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ADA, others urge HHS to ensure deeming rule is implemented

May 22, 2017

By Jennifer Garvin

Washington — The ADA is one of 51 organizations asking the U.S. Department of Health and Human Services to ensure that the final rule on tobacco products is implemented in accordance with its provisions following the Food and Drug Administration's decision to delay enforcement of the rule.

The final rule, also referred to as the "deeming rule," was published last year and was designed to expand FDA's regulation of tobacco products to include e-cigarettes, hookah, cigars and pipe tobacco. It was expected to go into effect Aug. 8 but will now be delayed for three months, FDA said.

In a May 17 letter to HHS Sec. Tom Price, M.D., the coalition expressed its concern with the FDA's decision saying, "the administration appears to be taking steps to reconsider" the rule and is "delaying implementation of important provisions of the rule, to the detriment of public health."

"The deeming rule was the product of a multiyear rulemaking proceeding and is supported by overwhelming evidence in the administrative record at the FDA," the groups wrote, adding that the U.S. Department of Justice strongly defended the rule in Nicopure Labs LLC v. FDA, one of several pending industry challenges to the rule.

"The public health justification for regulation is as compelling now as it was a year ago, when the FDA issued the final deeming rule," the coalition said.

"Every day of delay in its full implementation subjects the public to the continuing public health threat of unregulated, highly addictive and dangerous tobacco products, many of which come in sweet or candy flavors which are designed and marketed to appeal to children," the coalition said.

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