Will the US vaping market soon be dominated by the tobacco industry?

Vaping product makers face a September 9 deadline to submit marketing authorizations to the Food & Drug Administration or face having to pull their products from the market. This compliance represents a cost for many manufacturers that could lead to tobacco giants dominating the market.

The Family Smoking Prevention & Tobacco Control Act indicates that all new tobacco products must receive marketing authorisation (Premarket Tobacco Application (PMTA)) for sale in the United States. Any product without approval cannot be legally sold in the United States and is considered “illegal” under federal law.

The FDA estimates that each PMTA will cost between $117,000 and $466,000^[1]. A PMTA application must be made for each stock keeping unit (this is a unique product reference. For example for different flavours and nicotine levels) that the manufacturer wishes to place on the market.

This cost is easily surmountable for tobacco companies that have colossal financial resources and are particularly experienced in standards and regulations, but could represent a prohibitive obstacle for other manufacturers.

An opportunity for the different products of the tobacco industry

Philip Morris has already obtained the authority to market its heated tobacco product "modified risk tobacco product"[2] but also three heatstick flavors, two of which are mentholated (Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks). This gives the tobacco giant, which wants to position itself as an interlocutor and solution in the global tobacco pandemic, a dangerous competitive advantage.

Juul, owned 35% by Altria, has a strong chance of having its cigarette approved[3], despite being regularly criticized for contributing to the youth vaping epidemic. Several other tobacco companies have filed for authorizations, including Imperial Brands, which says it has submitted PMTAs for a wide range of its myblu e-cigarette products, as well as Japan Tobacco, which has submitted one for its Logic e-cigarette brand.