Modified Risk Tobacco Products

In the United States, the FDA can issue an order authorising the marketing of a modified risk tobacco product (MRTP). E-cigarettes have not been given this approval by the FDA. This hasn’t stopped Philip Morris International (PMI) from trying its luck with its heat not burn product.

The tobacco giant has recently submitted three claims to seek approval of its heated tobacco product, IQOS. The FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) rejected two of these three claims, this is a setback to PMI.

Heat not Burn - FDA (Food and Drug Administration)

“Switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases” was rejected by the board. As was the claim that “switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes”. However, did support one claim. This was that “switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals”.

TPSAC Rejection Could Affect FDA’s Decision

This rejection from the TPSAC is not binding but is very likely to affect the FDA’s decision. A successful application would mean PMI could make the associated claims when marketing the product.

This rejection from the TPSAC is unsurprising. The FDA hasn’t approved any of the “modified risk tobacco product” applications it has received. This includes that of e-cigarettes. In the UK, research shows that heated tobacco products carry less risk than cigarettes but a greater risk than e-cigarettes. On heat not burn, the IBVTA states:

“It is a tobacco product, and as the IBVTA’s own analysis and that of others has shown, it is significantly more harmful than vaping.”

The IBVTA deems heat not burn products as something designed to “muddy the waters’ between smoking and vaping.

IQOS is available in a number of countries including the UK and is particularly popular in Japan. In order for the product to be taken to market in the US, PMI must be successful in filing a pre-market tobacco product application (PMTA).

If IQOS gains MRTP status, the product would have a competitive advantage over e-cigarettes in the US. An advantage which would seem unfair. Especially considering the evidence which compares e-cigarettes with heated tobacco.

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