FDA Issues Final Rules on E-Cigarettes

On May 5, 2016, the FDA announced its issuance of a final rule regarding e-cigarettes, thus extending its authority to regulate tobacco products. The rule will take effect 90 days after its issuance. With broad implications for the tobacco industry and public health, this rule-totaling 499 pages-represents the first time e-cigarette producers have ever been subjected to federal regulations.  Not only will producers be required to register with the FDA and provide a detailed account of their ingredients and manufacturing processes, but they will also be required to apply for permission from the FDA to sell their product.  This requirement will include local "vape shops" that mix their own e-cigarette liquid, causing some controversy among smaller producers that argue they will not have the same resources as larger tobacco companies to navigate the FDA's two-year compliance period and application process.

 

Under the new regulations, all producers will also be required to seek FDA approval before marketing their e-cigarette products as "light" or "mild."  Further, companies will also be prohibited from handing out free samples. While the published rules do not include a specific ban on flavors in e-cigarettes, health officials have indicated that they are working on new rules to extend flavor bans for traditional cigarettes to cigars. Antismoking activists have expressed disappointment in the absence of flavor bans within the new regulations.  

 

In addition to production requirements, the new rules also establish new restrictions for "covered tobacco products" including: (1) Requirement for minimum age of purchase; (2) requirement for health warnings for product packages and advertisements; and (3) prohibition of vending machine sales of such products, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.

 

To review the final rules, click here.

 

Source:  International Municipal Lawyers Association, May 2016