Smoke versus Vapor
The Tobacco Industry vs the Electronic Cigarette
Researchers Call E-Cigarettes Unsafe as U.S. Court Weakens FDA Regulation
December 10, 2010
A federal court has ruled that the Food and Drug Administration (FDA) can only regulate e-cigarettes as tobacco products and not as drug-delivery devices, even as new research cast doubt on their safety.
The U.S. Court of Appeals for the D.C. Circuit said in its ruling that the Federal Food, Drug, and Cosmetic Act does not give the FDA the authority to regulate e-cigarettes under the same rules as nicotine gum or the nicotine patch, the Associated Press reported Dec. 7.
The ruling prevents the FDA from requiring e-cigarette manufacturers to conduct stringent clinical trials to prove the product's safety and effectiveness as an aid to quit smoking. The court said that the FDA did have the authority to regulate e-cigarettes as tobacco products.
The ruling was criticized by public health groups who have warned that e-cigarettes are unproven as stop-smoking aids, contain hazardous substances, and suffer from haphazard quality control and safety issues.
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said the ruling will permit "any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time."
Researchers question e-cigarette safety
Meanwhile, new research suggests the electronic nicotine delivery devices may be unsafe, according to a Legacy Foundation press released published Dec. 7 on PR Newswire.
Investigators at the Schroeder Institute for Tobacco Control and Georgetown University's Lombardi Center lab-tested different brands of e-cigarettes. They found that the amount of nicotine delivered varied greatly, depending upon the maker of the device, the cartridge used, and "even from puff to puff."
"This inconsistency suggests poor quality control measures, which contributes to the list of unknowns about [e-cigarettes] and adds to the public health community's skepticism surrounding the products," said the study's lead author, Nathan Cobb, MD, Research Investigator at the Schroeder Institute.
Cobb and his colleagues said that although manufacturers claim that e-cigarettes may reduce the harm associated with cigarette smoke, the devices also present risks not associated with tobacco.
The researchers found that e-cigarettes delivered three to five times less nicotine than advertised, but the "juice" bottles used to refill them could contain over 1.5 grams of nicotine - a lethal dose - in packages that were not child-resistant.
Cobb said, "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."
The study, "Novel Nicotine Delivery Systems and Public Health: The Rise of the 'E-Cigarette,'" appeared in the December 2010 issue of the American Journal of Public Health.
Meanwhile, researchers at the University of California conducted a separate study of e-cigarettes and concluded that they are unsafe to sell, HealthDay reported Dec. 7.
The investigators bought six different brands of e-cigarettes online and assessed their safety. Among other findings, they reported that most e-cigarette cartridges leaked nicotine onto users' hands; that cartridge labels rarely included expiration dates, health warnings, or information about what was in them; that cartridges with no nicotine content "looked identical to those that claimed to have higher nicotine content ... once removed from their packs and wrappers"; and that safety features often malfunctioned.
Printed and online marketing material for the devices also made factually inaccurate claims. For example:
- "Be careful to avoid inhaling any significant quantity of fluid. Although it gives you a slight tingling sensation, it is not harmful."
- "Within two weeks your lung capacity will increase by 30 percent ... Wrinkles in your skin will become less noticeable."
Investigators concluded that "regulators should consider removing [electronic cigarettes] from the market until design features, quality control, disposal and safety issues have been adequately addressed."
The study, "Electronic nicotine delivery systems: is there a need for regulation?" was released online December 7, 2010 in Tobacco Control.
COMMENTS ON THIS ARTICLE:
Judge OKs imports of e-cigarettes, blasts FDA
In a sharply worded decision, U.S. District Judge Richard Leon scolded the Food and Drug Administration for trying to assert jurisdiction over the cigarettes, which are battery-powered or rechargeable devices that vaporize a liquid nicotine solution.
WASHINGTON (Reuters) - A U.S. judge on Thursday granted a preliminary injunction barring the Obama administration from trying to regulate electronic cigarettes and prevent them from being imported into the United States.
"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," he said in granting an injunction barring the FDA from regulating the cigarettes as a drug-device combination.
E-cigarettes were first made in China and are sold mostly on the Internet. The battery-powered devices work by a emitting a "puff" or fine mist of nicotine in the lungs.
A law passed last year gave the FDA power over regular cigarettes and other tobacco products. But while e-cigarettes contain nicotine, they do not contain tobacco and are not subject to the new oversight.
But FDA maintains it has control over the products because they aim to treat people suffering from nicotine withdrawal, making them a combination drug and device -- two things the agency has regulated for years.
A company that imports the electronic cigarettes, Smoking Everywhere Inc., had two shipments detained by the agency in late 2008 because they were not FDA approved.
The FDA later barred the importation of electronic cigarettes and their components by three Chinese companies. The FDA also denied entry to more than 35 shipments from 20 other manufacturers, according to the court ruling.
Smoking Everywhere and another manufacturer asked the court to bar the FDA from refusing entry to their products and regulating them, which Leon agreed to do.
PRODUCE NO SMOKE
The court noted that the other company in the case, NJOY, labeled its products with a disclaimer that they were not for smoking cessation. On its website, NJOY says one main reason people use the product is that it produces no smoke and can be used in some places where smoking is prohibited.
Smoking Everywhere said in its original complaint last year that it had imported and sold more than 600,000 electronic cigarette kits.
A lawyer representing the companies said that he expected the FDA to appeal the decision, although he argued the judge anticipated many of the arguments the agency could make.
"It's going to be difficult for the FDA to get Judge Leon reversed," said the lawyer, Kip Schwartz of Thompson Hine LLP. "But that won't stop them."
FDA spokesman George Strait said the agency was reviewing the judge's decision, adding that "the public health issues surrounding electronic cigarettes are of serious concern."
The agency has said it is worried about safety issues and last year warned that some samples it tested contained carcinogens and toxic chemicals. The World Health Organization has also warned against their use, saying there was no evidence to prove they were safe or helped smokers break the habit.
The Campaign for Tobacco-Free Kids and other consumer advocacy groups blasted the ruling, saying it put U.S. consumers at risk.
"This is a misguided and mind-boggling decision by the court," said National Research Center for Women & Families President Diana Zuckerman. "Nicotine is an addictive drug, and therefore e-cigarettes are a drug delivery system."
A 2009 Zogby poll found Americans divided over whether the e-cigarettes should be regulated by the government
(Reporting by Jeremy Pelofsky and Susan Heavey, editing by Cynthia Osterman)
Lawyers Ask Judge to Lift Ban on Electronic Cigarettes
August 17, 2009
Lawyers for electronic cigarette distributors told a federal judge today that their clients do not market their products as a way to quit smoking, and that the Food and Drug Administration was acting like a dog chasing its own tail as it tried to explain why it was barring shipments of the devices into the United States.
Appearing this afternoon at the U.S. District Court for the District
of Columbia, attorneys for Smoking Everywhere and NJoy asked Judge
Richard Leon for a preliminary injunction that would lift the FDAs
embargo on their products. The companies sued the FDA in April,
claiming the agency had erroneously classified e-cigarettes as
unapproved drug devices, and banned imports of them into the states.
House Of Representatives
Tying It All Together: Learn about the Legislative Process
"All Legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives."
(Article I, Section 1, of the United States Constitution)
The chief function of Congress is the making of laws. The legislative process comprises a number of steps, and much information is available from this page concerning the legislation introduced and considered in the 111th Congress. To help you understand the information and how it interrelates, a very brief overview of the legislative process within the House of Representatives is presented below. There are many aspects and variations of the process which are not addressed here. A much more in-depth discussion and presentation of the overall process is available in How Our Laws Are Made. Most of the information presented below was excerpted from that Congressional document.
Forms of Congressional Action
The work of Congress is initiated by the introduction of a proposal in one of four principal forms: the bill, the joint resolution, the concurrent resolution, and the simple resolution.
It looks like there will be a need to provide information with regards to the electronic cigarette and the legalities involved, since there will most likely be a few issues that will need to be covered. With that in mind, I will do my best to keep you informed and up to date. Please feel free to contact me if you have pertinent information regarding these issues and I will pass word along though this page.
You can also access The Library of Congress THOMAS ...
In the spirit of Thomas Jefferson, legislative information from the Library of Congress
It is a highly informative website which you can access to keep up with the latest information on a number of different issues.
Search Multiple Congress Sites
Certified by Superintendent of Documents <[email protected]>
One Hundred Eleventh Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the sixth day of January, two thousand and nine
To protect the public health by providing the Food and Drug Administration with
certain authority to regulate tobacco products, to amend title 5, United States
Code, to make certain modifications in the Thrift Savings Plan, the Civil Service
Retirement System, and the Federal Employees Retirement System, and for
other purposes.
Smokefree Innotec, Inc.
NASHVILLE, Tenn.- Smokefree Innotec, Inc. (Pink Sheets: SFIO) (www.sfio.us or www.smokefree-innotec.com) announced today that it has retained the law firm of Troutman Sanders LP as counsel with respect to its FDA and other cigarette regulatory issues.
Smokefree Innotec, Inc. C.E.O., Thomas Schroepfer, stated that, With the FDA
now beginning to assert authority over all electronic cigarettes and having seen
the turmoil involving other companies in the electronic cigarette business, we
are pleased to have Ashley L. Taylor, Jr. and Bryan M. Haynes, both of whom are
partners in the Richmond, Virginia office of Troutman Sanders LLP, to advise our
Company. Mr. Taylor and Mr. Haynes are based in the heart of the United States
cigarette industry and both have extensive expertise in the legal issues of the
cigarette industry and government regulation of the industry. They will be of
great assistance to our launch of the Worlds first, totally smoke-free,
Hi-Tec cigarette in North America.
As we all know, one of the most important issues hanging in the balance right now is the Njoy & Smoking Everywhere vs the FDA court case ... as it will most likely set precedent with regards to the continued usage and enjoyment of the electronic cigarette, cigar and pipe.
Case 1:09-cv-00771-RJL
Document 1
Filed 04/28/2009
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
________________________________
SMOKING
EVERYWHERE, INC.,
Plaintiff,
Civ. No. 09-cv-0771 (RJL)
v.
U.S. FOOD AND DRUG
ADMINISTRATION,
and
U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Defendants.
_________________________________
Plaintiff Smoking Everywhere, Inc. For it's complaint against the United States Food and Drug Administration, Joshua M. Sharfstein, M.D., Acting Commissioner for Food and Drugs, and Margaret Hamburg, M.D., Commissioner Designate for Food and Drugs (collectively, "FDA"), and the United States Department of Health and Human Services, Charles E. Johnson, acting Secretary of the Department of Health and Human Services, and Kathleen Sebelius, Secretary Designate for the Department of Health and Human Services (collectively, "DHHS") hereby alleges as follows:
Preliminary Statement
1. This is an action for declaratory and injunctive relief pursuant to 28U.S.C. 2201 and 5 U.S.C. 702 et seq. to stop the FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes " electronic products that are derived from tobacco and allow a user to inhale a liquid vapor for the purpose of "smoking" pleasure.
Preliminary injunction Request
April. 30, 2009
INTRODUCTION
Plaintiff Smoking Everywhere, Inc., seeks a preliminary injunction requiring the United States Food and Drug Administration to permit SE to import an electronic cigarette product and its accessories "E-Cigarettes" for distribution in the United States. SE asserts that FDA lacks jurisdiction to regulate its product, which it claims is a "on-therapeutic" alternative to traditional cigarettes. SE is not entitled to this relief. It has no likelihood of success on the merits, it has not established an irreparable injury, and the balance of interests does not weigh in its favor.
Continued
FOR THE DISTRICT OF COLUMBIA
Plaintiff,
and Civ. No. 09-cv-0771 (RJL)
SOTTERA, INC., d/b/a NJOY,
Intervenor-Plaintiff,
v.
U.S. FOOD AND DRUG
ADMINISTRATION, et al.,
Defendants.
DEFENDANTS SUPPLEMENTAL BRIEF IN OPPOSITION TO PLAINTIFFS
AND INTERVENORS MOTIONS FOR A PRELIMINARY INJUNCTION
At the preliminary injunction hearing on May 15, 2009, the Court inquired about the effect that the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which was signed into law on June 22, 2009, might have on the legal issues before the Court. See FSPTCA, Public Law No: 111-31, H.R. 1256, 111th. Cong. (2009)
Continued ...
UNITED
STATES DISTRICT COURT
FOR THE
DISTRICT OF COLUMBIA
_________________________________
SMOKING
EVERYWHERE, INC.,
Plaintiff,
and
Civ. No. 09-cv-0771
(RJL)
Received Sept-09-2009
SOTTERA, INC., d/b/a
NJOY,
Intervenor-Plaintiff,
v.
U.S. FOOD AND DRUG
ADMINISTRATION, et al.,
Defendants.
_________________________________
ALLIANCE
OF ELECTRONIC SMOKERS MOTION FOR LEAVE TO
PARTICIPATE
AND FILE BRIEF AS AMICUS CURIAE
The
Alliance of Electronic Smokers (AES), as an interested nonparty, by
and through undersigned counsel, respectfully moves the Court for
leave to participate and file a brief as amicus curiae in this
litigation in support of Plaintiff's and Intervenor-Plaintiffs
Motions for Preliminary Injunction.
ARGUMENT
As set forth in greater detail in the Accompanying Brief of Amicus Curiae, AES is an ad hoc group consisting of current consumers of electronic cigarettes (e-cigarettes) that would like to preserve their current choice of tobacco products a right that is being eliminated by the efforts of the U.S. Food and Drug Administration (FDA) to improperly to exert regulatory authority over e-cigarettes. AES and its members are concerned that their right to choose a preferred vehicle for smoking pleasure could be infringed based on the outcome of the present case. Accordingly, AES and its members have significant interests in the outcome of this litigation. Moreover, AES believes that its perspective would be helpful to the Court in evaluating the merits of this matter.
Another extremely important issue is the PACT Act which is being moved steadily through channels at this time. The PACT Act ... will successfully intervene on behalf of the Government, should the aforementioned case be successful in it's attempt to move the electronic cigarette away from it's classification as a medical devise and moved into the tobacco category.
H.R.1676
Title: To prevent tobacco smuggling, to ensure the
collection of all tobacco taxes, and for other purposes.
Sponsor: Rep Weiner, Anthony D. [NY-9] (introduced 3/23/2009) Cosponsors
(3)
Related Bills: S.1147
Latest Major Action: 6/1/2009 Referred to Senate
committee. Status: Received in the Senate and Read twice and referred
to the Committee on the Judiciary.
House Reports: 111-117
- 3/23/2009:
- Referred to the House Committee on the Judiciary.
- 4/28/2009:
- Committee Consideration and Mark-up Session Held.
- 4/28/2009:
- Ordered to be Reported (Amended) by Voice Vote.
- 5/18/2009 7:55pm:
- Reported (Amended) by the Committee on Judiciary. H. Rept. 111-117.
- 5/18/2009 7:56pm:
- Placed on the Union Calendar, Calendar No. 60.
- 5/19/2009 1:21pm:
- Mr. Weiner moved to suspend the rules and pass the bill, as amended.
- 5/19/2009 1:21pm:
- Considered under suspension of the rules. (consideration: CR H5730-5738)
- 5/19/2009 1:21pm:
- DEBATE - The House proceeded with forty minutes of debate on H.R. 1676.
- 5/19/2009 1:34pm:
- At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
- 5/21/2009 1:46pm:
- Considered as unfinished business. (consideration: CR H5912-5913)
- 5/21/2009 1:53pm:
- On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 397 - 11 (Roll no. 287). (text: CR 5/19/2009 H5730-5736)
- 5/21/2009 1:53pm:
- Motion to reconsider laid on the table Agreed to without objection.
- 6/1/2009:
- Received in the Senate and Read twice and referred to the Committee on the Judiciary.
S.1147
Title: A bill to prevent tobacco smuggling, to ensure the collection of all tobacco taxes, and for other purposes.
Sponsor: Sen Kohl, Herb [WI] (introduced 5/21/2009) Cosponsors (5)
Related Bills: H.R.1676
Latest Major Action: 5/21/2009 Referred to Senate committee. Status: Read twice and referred to the Committee on the Judiciary.
5/21/2009--Introduced.
Prevent All Cigarette Trafficking Act of 2009 or PACT Act - Amends the Jenkins Act to: (1) include smokeless tobacco as a regulated substance; (2) impose shipping and recordkeeping requirements on delivery sellers (sellers using the telephone, mails, or the Internet) of cigarettes and smokeless tobacco; (3) require common carriers of cigarette products to obtain age and identity verification upon delivery of such products; (4) require the Attorney General to compile and publish a list of delivery sellers of cigarettes or smokeless tobacco who have not complied with the registration or other requirements of such Act; (5) increase criminal penalties and impose new civil penalties for violations of this Act; and (6) grant jurisdiction to U.S. district courts to prevent and restrain violations of this Act and direct the Attorney General to administer and enforce this Act.
5/21/2009 Introduced.
Prevent All Cigarette Trafficking Act of 2009 or PACT Act - Amends the Jenkins Act to:
(1) include smokeless tobacco as a regulated substance;
impose shipping and recordkeeping requirements on delivery sellers (sellers using the telephone, mails, or the Internet) of cigarettes and smokeless tobacco;
require common carriers of cigarette products to obtain age and identity verification upon delivery of such products;
require the Attorney General to compile and publish a list of delivery sellers of cigarettes or smokeless tobacco who have not complied with the registration or other requirements of such Act;
increase criminal penalties and impose new civil penalties for violations of this Act; and
grant jurisdiction to U.S. district courts to prevent and restrain violations of this Act and direct the Attorney General to administer and enforce this Act.
Amends the federal criminal code to:
treat cigarettes and smokeless tobacco as nonmailable and prohibit such items from being deposited in or carried through the U.S. mails (with specified exceptions, including for mailings for consumer testing); and
authorize officers of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to enter the premises of certain cigarette shippers to inspect records and inventories.
Prohibits a tobacco product manufacturer or importer from selling or delivering in states cigarettes not in compliance with model or qualifying state statutes.
Limits the applicability of this Act with respect to Indian tribes and certain tribal matters.
Directs the ATF Director to create regional contraband tobacco trafficking teams and a Tobacco Intelligence Center to monitor and coordinate tobacco diversion investigations.
Expresses the sense of Congress with respect to the precedential effect of this Act.
FOR THE WESTERN DISTRICT OF KENTUCKY
BOWLING GREEN DIVISION
COMMONWEALTH BRANDS, INC.;
CONWOOD COMPANY, LLC; DISCOUNT
TOBACCO CITY & LOTTERY, INC.;
LORILLARD TOBACCO COMPANY;
NATIONAL TOBACCO COMPANY, L.P.; and
R. J. REYNOLDS TOBACCO COMPANY,
Plaintiffs, CIVIL ACTION
NO. 1:09CV-117-M
v.
(Electronically Filed)
UNITED STATES OF AMERICA; UNITED
STATES FOOD AND DRUG
ADMINISTRATION; MARGARET
HAMBURG, Commissioner of the United States
Food and Drug Administration; and KATHLEEN
SEBELIUS, Secretary of the United States
Department of Health and Human Services,
Defendants.
__________________________________________
MEMORANDUM OF AMICI CURIAE
CAMPAIGN FOR TOBACCO-FREE KIDS,
AMERICAN CANCER SOCIETY, AMERICAN CANCER SOCIETY
CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION,
AMERICAN LEGACY FOUNDATION, AMERICAN LUNG ASSOCIATION,
AMERICAN MEDICAL ASSOCIATION, AMERICAN PUBLIC HEALTH
ASSOCIATION, KENTUCKY MEDICAL ASSOCIATION,
ONCOLOGY NURSING SOCIETY,
AND PUBLIC CITIZEN IN OPPOSITION TO
MOTION FOR PRELIMINARY INJUNCTION OF PLAINTIFFS
COMMONWEALTH BRANDS, INC., ET AL.
The legal arguments in this case cannot be considered in isolation from the public health context in which they arise: For more than 30 years, tobacco use has been the nations leading preventable cause of death, disease, and disability. It causes nearly one out of every three deaths from cancer; one out of every five deaths from heart disease; and nearly nine out of ten deaths from lung cancer. Tobacco alone kills more people each year in the United States than AIDS, car accidents, alcohol, homicides, illegal drugs, suicides, and fires, combined. The nicotine in tobaccoproducts is highly addictive, and 77% to 92% of smokers are addicted to nicotine.
Continued
I ran across this one today, so I wanted to share it with you. Bryn Garrett on behalf of himself and all others similarly situated
Class action complaint
Violation of Unfair Competition Law, Business and Professions Code 17200
Unjust Enrichment
[JURY TRIAL DEMANDED]
blah blah blah
THE PARTIES
blah blah blah
6. Plaintiff Bryn Garrett is an individual residing in Sacramento County, California. During the Class period, he purchased Defendants e-cigarettes, suffered injury in fact, and has lost money and property as a result of the unlawful, unfair, misleading and deceptive advertising described herein.
I want to know when the Law Courts are going to put a stop to this ... as far as I can tell, Smoking Everywhere had a case for Litigation Harassment approximately a month ago ... it's a shame that these vultures have nothing better to do with their time.
