But e-cigarettes and other vaping products were not covered by the original law.
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The 499-page final rule would require regulatory reviews for electronic cigarettes, cigars, and other products that went on sale after February 15, 2007, unless the manufacturers can prove to the FDA that they’re “substantially equivalent” to products already being sold or that there is some other reason they should be exempt.
“Most importantly, we are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop a nicotine addiction”. “It would be hard to make a product more harmful or toxic than cigarettes”.
Some studies have showed that using e-cigarettes would be a good way to help a person quit smoking.
Retailers will now be barred from selling the aforementioned items to minors-under age 18. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. “It also will allow the FDA to expose the potential risks to anyone using these products, including teens”.
Perhaps the biggest change is a requirement that producers of cigars and e-cigarettes register with the FDA, provide the agency with a detailed accounting of their products’ ingredients, and disclose their manufacturing processes and scientific data. Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application.
The action comes five years after the agency first announced its intent to regulate e-cigarettes and more than two years after it floated its initial proposal. Numerous small vape shops, device manufacturers and liquid nicotine producers won’t be able to afford the FDA’s approval process, which could cost anywhere from $2 million to $10 million per item, according to the regulatory consulting company SciLucent LLC.
OH already defines e-cigarettes as an alternative to nicotine products and prohibits sales to minors under 18, but Nader Rafeedie, owner of Alternative Smokes, said the rules aren’t strictly enforced, and he welcomes the regulation.
The FDA does not have the authority to ban tobacco-based products.
“At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco”.
The FDA announced today that it’s assuming oversight of e-cigarettes and implementing sweeping new rules that are expected to upend the previously unregulated industry.
A bill approved by the House Appropriations Committee on April 19 would prevent the FDA from requiring retroactive safety reviews of e-cigarette products introduced after 2007 and exempt some premium and large cigars as well. “All cigars pose serious negative health risks, and contain harmful and potentially harmful constituents”.
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Ellen Hahn, a professor at the University of Kentucky College of Nursing and co-chair of the UK Tobacco-free Task Force, told USA Today that she believed the new rule is an important first step in controlling e-cigarettes. The ruling expands the term “tobacco product” to include e-cigarettes, vape pens, and other similar electronic devices.
