UNITED STATES
Congress urged to block weakening of FDA pre-market review

Public health groups in a joint statement urged Congress to block attempts by legislators to weaken tobacco regulators’ authority to require manufacturers obtain pre-market approval for vaping paraphernalia and small cigars.

Republicans in the House of Representatives inserted language that would limit pre-market approval as proposed by the Food and Drug Administration (FDA) in regulations that would expand its regulating powers to include e-cigarettes, hookah, cigars and cigarillos. The review process has been criticized as cumbersome and too expensive for many companies.
One of the health groups, the American Lung Association (ALA), said the language inserted into a spending bill by the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administraion and Related Agencies amounted to an “outrageous favour for the tobacco industry.”
ALA and three other groups said the proposal, “would greatly weaken the new product review requirement for e-cigarettes, cigars and other tobacco products that would be regulated under a proposed rule the FDA issued in April 2014. In fact, it would completely exempt from this requirement any e-cigarettes or cigars that are already on the market when the FDA issues a final rule, which is expected later this year.”

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