The FDA has released its final guidance for e-cigarette makers looking to introduce vaping products into the market.
On Tuesday, the FDA issued its Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems guidance. It's meant to inform e-cig manufacturers looking to legally market a product about the FDA's evaluation process and offers recommendations to consider before they submit an application for review.
When reviewing a new tobacco product, the FDA says it will weigh "the risks and benefits to the population as a whole," including its effects on non-tobacco users. It will also consider "the likely impact of the products on people's behavior — specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products." And the agency will evaluate not only what the product is made of, but also how it's manufactured, packaged and labeled.
Acting FDA Commissioner Ned Sharpless said in a statement that the agency's oversight of said products "is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death." He added that "there are no authorized e-cigarettes currently on the market" and hopes companies "use this valuable document now as a guide to submit applications."
The announcement comes nearly a month after a federal judge ordered the FDA to start looking into thousands of e-cigarettes on the market after multiple public health groups sued the agency for postponing the reviews.
