Less than a year after the would-be nicotine replacement beverage applied for an exemption from regulation by the Food and Drug Administration as a drug, the agency turned it down.
Citing the (minimal) presence of nicotine, the active element in tobacco, in certain fruits and vegetables, Nic Lite had sought to be regarded as a dietary supplement, which would have left it a much less-heavily regulated class of product.
Nic Lite’s labeling told imbibers that they would be able to “live smoke free” while supplying a bit of the nicotine buzz to hold off a smoker’s fit.
The presence of nicotine in a product like eggplant, however, doesn’t mean that the purple vegetable is marketed as a nicotine source, according to the FDA. And nicotine is being tested as a drug, which means that Nic Lite would need FDA approval to be sold in the U.S.
Call it a smoking-cessation supplement that has found itself snuffed out.
Here is the letter from the FDA to Nico Worldwide:
http://www.ahpa.org/Portals/0/pdfs/06_0629_FDA_NicLite_ltr.pdf