The World Health Organization reminded member states on Monday that heated tobacco products fall fully under existing global tobacco control treaties. This warning follows a July decision by the US Food and Drug Administration to authorize the marketing of the IQOS tobacco heating system as a modified exposure product.
The global health body issued a statement regarding heated tobacco products and the US regulatory decision concerning the Philip Morris International device. Member states party to the WHO Framework Convention on Tobacco Control must uphold their obligations under the treaty, according to the WHO statement. Heated tobacco products meet the definition of tobacco products, meaning the treaty applies directly to them under Decision FCTC/COP8(22).
Article 13.4(a) of the convention requires member states to prohibit all forms of tobacco advertising and promotion that create a false or misleading impression about a product’s characteristics, health effects, hazards, or emissions. Reducing exposure to harmful chemicals in these devices does not render them harmless, the organization stated. Lower exposure does not reduce the risk to human health.
Certain toxins appear at higher levels in heated tobacco product aerosols than in conventional cigarette smoke. Additional toxins also appear in these aerosols that are completely absent from conventional cigarette smoke, with unknown long-term health implications.
FDA Authorizes IQOS Marketing Without Endorsing Product Safety
On July 7, the US Food and Drug Administration authorized the marketing of the IQOS Tobacco Heating System under the Federal Food, Drug and Cosmetic Act, as reported by the US FDA statement. This statute requires pre-market authorization for any new tobacco products before they enter the US market.
“Even with this action, these products are not safe nor “FDA approved“,” the US FDA statement said. The agency explained that exposure modification orders do not permit the company to make any other modified risk claims. Companies cannot make express or implied statements suggesting the agency endorses the products or deems them safe for consumers.
The US decision rejected claims that using the device is less harmful than other tobacco products or reduces overall health risks. The regulatory orders require the manufacturer to monitor youth awareness and use. The company must keep federal regulators informed of ongoing efforts to prevent youth access and exposure.
Treaty Obligations and Global Implementation
Claims that heated tobacco products reduce exposure to harmful chemicals relative to conventional cigarettes can mislead consumers since health may still suffer from exposure to additional unique toxins. The temporary market authorization granted within the US relies on factors specific to that nation, which is not a party to the WHO Framework Convention on Tobacco Control.
All tobacco products pose distinct risks to health, prompting the global health organization to urge full implementation of the treaty. Rigorous implementation supports quit attempts and reduces initiation by non-users, particularly younger demographics.
Heated Tobacco Products Carry Health Risks Despite Lower Chemical Exposure
- Heated tobacco devices are still tobacco products subject to international anti-tobacco rules.
- Lower chemical exposure does not mean zero health risk, and some new toxins are present in the aerosol.
- Regulatory clearance in the US does not mean the product is approved as safe or endorsed by health authorities.
Seek Medical Advice for Respiratory or Cardiovascular Changes
All individuals, especially non-users and youths, should avoid initiating the use of any tobacco products. Patients attempting to quit nicotine should consult healthcare professionals regarding validated cessation interventions. Medical evaluation is warranted if individuals experience acute respiratory symptoms, persistent cough, or cardiovascular changes after using tobacco or nicotine delivery systems.
The global health body recommends the complete cessation of all tobacco use through established interventions. These evidence-based methods include brief advice from health professionals, national toll-free quit lines, nicotine replacement therapies, and mobile text-messaging cessation programs.
References
- World Health Organization. WHO statement on heated tobacco products and the US FDA decision regarding IQOS.
- Knowledge Action Portal.
- U.S. Food and Drug Administration. FDA authorizes marketing of IQOS Tobacco Heating System with reduced exposure information.
