This morning saw the release of long-awaited regulations from the Food and Drug Administration that extend its authority over all tobacco-related products, including the broad spectrum of electronic cigarettes, all cigars and loose tobacco. Significantly, this regulation includes e-cigarettes even though they do not contain tobacco.
The FDA will prohibit sale of any tobacco product to persons under the age of 18 and will require the use of warning labels with these products. Distribution free samples of these products will also be prohibited. Little cigars, which for many years had been exempt from regulation, are included. These long-awaited aspects of the regulation are welcomed by the public health community.
The FDA also will require that manufacturers of products developed and marketed after the effective date spelled out in 2009’s Tobacco Control Act – Feb. 15, 2007 – must submit within two years submit information demonstrating the safety of their products. Those that do not meet the standards detailed by the FDA cannot be advertised or sold. The detailed scientific assessments are beyond the capacity of most e-cigarette manufacturers.
The burdensome complexity of these regulations are seen by many as impairing public health. Adult use of electronic cigarettes has begun to replace smoking combusted cigarettes and has the potential to reduce substantially the burden of tobacco-related disease and death. A large fraction of physicians advocate the use of e-cigarettes to their patients.
Vape establishments that mix or prepare liquids for use in e-cigarettes are treated in the same manner as manufacturers. These regulations, taken in aggregate, will severely diminish consumer access to e-cigarettes.
If the intent of the FDA deeming regulations has been to improve public health, they have done exactly the opposite. They have instead imposed an impossible regulatory threshold on manufacturers and distributers of e-cigarettes.