Unlike traditional cigarettes and other tobacco products, e-cigarettes have been placed on the market with little to no restrictions up until now. However, after coming under pressure from health groups and politicians in recent years, the FDA is now turning its attention towards e-cigarette products. In a move that could shake up the entire industry, the agency has until 9 September to review millions of applications from e-cigarette makers and decide which products are “appropriate for the protection of public health”. During the course of the review, the FDA has already stopped the sale of 55,000 flavoured vape products that did not fulfil the standard.
The process is likely to harm smaller companies that simply cannot afford the application cost or do not have enough resources to thoroughly answer the FDA’s scientific questions about safety. One small business owner said that his initial application cost was around USD 7,000 per flavour for 14 of the flavours he sells, reports Politico.
Bigger companies such as Juul, on the other hand, have much more resources to put into their applications making them more likely to be cleared by the FDA. The agency has already stated that it is prioritizing its review queue based on the applicants’ market share and is likely to miss the 9 September deadline for some applications, according to Politico.
“FDA really is at a critical juncture. In some critical ways how FDA will be perceived will probably be defined with what it does now with regard to pending applications,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids.