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FDA and the Electronic Cigarette

In 2009 an article in the New York Times featured ecigs pointing out that ecigs are "safe" and "healthy" which are not proven statements. This prompted the FDA (Federal Drug and Food Administration) to step in, they decided to halt all foreign shipments of ecig products into the United States until a formal review could be made. As all production model ecigs are foreign made this effected the products availability in the United States.

The FDA performed tests on several ecigs and released the findings to the general public pointing out one harmful element found during the study. It was reported that one of the cartridges (which contain the fluid commonly made of Propylene Glycol, flavoring and nicotine) tested positive for a trace amount (less than 1% of DEG (Diethylene Glycol) which is harmful to humans.

The fact is DEG is commonly used by cigarette manufacturers in a quick drying process of tobacco leaves for cigarettes which results in DEG being found in tobacco cigarettes at unknown levels. Since the cartridge in question had nicotine that was extracted from a tobacco leaf it is reasonable to conclude some trace elements may appear in the process. If you use a cartridge or eLiquid in a bottle that contains synthetic nicotine instead of nicotine extracted from tobacco leaves no trace elements like DEG will be found. PLEASE VIEW UPDATES BELOW.

Side Note
Propylene Glycol was classified by the U. S. Food and Drug Administration as "generally recognized as safe" (GRAS) for use as a direct food additive.

FDA official report in PDF Form

 

 

Jan, 14th 2010 - Federal Judge rules in favor of Electronic Cigarettes
 

"ORDER, For the reasons set forth in the Memorandum Opinion, it is this 14th day of January, 2010,

hereby ORDERED that Plaintiff Motion for Temporary Restraining Order and/or Injunctive relief , which the Court has converted to a Motion for Preliminary Injunction (Minute Order dated May 1, 2009), and Plaintiff’s Motion for Preliminary Injunction are GRANTED; it is further ORDERED that FDA shall not detain or refuse admission into the United States of Plaintiff’s electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. 301 et seq;

It is further ORDERED that FDA shall not detain or refuse admission into the United States of Plaintiff’s electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations under the FDCA, absent a proffer of evidence, consistent with the Court's Memorandum Opinion, that Plaintiff’s products are intended to have a therapeutic effect; it is further ORDERED that the Combined Motion for Leave to Submit a Brief Amicus Curiae and Brief Amicus Curiae in Support of Defendant FDA by Action on Smoking and Health and Alliance of Electronic Smokers' Motion for Leave to Participate and File Brief as Amicus Curiae are GRANTED; and it is further ORDERED that the Motion of Intervenor-Plaintiff Sottera, Inc. d/b/a PLANTIFF for leave to File Reply to Defendants' September 17th Response to Proposed Amicus and Plaintiff Motion for Leave to File Instanter a Status Report Concerning Recent Events Which May Impact Plaintiff's Continued Existence are DENIED.

SO ORDERED. Signed by Judge Richard J. Leon on 1/14/10. (kc) (see order.) (Entered: 01/14/2010)

 

 

A Brief Quote from the 32 page Memorandum
 

"FDA contends that the public interest in health and safety weighs in favor of denying preliminary relief because, by enforcing the FDCA as it sees fit, FDA protects the public from unsafe and ineffective drugs. FDA further contends that the potential harm to other interested parties or to the public interest, should the court grant the preliminary injunction and allow the unapproved electronic cigarettes into the market, would far outweigh the economic harm to plaintiffs, should the court deny the preliminary injunction."

 

(Judge Leon Reply) "I disagree. While FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Plaintiff's have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health"

 

 

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Court Says FDA Authority Over Electronic Cigarettes aka eCigs Is Limited

December 7 2010 - In a United States federal appeals court a decision made found that as long as electronic cigarettes aren't marketed as a way to treat or cure a disease, the U.S. Food and Drug Administration has no authority to block the importation of electronic cigarette products.

 

Court Reports regarding FDA Injunction

Order Opinion Judgment

 

 

 



Court Of Appeals Dissolved Its March 31 2009 Stay Of eCigs Injunction

December 16 2010 - The Court of Appeals dissolved its March 31st stay of Judge Leon's injunction. In English, Judge Leon (District Court) issued a preliminary injunction against the FDA, telling it that it could no longer seize NJOY and SE's shipments while the case was being heard.
The FDA appealed Judge Leon's grant of the preliminary injunction to the Court of Appeals.

The Court of Appeals said that until it actually had time to fully consider the issues, Judge Leon's injunction would be stayed (put on hold). The Court of Appeals has now dissolved that stay, effectively making Judge Leon's preliminary injunction once again in full force and effect. While this is directed at NJOY, this should in effect, potentially stop the FDA for seizing products at the border.

 

 

 



U.S. Court of Appeals again DENIES FDA
(U.S. Federal Drug Administration)

January 26th 2011 - The fledgling electronic-cigarette industry scored another victory against the Food and Drug Administration in federal court Monday, potentially setting the stage for the battery-powered devices to be regulated like conventional tobacco products.

The U.S. Court of Appeals for the District of Columbia Circuit rejected the FDA's request to have the entire court review a December decision by a three-judge panel that went against the agency. The FDA, which contends that the products should be regulated as drug devices, now has the option of........... see WSJ website, link below

E-Cigarette Industry Wins Federal Court Victory - WSJ.com

 

 



FDA Pushed To Define Scope Line Between Drug And Tobacco Products

March 31st 2011 - FDA Pushed To Define Scope, Line Between Drug And Tobacco Products

By Alaina Busch
FDA Weekly
March 31, 2011

A key Democratic lawmaker and a stakeholder group are urging FDA to close loopholes in the Tobacco Control Act that enable exemptions for certain tobacco goods, with the agency saying it is still considering its options for some tobacco-derived products as it defines the line between tobacco and drug products. FDA, citing current limitations in the law, recently said it could not to regulate dissolvable tobacco lozenges from a tobacco company, a decision that drew the ire of an anti-tobacco group, while a tobacco policy expert contends that drug companies could seize on the agency's conclusion to market their smoking-cessation goods without certain warnings or claims.

As part of this debate on how to draw FDA's jurisdictional lines for tobacco, some lawmakers are pressing the agency to expand the ban on clove cigarettes to cigars, which are not explicitly covered under the law. The issue also plays into how FDA will balance the interests of the drug and tobacco industries (see FDA Week March 4).

FDA recently indicated that it would not yet expand its jurisdiction over tobacco to also subsume dissolvable tobacco products. Star Scientific applied for modified risk tobacco status for its ARIVA-BDL and STONEWALL-BDL dissolvable tobacco products last year, but FDA said last week that the products did not fall under requirements for cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco, which are currently subject to the law, according to the company.

The agency's decision could open the market to other tobacco or drug companies to market their dissolvable or smoking cessation products without warnings, which are required for tobacco, said Bill Godshall executive director of Smokefree Pennsylvania. Drug companies have run clinical trials to make therapeutic claims to market similar tobacco products aimed at helping smokers quit, but these products must also include risk information, as they are regulated as pharmaceuticals. Drug companies could also have a piece of the market without stringent premarket and treatment controls, provided they drop the claims that their products help smokers quit, Godshall said.

The recommended course of treatments for these nicotine replacement therapies are 10 to 12 weeks, but recovering smokers often use the products longer, which is considered an off-label use, Godshall said. By marketing without therapeutic claims, drug companies would also not have to warn consumers to only use the products for a limited time, he added.

"I don't see the drug companies doing that because this is a public relations issue for them," he said. "They don't want to be viewed as another competitor in the tobacco industry."

While the agency has explicit powers to regulate the products stated in the law, the statute gives it the authority to draft regulations for all tobacco-derived products, provided the agency proves the requirements would be beneficial to public health, said Godshall. "The burden of proof is on the FDA now," he said.

FDA's Star Scientific decision was met with criticism from the Campaign for Tobacco-Free Kids, which said the products meet FDA's definition of smokeless tobacco and are explicitly regulated by the law.

"The FDA has created a loophole where no loophole existed in the law and issued an invitation to tobacco companies to introduce new unregulated tobacco products," according to the group's president Matthew Myers. "This is exactly what Congress sought to prevent when it passed the 2009 law granting the FDA authority over tobacco products. The FDA should reverse course and close this dangerous loophole immediately."

The law outlines a schedule of studies to be conducted on various topics regarding the public health implications of regulating or banning certain products. Like the agency's recent analysis of menthol cigarettes, FDA's Tobacco Products Scientific Advisory Committee will next study dissolvable tobacco. "They can still promulgate regulations and I anticipate they're going to," Godshall said.

FDA is grappling with establishing the boundaries between tobacco and other regulated products, including drugs and devices. The agency has pending litigation over its decision to regulate electronic cigarettes as medical devices, with federal courts saying the products are derived from tobacco and should be subject to those regulations.

"FDA recognizes there are uncertainties regarding the regulatory status of a variety of nicotine-containing products derived from tobacco; more specifically, whether these products are regulated as drugs or tobacco products," the agency said in response to its Star Scientific decision.

Aside from electronic cigarettes, FDA could expand its control over products like pipe tobacco and cigars, Godshall said. Clove flavored cigars drew the attention of Rep. Henry Waxman (D-CA), ranking member of the House Energy and Commerce Committee, who encouraged the agency to take advantage of the discretion allowed by the law to ban these products. In letter Monday (March 28) to FDA Commissioner Margaret Hamburg, he said the lead manufacturer of clove cigarettes, Kretek International, switched its clove cigarettes to cigars to circumvent FDA oversight.

Citing company documents from 2007, Waxman said company executives -- in anticipation of a ban -- started the process of switching the products to cigars. They did not plan to change the product formulation, but would not use a paper wrapper, thereby evading the definition of cigarette, according to Waxman.

"I recognize that there are historical differences between cigarettes and cigars," according to the letter. "Congress recognized these differences by requiring FDA to ban flavored cigarettes, while giving FDA discretion to decide whether to ban flavored cigars. In this case, however, Kretek is exploiting the distinction to keep its dangerous product on the market." The company did not respond to a request for comment.

With passage of the law, Congress instituted a ban on all cigarette flavoring, aside from menthol. While the legislation gives FDA the power to ban flavored products, it cannot enact a complete ban on nicotine or all cigarettes.

 

 

 



FDA Annoncement (U.S. Federal Drug Administration) eCigs now Tobacco Product

April 25th 2011 - After the most recent loss in the federal court of appeals the FDA made an announcement that electronic cigarettes will be regulated as a tobacco product. The good news is electronic cigarettes are now officially recognized by the United States government and is no longer banned for importation.

The new concern is that eCigs (electronic cigarette's) are not the same as tobacco products and should be regulated as a product lesser in health risks than tobacco cigarettes. In addition the FDA now also controls tobacco products and with the recent banning of flavored cigarettes the future is unknown for future regulation, taxation and restrictions.

Yahoo News Article

FDA Public Annoncement - Link on FDA Site

 

 


 

 

Are you thankful for your Electronic Cigarette?
 
Send Judge Leon a professional letter letting him know your story. The road is still a long one regarding this product as a court case is still to take place with Judge Leon presiding. We the people should stand up and let our voice be heard regarding the regulation of this product on both State and Federal levels.
 

The Honorable Richard J. Leon

Clerk's Office
United States District Court for the District of Columbia
333 Constitution Avenue, N.W.
Washington, D.C. 20001
 

 

 

Recent Links

Click LinkF.D.A. Ordered to Stop Blocking Imports of E-Cigarettes - NYTimes.com

 

 

 

FDA Response to Recent Court Ruling in FDA WEEK

 

Court Rejects FDA Bid To Regulate Nicotine Products Outside Tobacco Law

By Alaina Busch
FDA Week
December 9, 2010

A federal appeals court ruled that nicotine products, including electronic cigarettes, are to be regulated as tobacco, reaffirming previous decisions while going against recent FDA actions to regulate the products as drugs and devices. While opponents of the decision are raising safety concerns saying it will lead to an uptick in nicotine items and be detrimental to public health, some anti-smoking advocates have long pushed for the products to be regulated as tobacco, not requiring safety and efficacy data, to keep them on the market for former smokers who rely on them as cessation aids.

One opponent of the decision, which reaffirmed that FDA cannot ban electronic cigarette imports, equated the ruling to the creation of a "wild west" of nicotine products, while a longtime anti-smoking advocate lauded it as a public health victory saying FDA's attempt to strictly regulate the products has bolstered the tobacco industry.

The U.S. Court of Appeals for the District of Columbia Circuit on Tuesday (Dec. 7) affirmed a January ruling that tobacco-derived products are subject to the Family Smoking Prevention and Tobacco Control Act, which brought tobacco under FDA's power in 2009.

The ruling comes three months after FDA announced that it would regulate the products as drugs and devices under the Food, Drug and Cosmetic Act, requiring safety and efficacy studies. The agency sent letters to five distributors and a trade group announcing its intentions. The distributors received warning letters for making unsubstantiated claims and poor manufacturing practices (see FDA Week, Sept. 10).

Citing FDA v. Brown & Williamson Tobacco Corp., a Supreme Court case that denied FDA's efforts to regulate cigarettes as a drug-device combination in the 1990s, the court ruled that the tobacco law that has since passed further established that other tobacco products cannot be regulated as such either.

"To the extent that Congress believed Brown & Williamson left an insufficiently regulative environment for cigarettes, smokeless tobacco, cigars, and other tobacco products, it found the Tobacco Act an adequate remedy," according to the court decision, written by Circuit Judge Stephen Williams.

A federal judge had previously ruled that electronic cigarettes are not drug-device combinations and FDA could not block their shipment. The agency had been taking action against the products since 2008 (see FDA Week, Jan. 22).

Groups like Campaign for Tobacco-Free Kids said the decision will lead an unsafe level of nicotine in products. The group's president, Matthew Myers, said the ruling will have harmful implications for public health.

"While the court found that the FDA could regulate electronic cigarettes as tobacco products, it will take the FDA time to assert jurisdiction over these products and issue regulations governing them, leaving these products unregulated in the meantime," he said in a statement. "This ruling invites the creation of a wild west of products containing highly addictive nicotine, an alarming prospect for public health."

Other anti-smoking advocates, like Smokefree Pennsylvania, have lauded the decision as a public health victory. The group, in addition to the Washington Legal Foundation, filed an amicus curae brief on behalf of Sottera, Inc., the company listed in the lawsuit. The American Association of Public Health Physicians has also filed citizen petitions requesting the agency reclassify electronic cigarettes as tobacco products.

Bill Godshall, executive director of Smokefree Pennsylvania, said FDA's move to strictly regulate the products, which are mostly used by former smokers, has bolstered the tobacco industry because the most harmful products are still on the market. The majority of the e-cigarette companies, he said, were not making therapeutic claims, which would have made them subject to stricter regulations.

By reclassifying the products as tobacco, the 2009 tobacco law allows for safety monitors, he said. Quality concerns about the products, which are primarily imported, were cited when FDA announced its regulatory plans earlier this year.

"A lot of these things people are claiming are problems with the products can be resolved," Godshall said. The Tobacco Control Act would give FDA power to regulate health claims and require manufacturer registration as well as laboratory analyses of the products.

Depending on whether FDA appeals the decision, he said he expects tobacco companies to get into the product's market. Other nicotine products that had previously been banned, like lollipops, water and skin cream, will likely resurface, he said. "And that's good because these are all far less hazardous tobacco alternative products," he said.

The ruling comes as a collaborative study on the safety of electronic cigarettes was released by Legacy, Georgetown University School of Medicine and Johns Hopkins Bloomberg School of Public Health. After an analysis of several electronic cigarette brands, researchers found that there was no consistency in the delivery of nicotine, suggesting poor quality controls.

Nathan Cobb, a researcher at Schroeder Institute for Tobacco Research and Policy Studies at Legacy, said the poor standards present a new set of risks associated with e-cigarettes. "These devices and accessories present a new and wholly different set of risks apart from those of tobacco, including the real risk of inadvertent nicotine overdose," Cobb said in a release. "The variation in design and poor quality control emphasizes that they should not be on the market until and unless regulation to ensure device safety has been established."


 

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