HTPs are not novel products.
Heated Tobacco Products (HTPs) are not novel products. These products have been in existence for over 30 years. They were initial marketed as cleaner products with less smoke, less smell, and less ash.
Research shows that the first HTP, called Premier, was marketed in 1988 by an American tobacco company RJ Reynolds (RJR). Shortly after its launch, it was withdrawn from the market in early 1989, reportedly because smokers “did not like Premier’s taste or smell.”[1]
Sometime in 1996, RJR introduced another HTP called Eclipse, which was marketed to smokers as a new cigarette “with nearly 90 percent less second-hand smoke”.[2] This remained in the market until 2014, despite an earlier study proving it to be as toxic as conventional cigarettes.[3]
Philip Morris International (PMI) manufactured an HTP called Accord, which was later renamed as “Heat Bar”. It was marketed and sold for ten years (1996-2006) until discontinued for poor sales.[4]
Recently, HTPs found their way back into the market through the three major tobacco manufacturers: PMI, British American Tobacco (BAT), and Japan Tobacco (JTI). In 2014, PMI introduced its flagship product called “IQOS”[5] and in 2016 JTI followed with “Ploom Tech.” BAT entered the HTP market with “Glo” in the latter part of 2016.
In the Philippines, HTPs have not yet been formally introduced but some of the products such as IQOS are widely available in online stores, in some retail stores that sell conventional cigarettes, and in specialty stores selling electronic cigarettes.
HTPs are tobacco products.
The World Health Organization (WHO) defined HTPs “as products that produce aerosols containing nicotine and other chemicals, which are inhaled by users through the mouth. They contain the highly addictive substance nicotine (in the tobacco), which makes them addictive. They also contain non-tobacco additives, and are often flavoured. HTPs mimic the behaviour of conventional cigarette smoking, and some make use of specially designed cigarettes to contain the tobacco for heating”[6]
In the recent Conference of Parties under the WHO Framework Convention on Tobacco Control (FCTC), it was reiterated that HTPs fall under the definition of ‘tobacco products.’ State Parties like the Philippines were urged to ensure that HTPs, including heating devices, are properly covered in their legal regimes.[7]
With these, the Department of Health in Administrative Order No. 2019-0007 (Revised Rules and Regulations on Electronic Nicotine and Non Nicotine Delivery System (ENDS/ENNDS) excluded HTPs from the regulation.
HTPs are harm accelerators.
If HTPs are essentially considered as ‘tobacco products’, as they should be aptly referred to, then they cause health problems like conventional cigarettes. With that, rather than becoming a harm reducer, HTPs are fast becoming as harm accelerator. This, despite the tobacco industry claims that HTPs have the potential to present less risk of harm compared to continued smoking for adult smokers who switch to it completely.[8]
The reality is that these ‘harm reduction’ and ‘effective cessation strategy’ claims are not backed up by any independent evidence. Rather they are supported by their own funded researches.
Stanton A. Glantz, Ph.D., director of the University of California, San Francisco, Center for Tobacco Control Research and Education, in a statement said that “until now, most of the published research on HTPs had been done by tobacco companies.” He added that we have seen this charade from Big Tobacco before, going back to the 1960s, and the goal is always the same: to convince governments and the public that a new tobacco product is ‘safer,’ ‘cleaner’ or ‘less harmful’ than existing tobacco products. But in paper after paper demonstrate that the health and other claims made for IQOS and other HTPs are false and misleading.[9]
Further, a great majority of authorities declared that HTPs are just as harmful as smoking conventional cigarettes. The European Respiratory Society (ERS) in its website openly rejected the claim and declared[10]:
xxx xxx xxx
However, tobacco companies have not informed the public that some harmful substances were found in high concentrations in their studies, e.g.: particulate matter, tar, acetaldehyde (a carcinogen), acrylamide (a potential carcinogen) and an acrolein metabolite (toxic and irritant)2-6. Some studies found much higher concentrations of formaldehyde (a potential carcinogen) in heated tobacco products than in conventional cigarettes7, 8. Independent research: a substantially higher risk than claimed by the tobacco industry.
Historically, there is strong evidence that studies performed by the tobacco industry or by researchers funded by the tobacco industry cannot be trusted9-13. Former employees and contractors have detailed irregularities in the clinical experiments on heated tobacco products performed by the industry14.
Independent research shows that acrolein (toxic and irritant) is reduced by only 18%15, formaldehyde (a potential carcinogen) by 26%15, benzaldehyde (a potential carcinogen) by 50%15 and the level of TSNAs (carcinogens) is one fifth of those of conventional combustion cigarettes16. Furthermore, the potentially carcinogenic substance acenaphthene is found to be almost three times higher than in conventional cigarettes15 and nicotine and tar levels have been found to be almost identical to a conventional cigarette17. An experimental animal study found that exposure to iQOS led to decreased blood vessel function by 60% – comparable to that induced by cigarette smoke19. In addition, a study found that users of iQOS may be forced to smoke at a rapid pace which could lead to an increase in intake of carbonyls (potentially carcinogenic) and nicotine, inducing a high level of nicotine dependence19.
xxx xxx xxx
In addition to the adverse health effects already discussed, the ERS Tobacco Control Committee also listed some of the hazards of the HTPS as follows:
Apart from the deceptive claim of ‘harm reduction’, manufacturers of HTPs, like PMI endorses HTPs as ‘smoke free’. This tobacco industry narrative is perpetuated by the Foundation for Smoke Free World, which is known to have received contribution from PMI of around US$ 80 million annually for the next 12 years by supporting purportedly “independent” research to support a “smoke-free” world, not a “tobacco-free” world.[11] This Foundation serves as a platform to legitimize and accelerate sales of IQOS, its heat-not-burn tobacco product. In essence, this Foundation is really a foundation to promote its new product while simultaneously selling its cigarettes.[12]
However, a study revealed that the aerosol from HNB tobacco products contains nicotine and cancer-causing chemicals similar to those found in traditional cigarettes.[13]The fact that the aerosol emitted by these product is not seen by the naked eye is irrelevant since it still harms those that were able to inhale these toxic particles.
HTPs are not a cessation tool.
The tobacco industry also claims that HTPs can be a viable cessation tool. The WHO however disagrees as there are not enough studies to prove the veracity of this claim. On the contrary, studies suggest that use of HTPs may potentially lead to ‘dual use’.[14]
The body of scientific evidence already yields, which is not even contradicted by the industry, that HTPs are harmful to human body. It is therefore imperative for the government to come up with a policy that will prevent a new gateway to nicotine addiction. Even if the industry argues that the science is not yet sufficient to totally ban or strictly regulate HTPs, precautionary principle asserts that the burden of proof for potentially harmful actions by industry or government rests on the assurance of safety and that when there are threats of serious damage, scientific uncertainty must be resolved in favor of prevention.[15] The precautionary principle used in environmental cases applies in this case. HTPs are not only a threat to the human body through addiction and their harmful affects, they are also a treat to the environment as they affect air quality that lead to further degradation of health.
HTPs in Philippine jurisdiction: taxation and regulation.
In the Philippines, HTPs are subsumed under the definition of tobacco products in Republic Act No. 9211 (Tobacco Regulation Act of 2003). Essentially, since heated tobacco products, still uses tobacco leaf it falls under the definition of ‘tobacco products’ which is “any product that consists of loose tobacco that contains nicotine and is intended for use in a cigarette, including any product containing tobacco and intended smoking or oral or nasal use.”[16] The tobacco industry, however, claims that these products are ‘new’ product and does not combust tobacco leaf. But this claim is immaterial because the definition did not specifically indicate that tobacco leaf must be burnt to be covered by the law. Consequently, since the Tobacco Regulation Act of 2003 covers “all types of tobacco products placed into commerce in the Philippines, whether locally manufactured or imported”[17], HTPs are therefore subject to all the regulations on tobacco products.
At this point, the remaining legal issue that has to be settled is the regulation over the heating device that processes the tobacco product. For this, it may fall under the definition of “health-related devices” (“device not used in health care but [may] adversely affect the health of the people”) under RA No. 9711.[18] Moreover, Article 109 of the Consumer Act of the Philippines or R.A. 7394, advertisement and sales promotion with respect to food, drugs, cosmetics, devices and hazardous substances, shall also be within the exclusive jurisdiction of the Department of Health. With the passage of RA No. 9711, the function of regulating products with impact to health is now with the Food and Drugs Administration, which is an attached agency of the DOH.
Consequently, the taxation of heated tobacco products should be uniform with taxes imposed on tobacco products. This is however is not the case in the Philippines.
On 3 June 2019, the government imposed excise taxes on these products.[19] The taxes imposed on HTPs is considerably lower than those imposed in conventional cigarettes. HTPs will be imposed with tax of P10 per pack beginning Jan. 1, 2020 and five percent yearly increase effective Jan. 1, 2021. On the other hand, conventional cigarettes are imposed with P45 per pack tax effective Jan. 1, 2020 until Dec. 31, 2021, P50 on Jan. 1, 2021, P55 per pack on Jan. 1, 2022 and P60 per pack effective Jan. 1, 2023.
Be that as it may, this new law should be welcomed as it has dismissed the claims of the tobacco industry. Instead, the law first cautioned and expressly recognized “the need for further scientific evidence on the impact of these products”.[20] Second, prior to any sale or distribution to the market, it required manufacturers, importers, and sellers to comply with the provisions of Republic Act 10643 or the Graphic Health Warning Law.[21]Third, it prohibited sale or any form of distribution to minors.[22]
Likewise, the law did not preclude the issuance of a regulation which is more stringent or which would complement or supplement its provisions. Rightly, so because RA 11346 is primarily a tax measure with health implications. Thus, it must be construed as such.
Accordingly, product importers and distributors must still comply with other government regulatory requirements not covered by the law. This includes clearances, licenses, and any other requirements prior to importation or sale as mandated by R.A. 10863 or the Customs and Tariff Modernization Act.[23]
Most importantly, because the law is not primarily a regulatory measure, other government agencies, such as the Department of Health and the Food and Drug Administration (FDA) are not barred from exercising their regulatory powers over these products. Local government agencies are also not precluded from issuing Ordinances which would protect and promote the right to health of their constituents.
Without pre-empting any supplemental regulatory issuances as well as uniform and higher taxes on this new form of tobacco products, we must remind ourselves that the Philippines has been progressing in its effort to reduce the smoking prevalence and produce better health outcomes through the implementation of stricter tobacco control measures set forth in the WHO Framework Convention on Tobacco Control (FCTC).
There is a growing fear that the introduction of HTPs to the market may cancel the fruits of decades-long global effort to curb tobacco use. Global successes in tobacco control must not be put to waste. We must ensure that we are not unconsciously or willingly becoming cohorts to advance any harm reduction product of an industry which is known to invent products which are scientifically proven to hook and then kill its users. Public health advocates, legislators, and public servants must therefore act together to protect public health and not the tobacco industry’s profits.
[1] B. Horovitz, RJR Smokeless Cigarette test is Snuffed Out, Los Angeles Times, 1 March 1989, accessed July 2017
[2] Unknown, Press Release. The following press release was issued by R.J. Reynolds Tobacco Company on May 28, 1996 (199606528), 28 May 1996, Truth Tobacco Industry Documents, Bates no: 526348310-526348312, accessed July 2017
[3] https://www.tobaccotactics.org/index.php?title=Heated_Tobacco_Products#cite_note-16
[4] see Heated tobacco products: Another tobacco industry global strategy to slow progress in tobacco control by Stella A Bialous and Stanton A Glantz in https://tobaccocontrol.bmj.com/content/27/Suppl_1/s111
[5] Felberbaum, Michael (26 June 2014). “Philip Morris Int’l to Sell Marlboro HeatSticks”. Salon. Associated Press. Archived from the original on 28 June 2014.
[6] https://www.who.int/tobacco/publications/prod_regulation/heated-tobacco-products/en/
[7] https://www.fctc.org/wp-content/uploads/2018/09/FCACOP8Brief_HTPs_EN.pdf
[8] https://www.pmi.com/science-and-innovation/our-findings-to-date
[9] https://medicalxpress.com/news/2018-10-tobacco-product-industry-scrutinized.html
[10] https://www.ersnet.org/the-society/news/ers-position-paper-on-heated-tobacco-products
[11] https://www.who.int/fctc/mediacentre/statement/secretariat-statement-launch-foundation-for-a-smoke-free-world/en/.
[12] https://seatca.org/?p=11729
[13] Foster M, Lui C, Duke MG, Mc Adam KG, Proctor CJ; An experimental method to study emissions from heated tobacco between 100-200°C. Chem Cent J. 2015;9:20pmid:25941536 (https://pediatrics.aappublications.org/content/141/1/e20172383#ref-8)
[14] https://www.who.int/tobacco/publications/prod_regulation/heated-tobacco-products/en/
[15] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1446778/
[16] Section 4s of RA 9211
[17] Rule II, Inter-Agency Committee-Tobacco, Memorandum Circular No. 1, Series of 2004 (Rules and Regulations Implementing Republic Act No. 9211, Otherwise known as the Tobacco Regulation Act of 2003)
[18] An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Food and Drugs”…
[19] Through Republic No. 11346, signed by President Rodrigo Duterte on 24 July 2019.
[20] Section 2 ( C ), last paragraph.
[21] Section 2 ( B )
[22] ibid
[23] Chapter 3, Section 117
Download here: HTP-Heated tobacco products must be regulated like any tobacco product