WHO Statement on The US FDA Decision Regarding HTPs

The WHO reminds Member States that are Parties to the WHO Framework Convention of Tobacco Control (FCTC) of their obligations to refrain from marketing Heated Tobacco Products as safer alternatives.

Diane Caruana

August 3, 2020

Following a lengthy approval process which started four years ago, Altria Group, Inc. (Altria) (NYSE: MO) has recently announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of their IQOS tobacco heating device as a modified risk tobacco product (MRTP).

The WHO has released a statement reminding FCTC member states that despite this MRTP authorization, they should refrain from marketing the products as safer alternatives.

Being tobacco products, the WHO FCTC fully applies to these products. To this effect, the WHO has released a statement reminding FCTC member states that despite this MRTP authorization, they should refrain from marketing the products as safer alternatives. (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.”

Referring to the FDA approval, the WHO pointed out that reducing exposure to harmful chemicals in Heated Tobacco Products (HTPs) does not render them harmless. The health organization added that this also does not mean that they pose a reduced risk to human health.

This was also emphasised by an FDA statement. “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,” said the FDA.

Studies indicate otherwise

Meanwhile, a recent study comparing the amount of carcinogens between regular cigarettes and heated tobacco products, found that the latter contain about 10- to 25-fold lower carcinogens than cigarettes. However, the WHO insists that some toxins are present at higher levels in HTPs than in conventional cigarettes and that there are some additional toxins present in HTP aerosols that are not present in conventional cigarette smoke.

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