The Food and Drug Administration has sent warning letters to five distributors of electronic cigarettes, accusing them of violating federal law by making unsubstantiated claims that their products help smokers quit. The letters said e-cigarettes meet the definition of drugs and medical devices and must be evaluated for safety and effectiveness in order to be marketed legally.
The companies have 15 days to outline the steps they will take to come into compliance, according to the letters. To get FDA approval, the companies would have to conduct research to demonstrate the safety of the products.
The companies called the FDA’s action misguided. “There seem to be references in the letter to a variety of things that are a little bit dated and no longer accurate,” Bill Bartkowski, president of Ruyan Company, one of the five companies warned by the FDA, told Bloomberg. “We hope to address that in our response to the FDA.”
E-cigarettes are metal cartridges that do not burn or contain tobacco, but produce a vapor that the user inhales. Many, but not all, deliver a nicotine dose.
“Although these products are frequently marketed to help consumers quit smoking, the FDA has not evaluated them for safety or effectiveness,” the FDA’s Michael Levy told Bloomberg.
The Campaign for Tobacco Free Kids, a leading anti-smoking group, applauded the FDA’s action. ”No one is suggesting that these products should never be allowed on the market if they meet appropriate safety and efficacy standards,” the group said in a prepared statement.
“Rather, like other drugs and delivery devices, electronic cigarettes should be regulated to protect public health before they are permitted to be sold to consumers.”
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If its illegal in the market, then why it didn’t even announced in television or radio? Public must be informed regarding that matter because there are large number of people already using electronic cigarettes.