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.
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:
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.