FDA’s E-cigarette Regulation Brings Unregulated Industry Under Federal Scrutiny

The Food and Drug Administration issued new rules on May 6 that took the federal agency into a new area: the regulation of the electronic cigarette industry. The FDA’s step into the previously unregulated field of vapor smoking has stirred mixed opinions: some think it is a fine idea; others think it is a troubling step that may have unintended consequences.

Tobacco products have been under federal scrutiny since 1964, when Surgeon General Luther Terry issued a report linking smoking to health problems, including lung cancer and heart disease. The FDA did not get involved in the regulation of tobacco products until 2009, when Congress passed the Family Smoking Prevention and Tobacco Control Act. That law gave the FDA the authority to regulate tobacco products. The law was passed in response to the Supreme Court’s determination in FDA v. Brown & Williamson Tobacco Corp. that the FDA had no such regulatory authority absent an act of Congress.

Since the Family Smoking act, the FDA has been active in policing the tobacco industry. As it says on its website, it “closely monitors retailer, manufacturer, importer, and distributor compliance with Federal tobacco laws and regulations and takes corrective action when violations occur.” The agency’s efforts went so far as, in 2011, proposing new labels for cigarette packages with graphic photos of health damage caused by smoking. The proposal led to a lawsuit against the FDA by five tobacco companies. The FDA lost that case.

The new FDA regulation of e-cigarettes may have the effect of wiping out the $3.5 billion industry. The 499 pages of rules covering e-cigarettes will require products that entered the market after February 15, 2007 to go through an extensive premarket compliance process with the FDA. The application process will be a burdensome one that will take more than 5,000 hours to complete and will cost a minimum of $330,000 per product. Another estimate is that it will cost “$1 million or more for each e-cigarette or vaping product to seek federal approval.” The price tag for compliance suggests that the only companies that will be able to afford the compliance process with be large tobacco companies.

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