What’s Coming from FDA in 2016

It has been a long time coming, but 2016 looks like the year that FDA is going to crack down on e-cigarettes. FDA’s proposed rule on electronic cigarettes will probably be finalized this year. This is what is known as the ‘deeming rule’ that would extend FDA’s authority to regulate e-cigs. It will most likely mandate a pre-market approval of e-cigarettes. This is a lengthy – and expensive – process that determines if the product is safe for the market.

FDA is also most likely to ban e-cig sales to anyone under 18 and to mandate labels that the products contain nicotine. No one in the e-cig business has any problem with these two proposals, but the requirement of a PMA to market a new e-cig product could be the death knell for the industry.

FDA also could require child proof packaging for all e-liquids. These contain nicotine and are combined with various flavorings and colorings.

There is considerable evidence that smoking e-cigs helps smokers quit regular cigarettes. Of course, many public health types say e-cigs are a gateway to smoking cigarettes.

According to some vaping supporters, if FDA does go ahead and crack down on e-cigarettes, it will just open up a new, huge black market for e-cig products. Many people, according to one survey, will get their favorite e-cig products from overseas or on the black market.

That survey was done by the Consumer Advocates for Smoke Free Alternatives Association, and it examined 20,000 vapers at the end of last year. When asked what they would do FDA totally banned e-cigs, 50% said they would smoke cigarettes more and 20% said they had quit smoking and would start again if this happened.

The survey also asked what these vapers would do if FDA banned most e-cig products except for closed system cigalikes, which would be made just with menthol and tobacco. About 20% of respondents who had quit smoking said they would go back to cigarettes.

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