E-cigarettes Regulations Proposed by FDA

e-cigarettesTeenage vapers beware. The U.S. Food and Drug Administration (FDA) has issued proposed rules strictly regulating electronic cigarettes, and they are expected to set a minimum age limit of 18 to purchase e-cigarettes or related products. The proposed rules also call for regulation of pipe tobacco, cigars, nicotine gels, and hookahs. Currently FDA has regulatory control only over cigarettes, roll-your-own tobacco, and smokeless tobacco.

Health warnings about the potential for nicotine addiction would be required under the new rules, and e-cigarette vending machine sales would be prohibited. In addition, manufacturers would no longer be allowed to say that e-cigarettes are safer than tobacco unless they can provide scientific evidence that supports that claim. They also may not use language such as “mild” or “light” to describe their products.

Under the new rules, all products and ingredients would have to be registered with the FDA by the manufacturers, and any new products developed would require FDA approval. And no more free samples from companies.

The FDA’s proposed regulations on e-cigarettes begins a 75-day public comment period. Manufacturers have 24 months to submit required pre-market review applications. Products may remain on the market as long as the application is filed. The FDA has not proposed limiting television advertising or Internet sales.

The American Cancer Society’s Cancer Action Network was pleased with the proposal, but says without prompt action from the FDA to finalize the rule, manufacturers will continue to target youth with their advertising and use of flavors. FDA commissioner Dr. Margaret Hamburg says e-cigarette manufacturers’ use of flavors such as thin mint and strawberry make it clear that they are aiming their products at young people. She says they are an easy way for kids to start a nicotine habit, which then moves on to cigarettes and other tobacco products.

The Centers for Disease Control and Prevention (CDC) reported last year that the percentage of high school students who stated that they had ever used an e-cigarette doubled between 2011 and 2012, from 4.7 percent to 10 percent. The concentrated liquid form of nicotine is highly toxic and can be absorbed through the skin or inhaled. Calls to poison control centers have increased with the popularity of e-cigarettes. In February 2014 the CDC reported that poison control centers logged 215 e-cigarette related calls, 51 percent involving children.

Georgia State University’s School of Public Health is one of the 14 institutions conducting FDA-funded e-cigarette research. Dean Dr. Michael Ericksen says people treat the liquid nicotine as sugar, but it’s actually a toxin, basically a pesticide. Consumers to not take the same care with nicotine vials as they do with other toxic substances.

Public health experts have been pushing for the FDA to extend its authority to e-cigarettes as their popularity has increased. Hamburg says “it’s like the wild, wild West.” She says companies can do whatever they want and market however they want due to the lack of regulations.

The FDA’s newly proposed regulations on e-cigarettes are only the start of a long and burdensome process. It may take months or even years for the FDA to consider input received during the public comment period, which makes advocates unhappy.

By Beth A. Balen


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