What’s in a name?
The US Food and Drug Administration has done the tobacco industry a service by tackling head-on the issue of what to call certain new generation products. In a note issued through its Center for Tobacco Products, the FDA said that media reports and descriptions of these products had referred to them as heat-not-burn or heated tobacco product, and it could have added other names.
‘These colloquial terms do not appear to have universally-agreed-upon definitions (although they seem to be used on an interchangeable basis),’ the note said. ‘For the FDA’s purposes, a tobacco product that meets the legal definition of a cigarette, but for which there is evidence that the heat does not reach a level sufficient to cause combustion of the tobacco product is currently categorized as a “non-combusted cigarette”.’
The note was focused on pointing out that its system of Substantial Equivalence worked in respect of non-combusted cigarettes. ‘On July 19, FDA issued Substantial Equivalence (SE) orders for two R.J. Reynolds Tobacco Company tobacco products, Eclipse and Eclipse Menthol,’ the note said.
‘This marks the first time that FDA has issued SE orders on regular SE Reports for non-combusted cigarettes. This action demonstrates that the SE premarket review pathway is viable for non-combusted cigarettes. In addition, each of these products could serve as a predicate product for future SE Reports.’
To receive an SE order, the manufacturer must demonstrate that the new tobacco product has the same characteristics as the predicate tobacco product; or if it has different characteristics to those of the predicate tobacco product, that those differences do not cause the new tobacco product to raise questions of public health different to those raised by the predicate product. ‘The SE order permits the marketing of the new tobacco product.
The SE order means that FDA determined that these products met the statutory standards of the SE pathway. The review did not assess the harm or risk of these products compared to other tobacco products beyond the finding that the differences in characteristics between the new and corresponding predicate tobacco products do not cause the new tobacco products to raise different questions of public health.
‘FDA’s scientific review of the SE Reports for these two products found that there were differences in characteristics between the new and predicate products, but that these differences do not cause the new tobacco products to raise different questions of public health.
The predicate tobacco product was a non-combusted cigarette with the same name. The differences include, but are not limited to, differences in ingredients and the incorporation of a functional filter. This action is specific to the comparison between these new tobacco products and their respective predicate tobacco products.
