As many of our customers are aware, on February 15, 2011, as part of our efforts to ensure the uninterrupted availability of our products to customers in the United States, Totally Wicked filed a lawsuit against the United States Food and Drug Administration in the United States District Court for the District of Columbia. Totally Wicked was forced to file the lawsuit after FDA detained a shipment of Totally Wicked's electronic cigarettes and e-liquids at Miami International Airport in October 2010 on grounds that the products constituted "unapproved new drugs" or "misbranded drugs or devices" in violation of the federal Food, Drug & Cosmetic Act.
In addition to filing its complaint, Totally Wicked filed a motion for a temporary restraining order requesting an expedited determination by the District Court that FDA lacks the statutory authority to regulate Totally Wicked's products as "drugs" or "devices" under the Food, Drug & Cosmetic Act. Totally Wicked also requested that the Court order the immediate release of the detained Miami shipment. Instead of filing an opposition to the motion for a temporary restraining order, the FDA immediately entered into settlement negotiations with Totally Wicked's attorneys from Thompson Hine LLP.
As part of these settlement negotiations, Totally Wicked submitted much of its marketing material and product labeling to FDA for FDA's review throughout the months of March and April 2010. Totally Wicked also enacted several measures related to its website forum to address concerns raised by the FDA regarding certain claims made by forum users about Totally Wicked's products on the forum.
Near the conclusion of Totally Wicked's settlement negotiations with the FDA, on April 25, 2011, FDA released a "letter to stakeholders" regarding the regulation of electronic cigarettes
[http://www.fda.gov/
wherein FDA announced that it would no longer seek to regulate electronic cigarettes as "drugs" or "devices" so long as such products are not marketed for "therapeutic purposes."
Following the conclusion of the settlement negotiations between Totally Wicked and FDA, on May 9, 2011, the FDA provided Totally Wicked with a letter stating that FDA "does not intend to detain or refuse future shipments" of Totally Wicked products under the "drug" or "device" provisions of the federal Food, Drug & Cosmetic Act. On May 10, 2011, the FDA rescinded its "refusal" determination regarding Totally Wicked's shipment that had been held in Miami since October 2010 and released the shipment from detention.
Because the FDA had provided substantially all of the relief that Totally Wicked sought when it filed the lawsuit, on May 13, 2011, Totally Wicked voluntarily dismissed its case against the FDA, while retaining the right to immediately re-file the case in the event that the FDA fails to comply with its promised future course of action regarding Totally Wicked's products.
Totally Wicked is fully committed to ensuring that its customers in the United States continue to have unfettered access to our complete line of electronic cigarettes and e-liquids. We will continue to monitor FDA's activities relating to the regulation of electronic cigarettes and e-liquids and fully intend to take all measures necessary, even up to the point of further litigation against the FDA, to ensure that our products remain available to our customers and that our ability to import products into the United States remains uninterrupted. Thank you to all of our customers for their tremendous support—we look forward to continuing to be the premier supplier of electronic cigarettes and e-liquids in the United States for many years to come!
Regulation of E-Cigarettes and Other Tobacco Products
April 25, 2011
Dear Stakeholder:
The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco.
The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.” The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act.
Under the FD&C Act, the definition of “drug” includes articles intended: (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body. Similarly, “device” is defined to include articles intended: (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body.
Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.
The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.
Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.
Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions. Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to premarket review. Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”
FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:
- The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
- The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
- Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
- “Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health.
Sincerely,
Lawrence R. Deyton, M.S.P.H., M.D.
Director
Center for Tobacco Products
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
NOTE: Vaporia's Supplier, Totally Wicked, is based out of the United Kingdom. The company has seen many trials and tribulations over the years and are perceived by many as the sole pioneer of the fight for our rights to use E-Cigarettes. Totally Wicked is completely responsible for the correspondence above and have fought hard & tough for many years and vow to continue for many more. Vaporia happily joined the war in Jan of 2011. We are fighting for the same respect, in different countries.
The Electronic Cigarette, The Law and The User
The Law introduced in the United Kingdom in the Health Act 2006, banned the use of tobacco based cigarettes in public places.
The Act was introduced in response to where tobacco based cigarettes kills over 100,000 people each year in the UK, as lit tobacco produces tar, carcinogens, carbon monoxide and up to 400 other toxic substances.
In Chapter 28 that incorporates the Smoking ban, the definition of smoking is stated as : smoking refers to smoking tobacco or anything which contains tobacco, or smoking any other substance, and smoking includes being in possession of lit tobacco or of anything lit which contains tobacco, or being in possession of any other lit substance in a form in which it could be smoked.
The user of a electronic cigarette device is excluded from this Act as the device contains no tobacco; it is not ignited, and produces no smoke from burning substances.
The electronic cigarette can be used in any location and within any premises that introduced a ban on tobacco based cigarettes with the introduction into Law of the Health Act 2006.
Now for the United States of America and our Clean Air Act:
A Copy of the Wiki for 'The Clean Air Act 2009"
The first Clean Air Act was passed in 1963. It was amended first by the Clean Air Act Amendment in 1966, then by the Clean Air Act Extension of 1970 (84 Stat. 1676, Public Law 91-604). The 1970 extension is sometimes called the "Muskie Act" because of the central role Maine Senator Edmund Muskie played in drafting the content of the bill. The Clean Air Act Amendments in 1977 further modified the law.
The next major revision came with the 1990 Clean Air Act, which was enacted by the 101st United States Congress.
In accordance with Sections 111 and 112 of the CAA, the EPA established New Source Performance Standards (NSPS) and National Emissions Standards for Hazardous Air Pollutants(NESHAP) to protect the public.
The Clean Air Act requires the EPA to establish National Ambient Air Quality Standards
(NAAQS)for criteria pollutants. Since the initial establishment of 6 criteria pollutants ofozone, particulate matter, carbon monoxide, nitrogen oxides, sulfur dioxide, and lead. Advancements in testing and monitoring have led to the discovery of many other significant air pollutants since both the 1970 and 1990 Clean Air Acts.
Under EPA Administrator Carol Browner, in 1997 came a stringent tightening of the Clean Air Act's National Ambient Air Quality Standards regarding permissible levels of the ground-level ozone that makes up smog and the fine airborne particulate matter that makes up soot. The decision came after months of public review of the proposed new standards, as well as long and fierce internal discussion within the Clinton administration, leading to the most divisive environmental debate of that decade. The new regulations were challenged in the courts by industry groups as a violation of the U.S. Constitution's nondelegation principle and eventually landed in the U.S. Supreme Court, whose 2001 unanimous ruling in Whitman v. American Trucking Associations, Inc. largely upheld Browner's and the EPA's actions.
http://www.gpo.gov/fdsys/pkg/USCODE-2008-title42/pdf/USCODE-2008-title42-chap85.pdf
There really is no way I could reword the act and all the amendments to be sure each and every of of our readers was in complete understanding when they were finished, and thats always my goal when I am writing something to be published here. It is a very complicated document for some, and easy reading for others. Some people may even enjoy the read. I must be honest and say I was not one of those rare people who enjoyed it, however I did finish reading to the end unlike a few I am aware of here at Vaporia. Anyhow, we feel it's best to find the simplest guide and just post it.
The following is provided for your reading pleasure...
The Plain English Guide to the Clean Air Act:
Some background Information on why the FDA is involved.
About the Center for Tobacco Products
The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.
Strategic Overview: Vision, Mission, and Core Values
CTP's strategic overview provides a high-level view of our work and priorities and will be augmented by detailed strategic and tactical work plans currently being developed by every CTP office. These will include a list of objectives tied to the CTP-wide goals and priority activities for achieving them.
CTP Offices:
- Director, Lawrence R. Deyton, MSPH, MD
- Director, Office of Health Communication and Education, Kathy Crosby
- Director, Office of Management, Brian Trent, MPA
- Director, Office of Regulations, Beverly Chernaik, J.D.
- Director, Office of Compliance and Enforcement, Ann Simoneau, J.D.
- Director, Office of Policy, Eric Lindblom, J.D.
- Director, Office of Science, David Ashley, Ph.D
