Clark County bans sale of e-cigarettes to minors

Selling electronic cigarettes — the plastic-and-metal cigarette lookalikes that puff vaporized nicotine — to minors will be illegal in e-cigarettesClark County.
The county commissioners, acting as the county’s Board of Health, approved the measure on Monday. Public health officials feared the e-cigarettes, which come in fruit and candy flavors, were being marketed to young people.
Many e-cigarettes are designed to look like real cigarettes, complete with a red light at the end to simulate burning tobacco. But instead of tobacco, the battery-powered devices contain a replaceable nicotine solution cartridge, and users puff on the vapor rather than smoke.
The e-cigarettes don’t produce tar and carbon monoxide like real cigarettes, nor secondhand smoke. They usually do contain nicotine, the addictive substance in cigarettes. They haven’t been fully evaluated by the U.S. Food and Drug Administration, but testing in 2009 found dangers including carcinogens and a toxic chemical used in antifreeze.
The ordinance would prohibit selling e-cigarettes to anyone under 18. Originally, a draft ordinance banned their use in public places where cigarettes are prohibited, but the county commissioners opted to leave that up to business owners.
Much of the debate had nothing to do with e-cigarettes. Commissioner Tom Mielke objected to language in the ordinance that read “exposure to secondhand smoke is known to cause cancer in humans.” The section continued to list other risks associated with secondhand smoke.
“I think the jury’s still out on that,” Mielke said. “On the Internet, I found there were conflicting statements and facts.”
The language is in the ordinance because the county included language adopting provisions of state law banning smoking in public places, and it directs the public health department to enforce those laws.
“We’re using this as a vehicle to implement the state law,” County Administrator Bill Barron said.
Dr. Alan Melnick, the county’s health officer, assured Mielke the body of research concludes that secondhand smoke causes cancer and other diseases, like asthma.
But Mielke asked that the section be removed. Commissioner Marc Boldt, the other commissioner present, agreed to strike it.
“I guess I would be on the doctor’s side, but I want to pass the ordinance,” he said.
Mielke and Boldt approved the ordinance without the secondhand smoke language. Commissioner Steve Stuart, the board’s third member, was absent.
The ordinance takes effect Thursday.
By Elliot Njus
503-294-5034

RFID Makes Matches for E-Cigarette Smokers

Smokers of Blu Cigs electronic cigarettes already use technology to update an ancient practice. Rather than inhaling the smoke of e-cigarettes matchburning tobacco, they breathe in water vapor that delivers the same dose of nicotine provided by a traditional cigarette. But there is a social aspect to using the company’s e-cigarettes. Every time that a Blu pack is opened to retrieve or put away an e-cigarette, a blue LED light on the pack’s front is illuminated. According to the company, a blue light shining on the pack is a conversation starter that pleases users. With that in mind, Blu Cigs is adding a new component—RFID—to help its customers connect with each other, as well as start conversations between them. With an active RFID tag in each pack, one pack of Blu Cigs can detect the presence of another from the same manufacturer, and the packs will then light up and vibrate to indicate that someone in the vicinity also uses that brand. The system, expected to be made commercially available in August 2011, is known as BluBand.
A Blu pack holds five cartridges (also known as e-cigarettes), which look much like traditional cigarettes, powered by small batteries charged by a rechargeable battery in the pack itself, causing the blue light to pulsate. About the size of a traditional pack of cigarettes, the Blu pack can be plugged into a wall outlet or a computer to recharge its own battery. Each e-cigarette contains a sensor, a heater and a water-based mixture containing nicotine and other flavoring products (the company also offers a non-nicotine version of the mix), says Ramon Alarcon, Blu Cigs’ principal product-development engineer. When an individual sucks on the end of one of the e-cigarettes, its sensor detects that action and activates its heater. As heat is applied to the mix, the e-cigarette produces a mist that provides the physical sensation, appearance and flavor of smoke inhaled from a traditional cigarette.
The Blu pack has a light that illuminates each time it is opened.
The company has sold 500,000 packs to date, and based on feedback from its customers, it found that the electronic pack with its glowing blue light was a conversation starter. Smokers reported that in public places, such as restaurants, nightclubs or bars, other people often asked them about the packs. Blu Cigs has since developed technology that it hopes will further encourage conversations. The solution includes a transceiver that both sends and receives RFID transmissions. The transceiver, embedded in the center of the pack, includes a battery, a chip and an antenna. The chip stores the transceiver’s unique ID number, which can be transmitted several times per second, Alarcon says. He declines to provide the specific RF frequency or air-interface protocol that the system will employ, but notes that it will transmit within an industrial, scientific and medical (ISM) RF band that can operate in both Europe and North America.
As the transceiver beacons, in the event that another RFID-enabled Blu pack comes within range (approximately 10 meters, or 33 feet) the second pack’s transceiver responds to the transmission by sending its own unique ID—which, in turn, is captured by the first Blu pack. At that time, both packs illuminate their own blue LED screens, and also vibrate. The users must then look around the room to determine with whom they have connected. The company envisions a user holding up a pack in order to try to catch the attention of another user in the room or immediate area. When BluBand is launched commercially in August, it will provide only the light and vibration alert, but future versions are expected to also include software options that could help smokers link up with each other after heading home.
Once the software option becomes available, a user would first sign into the system via Blu Cigs’ Web site, where he would be invited to provide such personal data as a name and contact information, that could include an e-mail address or Facebook page. The pack can be plugged into a PC via a USB cord, allowing access to Blu Cigs’ server software, and enabling a user to charge the pack’s battery. Once the pack is plugged in, and if the user opts to input personal details, the pack’s ID is linked to that person’s name and contact information. As the smoker then uses the pack in public places, if another pack captures the ID number of that individual’s pack, it will store that information, and the pack user can then go back to his own account by plugging his pack into his PC, and then determine whether the other Blu pack user provided his or her name and contact information. When this functionality will be available has yet to be determined, Alarcon says.
“We began developing the RFID function a little under a year ago,” Alarcon states, “The pack and its features, including the social-networking feature, was all user-driven.” He adds that users claimed they enjoyed the social aspect of meeting people because of their unique cigarette brand. “It’s designed to be both informative and entertaining in social situations one might encounter in places such as restaurants, night clubs and parties.”
The cost of the RFID-enabled Blu pack will be slightly higher than the price for the standard version, Alarcon says, though he declines to reveal the exact amount of increase. The cartridges themselves are not expected to be higher priced than those used in the standard packs.

Tobacco Free Florida Statement On Electronic Cigarettes

Tobacco Free Florida about the issue of electronic cigarettes

“Recently, consumers have been led to believe electronic cigarettes are a safe alternative to normal tobacco cigarettes, and even an effective way to quit smoking. However, there is currently no scientific evidence to support that electronic cigarettes will help people quit smoking and preliminary research from the Food and Drug Administration (FDA) reveals that e-cigarettes contain toxic substances and carcinogens.
“On April 25, 2011, the FDA announced that it would regulate electronic cigarettes as tobacco products and not as a drug or device. In 2009, the FDA gained authority to oversee tobacco products and this decision allows the agency to provide regulations including requiring ingredient listings for electronic cigarettes, which until now, have not been subject to government oversight.
“Tobacco Free Florida also has concerns about electronic cigarettes utilizing candy flavors and the unique appeal those products might have to young people.
“The most effective way to quit smoking is to talk to your healthcare provider or seek help from a qualified quit coach to help you make a personalized plan. Prescription medication and nicotine replacement therapies like the patch, gum and lozenges have also been proven effective as part of a comprehensive quit plan. Florida’s smokers have access to free and convenient help in quitting through the Florida Quitline. (877-U-CAN-NOW)
“According to Kim Berfield, Deputy Secretary of the Florida Department of Health, the Florida Quitline provides Floridians with the necessary support needed for quitting:
“‘Those looking to quit using tobacco should focus on what we know works according to the data. The Department of Health and Tobacco Free Florida encourage Florida’s smokers to call the Florida Quitline. It is a great resource providing free counseling and free nicotine replacement therapies for those who wish to quit.'”

If e-cigarettes aren't harmful, then prove it

In 2005, Washington voters overwhelmingly passed the Smoking in Public Places Act to protect our residents from the harmful effects of secondhand smoke in public places and places of employment. While the benefits of this law are great, it came long after the health effects of secondhand smoke (death, disability and economic impacts) were well documented.
For decades, tobacco companies hid evidence of harmful effects, cleverly marketed cigarettes as glamorous and even healthy, and lobbied to block attempts at regulation. Public health officials finally stepped in, but after it was too late for many who became sick or died from asthma, emphysema, chronic lung disease, cancer, heart disease and stroke.
And here we are today, in what feels like an all-too-familiar storyline.
Business owners tell you that their product is safe, harmless, and even helpful to quit smoking. They tell convincing, anecdotal stories but never show proof of safety and efficacy, and certainly never discuss their financial motives.
On one hand, e-cigarette manufacturers argued that e-cigarettes should not be regulated by the Food and Drug Administration as drug-delivery devices because they are not marketed as or meant to be cessation aids.
Yet here in Pierce County, e-cigarette retailers extol their products as an effective way to help people quit. It all sounds strikingly similar to the insincere arguments made four decades ago by the tobacco industry.
In the absence of FDA regulation, e-cigarette manufacturers are not subject to the same rigorous standards as the manufacturers of approved cessation products.
Approved nicotine patches, gum and inhalers all had to be proved safe and effective; e-cigarettes have never been shown to be either. FDA analysis of e-cigarettes found their vapor contains nicotine and other harmful chemicals known to be toxic and cancer-causing.
At the Tacoma-Pierce County Health Department, we have the responsibility to protect people’s health and believe it is bad policy to allow the public to be exposed to harmful chemicals such as nicotine and nitrosamines. The burden of proof to show that e-cigarettes are safe and effective should reside with manufacturers and retailers, and the product should not risk our residents’ health in the meantime.
Opponents of the proposed regulations argue that we should not pass policy without solid evidence. While we agree that regulation should be based on data, where conclusive evidence is absent we need to use known facts and common sense to guide us.
Let us be clear: Nicotine is not benign. It is a nerve poison that affects the brain, heart and many other organs. Approved cessation products have to release nicotine in very precise and controlled ways, but e-cigarettes have been found to deliver inconsistent amounts of nicotine.
As the May 6 News Tribune editorial noted, our county has seen adult tobacco use decline dramatically in the last decade. The editorial also states, “Fake smokes, many of which look almost indistinguishable from real cigarettes, keep smoking in the public eye and help normalize the act of lighting up.”
We too are concerned about the role-modeling aspects of e-cigarettes and potential increase in the social acceptability of smoking. Any increase will not only harm smokers but will also drive up cancer and heart and lung disease, which in turn will drive up health care costs to businesses and taxpayers.
Our mission is to safeguard and enhance the health of the communities of Pierce County. We will continue to do this with the best available information, common sense and a belief that we should err on the side of safety when it comes to protecting our residents’ health.
When the e-cigarette industry can prove that its product has no harmful side effects to users and bystanders, we will reconsider our position. In the interim, we will continue to promote prevention of tobacco use and cessation resources that have been proved safe and effective and propose regulations needed to protect the health of Pierce County. Anthony Chen, M.D., is director of health with the Tacoma-Pierce County Health Department.
By DR. ANTHONY CHEN

What are e-cigarettes?

LITTLE ROCK, Ark. – In this THV Extra, we are taking a closer look into E-Cigs. Are they really healthier than an average cigarette?
Some are calling it the everyday smoker’s savior: e- cigarettes. The smokeless, odorless and tobacco free alternative to your average square.
But how do they even work? Can someone actually kick the habit and how healthy, if at all are they?
The e-cigarette, it looks almost like a real cigarette. Maybe a little larger, but the LED lighted tip, the vapor and the filter serving milligrams of nicotine into the user may have some looking or puffing twice.
Setting it even farther apart from the real thing is the absence of nearly 4000 carcinogens.
“These are an electronic device that you put a cartridge inside that contains nicotine and heaven knows what else,” says Dr. Carolyn Dresler.
Dresler with the Arkansas Department of Health says a lack of data and studies from e-cig companies themselves has raised red flags with many health officials.
“These products have been out too new to really know the science. The tobacco industry that makes them they’re not doing any science on it, so who knows what’s really in it,” says Dresler.
In 2009 an FDA preliminary study revealed traces of diethylene glycol, an ingredient commonly used in antifreeze.
Late last month, the FDA agreed to take action in attempts to regulate the product.
Harmful or not– full time college student Kari Ellis has used the device for six months and claims the effects have been monumental in her everyday life.
“It’s almost like put a piece of spearmint candy in your mouth and inhale,” says Ellis.
Having smoked on and off for years, Ellis says stress just keeps bringing her back. “Right now is just not the time in my life where I can quit.”
Liam Hill, who isn’t looking to quit smoking anytime soon tried it out.
A little tough at first, but a second drag had him asking questions. “I don’t know how much these things cost.”
Each changeable filter on the cigarette is the equivalent of one pack of cigarettes.
A one time purchase price of $140 for an e-cig, plus a weeks worth of filters for no more than $30, would bring it’s yearly cost to around $1,400.
A pack a day smoker buying cigarettes at six dollars could expect to spend around 2,200.
“In the six weeks I’ve been using. I’ve saved about $230.”
But still the electronic choice may not be for everyone. Take Joseph Burgess for instance, who tried it for his first time alongside his friend Justin Kroger.
“You have to really pull on it to feel it,” says Burgess, who says he would not pay $140 for one.
Kroger, though goes back to it being a mind thing. “It’s kind of like the oral fixation thing. It’s kind of like having something there, and if it’s better for you, you might as well do it.”

Tacoma-Pierce County wants to ban electronic cigarettes in public places

The proposal also would ban the sale of the e-cigarettes to minors.
A separate proposed regulation would give the health department greater powers in enforcing anti-smoking laws in the county.
The proposals are posted on the Health Department website today and will be the subject of a public meeting May 16; a Board of Health study session May 18; and consideration of adoption by the board on June 1.
Health Department chief Dr. Anthony Chen told me the regulations are intended to further protect the public from the harmful effects of nicotine and other chemicals associated with the use of e-cigarettes or tobacco.
But it appears the Board of Health already is somewhat split on the issue. Chairman Dick Muri and vice-chairman Stan Flemming, both Pierce County Council members, told me Tuesday they believe the proposed e-cigarette regulations go too far.
They’re not opposed to banning their sale to minors, but they don’t believe there’s enough science on their potential harm to back up regulations preventing people from using them in public.’
In fact, Muri and Flemming said, they could be a good alternative for smokers searching for a way to kick the tobacco habit.
E-cigarette seller Kim Thompson, owner of The Vaporium in Lakewood, calls the proposed regulation “unfair and unjust.”
The King County Health Department enacted stiff regulations on e-cigarettes effective Jan. 15.
Here’s copy of the Health Department’s news release on the proposed regulations:

The Tacoma-Pierce County Health Department Proposes New Regulations Related to Tobacco Prevention and Control
The Tacoma-Pierce County Health Department is tasked with safeguarding and enhancing the health of the communities of Pierce County. As part of its mission, the Health Department tackles emerging health risks through policy, programs and treatment in order to protect public health.
According to the Centers for Disease Control, tobacco use is the number one cause of preventable deaths in the United States and is responsible for one in every five deaths annually.
In Pierce County, 17% of adults smoke, representing more than 100,000 of our family members, neighbors, co-workers and friends.
Even for individuals who don’t smoke, secondhand smoke poses a serious health risk. In adults, secondhand smoke can cause heart disease and lung cancer
For children, secondhand smoke can increase symptoms of asthma, respiratory infections, sudden infant death syndrome and a number of other health conditions.
The Tacoma-Pierce County Health Department has brought forth two proposed regulations that relate to the Health Department’s ongoing work to protect the people of Pierce County from the risks associated with tobacco use.
The Board of Health may vote on these regulations at the June 1, 2011 Board of Health meeting and the Health Department is interested in receiving feedback from the community prior to that date.
The two proposed regulations are:
• Environmental Health Code, Chapter 8: Smoking in Public Places.
This local regulation provides greater clarity and interpretation of RCW 70.160, Washington State’s Smoking in Public Places law, allows for local enforcement including fees and fines and aids local businesses that wish to comply with the State law. Adopting a local regulation facilitates compliance of the state code.
Review the full regulation.
Environmental Health Code, Chapter 9: Restrictions on Sale, Use and Availability of Electronic Smoking Devices and Unregulated Nicotine Delivery Products.
The proposed regulation prohibits smoking and the purchase of e-cigarettes and other unregulated nicotine delivery products by youth under age 18, disallows e-cigarettes to be used in public places and anywhere that regular cigarettes are prohibited and prohibits free or heavily discounted e-cigarettes.
Currently, e-cigarettes are unregulated in the United States. They contain varying levels of nicotine and other known carcinogens and toxic chemicals. The FDA recently announced that it intends to regulate e-cigarettes as a tobacco product and not an approved cessation aid.
Review the full regulation.
Public Meeting
The Tacoma-Pierce County Health Department will host a public meeting to preview and receive public feedback regarding the two regulations. The meeting will include a brief presentation of the proposed regulations, a question and answer period and an opportunity for attendees to provide brief comment.
When:
Monday, May 16, 2011
6:00-7:00 PM
Where:
Tacoma-Pierce County Health Department Auditorium
3629 South D Street
Tacoma, WA 98418

E-cigarettes ruled tobacco products

E-cigarettes have joined cigars and pipe tobacco as unregulated tobacco products, clearing the way for mainstream stores to begine-cigarettesselling the electronic devices.
Last year, a U.S. federal court ruled that as long as electronic cigarettes aren’t marketed as a way to treat or cure disease, the U.S. Food and Drug Administration has no authority to block the importation of the battery-powered products.
On Monday, the FDA announced it would not appeal the ruling to the U.S. Supreme Court.
Sebastian Cangemi, president of Liberty Stix, a Mayfield Heights-based manufacturer and distributor of E-cigarettes, credits the court decision with most likely saving his business that was formerly located in Willoughby.
“Smokers will now have access to a product that is a great alternative to traditional tobacco. And as the industry evolves, it will become an alternative that will change the entire world’s smoking habits,” Cangemi said.
“The majority of sane, anti-smoking advocates will also agree that this alternative, while initially pigeonholed as a substandard product, will soon become the norm.”
The FDA has indicated that it plans to propose regulations for the smoke-free nicotine alternatives.
Cangemi said Liberty Stix welcomes case-by-case regulation, adding that he believes his company makes the only American pre-filled cartridge.
Sellers of E-cigs say they are odorless, flameless and contain none of the carbon monoxide, tar, tobacco, smoke or cancer-causing agents found in regular cigarettes.
The FDA argued that the safety of E-cigs has not been proven, so they should be regulated as drug devices rather than a tobacco product.
Federal officials had been seizing shipments of electronic cigarettes amid concerns that the products were being marketed as safer alternatives to traditional tobacco.
By Tracey, ReadTRead@News-Herald.com

Tobacco rules apply to electronic smokes

RICHMOND — The Food and Drug Administration said yesterday that it plans to regulate smokeless electronic cigarettes as tobacco products and won’t try to regulate them under stricter rules for drug-delivery devices.
The federal agency said in a letter to stakeholders that it intends to propose rule changes to treat e-cigarettes the same as traditional cigarettes and other tobacco products.
The news is considered a victory for makers and distributors of the devices, which continue to gain popularity worldwide.
E-cigarettes are plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the “smoker’’ inhales. A tiny light on the tip even glows like a tobacco cigarette.
Users and distributors say e-cigarettes address both the nicotine addiction and the behavioral aspects of smoking — the holding of the cigarette, the puffing, seeing the smoke come out, and the hand motion — without the more than 4,000 chemicals found in cigarettes.
First marketed overseas in 2002, e-cigarettes didn’t become easily available in the United States until late 2006. Now, the industry has grown from the thousands of users in 2006 to several million worldwide, with tens of thousands new e-smokers every week.
No timeline has been set on the proposed rule changes.
The FDA said e-cigarettes could still be regulated as drugs or drug-delivery devices if they are “marketed for therapeutic purposes,’’ — for example, as a stop-smoking aid.
Craig Weiss, president of Sottera Inc., the Arizona-based company involved in the lawsuit that led to the FDA’s decision, said he was “very happy’’ with the agency’s decision.
Jason Healy, president of e-cigarette maker Blu Cigs, also praised the decision. Once the FDA’s rules covering e-cigarettes are in place, he said, they will help in “weeding out the shady companies.’’
Some e-cigarette makers have claimed that the products will help smokers quit using traditional cigarettes, while other manufacturers have tried to steer clear of the issue.
Nearly 46 million Americans smoke cigarettes. About 40 percent try to quit each year, according to the Centers for Disease Control and Prevention. But unlike nicotine patches or gums, e-smokes have operated in a legal gray area.
The FDA lost a court case last year after trying to treat e-cigarettes as drug-delivery devices, rather than tobacco products. A federal appeals court ruled that electronic cigarettes should be regulated as tobacco products rather than as drug-delivery devices, which must satisfy more stringent requirements such as expensive clinical trials to prove they are safe and effective. The FDA had until yesterday to appeal to the Supreme Court.
The agency issued warning letters last year to several makers of e-cigarettes and their components, saying the companies’ health claims and manufacturing practices broke the law.
The FDA has said its tests found that the liquid in some electronic cigarettes contained toxins besides nicotine — which is toxic in large doses — as well as carcinogens that occur naturally in tobacco.
By Michael Felberbaum, Boston.com

FDA Act to Extend Authority over Tobacco Products, Including E-Cigarettes

WASHINGTON, D.C. — We are disappointed that the government today announced that it will not appeal a federal appeals court ruling that the Food and Drug Administration cannot regulate electronic cigarettes as drugs and devices. That ruling opened a loophole that would allow manufacturers to add nicotine to a wide range of products without the stringent regulation traditionally applied to smoking cessation medications and other non-tobacco products to which nicotine has been added.
However, the FDA today has taken appropriate action to protect public health by announcing that it intends to assert authority over other tobacco products that meet the statutory definition of “tobacco products” under the landmark 2009 tobacco regulation law. This includes regulating e-cigarettes as tobacco products, as the appeals court suggested.
The 2009 law specifically directed the FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. It also authorized the agency to extend its authority to other categories of tobacco products and to determine which regulations that Congress applied to cigarettes and smokeless tobacco products should apply to other tobacco products.
The FDA’s decision to assert jurisdiction over other tobacco products in light of the electronic cigarette decision is important because it will help prevent tobacco companies from creating loopholes and circumventing the law. Already, some companies have sought to evade a ban on flavored cigarettes by marketing flavored little cigars, and the FDA recently concluded that its current authority does not include certain non-traditional smokeless tobacco products. The FDA’s assertion of authority over other tobacco products will make it clear what products are subject to regulation and help prevent future evasions of the law.
It is important to note that the FDA today has taken only the first step by announcing its intention to extend its authority to other categories of tobacco products. Once it has asserted jurisdiction, the agency will then establish a regulatory scheme appropriate to each category of products.
With regard to e-cigarettes, the FDA should quickly assert jurisdiction and issue specific regulations protecting public health, including restrictions on marketing, sales to anyone under 18, health claims and product quality. The FDA should also make it clear that it will regulate any e-cigarettes that make smoking cessation claims, which many do, as drugs and devices and subject them to the same rigorous scientific review as other smoking cessation products.
The FDA’s rigorous regulation of tobacco products is critical to reduce the toll of death and disease from tobacco, which kills more than 400,000 Americans annually and is the number one cause of preventable death in the United States and around the world.

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