UNITED STATES
FDA warns makers of e-cigarettes

The U.S. Food and Drug Administration (FDA) sent warnings to five makers of e-cigarettes for marketing them illegally as stop-smoking aids and said it intends to regulate the products as drugs, reports Reuters.

Michael Levy of the FDA's Center for Drug Evaluation and Research told a news briefing the warnings sent to E-CigaretteDirect, Ruyan America, Gamucci America (Smokey Bayou), E-Cig Technology and Johnson Creek Enterprises were for violations of the Federal Food, Drug and Cosmetic Act, including making unsubstantiated claims and poor manufacturing practices.
Under the act, a company cannot claim that its drug can treat a disease, such as nicotine addiction, unless the drug's safety and effectiveness have been proven.
In a separate letter sent yesterday to the Electronic Cigarette Association, the FDA explained also that it intended to regulate electronic cigarettes and related products "in a manner consistent with its mission of protecting the public health".
The FDA said it "invites" electronic cigarette firms to work in co-operation with the agency toward the goal of assuring that electronic cigarettes sold in the US are lawfully marketed.
"For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use," the FDA said in a press note.
The five companies who received a warning letter claim that their products help users quit smoking. The warning letters say they have 15 days to respond. The FDA will wait to act depending on what the companies say, Levy said. (pi)

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