FDA Warns Five E-Cigarette Makers

WASHINGTON -- The U.S. Food and Drug Administration (FDA) warned five electronic cigarette makers last week that they were violating federal law, stating that the products -- which turn nicotine liquid into a vapor mist that users inhale -- are drugs that require FDA approval before they can be marketed, The Wall Street Journal reported.

The companies receiving warning letters were E-CigaretteDirect LLC of Parker, Colo.; Ruyan America Inc. of Minneapolis; Gamucci America, also known as Smokey Bayou Inc., of Jacksonville, Fla.; E-Cig Technology Inc. of Las Vegas; and Johnson's Creek Enterprises LLC of Johnson, Wis., the newspaper reported. The companies have 15 days to respond to the FDA.

There are an estimated 300 firms that make or distribute electronic cigarettes, according to the Journal.

The agency also sent a letter to the Electronic Cigarette Association, the industry's trade group, outlining steps companies can take to file for agency approval of electronic cigarettes.

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter said, as cited by the Journal.

The FDA characterized the electronic cigarettes as nicotine-replacement products, and said the e-cigarette companies are marketing their products as tools to help people quit using cigarettes. It also suggested the companies would need to conduct clinical studies showing the products are an effective treatment for nicotine addiction, according to the report.

William Bartkowski, president of Ruyan America, told the paper the company hasn't distributed nicotine-containing products since last year due to the regulatory uncertainty, but it would respond to the warning letter. The company currently sells a product called the Ruyan RAPP E-Mystick, which contains an herbal supplement.

Johnson Creek Enterprises, which markets Smoke Juice, a liquid solution used to refill depleted cartridges in e-cigarettes, was cited by the FDA for deficiencies in its manufacturing processes. E-Cig Technology, meanwhile, was warned because some of its products contain tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that's not approved for use in the U.S., the report stated. Keith King, sales manager for E-CigaretteDirect, told the newspaper the company doesn't promote its e-cigarette products as stop-smoking aids.

Johnson Creek didn't respond to a request for comment from the Journal, and E-Cig Technology and Gamucci America couldn't be reached.

Michael Levy, director of labeling compliance for FDA's drug division, told the newspaper the agency would wait to see what the company responses were before deciding its next action. However, he added the FDA believes the products containing tadalafil and rimonabant should be pulled from the U.S. market.

While the FDA could act to remove e-cigarettes from the market, it would likely involve a court fight, the newspaper noted.

"We have not made a decision to remove all e-cigarettes from the market," Levy said in the report.

In other FDA tobacco regulatory news, the agency's Center for Tobacco Products launched a six-month text messaging pilot program as part of its ongoing efforts to educate retailers and the public about federal regulations to protect kids from tobacco. To participate in the program, text "BreakChain" to 87000 from a mobile phone. Subscribers will begin receiving text messages in mid- to late September. There is no charge to participate in the program, but standard text messaging and data rates from wireless carriers may apply, the agency noted.

Subscribers will receive approximately three messages a week for the first month, with educational messages sent on Mondays and Wednesdays, and a weekly quiz on Friday covering new tobacco legislation. Subscribers who correctly answer the quiz each week have the chance to be featured on www.fda.gov/tobacco via FDA/CDC's bi-weekly podcast series: Tobacco Control Act: What Retailers Need to Know.

At the end of four weeks, FDA will ask for feedback so it can make improvements to the program.

For the remaining five months of the program, subscribers will receive one message a week.

For more information about the text message program, and for complete contest rules, visit the www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm219686.htm. Additional resources on tobacco regulations can be found at: www.fda.gov/breakthechain.

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