Electronic cigarettes will be regulated the same way as tobacco in America under rules that place the first federal controls on an industry that has grown from nothing to $3 billion in a few years.
The Food and Drug Administration will ban the sale of e-cigarettes to under-18s and require health warnings. The rules go further than tough new regulations being introduced across Europe later this month because they will require manufacturers to register with the FDA, provide the agency with a detailed list of ingredients, and disclose their manufacturing processes and scientific data. Producers will also be subject to inspections.
The rules apply to e-cigarette products that hit stores after February 2007, virtually the entire market.
The demand for e-cigarettes has escalated since 2012 and is anticipated to grow to $50 billion by 2025, according to BIS Research. The products contain a nicotine-based liquid that is vaporised and inhaled. While some medical experts believe them to be less harmful than cigarettes, many doctors and public health experts remain sceptical.
B0onnie Herzog, an analyst at Wells Fargo, said the new regulations may provide a boost for big tobacco companies that operate in the e-cigarette market, such as Altria, owner of Marlboro-maker Phillip Morris and of the popular IQOS smokeless cigarettes. Smaller companies without the resources to meet the product requirements might suffer.
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“Most new products will require a pre-market tobacco application, which could take an average of 1,500 hours to complete,” she said.
She added that the new regulations could have a negative effect on public health by stifling product innovation, dramatically slowing industry growth by disincentivising consumer conversion from combustible cigarettes.