Wrong, here's a direct quote form the JC letter. It begins by referring to the testimonials on the JC site which i didn't copy:
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"The above statements demonstrate that the Johnson Creek Smoke juice products marketed by your firm are intended both to affect the structure or function of the body and to mitigate, treat, or prevent disease. See 21 C.F.R. § 201.128 (describing the meaning of "intended use"). In particular, these statements suggest that these products are intended for use as smoking deterrents or to reduce dependence on traditional tobacco products, and are also capable of delivering nicotine. The scientific and medical communities have determined that nicotine is a pharmacological agent,1 that nicotine addiction is a disease,2 and that nicotine withdrawal is itself a recognized medical condition.3 It is well understood that people smoke for the pharmacologically rewarding effects of nicotine, such as alleviation of stress and negative mood, enhancement of thinking, and increased alertness.4 For an addicted smoker, the body has adapted to nicotine, and abstinence produces withdrawal and craving.5 As a result, people also smoke to avoid the negative effects of nicotine withdrawal, such as anxiety, difficulty concentrating, negative mood, increased appetite, insomnia and irritability.6 Therefore, the claims noted above demonstrate that the Johnson Creek Smoke juice products are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease.
Also, as to "fairly simple quality procedures"... Ummm, no, they would be required to maintain a clean room and all other regulations that large drug manufacturers must comply with. While some level of inspections would be a good thing, maybe something similar to food service inspections for cleanliness and proper handling procedures, etc. Only the larger established businesses and corporations can afford to comply to the myriad of drug production regulations which "quality control" is one of the smallest expenses. Clean rooms for repackaging, certified chemists for production, years of expensive clinical trials on animals then on humans before your product can even be considered for marketing approval and FDA certification and so on and so on.
That will kill the "above ground" cottage industry of eliquid suppliers and postpone any liquid on the market for at least 5-10 years with a vast increase in cost to consumers IF it ever gets funded by a corp and actually approved.
As described in 21 C.F.R. § 310.544, any product that bears labeling claims that it "helps stop or reduce the cigarette urge," "helps stop or reduce smoking," or similar claims is a smoking deterrent drug product.7 Products that are labeled, represented, or promoted as smoking deterrents, such as the Johnson Creek Smoke Juice products marketed by your firm, are regarded as "new drugs"
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If you read that quote you'll see the testimonials were the grounds the FDA cited as the reason the JC juice is being classified as a "new drug". That then opens them up to a lot of regs regarding drugs which is under the authority of the FDA which includes quality control standards. It's not the JC current quality control standards that empower the FDA to make this move, it's merely one of the regs that JC now falls under since their posted testimonials puts their product under a "new drug" classification.
Also, as far as "conform to fairly simple quality procedures"... while quality control standards for drug production is expensive, it is also one of the least expensive regulations placed on "new drugs" prdouction. Years of wildly expensive clinical trials on animals and then humans are required prior to a drugs approval and then there's quality control, clean rooms, certified chemists, to mention a few things that make it so only large corps can produce "new drugs".
This would kill the cottage industry and remove availablilty for at least 5-10 years. IF a corp decides to invest in legalizing ecigs with FDA approval, you can bet they will be far more expensive then they are now, with only a minimaly lowered risk benefit to consumers.
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