WHO's statement on heated tobacco products and the US FDA decision regarding IQOS is spot on

The full statement is reproduced below and also available on the WHO website: https://www.who.int/news-room/detail/27-07-2020-who-statement-on-heated-tobacco-products-and-the-us-fda-decision-regarding-iqos

WHO statement on heated tobacco products and the US FDA decision regarding IQOS

27 July 2020

WHO takes this opportunity to remind Member States that are Parties to the WHO Framework Convention of Tobacco Control (FCTC) of their obligations under the Convention. Heated tobacco products are tobacco products, meaning that the WHO FCTC fully applies to these products. (Decision FCTC/COP8(22)) Specifically, Article 13.4(a) obliges Parties, to prohibit "all forms of tobacco advertising, promotion and sponsorship that promote a tobacco product by any means that are false, misleading or deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions."

WHO reiterates that reducing exposure to harmful chemicals in Heated Tobacco Products (HTPs) does not render them harmless, nor does it translate to reduced risk to human health. Indeed, some toxins are present at higher levels in HTP aerosols than in conventional cigarette smoke, and there are some additional toxins present in HTP aerosols that are not present in conventional cigarette smoke. The health implications of exposure to these are unknown.

On 7 July 2020, the US FDA authorized the marketing of a heated tobacco product, the IQOS Tobacco Heating System, under the Federal Food, Drug and Cosmetic Act. This Act requires pre-market authorization of new tobacco products before they can be placed on the US market.

The US FDA statement noted that, “Even with this action, these products are not safe nor “FDA approved“. The exposure modification orders also do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.”

The US FDA authorization rejected claims that the use of the product is less harmful than another tobacco product or reduces risks to health. The FDA orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use. The company must also keep the FDA apprised of efforts to prevent youth access and exposure.

Given that health may be affected by exposure to additional toxins when using HTPs, claims that HTPS reduce exposure to harmful chemicals relative to conventional cigarettes may be misleading.

Moreover, the relevant orders grant a temporary market authorization within the US and are based on factors specific to the US, which is not a Party to the WHO Framework Convention on Tobacco Control (WHO FCTC).

All tobacco products pose risks to health and WHO urges full implementation of the WHO FCTC. Rigorous implementation will support quit attempts and reduce initiation by non-users of tobacco products, especially the young. WHO recommends cessation of all tobacco use with interventions, such as brief advice from health professionals, national toll-free quit lines, nicotine replacement therapies and cessation interventions delivered via mobile text messaging.

Heated Tobacco Products (HTPs) are not safer alternatives to smoking

What utter rubbish!

According to a South China Morning Post article on 28 October 2019, Philip Morris’s president for East Asia and Australia, Paul Riley "pointed out that heated tobacco products were not the same as e-cigarettes, which have been linked to more than one thousand cases of illnesses and 34 deaths in the US. While in e-cigarettes, a cartridge of solution that usually contains nicotine, propylene glycol, glycerine, flavourings and other chemicals are heated up, in heated tobacco products, only a tobacco stick is involved."

Riley is trying to emphasize the distinction between heated tobacco products (HTP) and liquid-based e-cigarettes in order to distance HTPs from the "more than one thousand cases of illnesses and 34 deaths in the US linked to e-cigarettes," but:

1. Aerosols (not vapor) emitted by HTPs also contain nicotine, propylene glycol, glycerine, flavorings, and various other toxicants and chemicals.

2. He fails to mention that Altria (Philip Morris in the US) owns 35% of Juul, which is an e-cigarette company that uses nicotine salts in its e-cigarettes and holds over 70% of the US e-cigarette market. 

3. He also fails to mention that Philip Morris also makes its own e-cigarettes branded as IQOS MESH, and aside from Juul, Philip Morris has another nicotine salt e-cigarette called STEEM.

4. Some HTPs heat up a cartridge of liquid, whose aerosol is then passed through a tobacco plug/capsule.


5. There is no evidence that proves that HTPs are less harmful than cigarettes. Even if some toxicants appear to be less than those in cigarettes, there are more of some other toxicants.

6. The US FDA's tobacco advisory panel rejected PMI's claim that IQOS is safer than conventional cigarettes. Even if allowed for sale in the US, the FDA prohibits Philip Morris form making any claims of reduced harm or modified risk.

US Court orders tobacco companies to "tell the truth"

In June 2014, U.S. District Judge Gladys Kessler of the District of Columbia issued a final order in a long-standing case detailing how the major U.S. tobacco companies must publish court-ordered "corrective statements" to atone for decades of deception of the American public about their deadly products. The order by Judge Kessler includes a list of newspapers and TV networks in which the corrective statements must run, website announcements, and cigarette package “onserts” (information affixed to the packaging or cellophane wrapping).

Judge Kessler in November 2012 finalized the text of corrective messages that are to be made public.  United States v. Philip Morris USA Inc. et al., No. 99-CV-2496 (GK), 2012 WL 5928859 

Earlier this month, tobacco companies filed an appeal claiming that the phrasing in the proposed statements would "punish and humiliate" them, objections that rest largely on matters that were already decided by the D.C. court in 2009.

Below is the text of the five court-ordered Corrective Statements:

Adverse Health Effects of Smoking

A Federal Court has ruled that Philip Morris USA, R.J. Reynolds Tobacco, Lorillard, and Altria deliberately deceived the American public about the health effects of smoking, and has ordered those companies to make this statement.

Here is the truth:
• Smoking kills, on average, 1200 Americans. Every day.
• More people die every year from smoking than from murder, AIDS, suicide, drugs, car crashes, and alcohol, combined.
• Smoking causes heart disease, emphysema, acute myeloid leukemia, and cancer of the mouth, esophagus, larynx, lung, stomach, kidney, bladder, and pancreas.
• Smoking also causes reduced fertility, low birth weight in newborns, and cancer of the cervix.

Addictiveness of Smoking and Nicotine

A Federal Court has ruled that Philip Morris USA, R.J. Reynolds Tobacco, Lorillard, and Altria deliberately deceived the American public about the addictiveness of smoking and nicotine, and has ordered those companies to make this statement.

Here is the truth:
• Smoking is highly addictive. Nicotine is the addictive drug in tobacco.
• Cigarette companies intentionally designed cigarettes with enough nicotine to create and sustain addiction.
• It's not easy to quit.
• When you smoke, the nicotine actually changes the brain - that's why quitting is so hard.

Lack of Significant Health Benefit from Smoking “Low Tar,” “Light,” “Ultra Light,” “Mild,” and “Natural” Cigarettes

A Federal Court has ruled that Philip Morris USA, R.J. Reynolds Tobacco, Lorillard, and Altria deliberately deceived the American public by falsely selling and advertising low tar and light cigarettes as less harmful than regular cigarettes, and has ordered those companies to make this statement.

Here is the truth:
• Many smokers switch to low tar and light cigarettes rather than quitting because they think low tar and light cigarettes are less harmful. They are not.
• “Low tar” and filtered cigarette smokers inhale essentially the same amount of tar and nicotine as they would from regular cigarettes.
• All cigarettes cause cancer, lung disease, heart attacks, and premature death - lights, low tar, ultra lights, and naturals. There is no safe cigarette.

Manipulation of Cigarette Design and Composition to Ensure Optimum Nicotine Delivery

A Federal Court has ruled that Philip Morris USA, R.J. Reynolds Tobacco, Lorillard, and Altria deliberately deceived the American public about designing cigarettes to enhance the delivery of nicotine, and has ordered those companies to make this statement.

Here is the truth:
• Philip Morris USA, R.J. Reynolds Tobacco, Lorillard, and Altria intentionally designed cigarettes to make them more addictive.
• Cigarette companies control the impact and delivery of nicotine in many ways, including designing filters and selecting cigarette paper to maximize the ingestion of nicotine, adding ammonia to make the cigarette taste less harsh, and controlling the physical and chemical makeup of the tobacco blend.
• When you smoke, the nicotine actually changes the brain - that’s why quitting is so hard.

Adverse Health Effects of Exposure to Secondhand Smoke

A Federal Court has ruled that Philip Morris USA, R.J. Reynolds Tobacco, Lorillard, and Altria deliberately deceived the American public about the health effects of secondhand smoke, and has ordered those companies to make this statement.

Here is the truth:
• Secondhand smoke kills over 38,000 Americans each year.
• Secondhand smoke causes lung cancer and coronary heart disease in adults who do not smoke.
• Children exposed to secondhand smoke are at an increased risk for sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, severe asthma, and reduced lung function.
• There is no safe level of exposure to secondhand smoke.