Electronic cigarettes are battery-powered tubes that vaporize a nicotine-laced liquid — e-cigarette juice — instead of burning dried tobacco and producing known carcinogens. Naturally the FDA wants this stopped:
The FDA began detaining some shipments from China in June 2008 on the grounds that the products were unapproved drug devices aimed at treating nicotine addiction. Smoking Everywhere Inc., a Florida distributor of e-cigarettes, sued the agency in April 2009, claiming that the FDA had no jurisdiction over the products. Another purveyor, Sottera Inc. of Scottsdale, Ariz., later joined the case as a plaintiff.
While the case was pending, Congress, in an unrelated move, passed landmark legislation that gave the FDA authority to regulate tobacco products, which lawmakers broadly defined as “any product made or derived from tobacco that is intended for human consumption.” But the agency continued to maintain that e-cigarettes were drug devices, not a tobacco product like a pack of cigarettes or can of snuff.
Richard J. Leon, a judge in the U.S. District Court for the District of Columbia, issued a preliminary injunction against the FDA in January, ruling that Smoking Everywhere and Sottera generally marketed their e-cigarettes as recreational alternatives to cigarettes, rather than as quit-smoking aids. The judge called the FDA’s approach a “tenacious drive to maximize its regulatory power.” He noted that e-cigarettes contained nicotine derived from tobacco and said they appeared to fall under the provisions of the new tobacco law.
The FDA won a stay of Judge Leon’s ruling, pending an appeal to the U.S. Court of Appeals for the District of Columbia Circuit. The agency is still detaining and refusing entry of e-cigarettes, a spokeswoman says.
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Ms. Vasconcellos says that she has lost tens of thousands of dollars on shipments from China that were blocked by the FDA and that the agency’s actions make it tough to do business. The FDA has refused to allow e-cigarette battery chargers and other products Ms. Vasconcellos has ordered from China and other countries, according to FDA documents reviewed by The Wall Street Journal. To try to stay under the radar, Ms. Vasconcellos orders shipments in smaller packages and has them sent to friends’ homes around the U.S.The FDA spokeswoman says the agency has refused the entry of more than 700 shipments of e-cigarettes nationally since it began detaining and reviewing the products two years ago.
Steve McVey, owner of PureSmoker.com in Goodlettsville, Tenn., near Nashville, had $59,000 in shipments from China seized last year and has faced lengthy delays on other shipments as federal inspectors scrutinized them.
“We’ve almost closed up shop three or four times,” Mr. McVey says.
Nevertheless, Mr. McVey says his company, Pure Enterprises Inc., collected $1.3 million in revenue last year.