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FDA Rule Is Wrong

New FDA Rule is Wrong on the Law

A new FDA rule that establishes conditions in which e-cigs would be considered a drug was just announced but unfortunately it is wrong.  Dr. Michael Siegel explains why.

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On Monday, the FDA will issue a new rule 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:

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1) If the manufacturer makes a therapeutic claim

This means a claim that the product is intended to prevent or treat a “disease.”

2) If the manufacturer makes a structure/function claim

This 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.

Read the Tobacco News Analysis and Commentary article

 

 

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About The Author

Jim is the editor of Spinfuel's Vapers News. Every day Jim scours the Internet, newspapers, magazines, and anywhere and everywhere else to find the most important articles that are of interest to vapers all over the globe.

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