Drug & Device Law

FDA will soon regulate e-cigarettes and increase oversight of other tobacco products

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In a Thursday announcement, federal officials introduced a finalized rule (PDF) that will for the first time regulate e-cigarettes, as well as strengthen oversight by the U.S. Food and Drug Administration of other tobacco products.

As of Aug. 8, the FDA will include e-cigarettes, vape pens, hookahs, pipe tobacco, premium cigars and nicotine gels within the definition of tobacco products it regulates.

Sales will be restricted by the feds to those 18 and over; warning labels will be required; and all products, including those already being marketed, will be subject to FDA approval, reports the Wall Street Journal (sub. req.). The product-approval process will be phased in over a three-year period, the article notes.

“This action is a milestone in consumer protection—going forward, the FDA will be able to review new tobacco products not yet on the market, help prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate the potential risks of tobacco products,” the FDA said on a web page about the new rule.

Industry representatives and even some health experts were less enthusiastic about the new FDA oversight.

“This is going to be a grim day in the history of tobacco-harm reduction,” president Greg Conley of the American Vaping Association told the Wall Street Journal. “It will be a day where thousands of small businesses will be contemplating whether they will continue to stay in business and employ people.”

The industry trade group argues—in agreement with some health experts—that e-cigarettes and similar products are less harmful to consumers and hence should be encouraged as an alternative to traditional cigarettes. The FDA approval process is likely to create a significant roadblock for the smaller businesses that often offer these products, reports the New York Times (reg. req.).

However, the long-term effects of e-cigarettes and vaping are “largely unknown,” according to the Wall Street Journal, and concerns were voiced by public health groups that e-cigarettes could act as a gateway to traditional smoking. The American Lung Association came out in support of the FDA’s announcement.

CNN also has a story.

See also:

ABAJournal.com: “California lawmakers OK raising legal smoking age from 18 to 21”

CNN: “California raises smoking age to 21”

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