not support PMI\'s risk reduction statements about IQOS, they are false, misleading and/or deceptive, it may have a health impact on IQOS as if the claims of \"light\" and \"secret\" were found to have misled consumers.
26 27 accordingly, 11 and 13 prohibited the use of these weapons.
Specification of HTPs for tobacco products tsfctc article 1 definition of \"tobacco products\" as \"products made entirely or partially from tobacco leaves as manufactured for smoking, sucking, chewing or snuggling(Article1)
5 unlike the definition provided by US law, FCTC\'s definition of \"tobacco products\" does not explicitly include \"any component, part or attachment of tobacco products \".
However, since HTPs are integrated products made in part from tobacco for smoking or sucking, some countries may interpret their laws as treating HTPs as tobacco products.
It is worth noting that PMI said in its own document and marketing statement that its \"I qos system\" is a comprehensive tobacco product.
PMI pointed out that the smoke branch of IQOS is \"specifically designed to work with the holder\" and alternately called IQOS \"IQOS \", that is, the IQOS system composed of cigarettes and supports and the \"tobacco heating system \".
On its website, PMI sells three major IQOS components as a single tobacco product, the IQOS \"tobacco heating system.
54 several statements issued by the Convention Secretariat confirm that HTPs is considered a \"tobacco product\" under the Tobacco Products convention \".
55 meeting of the parties in 2016 (COP)
The governing body of the treaty said, \"all new and emerging tobacco products should be regulated by the WHO Framework Convention on Tobacco Control.
This should include products such as vaporizers and any other new equipment that can be used for tobacco consumption that do not belong to e-cigarettes.
WHO information sheet on HTPs 56 A 2017 states that \"all forms of tobacco use, including HTPs, are harmful \", it is also recommended that \"HTPs should comply with the agreement that applies to all other tobacco to who fctc.
On September 2017, the Secretariat of the Framework Convention on Tobacco Control, in introducing new tobacco products such as HTPs, pointed out that, parties have an obligation to deal with these and \"other new tobacco products that may appear in the same way are regulated in accordance with the Framework Convention on Tobacco Control.
55 accordingly, parties shall include HTPs in all restrictions currently applicable to other tobacco products, including, but not limited to, regulation of product content and disclosure, packaging and labeling requirements, full bans (
Or strict restrictions)
Regarding product advertising, promotion and sponsorship, prevention of exposure to product smoke/aerosol, prohibition of sales to minors and price and tax measures.
In March 2017, Israel became the first country to regulate IQOS as a tobacco product and apply all tobacco product restrictions to IQOS. In March 2018, the Israeli finance committee approved the Israeli tobacco tax on IQOS.
59 The easiest and most effective way to prohibit HTPs from handling HTPs according to FCTC is to prohibit the introduction of HTPs supported by FCTC targets, including protecting future generations from the devastating consequences of tobacco consumption on health ,(Article 3)
5 prevent the start of production of \"any form\" of tobacco products (Article 4)
Prevent and reduce \"nicotine addiction \". (Article5)
Five historical arguments against the ban on smoking (
This will lead to addictive smokers looking for nicotine elsewhere and creating a black market)
60 does not apply to products such as banning HTPs that have not yet been introduced or have not yet become a small part of the nicotine market.
By introducing IQOS or other HTPs, tobacco companies may increase tobacco consumption, increase nicotine addiction, and increase the initiation of adolescents and non-adolescents
62-year-old smokers have disrupted efforts to eliminate tobacco pollution and significantly reduce tobacco use, and 63-year-old smokers have created a new market for tobacco products that are difficult to control once established.
PMI has introduced IQOS in some markets where it differs from cigarettes under the existing regulatory framework, allowing it to promote IQOS and conduct intensive publicityto-
A marketing that switches current smokers to IQOS, which is not allowed by FCTC in these countries --
Consistent legislation on tobacco control.
The fact that 9 60 IQOS can be programmed to maximize the potential for addiction (Discussed above)
Particularly worrying.
Latest experience in e-commerce
Cigarettes indicate that the introduction of new highly addictive tobacco products where cigarettes are available may increase the initiation and encouragement of dual use, especially among young people, and in violation of the Framework Convention on Tobacco Control
Some FCTC parties have effectively banned HTPs.
In 2015, for example, Singapore banned emerging tobacco products, including e-commerce.
Cigarettes and equipment that smoke or imitate smoking.
Nicotine is a predetermined poison in Australia, so unless \"for human therapeutic use \"(
Cigarettes are ancestral).
68 definitions in national implementation legislation the statutory systems of 181 parties to the framework convention vary, and legal mechanisms for drafting, revising or interpreting laws will be directed to each country.
Because many parties have enacted national legislation to implement FCTC before the current generation of HTPs is listed, the laws of some countries use the definition of \"tobacco products\" related to HTPs.
Eliminating the possibility of any ambiguity or misconception will make it more difficult for tobacco companies to claim that there is a loophole that will exempt HTPs or any HTP components from the constraints of tobacco control laws.
As mentioned above, tobacco companies are trying to take advantage of this ambiguity by dismantling their integrated tobacco products and selling tobacco-free ingredients in separate packaging and even in separate stores to escape labeling and advertising.
Parties to the Framework Convention on Tobacco Control should ensure that all tobacco control measures contained in the Framework Convention on Tobacco Control apply to all components of the HTP system, whether sold as a single system or as a separate
Similar to the case where the IQOS stand and charger are sold separately from the IQOS smoke branch, the hookah pipe is typically sold separately from hookah tobacco.
In response to the potential problems this poses with respect to regulatory warning labels, the Conference of the parties issued a decision in November 2016 highlighting the need for all parties to fully implement all aspects of the climate convention in all aspects of water pipe use
69 we have found a country, Turkey, whose labeling law explicitly requires the placement of health warnings on hookah and water pipe tobacco packaging.
70 countries should interpret their definition as including HTPs (
New tobacco products)
, If it is necessary to avoid ambiguity, modify their definition, for example, \"tobacco products\" means products made entirely or partially from tobacco for inhalation, smoking, sucking, chew, snuggle or in any other way (
See, for example, the definition of \"tobacco products\" found in Thailand, the Philippines, Cambodia, Oman and Uganda).
71. Alternatively, states may add language to clarify their existing definitions of tobacco products, including ingredients such as the US definition, and ensure that all regulations applicable to tobacco products also apply to their ingredients.
The conference of the parties should make an opinion to recommend parties that implement all FCTC regulatory measures applicable to tobacco products for HTPs and prohibit the tobacco industry from trying to evade them.
Countries can also clarify and expand the definition of \"smoking\" in their laws.
The FCTC Article 8 guide recommends that \"smoking\" be defined as \"possession or control of lit tobacco products whether smoking is active inhalation or outgoing \". (Article8)
Six countries adopting this language should change the definition in order to explicitly include HTPs.
This can be achieved by explicitly adding HTPs to the definition of smoking.
The conference of the parties should issue a decision recommending that all parties ensure that their definition of \"smoke\" includes HTPs and other new tobacco products that may arise.
Article fctc for packaging, advertising and marketing requires parties to take measures to prohibit the promotion of packaging and labeling of tobacco products in any false and misleading manner, deception may have a false impression of its features, health effects, hazards or emissions, include any metaphor or other sign that directly or indirectly causes a false impression that a particular tobacco product is less harmful than other tobacco products.
72 FCTC defines \"tobacco advertising and promotion\" as \"any form of commercial communication, advice or action that directly or indirectly promotes the purpose, effect or possible effect of tobacco products or tobacco use\"(Article1(c))
5 terms of advertising, promotion and sponsorship of FCTC (Article 13(2))
5. Urge all parties to ban all advertising, promotion and sponsorship of tobacco products in an all-round way to reduce the consumption of tobacco products.
Article 13 guidelines for implementation (Article 13)
6 it is emphasized that this \"full prohibition\" applies without exception to all acts that may have promotional effects and commercial communications, including indirect advertising.
For example, in addition to traditional media and Internet advertising, the limitations of 13 \"advertising, promotion and sponsorship\" include the display of tobacco products at the point of sale, packaging and product features (
Including color, logo, picture, material)
Brand extension and corporate social responsibility activities. (Article13)
Article 6 guidelines are particularly relevant to current IQOS promotions, including their \"smoke-
Free Future activity 73 and its product features and marketing that appeal to teenagers, including packaging using colors, logos and materials that mimic the iphone, and selling IQOS in stores that mimic the Apple computer store.
9 10 61 62 it is important to recognize that any advertising or promotion of IQOS, in particular including the promotion of any other IQOS component that the holder, individually or for marketing purposes, is separate from the essential cigarette support, promote tobacco in the sense of FCTC, as it is not only possible to promote tobacco products or use, but its specific purpose is to promote the use of IQOS cigarette sticks (
Hot bar or table).
Except when used together, neither the IQOS holder nor the IQOS tobacco stick has any utility.
According to this reasoning, in April 2018, Lithuanian tobacco regulators imposed a fine on PMI subsidiaries for advertising on IQOS devices, according to the view that the device can only be used for smoking, determine that the device is subject to the same advertising restrictions as other tobacco products 74.
As of May 2018, PMI is promoting IQOS as a substitute for less harm to cigarettes.
9. 50. 60. 76 since these claims have not been confirmed by scientific evidence, they have violated the prohibitions of Articles 11 and 13 of the Tobacco Control Commission. PMI’s ‘smoke-
The \"Free Future\" campaign appears to be aimed at changing the use of tobacco rather than treating tobacco dependence or promoting the end of tobacco.
63. 2018 on February, who issued a statement condemning bat\'s promotional statement to its glo HTP, implying that who supported glo as a harmless alternative to traditional cigarettes, he said there was no evidence that HTPs were less harmful than traditional tobacco products.
13 countries that cannot issue a comprehensive ban (4)
State that the party shall at least prohibit, by any false means, propaganda of all forms of tobacco advertising, promotion and sponsorship of tobacco products, misleading or deceptive, or may have a false impression of its features, health effects, hazards, or emissions. (Article13(4))
Under this regulation, countries should prohibit any form of advertising or promotion of IQOS by PMI.
In the absence of such a ban, countries should at least not allow PMI to market IQOS with unproven express or implied claims that it is safer than conventional cigarettes, including changing consumers\' perception of product harm by using deceptive packaging or color.
78-83 since the scientific evidence does not support PMI\'s risk reduction statements about IQOS, they are false, misleading and/or deceptive, it may have a health impact on IQOS as if the claims of \"light\" and \"secret\" were found to have misled consumers.
26 27 accordingly, 11 and 13 prohibited the use of these weapons.
Conclusion tobacco manufacturers are using unproven claims that health risks associated with their new HTPs and active marketing campaigns are reduced, which are particularly effective among adolescents to introduce and
The companies did not provide evidence that these new products were actually less harmful, and there was evidence that their marketing claims misled consumers.
Companies are trying to evade existing laws aimed at regulating tobacco products, including HTPs, by taking the product apart and selling components separately.
Because tobacco sticks can only be used when connected to HTP heating devices, sales bans, youth access, and advertising and labeling laws (
Including FCLAA restrictions for US cigarettes)
Should be applicable to a complete HTP system including all components.
Loopholes in laws and regulations (
Including the rules that the FDA believes)
If the holder is sold separately from the cigarette stick, this will allow HTPs to escape the tobacco control restrictions.
PMI uses targeted customer intervention and sophisticated technologies to access data, monitor usage and transform customers, and active marketing techniques for IQOS should focus on privacy and public health advocates. Policy-
Manufacturers in places where HTPs are not prohibited should modify or enact comprehensive tobacco control laws to ensure that HTPs are captured, to comply with all tobacco products under the TCA and FCTC measures include appropriate smoke-free laws, advertising, promotion and sponsorship, packaging and labeling, tax and content regulations.
In no event should HTPs be lower than combustible tobacco products.
Many tobacco companies are developing heating tobacco products (HTPs)
The sale of such cigarettes lacks evidence compared to traditional cigarettes, claiming to be less harmful.
The company has
The tobacco composition of HTPs is separated from Tobacco
Contains ingredients that use the ambiguity of the definition of government \"tobacco products\" to evade tobacco control laws and public health restrictions.
Philip Morris International has not submitted sufficient scientific evidence required by US law that marketing IQOS in the US is \"appropriate to protect public health \", or prove that IQOS does much less harm to users than other tobacco products, that its label does not mislead consumers, nor does it mislead marketing --
Risk claims with or without modification-
It will benefit the health of the entire population.
WHO Framework Convention on Tobacco Control (FCTC)
Provides a strong framework for parties outside the United States to formulate and implement laws that effectively regulate HTPs;
Parties should revise their laws to eliminate ambiguity and ensure that HTPs are covered by national laws.
The United States and the parties to the Framework Convention on Tobacco Control shall ensure that all components of HTPs are at least as tightly regulated as tobacco products and comply with all tobacco control laws applicable to other tobacco products, including restrictions on misleading labeling, advertising, promotion and sponsorship, sales of minors, prices and tax policies, and smoke-free measures.
Thanks to Catherine Shutz, Master of Law, Bachelor of Law, Bachelor of Science, legal adviser to the international legal union, tobacco movement
Free children to assist in legal analysis of FCTC and Stella
Bialous, RN, DrPH, FAAN, associate professor of Social and Behavioral Sciences, School of Nursing, University of California, San Francisco, and Eric Lindblom, JD, o\'Neill, director of tobacco control and food and drug law, National and Global Health Law Institute, commented, greatly improving the manuscript.
Elias J. , Dutra LM, St. Helen G, et al.
Revolution or revolution?
Evaluate IQOS through pilot products.
Control 2018; 27(Suppl1):s102–s110.
OpenUrlAbstract/free full Text hardlay J, 2016.
What do you need to know about heat? not-Burn (HNB)cigarettes (
Visit February 14, 2018). ↵PMI.
Science and Innovation: what we have discovered so far. (
Visit February 18, 2018). ↵U. S.
Food and Drug Administration
Family Smoking Prevention and Tobacco Control Act, bar. L. 111-31, 21 U. S. C. 387 et seq. 2009.
World Health Organization, 2005
WHO Framework Convention on Tobacco Control (
Visit February 1, 2018).
World Health Organization, 2013
WHO Framework Convention on Tobacco Control: guidelines for implementation (
Visit February 1, 2018). ↵FDA.
Philip Morris ProductsA.
Improved risk tobacco products (MRTP)Applications. (
Visit May 13, 2018). ↵PMI, 2017.
Briefing materials of the Advisory Committee: tobacco heating system (IQOS)
Briefing documents (
Visit February 14, 2018).
Alimmathers A, Schwartz R, O\'Connor, etc.
Marketing IQOS in dark markets.
The Tob controls 2018. doi: 10.
1136/tobacco control-2017-054216 (
Epub print in advance 03 May 2018). ↵Kim M.
Philip Morris International Launches New Heatnot-
IQOS products launched in Korea.
Control 2018; 27:e76–8. doi:10.
1136/tobacco control-2017-
053965 full text of OpenUrlFREE fda, 2018.
Table: meeting materials and information of the Central Propaganda Department on January 24
25, 2018: the first day of the transcript (
Visit May 16, 2018).
Laslasseter T, Wilson D, Wilson T, etc. , 2018.
Special report: Philip Morris equipment is very familiar with your smoking habits (
Visit May 16, 2018). ↵FDA, 2018.
Table: meeting materials and information of the Central Propaganda Department on January 24
25, 2018: the second day of the transcript (
Visit May 16, 2018). ↵Connolly GN.
Reduce the risk of nicotine delivery devices or devices that enhance and control abuse (Addiction)
Potential by manipulating the mode of nicotine delivery? (
Visit February 15, 2018).
Cheng Henningfield J, Cone EJ, Buchhalter AR, etc.
Evaluation of the electronic nicotine delivery system: regulatory precedent for the draft FDA 2013 abuse guidelines
Deterrence class opioid class drug
2015 per cent dependence on drugs and alcohol; 156:e94–5. doi:10. 1016/j. drugalcdep. 2015. 07.
1174 OpenURL allempert LK, base grain R, Glantz SA.
Importance of product definition in US e-commerce
Cigarette laws and regulations.
Control 2016; 25(e1):e44–51. doi:10.
1136/tobacco control-2014-
051913 public summary/free full text Code of Federal Regulations, cigarettes, non-smoking tobacco and covered tobacco products.
It is prohibited to sell and distribute to persons under the age of 18, conditions of manufacture, sale and distribution, 21 CFR 1140. 16.
Code of Federal Regulations, cigarettes, non-smoking tobacco and covering tobacco products.
Definition of Sec. 1140. 3, 21 CFR 1140. 3.
Code of Federal Regulations.
Tobacco products authorized by the FDA, range, 21 CFR 1100. 1.
Code of Federal Regulations, cigarettes, non-smoking tobacco and covering tobacco products.
It is prohibited to sell and distribute to persons under the age of 18, the additional responsibility of the retailer, 21 CFR 1140. 14.
Federal Cigarette Labeling and Advertising Law.
Definition, 15 USC 1332.
Federal regulations, cigarette packaging and advertising warnings, requirement warnings, 21 CFR 1141. 10.
Federal Cigarette Labeling and Advertising Law.
Definition, illegal advertising on electronic communication media, 15 USC 1335.
Family Smoking Prevention and Tobacco Control Act. Sec. 901, Pub. L. 111-31, 21 U. S. C. 387a. 2009.
Lester J Berman ML Jenson D.
FDA\'s wrong priorities: pre-market review under the Family Smoking Prevention and Tobacco Control Act.
Control 2016; 25:246–53. doi:10.
1136/tobacco control-2015-
052391 OpenUrlAbstract/free full text US v.
Philip Morris American company, 449 F. Supp. 2d 1 (D. D. C. 2006). (
Visit February 1, 2018).
Lompova L Lamba Road, Glantz SA.
Mild and mild redux: less exposure to heated tobacco products may be misinterpreted as less risk.
Control 2018; 27(Suppl1):s87–s95. doi:10.
1136/tobacco control-2018-
054324 OpenUrlAbstract/free full text pmi science, 2017.
Scientific Update of smokeFree products (
Visit January 2, 2018).
Helen G. , Jacob P. , Naden N.
IQOS: review of claims for reduced exposure by Philip Morris International.
Control 2018; 27(Suppl1):s30–s36.
OpenUrlAbstract/free full Text Gallery glantsa.
PMI\'s own in-vivo clinical data on potentially harmful biomarkers in the United States show that there is no detectable difference between IQOS and traditional cigarettes.
Control 2018; 27(Suppl1):s9–s12.
OpenUrlAbstract/free full Text Gallery glantsa.
PMI\'s own data on potential hazard biomarkers in Americans shows that there is no detectable difference between IQOS and traditional cigarettes, so the FDA must deny the risk Statement revised by PMI in November 13, 2017.
Public comment, directory number: FDA-2017-D-
3001, tracking number 1k1-8zrx-juh9. (
Visit May 13, 2018).
Chun moazed F, Chun L, Matthay MA, etc.
Industry data evaluation of IQOS lung and immune suppression effects.
Control 2018; 27(Suppl1):s20–s25. doi:10.
1136/tobacco control-2018-
054296 OpenUrlAbstract/free full text chun LF, Moazed F, Matthay MA, etc. , 2017.
In November 30, 2017, IQOS emissions pose a risk of immune suppression and lung toxicity, so the FDA should not issue an order to allow the marking or sale of IQOS with a statement that reduces risk.
Public comment, directory number: FDA-2017-D-
3001, tracking number: 1k1-903a-mnpl (
Visit May 13, 2018).
↵ Chun L, Moazed F, Matthay M, etc.
Possible liver toxicity of IQOS.
Control 2018; 27(Suppl1):s39–s40. doi:10.
1136/tobacco control-2018-
054320OpenUrlFREE full text chun LF, Moazed F, Matthay MA, etc.
In November 30, 2017, PMI did not fully assess the potential of liver toxicity risk for MRTP applications of IQOS.
Public comment, directory number: FDA-2017-D-
3001, tracking number: 1k1-9039-d91g. (
Visit May 13, 2018).
Nabnabavizadeeh P, Liu Wei, Haver, etc.
The aerosol of a single IQOS hot rod can impair the vascular endothelial function to the same extent as cigarette smoke.
Control 2018; 27(Suppl1):s13–s19. doi:10.
1136/tobacco control-2018-
054325 OpenUrlAbstract/free full Text Springer ML, nabavizadeeh P. Muhanmerdi L.
The evidence provided by PMI in its MRTP application for IQOS is misleading and does not support the conclusion that IQOS will not compromise the function of the endothelial;
In November 20, 2017, independent studies conducted in a more relevant physiological model showed that IQOS impaired endothelial function as much as conventional cigarettes.
Public comment, directory number: FDA-2017-D-
3001, tracking number 1k1-8zxa-mq9v. (
Visit May 13, 2018).
Davis B, Williams M, Talbot P.
IQOS: Evidence of pyrolysis and release of toxic substances in plastics.
Tob Control 2018: Classification Number: month.
1136/tobacco control-2017-054104 (
Epub print in advance March 13, 2018).
O\'connelke, Wilkinson, Burseg K, etc.
Tobacco products after heating
River discharge: the impact on regulation.
J. Environmental Chemistry 2015; 2.
Helen G. , Jacob P. , Naden N.
Because the PMI application does not report all HPHCs in The IQOS aerosol, HPHCs are characterized in side flow emissions, including non-
In November 29, 2017, the FDA must reject the PMI application, conduct targeted analysis of chemicals in emissions, or conduct clinical studies to describe exposure to toxic substances during dual use with other tobacco products.
Public comment, directory number: FDA-2017-D-
3001, tracking number 1k1-902j-m8kv. (
Visit May 13, 2018). Conauer R, Concha-Jicot-Lozano N
Sadowski and so on. Heat-Not-
Burning tobacco cigarettes: smoke under any other name.
Jia Ma Intern Med 2017; 177:1050–2. doi:10.
1001/jamainternmed. 2017.
1419openurlleigh leigh NJ, Palumbo MN, Marino AM, etc. Tobacco-
Specific Nitro (TSNA)
In the heated tobacco product IQOS.
Control 2018; 27(Suppl1):s37–s38. doi:10.
1136/tobacco control-2018-
054318 the full text of OpenUrlFREE laslasseter T, Bansal P, Wilson T, et al. , 2017.
Special report: Scientists describe the problem of Philip Morris
Cigarette experiment (
Visit May 13, 2018). ↵Lempert LK.
Reuters published a special report on December 20, 2017, pointing out some of the violations in Philip Murray\'s IQOS study.
The industry behaviour recorded in this report is suspicious, but not new, and the FDA should consider this when determining the IQOS application for PMI, December 21, 2017.
Public comment, directory number: FDA-2017-D-
3001, tracking number 1k1-90gh-rnjp. (
Visit May 13, 2018).
Max W, singing high, light, etc.
Philip Morris\'s Population Health Impact model is based on questionable assumptions and inadequate health impact measurements.
Tobacco control 2018 (
Epub print in advance November 22, 2018).
Alimmax W, lamberjack, Song H-Y, et al.
In November 22, 2017, Philip Morris\'s Population Health Impact model based on questionable assumptions and inadequate health impact measures did not fully support its MRTP application.
Public comment, directory number: FDA-2017-D-
3001, tracking number 1k1-8zy0-6rfg. (
Visit May 13, 2018).
Mcmckelvey K, Popova L, Kim M, etc.
Intense tobacco products may attract young people and young people.
Tobacco control 2018; 27(Suppl1):s41–s47.
OpenUrlAbstract/free full Text package Halpern-
Felsher B, McKelvey K, Kim M, etc.
In December 7, 2017, PMI\'s iqos mrtp application does not take into account the attractiveness of IQOS to adolescents, nor will teenagers start tobacco use with IQOS or use IQOS with other tobacco products
Public comment, directory number: FDA-2017-D-
3001, tracking number 1k1-9087-458e. (
Visit May 13, 2018).
National Academy of Sciences, College of Engineering and Medical School.
The impact of e-commerce on public healthCigarettes.
Washington, DC: National Academy of Sciences Press, 2018.
Mcmckelvey K, Popova L, Kim M, etc.
The IQOS tag will mislead consumers.
Control 2018; 27(Suppl1):s48–s54. doi:10.
1136/tobacco control-2018-
054333 OpenUrlAbstract/free full Text limpiert LK, Beauvoir L, Halpen-
Fisher B and others.
Since PMI does not establish that IQOS is associated with lower risk, the FDA should not allow modified risk claims as they may be misinterpreted as modified risk claims, December 11, 2017.
Public comment, directory number: FDA-2017-D-
3001, tracking number 1k1-90at-5wj2. (
Visit May 13, 2018). ↵El-
Toukhy S, Baig SA, Jeong M, etc.
The impact of the revised risk tobacco product statement on the beliefs of American adults and adolescents.
Control 2018; 27(Suppl1):s62–s69. doi:10.
1136/tobacco control-2018-
054315 OpenUrlAbstract/free full text pmi.
PMI 2017 Annual Report(
Visit May 13, 2018). ↵PMI.
Our tobacco heating systemIQOS. (
1Feb 2018).
The World Health Organization.
WHO Framework Convention on Tobacco Cont