The Edition


FDA authorizes marketing of IQOS as 'reduced exposure', in historic first for electronic nicotine products

Ahmed Aiham
08 July 2020, MVT 14:36
Ahmed Aiham
08 July 2020, MVT 14:36

The United States' Food and Drug Administration (FDA) on Tuesday, authorised the marketing of Philip Morris International’s (PMI) electrically heated tobacco system 'IQOS', as a modified risk tobacco product (MRTP).

The IQOS system became the first and is currently the only electronic nicotine product that received marketing orders with a 'reduced exposure' rating through the FDA’s MRTP process.

The decision follows FDA’s approval in 2019 to authorize the commercial sale of IQOS in the US, without the MRTP branding.

However, the IQOS system is mandated to market the products with the following information:

- "The IQOS System heats tobacco but does not burn it"

- "This significantly reduces the production of harmful and potentially harmful chemicals"

- "Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces your body’s exposure to harmful or potentially harmful chemicals"

The agency stated, "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".

According to FDA, available scientific evidence demonstrated that IQOS is expected to benefit the health of the population as a whole, taking into account both smokers and non-smokers.

Studies revealed that transitioning from combusted cigarettes to the IQOS system significantly reduced a persons exposure to 15 harmful and potentially harmful constituents.

Compared with cigarette smoke, a toxicological assessment further found that the IQOS aerosols contain considerably lower levels of potential carcinogens and toxic chemicals that harm the respiratory and reproductive systems.

FDA has declared that it may withdraw the initial and any subsequent exposure modification orders if the agency determines that IQOS is no longer beneficial to the health of the population.

In the wake of the FDA's announcement, business stakeholders in Maldives have raised concerns over the government's present proposal to increase import duty of all electronic tobacco products, such as e-cigarettes and vapes, from 20 percent to 200 percent. Stakeholders cautioned there could be the potential creation of a black market for the IQOS product as a result, noting the need to maintain the tariff at 20 percent.

The stakeholders attributed their concerns to the comparatively high duty fees imposed on tobacco products imported into Maldives. They noted that while the European Union and United Kingdom charge 3.7 percent as import duty, countries such as Malaysia and Japan charge zero percent, as well as the nations comprising the Gulf Cooperation Council (GCC) which have set 0-5 percent import duty on electronic tobacco products.