APhA to FDA: More research needed on e-cigarettes
From: American Pharmacists Association
FDA has proposed restrictions on the sale and distribution of electronic cigarettes (e-cigarettes) and other vapor-inhalation tobacco products to patients younger than 18 years, and requiring the full disclosure of all ingredients on package labels for e-cigarettes and other vaporized nicotine products. On August 8, APhA submitted comments to the agency that reflected APhA members’ support of the proposed rule and offered specific feedback on FDA’s request for more information on how e-cigarettes are used.
The proposed rule would extend the agency’s tobacco authority to cover additional tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009. Through a process called “deeming,” FDA would be able to regulate currently unregulated marketed tobacco products, including e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables. The agency currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
“Many patients who are trying to quit smoking are now turning to e-cigarettes or other vapor-inhalation products as a means to quit, rather than utilizing approved prescription and nonprescription therapies. In many cases, e-cigarettes are cheaper than approved smoking therapies that may not be covered by insurance,” the Association wrote. “We strongly encourage the FDA to conduct additional analyses of the potential health effects of e-cigarettes, vapor inhalation products, and their components, as well as the use of these products as possible smoking cessation aids.”