FDA Cracks Down on Online Sales by E-Cigarette Industry
September 15 2016 - 6:00PM
Dow Jones News
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.
Write to Tripp Mickle at Tripp.Mickle@wsj.com
(END) Dow Jones Newswires
September 15, 2016 17:45 ET (21:45 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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