Note: My previous post is an extract from the written comment on Sec. 918 that CASAA is submitting.
I just realized that although the audience (the people who must write the report to congress on Section 918, all of whom are FDA employees) for this will understand what I meant by "continue its efforts to ban e-cigarettes" I am referring to the FDA history.
Late in 2008, the FDA issued an import alert that had Customs begin seizing shipments of e-cigarettes coming in from China. The Agency claimed that these were unapproved drug and/or drug delivery device combinations. They would not be allowed to be sold until the manufacturers completed the New Drug Approval process. The NDA process is what pharmaceutical companies must go through to get a new drug or medical device approved. The requirements are substantial, starting with molecular studies, cellular studies, animal testing, human testing and then randomized clinical trials. The process takes on average of 8 years to complete and can cost up to a billion dollars--and after all that, the FDA can turn you down.
Early in 2009, one of the largest vendors at the time, Smoking Everywhere filed suit in the U.S. District Court for the District of Columbia, asking for an injunction against the product seizures. Shortly thereafter, Soterra, Inc. (d/b/a NJOY) joined as plaintiff. The plaintiffs argued that their product was not intended to treat a condition. E-cigarettes were intended to be used as a replacement for smoking.
In July, the FDA held a press conference that was intended to frighten and inflame the public. They announced that they tested 18 samples from two companies (What a coincidence....they happened to be the SAME two companies that were plaintiffs in the case against the Agency.) The FDA said they found detectable levels of "carcinogens" and toxins, including Diethylene Glycol, "an ingredient used in anti-freeze." Of course, they didn't bother to mention that the type of carcinogens are the same as those contained in FDA-approve nicotine patches and gum. They also did not bother to specify how much. But we knew from other research that the quantity in a ml of 16 mg liquid is about 8 nanograms (parts per billion) and furthermore this is equivalent to the quantity in a nicotine patch. The only toxin mentioned in the lab report was 1% of Diethylene Glycol. In a gram of liquid, that would be about 10 mg worth, a quantity that has never been shown to cause injury. [NOTE: That press release is still posted, with no correction, no updates, and no apology from the FDA -
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm173222.htm]
The Judge finally ruled in December, against the FDA. The FDA appealed, and then the Appeals Court upheld the lower court ruling. The FDA appealed again, asking the Appeals Court to hear the case again, in front of the entire set of 9 judges, rather than the 3 judge panel. The Appeals Court turned them down. The only place left for the FDA to go would have been the Supreme Court, but they wisely decided to stop wasting taxpayer dollars fighting this losing battle.
Between the time that the case was filed and the judge rendered his opinion, the Family Smoking Prevention and Tobacco Control Act was signed into law. In his opinion document, Judge Richard J. Leon, of the district court advised the FDA that e-cigarettes could only be regulated as a drug if the vendor made health claims. Otherwise, if the FDA wanted to regulate the products it might do so using the Tobacco Act, which defines a "tobacco products" as a product made of or derived from tobacco.
If the FDA had won that court case, we would not be having this discussion today. The FDA would have continued to seize product imports and driven the industry out of business here.
But we don't trust the FDA to "regulate" e-cigarettes as tobacco products with the best interests of the health of smokers in mind. They have given no indication that they even care about helping adult smokers. We should just quit or die.
If I'm wrong about that, please point out something on the FDA site that tells you we will be getting a fair shake.
