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House Appropriations Committee Undercuts FDA 's Authority to Regulate Tobacco Products and LDTs

April 19, 2016

WASHINGTON, D.C. April 19, 2016 The U.S. House Appropriations Committee today passed an Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies appropriations bill for Fiscal Year 2017 that included provisions that would greatly weaken FDA oversight of tobacco products and laboratory developed tests (LDT).

A statement from the American Cancer Society Cancer Action Network (ACS CAN) follows:

The appropriations language passed today by the Committee would significantly limit the FDA 's ability to protect youth from cigars, e-cigarettes, and other unregulated tobacco products. An adopted provision in the bill would require the FDA to exempt many cigars, including some cheap and some flavored cigars often popular with youth, from oversight and could also block FDA regulation of a significant number of other increasingly popular tobacco products.

Additionally, an amendment passed by the Committee clearly benefits the cigar and e-cigarette industries at the expense of the nation 's public health and would undermine the 2009 law giving the FDA authority over all tobacco products. The loophole to change the grandfather date would allow cigars, e-cigarettes, and other tobacco products to escape a critical first-step review by the FDA and make it easier for new products to stay on the market before it is determined whether they attract youth or otherwise harm public health.

Congress made a commitment to protect the nation 's public health when they passed the Tobacco Control Act, but the Committee 's move today is a significant abandonment of that promise.

The House Appropriations Committee Report also included language that would limit FDA 's ability to finalize LDT oversight guidance.

As cancer patients and their doctors become more reliant on diagnostic tests, including LDTs, to identify the best treatment options, it is critical that the tests produce accurate and meaningful results, and current oversight of LDTs falls short of ensuring these tests live up to patient expectations. Further, LDTs are not required to report adverse events impacting patient health, which is why we firmly believe that the FDA is the most appropriate agency to verify the accuracy of these diagnostic tests.

ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem.ξACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visitξwww.fightcancer.org.

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FOR MORE INFORMATION, CONTACT:

Jill Courtney or Alissa Crispino

American Cancer Society Cancer Action Network

Phone: (202) 585-3278 or (202) 661-5772

Email: [email protected] or [email protected]

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