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Health groups sue FDA for delaying e-cigarette regulation

By Allen Cone
Health groups sue FDA for delaying e-cigarette regulation
The Food and Drug Administration is being sued by seven public health groups and five pediatricians for delaying the regulation of e-cigarettes, cigars and hookah, including ones that are flavored. Photo by John Angelillo/UPI | License Photo

March 27 (UPI) -- Seven public health groups and five pediatricians on Tuesday filed a lawsuit against the Food and Drug Administration for delaying the regulation of e-cigarettes, cigars, piped tobacco and hookah, including ones that are flavored.

The 45-page lawsuit was filed in federal district court in Maryland by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and several individual doctors.

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The FDA recently took the first steps reduce nicotine levels in cigarettes to minimally or non-addictive levels as well as limit fruit flavoring and menthol in tobacco products.

But the groups believe that the FDA's decision last August to exempt e-cigarettes, cigars and other tobacco products from agency review for several years is unlawful and harms public health.

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"As a result of the guidance, consumers will continue to be exposed for many years to thousands of tobacco products containing lethal and addictive components that have not met the statutory requirements," the groups said in their complaint.

The lawsuit states that the FDA's decision was "arbitrary and capricious and not the product of reasoned decision making."

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"In issuing the guidance, the FDA flagrantly breached that obligation," the suit said. "It offered no meaningful justification for ripping a hole in the statutory framework by exempting, for more than half a decade, newly deemed products from premarket review -- review FDA previously described as 'central' to the regulatory scheme Congress enacted for tobacco products."

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In 2016, the Obama administration announced the federal agency had the authority to regulate cigars and e-cigarettes under the 2009 Family Smoking Prevention and Tobacco Control Act.

But last summer, under President Donald Trump, the FDA extended the deadline as part of a sweeping plan to overhaul tobacco regulation. Manufacturers won't need to file until 2021 for combustible products that include cigars and until 2022 for noncombustible products that include e-cigarettes.

Last week, Commissioner Scott Gottlieb said FDA is taking the first step toward possibly limiting fruit flavoring and menthol in tobacco products in an effort to reduce the appeal for children. And on March 15, the FDA began the first steps to lowering nicotine in cigarettes. The FDA can't ban tobacco products but it can limit sales and content.

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"Our concern is that we can't leave our kids vulnerable while FDA waits for e-cig manufacturers to apply," Campaign for Tobacco-Free Kids President Matthew Myers said in a statement to CNBC.

FDA spokesman Michael Felberbaum told UPI "the agency does not comment on possible, pending or ongoing legislation."

Newly regulated products must include warning statements, list ingredients and remove modified-risk claims, among other requirements.

The law firm of WilmerHale, lawyers at Democracy Forward Foundation and the legal staff of the Campaign for Tobacco-Free Kids are working pro bono on behalf of the public health groups, according to a press release from the Campaign for Tobacco-Free Kids.

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