FDA unveils new guidelines for e-cigarette makers


The US Food and Drug Administration on Tuesday carved out new recommendations for makers of e-cigarettes, or vapes, including guidelines on how to address public health issues while designing their products.

Currently, there are no authorized e-cigarettes on the US market.

The FDA, which has recently clamped down on e-cigarettes following a surge in their use among teenagers, said the new guidelines cover issues like accidental nicotine exposure and battery safety. 

Now, the agency will require e-cig makers to get their devices approved according to the same pathway to market that tobacco companies must follow to sell approved cigarettes, cigars, snuff and more. 

Chief among the new rules is a requirement that the way e-cigs are marketed must be ‘appropriate for the protection of the public health,’ a dig at the companies that have come under fire for targeting children and teenagers with their ads. 

Until now, e-cigarette companies have been able to get away with selling millions of products unregulated – at least until the FDA found particular reason to investigate them. 

The jury is still out on many of the devices’ health effects, but research suggests the devices are just as bad for cardiovascular health as cigarettes, but perhaps less carinogenic. 

All clinical concerns aside, the FDA has come down hard on the bursting industry for its marketing practices. 

The US Surgeon General, Dr Jerome Adams declared teen vaping an ‘epidemic,’ driven largely vape giant, Juul. 

For the last year, the company has been under relentless fire for its slim, easily hidden devices and advertising campaigns, which featured young, attractive models the FDA believes made Juul all the more appealing to children and teenagers. 

The FDA even raided Juul’s headquarters last year, looking for proof the e-cig maker intentionally designed its products and advertising to appeal to youth. 

But before it marched into Juul’s offices, the FDA passed on its chance to regulate the very same products. 

Now, it’s at last made good on its promise of guidelines for e-cigarettes.  

Vape makers will have to bring their products to the market along the same pathway the FDA recommends for other tobacco products, the PMTA (premarket tobacco product application). 

Under the PMTA’s standards, the FDA is recommending that e-cig makers submit their intended product packaging and marketing materials to the agency to assess whether or not they have protection of the public good in mind. 

The agency also asks packaging be deterrent to children who might find the devices or the e-liquids that fuel them. 

FDA officials will now also have the chance to analyze the batteries used in e-cigs to be sure they are safe and will not explode and cause burns and injuries, as has already happened to about a dozen people. 

‘The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health,” said Acting FDA Commissioner, Dr Ned Sharpless. 

‘At the same time, the public can be assured that the FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren’t being marketed to, sold to or used by kids.’    

(Reporting by Tamara Mathias in Bengaluru; Editing by Anil D’Silva)


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