“The Alpha-1 Foundation strongly agrees with the American Thoracic Society (ATS) position objecting to the FDA’s authorization of the tobacco-flavored versions of RJ Reynolds e-cigarette brand Vuse. While the FDA rejected sweet-flavored versions of the Vuse product. The Alpha-1 Foundation joins the ATS in their long-held position that e-cigarettes are not safe and that the claims that e-cigarettes are a harm reduction tool remain unproven. The ATS calls on the FDA to protect our nation’s youth by rejecting all e-cigarette products, including menthol flavored e-cigarettes, which are still under consideration for authorization. The Foundation is focused on the community that we serve and the long-term consequences of this authorization, especially on adolescents, ” stated Scott Santarella, President & CEO of the Alpha-1 Foundation.
OCTOBER 16, 2021- FDA AUTHORIZES FIRST E-cigarette Product
The FDA authorized the tobacco-flavored versions of RJ Reynolds e-cigarette brand Vuse while rejecting sweet flavored versions of the Vuse product. The FDA’s action on Vuse represents the first time the agency took action on an e-cigarette product that has a large share of the US e-cigarette market. While the FDA did reject Vuse flavored product applications, the agency has not made any decisions on menthol flavored Vuse products.
“The ATS reiterates our long-held position – e-cigarettes are not ‘safe’ and the claims that e-cigarettes are a harm reduction tool remain unproven. All e-cigarettes have significant health risks including nicotine addiction and respiratory disease,” said ATS President Lynn Schnapp, MD, ATSF in respond to the FDA announcement.
The ATS notes that the FDA has finally issued decisions on e-cigarette products that constitute a large share of the e-cigarette market. This is an important step by the FDA to finally rein in the U.S. e-cigarette marketplace.
The ATS is concerned that the agency has approved Vuse products with high nicotine concentration. The ATS appreciates that the FDA rejected RJR/Vuse application for flavored e-cigarette products, we note with concern that the agency has not yet rejected the Vuse application for menthol e-cigarette products. The presence of any flavored e-cigarette product poses an unacceptable risk to our nation’s youth.
The ATS calls on the FDA to protect our nation’s youth by rejecting all flavored e-cigarette products, including menthol flavored e-cigarettes.
“The Alpha1 Foundation is deeply concerned with the FDA’s authorization of E-cigarettes, products that target youth and vulnerable adolescents. The Alpha-1 community is at a higher risk of developing diseases related to Alpha-1 Antitrypsin Deficiency, especially pulmonary emphysema, when exposed to the unregulated and understudied components of e-cigarettes. Additionally these products are known to lead to addiction and encourage subsequent use of traditional cigarette products. E-cigarettes also pose a risk for individuals that are carriers of a single abnormal gene for Alpha-1.The assumption that tobacco- flavored e-cigarettes are less appealing to youth and may be beneficial for adult cigarette smokers who switch to electronic nicotine delivery system (ENDS) remains unproven. The older generation of Alphas were detrimentally affected by the cigarette products of the past and now the same tobacco companies are putting the next generation of Alphas at risk. Regardless of the rejection of sweet- flavored versions of e-cigarettes, approval of these products is an unacceptable threat to our patient population,” said Dr. Jeanine D’Armiento, MD, PhD, Chair, Alpha-1 Foundation Board of Directors.