FDA rule on tobacco products under final review

FDA rule on tobacco products under final review
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The White House is reviewing a final rule from the Food and Drug Administration (FDA) on tobacco products.

The rule aims to clarify when the FDA can regulate a product like nicotine gum as a drug or device versus a tobacco product like electronic cigarettes. For the agency it all comes down to the product’s intended use.

The FDA sent the rule, first proposed in September 2015, to the White House Office of Management and Budget (OMB) on Monday.

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The proposed rule states that tobacco products intended for human consumption are regulated as a drug, device or combination product if intended for diagnosing or treating a disease.

Tobacco products will also be regulated as a drug or device if they contain nicotine that affects the body differently than traditional cigarettes, as well as smokeless tobacco products on the market prior to March 21, 2000.

The agency wants to keep a close eye on products that contain tobacco and claim to help consumers quit smoking.

In its proposed rulemaking, the FDA said it has approved a number of drug products made or derived from tobacco as nicotine replacement therapies to reduce withdrawal symptoms, including nicotine cravings associated with quitting smoking.

“Given the availability of FDA approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking,” the rulemaking said.

FDA spokesman Michael Felberbaum said it would not be appropriate for the agency to discuss the rule in detail since it is under review at the OMB.

This story was updated at 3:16 p.m.