New FDA Rule is Wrong on the Law: Smoking Cessation Claims are Not Inherently Therapeutic Claims Because Smoking is Not a Disease

On Monday, the FDA will issue a newrule whose intent is to clarify the conditions under which electronic cigarettes will be regulated as drugs instead of as tobacco products. Essentially, this amounts to a rule regarding what claims electronic cigarette companies are allowed to make (since few, if any, of these companies can afford the expenses associated with preparing a new drug application).As the FDA explains, by statute there are two claims that would make an electronic cigarette subject to regulation as a drug under the Food, Drug, and Cosmetic Act:1)If the manufacturer makes a therapeutic claimThis means a claim that the product is intended to prevent or treat a " disease. "2)If the manufacturer makes a structure/function claimThis means a claim that the product will affect the structure or function of the body in a way different than the way cigarettes have traditionally been marketed.So far, so good.Under the second prong (structure/function claims), the FDA correctly points out that if an electronic cigarette were to be marketed with the intended purpose of treating nicotine dependence, preventing nicotine withdrawal, or another purpose associated with the delivery of nicotine that is not typically used with cigarettes, it would be subject to regulation as a drug.So far, so good.The Rest of the StoryThe problem comes under the FDA ' s interpretation of the first prong. The FDA argues that pretty much any smoking cessation claim is inherently a therapeutic claim. Whi...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs