FDA Retreats on Plans for Regulating E-Cigarettes

The Food and Drug Administration has given up on its bid to regulate electronic cigarettes as drug delivery devices, which would have enabled authorities to require extensive clinical trials before the products could come out on the market.

Instead, the agency will regulate e-cigarettes as tobacco products, which means manufacturers will face less stringent requirements, such as providing lists of ingredients.

The FDA’s retreat came on Monday, its deadline for deciding whether to appeal to the U.S. Supreme Court a December appellate court decision rebuffing the agency’s effort to treat e-cigarettes as drug delivery devices.

As the Los Angeles Times reports, the FDA had contended that the widespread marketing of e-cigarettes as a smoking-cessation aid made the products a legitimate target for regulation as a medical device. That argument was shot down, however, by the appellate court, which found that e-cigarettes are not primarily marketed that way.

In a dry statement, the FDA said the government “has decided not to seek further review of this decision.”  E-cigarette companies such as Sottera, which brought the initial lawsuit challenging the FDA, expressed delight with the announcement.

The FDA didn’t back off its initial stance completely, however. It said in a separate posting on its website that e-cigarettes that the agency regards as being marketed for therapeutic purposes “will continue to be regulated as drugs and/or devices.”

E-cigarettes, which have grown in popularity in recent years, are small, metallic tubes designed to resemble cigarettes. When users inhale, they ingest a nicotine-laced vapor. Marketers of e-cigarettes, however, have claimed that the items are a safer alternative to smoking, because they drastically reduce the number of harmful chemicals that users consume.

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