Several weeks ago I sent an email to the FDA requesting confirmation one way or another on customs holding shipments. I had recently read conflicting FDA quotes in regards to the matter. My first email was returned with the same scripted letter that has been posted in one form here or another. So I inquired again.
My second letter to the FDA
Your thoughts?
My second letter to the FDA
Their response,Thank you for your response,
However I still have a few questions. I should have made myself more clear. I intend to sell the product without nicotine, to my knowledge this is the only "drug" in the liquid. Will the same rules still apply if there is no "drug" in my device sold to the public? Will the same rules classify this no-nicotine e-cigarette as the "drug" delivery system and again bar it from importation?
Thank you,
There were a few different ideas as to what she meant in her replay. So I inquired again.To clarify, regardless of whether the cartridges contain nicotine or not, they contain chemicals that are intended to be volatilized and inhaled by the user upon each inhalation through electronic cigarette articles. Based on various claims, statements, and representations of the products that we have reviewed, they suggest that these articles are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease with or without nicotine. Therefore, they would require a new drug application, which we encourage manufacturers to submit.
To address your last question, FDA has detained and refused several importations of various brands of these "electronic" cigarettes, cigars, and pipes, and their components, and the agency continues to evaluate these products on a case-by-case basis.
Kristine Wollscheid
Compliance Officer
Food and Drug Administration
CDER/Office of Compliance
Division of New Drugs & Labeling Compliance
OTC Drugs Team
10903 New Hampshire Ave.
WO51-1333
Silver Spring, MD 20993
Ill edit the post if I hear back from her again.Again thank you for your quick responce.
Please excuse me but I am still unsure of what you are saying here. I understand that the FDA's stance is that this is a drug/delivery device. Surely you are not saying that a devices "intended" use is determined strictly by the claims of some vendors. I would assume that the you mean to say that the other chemicals involved such as Propylene glycol and the food flavorings are considered drugs? The only other components of the e-cigarette liquid besides nicotine are already FDA approved as far as I am aware, or do you mean the idea that the device being sold as a placebo for a cigarette makes it a drug?
Thank you again,
Your thoughts?