January 10, 2017
Authored and Edited by Laith M. Abu-Taleb; Mark J. Feldstein, Ph.D.
On January 9, 2017, FDA published a final rule, Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses.” The Rule took effect on February 8, 2017, and clarifies the Tobacco Control Act of 2009.
Generally speaking, the Tobacco Control Act gave FDA authority to regulate “tobacco products,” defined by regulation to include “accessory” devices—think hookahs, e-cigarettes, vaporizers, electronic cigars, and vape pens. 21 C.F.R. 1100, 1140, 1143; 81 FR 28973. Excluded from these “tobacco products” are drugs, medical devices, and combination products, all of which are subject to more stringent FDA regulations. However, some e-products are marketed as devices to help curb one’s addiction to tobacco. Herein lies the problem: when is a tobacco device regulated as a medical device subjected to stricter regulations?
The answer, according to the Rule, depends on the “intended use” of the device. If the device’s intended use is in the diagnosis, cure, mitigation, treatment, or prevention of a disease—including nicotine addiction—it will be subject to more stringent medical device regulations. But if the device is only intended to aid in the enjoyment or consumption of tobacco or nicotine, it will only be subject to the Tobacco Control Act. In determining the “intended use,” FDA can consider, among other things, the products’ labeling, promotional claims, and advertising.
What about products—like hookahs, vaporizers, and e-cigarettes—promoted as providing a reduced risk of tobacco-related diseases? Does the intended “reduced risk” use convert them into medical devices? No. Under the Rule, manufacturers would still be able to tout reduced risks as a health benefit without being regulated as a medical device, provided the manufacturer first files a Modified Risk Tobacco Product Application. The FDA practice of not treating these products as medical devices, which would presumably make them more costly and less available, is consistent with studies showing that vapes and e-cigarettes are “almost certainly less lethal than conventional cigarettes.” John Ross, MD, FIDSA, Harvard Health Publications, Harvard Medical School (July 25, 2016).
In sum, hookah, vape pen, and e-cigarette manufacturers may still be able to market products intended for the enjoyment of tobacco as less dangerous than traditional means of tobacco consumption. But if intended to treat a disease (including nicotine addiction), it will be subject to the stricter medical device regulatory scheme.
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