A U.S. Court of Appeals ruling reinstates the FDA’s authority — at least temporarily — to stop e-cigarettes from entering the country after a lower court ruled that the agency does not have the authority to regulate electronic cigarettes, even though Congress granted the agency the power to regulate tobacco products in 2009.
The FDA filed the appeal (15-page PDF; About PDFs) after a U.S. District Court judge granted an injunction (2-page PDF; About PDFs) on Jan. 14 that blocked the FDA from stopping electronic cigarettes from entering the country. The appeals court granted a stay (1-page PDF; About PDFs) of the district court’s injunction, pending an appeal. The stay reinstates the FDA’s authority.
District Court Judge Richard Leon said in the Jan. 14 ruling that the Family Smoking Prevention and Tobacco Control Act passed last year does give the agency the authority to regulate “any product made or derived from tobacco that is intended for human consumption.” That could include e-cigarettes, which contain nicotine extracted from tobacco.
FDA officials, however, say they would prefer to regulate e-cigarettes as drug delivery devices rather than as tobacco products because treating e-cigarettes as the former would give the agency far broader control, including the ability to block importation of the devices and their components.
The agency said in its appeal that it has regulated nicotine products, including nicotine patches, for years under the drug and device provisions of the Food, Drug and Cosmetic Act, or FDCA. The agency argued that tobacco legislation enacted last year “expressly excludes from the definition of ‘tobacco product’ any article that is a drug, device or combination product under the FDCA, and provides that such articles shall be subject to regulation under the pre-existing FDCA provisions.”
An agency spokesperson declined to comment on the case, which is ongoing.
According to court records, the dispute between the FDA and e-cigarette distributors started in September 2008 — before the tobacco legislation passed — when the agency put a hold on two shipments of e-cigarettes at Los Angeles International Airport. A month later, FDA officials issued notices of detention on the grounds that shipments belonging to Smoking Everywhere Inc. — one of the companies that later sued the FDA — appeared to be “adulterated, misbranded or otherwise in violation” of the FDCA.
In July 2009, the FDA issued a warning about e-cigarettes to consumers and physicians after the Division of Pharmaceutical Analysis in the agency’s Center for Drug Evaluation and Research said samples from the products had detectable levels of known carcinogens and toxic chemicals.
Manufacturers have touted the smokeless products, which are battery-operated devices that turn nicotine and other chemicals into a vapor that is inhaled by the user, as safer than conventional cigarettes. However, public health officials have countered that the products have not been adequately tested and should not be marketed to young people
An average smoker who smokes a pack a day of tobacco cigarettes at $6/pack can spend over $2190 a year. That same smoker can save over $1600 annually just by switching to electronic cigarettes. Keeping this routine of a pack a day with electronic cigarettes they would now only spend $548 a year on cartridges!
The Cancer Society has this to say about nicotine: “Many people mistakenly think that nicotine is the substance in tobacco that causes cancer. This belief may cause some people to avoid using nicotine replacement therapy when trying to quit. Although nicotine is what gets (and keeps) people addicted to tobacco, other substances in tobacco are responsible for its cancer-causing effects.”
With traditional cigarettes, the smoker is forced to inhale thousands of unwanted chemicals (over 3900) and carcinogens along with the nicotine. What is an electronic cigarette? They’re a revolutionary new nicotine delivery system that provides a smarter alternative to traditional cigarette smoking. Electronic cigarettes deliver only the nicotine, they contain mainly water, nicotine and propylene glycol (a common additive in food coloring and cake mixes).
Tobacco smokers everywhere are taking notice of a smarter alternative to cigarettes and the proof is certainly evident. Electronic cigarette reviews are pouring in from all over the world with tobacco smokers posting their experiences on social sites such as YouTube… their exceptance has just been phenomenal.
An average smoker who smokes a pack a day of tobacco cigarettes at $6/pack can spend over $2190 a year. That same smoker can save over $1600 annually just by switching to electronic cigarettes. Keeping this routine of a pack a day with electronic cigarettes they would now only spend $548 a year on cartridges!
The Cancer Society has this to say about nicotine: “Many people mistakenly think that nicotine is the substance in tobacco that causes cancer. This belief may cause some people to avoid using nicotine replacement therapy when trying to quit. Although nicotine is what gets (and keeps) people addicted to tobacco, other substances in tobacco are responsible for its cancer-causing effects.”
With traditional cigarettes, the smoker is forced to inhale thousands of unwanted chemicals (over 3900) and carcinogens along with the nicotine. What is an electronic cigarette? They’re a revolutionary new nicotine delivery system that provides a smarter alternative to traditional cigarette smoking. Electronic cigarettes deliver only the nicotine, they contain mainly water, nicotine and propylene glycol (a common additive in food coloring and cake mixes).
Tobacco smokers are choosing this smarter smoking alternative at an unbelievable rate. Taking a stroll down any city street or being part of any social gathering and your bound to see users of this hugely popular device.
The accusation, however, was misleading and ran totally contrary to the facts.
The United States, which is embracing trade protectionism itself, is trying to confuse black and white by accusing others.
Who on earth is creating “headaches” for foreign companies? Facts speak louder than words.
China is the third largest export market of the U.S., and has been the fastest growing one for years.
Posted: March 6th, 2010
at 7:10am by admin
Categories: e-cig
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Trade disputes between China and the United States continued to escalate as the US Department of Commerce on Tuesday said it would impose preliminary duties on imports of China-made potassium phosphate salts and coated paper, accusing the Chinese government of giving subsidies to the manufacturers.
Chinese producers of potassium phosphate salts may have to face a countervailing duty of up to 109 percent if they export their products to the US, while domestic makers of coated paper face a tariff between 4 and 13 percent.
The final ruling will be announced in May. Before the announcement, the US Customs and Border Protection will collect a cash deposit or a bond based on the preliminary rates.
US imports of Chinese potassium phosphate salts soared 228 percent by value from 2006 to US$16.4 million in 2008. The value of Chinese coated paper sold in the US was estimated at US$228.7 million in 2008, Xinhua news agency said.
The two cases emerged less than a week after the US decided to levy a tariff of up to 12.97 percent on Chinese seamless steel tubes.
Yao Jian, spokesman for the Ministry of Commerce, blasted the US “protectionism” actions in the earlier case, saying that “this is the US abusing its own trade relief measures.”
Potassium phosphate salts are found in industrial cleaning products, fertilizers and food additives. Coated paper is used to print high-end magazines, catalogues and corporate reports.
U.S. Commerce Secretary Gary Locke last week accused China of protecting domestic firms and creating barriers for foreign investment.
He warned Beijing against backsliding on economic openness and rule of law, saying it could cause American companies to lose interest in China.
The accusation, however, was misleading and ran totally contrary to the facts.
The United States, which is embracing trade protectionism itself, is trying to confuse black and white by accusing others.
Posted: March 6th, 2010
at 7:09am by admin
Categories: e-cig
Comments: No comments
About a month ago, I had a discussion with a friend in US studies on emerging Sino-US disputes in the climate change conference at Copenhagen. Don’t believe these superficial phenomena, he said. This is a drama co-acted by China and the US. In other words, China and the US are pretending to be at odds to dismiss the international community’s worries that the G2 is ruling the world. The evidence that justify his opinions is the concept conveyed by US President Barack Obama that the Sino-US relation is one of the most important bilateral relations in the world. State Secretary Hillary Clinton once said that the two countries should “be in the same boat” to handle global issues, which also contributes to my friend’s view. If his drama theory were true, then it had been overthrown by the recent US policies regarding China. Obama has been consistently challenging Sino-US trade relations, which could trigger a trade war. This is a policy that seeks to contain the development of China. He also declared an arm sales deal to Taiwan, despite the fact that tension across the Straits has relaxed. This is a policy that intervenes in the sovereignty of China and its own process of reunification. The Obama administration also took the opportunity brought forth by Google to attack China’s Internet management, while the US has sold the value of Internet freedom to Chinese people. This is a policy that distorts China’s international appearance and at the same time intentionally influences China’s mainstream values.
Posted: March 6th, 2010
at 7:07am by admin
Categories: e-cig
Comments: No comments
This means electronic cigarettes will stay in the market for now. The ruling could have far-reaching implication on federal regulation of tobacco products. Those in favor of tobacco-control said that this ruling could give birth to a range of new nicotine-laced products that have been controlled by the FDA. The case In September 2008, the FDA confiscated imports of battery-operated devices that were used for turning a nicotine solution into vapors, for inhalation. The FDA labeled these as drug delivery devices and banned their entry in the nation on the pretext that they these e-cigarettes were unapproved, misbranded products being used as a substitute to traditional cigarettes. The agency had also expressed concerns over the indefinite intensity of nicotine and other chemicals in these. FDA was sued by Smoking Everywhere Inc. and NJOY, whose e-cigarettes were seized. The companies alleged that the agency had overstepped its authority. On Jan. 14, a U.S. District Court of the District of Columbia agreed to this argument. Judge Richard J Leon wrote, “There is no basis for FDA to treat electronic cigarettes … as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette.” “FDA cites no evidence that [e-cigarettes] … are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available,” the court observed, adding that FDA’s concerns did not in any way prevail over the economic harm sustained by the plaintiffs.
A federal judge has ruled that electronic cigarettes cannot be regulated as drug delivery devices by the Food and Drug Administration (FDA). This decision has left the public health community red-faced
The study, led by psychologist Thomas Eissenberg, included 16 smokers. In four different phases of the study, each separated by two days, they were asked to: smoke a cigarette from their preferred brand; “sham smoke” a cigarette—or basically “puff” on it without lighting it; use an Njoy NPRO electronic cigarette filled with a 16mg nicotine cartridge; and use a Crown 7 Hydro e-cigarette filled with a 16mg nicotine cartridge. Both e-cigarettes’ batteries were fully charged for each “smoking” session.
Prior to the trials, smokers were asked to abstain from nicotine for 12 hours. At the beginning of each session, they had catheters inserted into their veins, enabling researchers to take blood samples multiple times—5, 15, 30 and 45 minutes after the first puff—to measure for nicotine content. They found that, as you would expect, actually smoking dramatically increased nicotine content in the blood. Yet, when it came to the e-cigarettes, both brands increased nicotine content only nominally more than sham smoking. What’s more, the products did little to reduce cigarette cravings.
