FDA proposes lowering tobacco nicotine levels

2016 11 14 17 08 22 202 Cigarette Smoking 400

The U.S. Food and Drug Administration (FDA) announced on July 28 plans to regulate nicotine in cigarettes and other tobacco products to make cigarettes less dangerous and encourage the development of newer tobacco products that may be less dangerous than cigarettes. The goal is to lower the amount of nicotine to nonaddictive levels, reducing the risk of addiction and making it easier for current users to quit smoking.

In addition to cigarettes, the proposed change will apply to e-cigarettes, cigars, pipe tobacco, and hookah; however, the manufacturers of those products will have more time to comply with the new rule. ADA President Gary Roberts, DDS, was concerned the delay for some products will not benefit the public's health.

"We're not convinced that swapping one cancer-causing product for another is in the public's best interest," Dr. Roberts wrote in a statement to DrBicuspid.com.

Upcoming change varies by tobacco type

The proposed rule was part of the FDA's strategy to combat the addiction crisis, according to FDA Commissioner Scott Gottlieb, MD. The administration has not yet announced how much it intends to reduce nicotine levels by, but it will issue a notice of proposed rulemaking with more information and so that the public can comment on the regulation. It also announced plans for public comment on flavored tobacco products and premium cigars.

“You can't say that 'innovative' tobacco products are 'less dangerous' than cigarettes without knowing their immediate and long-term effects on oral health.”
— Gary Roberts, DDS, ADA president

The new nicotine proposal would extend the timeline that newly regulated products have to comply with the rule. Combustible products (cigars, hookah, pipe tobacco) will have until August 8, 2021, to submit tobacco product review applications, and noncombustible products (e-cigarettes) will have until August 8, 2022, to apply.

The extension for some products echoes the FDA's consideration to push back the compliance time frame to extend its regulatory authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco -- a move that is strongly opposed by the ADA, American Medical Association, American Public Health Association, and dozens of other prominent healthcare associations.

"We asked the FDA not to go down this path," Dr. Roberts stated. "But if they do, the agency should at least require these companies to furnish data showing how their 'innovative' products impact oral health."

The FDA stated that reason for the extension was to "make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes," but the ADA was unsure whether the delay is in the public's best interest.

"You can't say that 'innovative' tobacco products are 'less dangerous' than cigarettes without knowing their immediate and long-term effects on oral health," Dr. Roberts stated.

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