March 27, 2018
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Major medical groups sue FDA for delaying e-cigarette, cigar reviews

Several leading medical and public health associations filed a lawsuit today against the FDA, challenging its August 2017 decision to delay the regulation of e-cigarettes and cigars, according to a press release.

The American Lung Association, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, Campaign for Tobacco-Free Kids and Truth Initiative and five individual pediatricians have joined forces to file the suit.

The groups support the FDA’s efforts to lower nicotine in combustible cigarettes to minimally or nonaddictive levels, but assert that the FDA’s decision to exclude e-cigarettes and cigars from reviews and allow these products to stay on the market for years without being reviewed is “unlawful and harms public health,” according to the release.

The organizations argue that the FDA’s decision denies the public of crucial information regarding how e-cigarettes and cigars that are already on the market affect health and does not enforce that manufacturers generate evidence that their products are beneficial to public health. Additionally, the FDA’s decision places young individuals who are more susceptible to flavored e-cigarette and cigar products at higher risk for addition to tobacco, according to the release.

Several leading medical and public health associations filed a lawsuit today against the FDA, challenging its August 2017 decision to delay the regulation of e-cigarettes and cigars.
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In the lawsuit, the groups argue that the product review delay exceeds deadlines under the Family Smoking Prevention and Tobacco Control Act, according to the release. The FDA’s decision did not allow public comment and did not give a justification for the rule, violating the Administrative Procedure Act, according to the release.

In May of 2016, the FDA extended authority over e-cigarettes, cigars and hookah tobacco, indicating two years without action.

The FDA declined to comment.