On April 10, the AAFP wrote a letter(3 page PDF) to Leslie Kux, associate commissioner for policy at the FDA, offering guidance on the use of nicotine for combustible tobacco product cessation to the agency's newly created Nicotine Steering Committee.
"The AAFP calls for strong regulatory action on all nicotine and tobacco-related issues," the AAFP stated in the letter, which was signed by Board Chair John Meigs, M.D., of Centreville, Ala. "Tobacco use is the leading cause of preventable death in the United States. Nicotine is the leading cause for addiction to tobacco products, further propagating the public health crisis."
Although it wasn't addressed in the FDA's request for comments, which was published in the Feb. 20 Federal Register,(www.gpo.gov) the AAFP called on the agency to work with CMS to increase opportunities for family physicians and other health care professionals to counsel patients about tobacco cessation.
Additionally, the AAFP asked the FDA to clarify the interim final rule titled "Coverage of Certain Preventive Services Under the Affordable Care Act"(www.federalregister.gov) to include both counseling and pharmacotherapy as described in the 2008 Public Health Services guideline.
- On April 10, the AAFP wrote a letter to the FDA in response to the agency's request for comments on the use of nicotine for tobacco product cessation.
- The letter stated the AAFP's support of over-the-counter nicotine replacement therapy, calling it a "safe and effective form of therapeutic nicotine used for combustible tobacco product cessation."
- The Academy does not support the use of electronic nicotine delivery systems for cessation or as a therapeutic nicotine product.
The Academy pointed out the U.S. Preventive Services Task Force (USPSTF) released tobacco cessation recommendations in 2015(www.uspreventiveservicestaskforce.org) that gave "A" grades(www.uspreventiveservicestaskforce.org) for these services.
The letter noted that "the USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco and provide behavioral interventions and FDA-approved pharmacotherapy for cessation to adults who use tobacco."
Insurance companies and health plans don't offer uniform coverage of tobacco cessation services, the AAFP said, because neither counseling nor pharmacotherapy were specified in previous government rules on tobacco cessation treatment.
"The AAFP strongly encourages the FDA to work with other federal agencies through existing collaborations such as the Surgeon General's Interagency Committee on Smoking and Health to discuss these issues," the AAFP wrote.
The letter stated the AAFP's support for over-the-counter nicotine replacement therapy (OTC NRT) -- which includes lozenges, patches, gums and nasal sprays -- calling it a "safe and effective form of therapeutic nicotine used for combustible tobacco product cessation."
"These products are more effective when partnered with counseling, highlighting the need for reimbursement for uniform coverage of tobacco cessation services, including counseling and pharmacotherapy," the Academy said.
The letter explained that strong evidence in peer-reviewed literature supports the effectiveness of combination OTC NRT for ceasing use of combustible tobacco products -- such as combining a passive, long-acting patch with a "rescue" OTC NRT to help stop cravings.
"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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