The U.S. Food and Drug Administration (FDA) recently released exposure modification orders to Philip Morris International's (PMI) IQOS Tobacco Heating System, including a heat-not-burn device system and three Marlboro Heatstick variants:
- IQOS System Holder and Charger
- Marlboro Heatsticks
- Marlboro Fresh Menthol Heatsticks
- Marlboro Smooth Menthol Heatsticks
The FDA claimed that although the contemporary market strategy of the IQOS device system doesn't meet the standard for the risk reduction claims, it is marketed with a reduced exposure claim.
According to the announcement, below information is what the FDA allows companies to claim:
- 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 significantly reduces your body's exposure to harmful or potentially harmful chemicals.
Post-market surveillance studies will be required to conduct by PMI and Altria, and they will need to renew the order for four years from July 7.
Morgan Stanley is a multinational investment bank and financial services company in American. It talked about the FDA's modification order in a note to investors that this order is a positive development because it provides greater flexibility for IQOS to be marketed as relatively less harmful than traditional cigarettes.
Pamela Kaufman, analyst Morgan Stanley wrote:
"The inability to make relative lower harm claims is a constraint to broader IQOS adoption in the U.S.."
"Over time, PM can continue to submit additional information towards a full MRTP approval. The modified exposure designation combined with pending PMTA approval for IQOS 3 should accelerate MO's [Altria's] U.S. expansion strategy for IQOS. The FDA's recognition of IQOS's benefits relative to cigarettes may also enhance IQOS' perception with international health agencies, helping its growth prospects."
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