What is this court case in DC about? Banning it in total, banning it in NY State?
What is this up coming case between the FDA and The ecig about
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I was going to provide the link to a Sticky in the News subforum that explained it well, but the sticky is gone and I couldn't track down the thread.
I'll try to explain the situation as best I can. Our resident lawyer who reports on the case (JustJulie) can come and correct anything that I got wrong.
Back in late 2008, the FDA began seizing incoming shipments of e-cigarettes. In March 2009, Smoking Everywhere received a notice that the FDA was holding some of their imports because the product they were importing was considered an "unapproved drug-delivery device."
In April 2009, Smoking Everywhere filed a lawsuit against the FDA, seeking an injunction against product seizures. Soon, Sotterra Inc (dba njoy) joined in as an "intervenor plaintiff."
In July 2009, the FDA held an (infamous) press conference to announce that they had tested e-cigarettes and found that they contain carcinogens and an ingredient used in antifreeze that is toxic to humans.
What the FDA failed to reveal is that, of hundreds of companies, it only tested products of the two companies that filed the lawsuit. Also, the "carcinogens" turned out to be Tobacco-Specific Nitrosamines (TSNAs). The FDA never did say the quantity, but we know from other sources (Health New Zealand) that the amount is equivalent to the amount of TSNAs in FDA-approved Nicotine Replacement Therapy (NRT) products such as the patch and gum. FDA never qualified how dangerous 1% of DEG in a mililiter of liquid might be, but obviously there was no danger of immediate poisonings. Otherwise the FDA would have issued a recall of the products already being sold in the U.S.
The bottom line is that the FDA did not find anything in the liquid or the vapor that presents a danger to human health (aside from nicotine). The press conference was a blatant attempt to sway public opinion against e-cigarettes. The unfortunate thing is that, for the most part, it worked. Several foreign countries have banned sales, citing the fact that the U.S. Food and Drug Administration says the products aren't safe.
Meanwhile in the briefs filed in the court case, we learned that the FDA's contention is that the products deliver nicotine, therefore they are a drug-delivery device combination that FDA can regulate under the Food, Drug and Costmetics Act (FDCA).
The plaintiffs contended that their products are not drugs. They are recreational products intended to be used as an alternative to smoking.
Meanwhile the Family Smoking Prevention and Tobacco Control Act (Tobacco Act) was passed into law, giving the FDA authority to regulate all tobacco products. Previously the FDA had tried to regulate tobacco cigarettes as drug-delivery devices, but the courts ruled that FDA did not have authority over tobacco. This act changed that.
In January 2010, U.S. District court Judge Riochard J. Leon granted the injunction sought by the plaintiffs. Essentially, this action blocked the FDA from continuing to seize the shipments bound for Smoking Everywhere and njoy but had no binding effect on FDA seizing products bound for other companies.
Judge Leon's opinion document stated that due to the fact that the intended use of the products was not to treat a disease, they should not be regulated under the FDCA. He said that the FDA could regulate them as tobacco products under the Tobacco Act.
Within a month, the FDA filed an appeal. The appeals court automatically granted a stay of the injunction, pending the outcome of the appeal. The FDA continues to seize incoming shipments to this day.
On September 23, oral arguments will be heard in the Court of Appeals. The attorneys for each side will give a speech. The panel of three judges might ask questions. They will not make a ruling on that day. It is expected that their ruling will not be pulished until January of 2011.
If the FDA wins the appeal, the seizures will continue, and it is likely that njoy(Smoking Everywhere has dropped out of the case due to financial difficulties) will appeal to the Supreme Court. If NJOY wins the appeal, there is no doubt that FDA will appeal to the Supreme Court. They do so love their power. Meanwhile, the injunction against the FDA seizing NJOY's shipments will be reinstated.
If the FDA ultimately wins and is permitted to regulate the products as though they were some new form of NRT, all products would ordered removed frrom the marketplace. Subsequently, if some e-cigarette company had millions of dollars to spend on clinical trials, we might see an FDA-approved e-cigarette available within 8 to 10 years.
I'll try to explain the situation as best I can. Our resident lawyer who reports on the case (JustJulie) can come and correct anything that I got wrong.
Back in late 2008, the FDA began seizing incoming shipments of e-cigarettes. In March 2009, Smoking Everywhere received a notice that the FDA was holding some of their imports because the product they were importing was considered an "unapproved drug-delivery device."
In April 2009, Smoking Everywhere filed a lawsuit against the FDA, seeking an injunction against product seizures. Soon, Sotterra Inc (dba njoy) joined in as an "intervenor plaintiff."
In July 2009, the FDA held an (infamous) press conference to announce that they had tested e-cigarettes and found that they contain carcinogens and an ingredient used in antifreeze that is toxic to humans.
What the FDA failed to reveal is that, of hundreds of companies, it only tested products of the two companies that filed the lawsuit. Also, the "carcinogens" turned out to be Tobacco-Specific Nitrosamines (TSNAs). The FDA never did say the quantity, but we know from other sources (Health New Zealand) that the amount is equivalent to the amount of TSNAs in FDA-approved Nicotine Replacement Therapy (NRT) products such as the patch and gum. FDA never qualified how dangerous 1% of DEG in a mililiter of liquid might be, but obviously there was no danger of immediate poisonings. Otherwise the FDA would have issued a recall of the products already being sold in the U.S.
The bottom line is that the FDA did not find anything in the liquid or the vapor that presents a danger to human health (aside from nicotine). The press conference was a blatant attempt to sway public opinion against e-cigarettes. The unfortunate thing is that, for the most part, it worked. Several foreign countries have banned sales, citing the fact that the U.S. Food and Drug Administration says the products aren't safe.
Meanwhile in the briefs filed in the court case, we learned that the FDA's contention is that the products deliver nicotine, therefore they are a drug-delivery device combination that FDA can regulate under the Food, Drug and Costmetics Act (FDCA).
The plaintiffs contended that their products are not drugs. They are recreational products intended to be used as an alternative to smoking.
Meanwhile the Family Smoking Prevention and Tobacco Control Act (Tobacco Act) was passed into law, giving the FDA authority to regulate all tobacco products. Previously the FDA had tried to regulate tobacco cigarettes as drug-delivery devices, but the courts ruled that FDA did not have authority over tobacco. This act changed that.
In January 2010, U.S. District court Judge Riochard J. Leon granted the injunction sought by the plaintiffs. Essentially, this action blocked the FDA from continuing to seize the shipments bound for Smoking Everywhere and njoy but had no binding effect on FDA seizing products bound for other companies.
Judge Leon's opinion document stated that due to the fact that the intended use of the products was not to treat a disease, they should not be regulated under the FDCA. He said that the FDA could regulate them as tobacco products under the Tobacco Act.
Within a month, the FDA filed an appeal. The appeals court automatically granted a stay of the injunction, pending the outcome of the appeal. The FDA continues to seize incoming shipments to this day.
On September 23, oral arguments will be heard in the Court of Appeals. The attorneys for each side will give a speech. The panel of three judges might ask questions. They will not make a ruling on that day. It is expected that their ruling will not be pulished until January of 2011.
If the FDA wins the appeal, the seizures will continue, and it is likely that njoy(Smoking Everywhere has dropped out of the case due to financial difficulties) will appeal to the Supreme Court. If NJOY wins the appeal, there is no doubt that FDA will appeal to the Supreme Court. They do so love their power. Meanwhile, the injunction against the FDA seizing NJOY's shipments will be reinstated.
If the FDA ultimately wins and is permitted to regulate the products as though they were some new form of NRT, all products would ordered removed frrom the marketplace. Subsequently, if some e-cigarette company had millions of dollars to spend on clinical trials, we might see an FDA-approved e-cigarette available within 8 to 10 years.
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