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FDA delays enforcement of ‘deeming rule’

May 04, 2017

By Jennifer Garvin

Silver Spring, Md. — The Food and Drug Administration announced May 3 that it is delaying enforcement of the final rule on tobacco products in response to lawsuits associated with the rule.

The final rule, also referred to as the “deeming rule,” was published last year and expands the agency’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, the agency said.

Compliance measures included requiring manufacturers to place health warnings on product packages and advertisements; and not to sell modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“The FDA’s decision is a real disappointment,” said Dr. Gary L. Roberts, ADA president. “We spent years trying to get this rule in place. Now we're being told its enforcement is being delayed and the rule might even be gutted or repealed.”

In July 2016, three Alabama-based vaping device manufacturers filed a complaint against the FDA in federal court asking the court to dismiss the rule for reasons that include it is “contrary to and exceeds FDA’s statutory authority under the Tobacco Control Act and Food, Drug and Cosmetic Act.” There are also suits pending in Washington, D.C., and California.

The FDA said it plans to “issue guidance describing its position” on the final rule in the “near future.” The agency also said that the delay doesn’t apply to final rule provisions already in place such as “mandatory age and photo-ID checks to prevent illegal sales to minors.”

FDA said the extension will give its new commissioner — the agency is currently awaiting confirmation of Scott Gottlieb, M.D., — and the Department of Health and Human Services additional time to “more fully consider issues raised by the final rule that are now the subject of multiple lawsuits” in federal court.

The Association, which supported the final rule, has long advocated for tighter federal regulations on all forms of tobacco. In August 2014, ADA wrote a letter urging FDA to expand its regulation of products it deemed to be covered by the Family Smoking Prevention and Tobacco Control Act.

"We're looking at all options for keeping this rule intact," Dr. Roberts said. "This is about finding and preventing oral cancer in our patients. We just can't sit this one out."

Oral cancer is among the eight most common cancers in the world, according to FDI World Dental Federation. The five-year survival rate for these cancers is only about 50 percent (globally) and early detection is key to increasing the survival rate.

For more information on the ADA’s advocacy efforts on tobacco visit ADA.org/tobacco.