Wednesday, April 18, 2018 1:55:26 PM
"The AAFP acknowledges that no level of tobacco use is safe," the letter stated, noting that OTC NRT should be used "with the end goal of complete cessation, not smoking reduction."
As for the use of electronic nicotine delivery systems (ENDS) for cessation or as a therapeutic nicotine product, the Academy said it does not support the devices. The letter cited mixed evidence on the benefits and harms of using ENDS as smoking cessation devices and the lack of evidence on long-term health outcomes of ENDS use.
The letter also noted that ENDS are toxic to pregnant women and children, affecting fetal and child development; and that ENDS vapors and aerosols contain substances and toxins that can be harmful to the body.
In addition, the AAFP said several unintentional injuries have been associated with ENDS, including fires caused by charging batteries and poisoning from acute nicotine exposure at toxic levels.
The letter pointed out that despite a final rule(www.federalregister.gov) deeming tobacco products subject to the Food, Drug and Cosmetic Act, "many manufactures are still not currently required to submit the ingredients list to the FDA. Lack of enforcement around manufacturing could result in unsafe and inconsistent levels of nicotine and other chemicals within each cartridge, which is not conducive to cessation."
The Academy said the combination of the unknown efficacy of ENDS as cessation devices with the known negative health outcomes and the lack of regulation enforcement means ENDS is not an option as therapeutic nicotine for combustible tobacco product cessation.
"The AAFP calls for more robust research around the use of ENDS as tobacco cessation devices and the health effects of ENDS," the letter stated. "The AAFP also calls for the same regulations around traditional tobacco products to apply to ENDS in a timely manner."
In conclusion, the Academy said that because nicotine is an addictive drug, the FDA should have full jurisdiction over all tobacco products and nicotine delivery devices.
Furthermore, the letter stated that FDA decisions should be subject to the same standard of review that generally applies under the Food, Drug and Cosmetic Act.
"The tobacco industry should respond to the same regulatory forces that govern other similar industries and should not be able to choose the amount of regulation they accept," the AAFP said. "Further, the FDA should have authority to regulate the manufacture, sale, labeling, distribution and marketing of tobacco products and nicotine delivery devices including products such as nicotine water."
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