British American Tobacco (BAT) has received Substantial Equivalence clearance from the US Food and Drug Administration (FDA) for a new version of its Eclipse heated tobacco platform, and will be the first company to test market a heat-not-burn (HNB) product in the country, Reuters reported.

Test marketing of BAT’s Eclipse in a “small US area” will begin by the end of 2018, with a full market launch slated for 2019, Reuters reported, citing comments made by BAT Chief Executive Officer, Nicandro Durante.
Clearing the FDA’s regulatory hurdle means BAT can launch its HNB device before competitors such as domestic tobacco giant Altria, which has obtained US marketing rights to Philip Morris International’s IQOS HNB product. An FDA Substantial Equivalence review of IQOS, and an application to have IQOS sold as a Modified Risk Tobacco Product (MRTP) in the country, are currently pending.
“We are delighted to be the first tobacco company to be able to launch a THP [tobacco heating product] proposition in the United States,” Durante was quoted as saying.
The FDA market clearance was given for an “improved” version of Eclipse, BAT’s carbon-tipped HNB device that resembles a combustible cigarette. The company is not seeking FDA recognition of Eclipse as an MRTP, Reuters said.