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Friday, 09/16/2016 4:06:29 PM

Friday, September 16, 2016 4:06:29 PM

Post# of 87250
FDA Cracks Down on Online Sales by E-Cigarette Industry

The WSJ article from September 15, 2016 is listed below. After some digging, I didn't see ECIG as one of the 24 websites listed at FDA here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/default.htm?Page=1


http://www.wsj.com/articles/fda-cracks-down-on-online-sales-by-e-cigarette-industry-1473974027

A month after assuming regulatory oversight over e-cigarettes, the U.S. Food and Drug Administration has cracked down on online sales by the industry, issuing 24 letters to websites for illegal sales to minors.

The letters, which the FDA released Thursday, are the first sent since the FDA banned e-cigarette sales to anyone under 18 years old on Aug. 8. The agency also issued warning letters to 28 retailers of cigars and e-cigs and three letters to websites selling cigars.

The websites and stores have 15 days to reply to the FDA letters and explain how they plan to prevent future underage sales, an FDA spokesman said. Repeat violators will be fined $275.

The FDA hasn’t moved to ban online sales, as many in the industry expected, but the letters show the agency is closely monitoring those outlets for underage sales.

American Vaping Association President Greg Conley said the FDA has provided no compliance guidelines to online retailers, making it difficult for them to identify an age-verification platform that would satisfy the FDA. The agency is far more transparent with how it checks brick-and-mortar stores, said Mr. Conley, whose association receives funding support from online retailers.

The FDA said that, between Aug. 8 and Aug. 31, it completed about 8,700 inspections of “brick-and-mortar” tobacco retailers—including vape shops—for sales to minors. It issued 400 additional warning letters related to cigarette and smokeless-tobacco sales.

Retailers who received warnings for cigar and e-cig sales included gas stations, convenience stores and drugstores. Most were cited for sales of cigars from brands such as Swisher Sweets, owned by Swisher International Inc., and Black & Mild, owned by Altria Group Inc., the nation’s largest tobacco company.

No vape shops received warning letters for selling to minors, the FDA said.

Before the FDA assumed oversight of e-cigs, vape-shop owners worried that the agency’s regulatory authority over the industry would put many of them out of business. Those shops and the liquid nicotine they sell for some e-cigs account for about $1.4 billion of the estimated $4 billion e-cigarette market, according to Wells Fargo.

The bigger challenge confronting shops is the cost of applying for FDA approval of some products they sell. Many of the shops make their own liquid nicotine flavors, such as cherry or pineapple. They fear that they won’t be able to afford the application process for those products, which could cost anywhere from $2 million to $10 million per item, according to the regulatory-consulting company SciLucent LLC.

Since gaining oversight of tobacco in 2009, the FDA has performed about 660,000 inspections of tobacco retailers and issued 48,900 warning letters. It also has issued 8,290 fines.

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