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  • On April 8, 2016

FDA Wants to regulate the Electronic Cigarette Industry

The FDA has recently proposed that it begin regulating the e-cigarette industry in a similar way as it does the tobacco industry. This has not come without controversy and pushback from both industries. There are currently nine major lawsuits against this regulation, and well as the concerns of Congress. Given the tobacco industry’s history of litigation, it is likely that the regulation will be challenged in court. Such a lawsuit could potentially put implementation of the regulation on hold until the litigation is decided.

Sen. Ron Johnson (R), Wisconsin sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf raising concerns about the regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences.

When will the deeming regulation take effect?

The FDA will begin enforcing some of the new requirements on August 8, 2016, which is ninety days after the rule’s May 10 publication date. However, the agency is delaying the enforcement of many provisions much further into the future.

Who else opposed the legislation?

In addition to the e-cigarette industry and Congress, numerous health organizations have condemned the legislation. In a letter to politicians, 31 groups, including the American Academy of Pediatrics, the American Heart Association, and the Campaign for Tobacco-Free Kids came out against the amendment, arguing that it would make the FDA’s job of addressing the public health threat of tobacco products more difficult.

The American Heart Association Says Vaping Is Safer Than Smoking – “E-cigarettes either do not contain or have lower levels of several tobacco-derived harmful and potentially harmful constituents compared with cigarettes and smokeless tobacco,” it states. E-cigarettes also “present an opportunity for harm reduction if smokers use them as substitutes for cigarettes.”

Boston University – argues that e-cigarettes could be the beginning of the end of smoking in America. He sees them as a disruptive innovation that could make cigarettes obsolete, like the computer did to the typewriter.

U.S. National Institutes of Health – “Current evidence suggests that there is a potential for smokers to reduce their health risks if electronic cigarettes are used in place of tobacco cigarettes and are considered a step toward ending all tobacco and nicotine use,”

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