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The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.
The warning letters directed the companies to cease the marketing and sale of these products immediately or to take other appropriate action to bring the products into compliance with the law. Failure to do so may result in additional regulatory actions such as seizure or injunction. In addition, FDA requested a written response from each of the companies within 15 days outlining the corrective actions taken.
Enforcement of the flavored cigarette ban is FDA’s effort to remove cigarettes that contain certain candy or fruit flavors from the marketplace. Removal of these products from the market will assist in the prevention of children and adolescents from starting to smoke and in the reduction in death and disease caused by smoking.
“FDA takes the enforcement of this flavored cigarette ban seriously,” said Lawrence R. Deyton, M.S.P.H, M.D., director of FDA’s Center for Tobacco Products. These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.” . . .
Report possible violations of the flavored cigarette ban: www.fda.gov/flavoredtobacco
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The Food and Drug Administration said Friday that it has warned several companies to stop selling banned flavored cigarettes to U.S. consumers online.
The agency sent letters this week to more than a dozen Web-based companies saying they are violating a new ban and asking the companies to describe in writing what action they have taken to comply.
The FDA banned candy-, fruit- and clove-flavored cigarettes in September. Federal health authorities and regulators say those products appeal especially to young people and are thought to attract new smokers.
"FDA takes the enforcement of this flavored cigarette ban seriously," Dr. Lawrence R. Deyton, director of FDA's Center for Tobacco Products, said in a statement. "These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use."
The AAFP has weighed in with numerous suggestions to a July request from the FDA for public input on how the agency should implement its newfound authority to regulate tobacco.
The FDA gained the authority to regulate the manufacture, marketing and distribution of tobacco products to protect public health and reduce tobacco use in minors when President Obama signed the Family Smoking Prevention and Tobacco Control Act in June.
In its comments, the AAFP lauded the agency's recent ban on cigarettes with fruit, candy or clove flavoring and suggested the agency go a step further by forcing manufacturers to remove menthol as a flavoring agent.
The Academy also recommended that the FDA
* ban single sales of little cigars to reduce initiation of smoking among adolescents;
* broaden restrictions on misleading information on cigarette packaging;
R.J. Reynolds Tobacco Co.'s bid to carve out a "free speech" marketing niche for innovative products received a setback yesterday.
A U.S. District Court judge denied a motion for a preliminary injunction by Reynolds regarding the Family Smoking Prevention and Tobacco Control Act, which became law in June.
Judge Joseph McKinley ruled that "the plaintiffs have little likelihood of success" in challenging the modified-risk tobacco-products provision of the law.
A lawsuit was filed Aug. 31 in the Western District of Kentucky against the federal government and the Food and Drug Administration by Reynolds; Conwood Co. LLC, a sister company with Reynolds American Inc.; Lorillard Inc.; Commonwealth Brands Inc.; and two other parties.
The companies said they are trying to "protect their First Amendment right to communicate with adult tobacco consumers about their products." . . .
However, Adam Spielman, an analyst with Citigroup Global Markets Inc., said he believes that regulation will not undercut Reynolds' smokeless innovations. "The rules on new products do not require sign-off from the FDA if the product is substantially equivalent health-wise to existing products," he said.
The decision comes at a time when the National Cancer Institute has provided grants for a new series of medical studies on smokeless-tobacco products, some focused on whether the products provide a less harmful alternative to conventional tobacco products.
A federal judge ruled Thursday that tobacco companies hoping to block new restrictions on their marketing have little chance of succeeding.
The companies had asked U.S. District Judge Joseph H. McKinley Jr. to issue a preliminary injunction in a lawsuit they filed in August claiming new tobacco regulations violate their right to free speech.
The companies, including two of the industry's three largest, are challenging provisions of a law that gave the U.S. Food and Drug Administration new authority over tobacco. In a 29-page decision, McKinley outlined the arguments in the lawsuit and found that blocking the provisions was not warranted. The ruling focused on a narrow portion of the legal challenge dealing with modified-risk tobacco products.
The question before the Court is whether Plaintiffs have met their burden of showing the need for the “extraordinary remedy” of a preliminary injunction against enforcement of the MRTP provision. Tennessee Scrap Recyclers Ass’n v. Bredesen, 556 F.3d 442, 447 (6th Cir. 2009). In determining whether to issue a preliminary injunction, courts consider four factors: (a) whether the movant has a strong likelihood of success on the merits; (b) whether the movant would suffer irreparable injury without the injunction; (c) whether issuance of the injunction would cause substantial harm to others; and (d) whether the public interest would be served by the issuance of the injunction. . . .
Assuming that the MRTP provision implicates the First Amendment, it seems likely that its restrictions on speech are constitutionally permissible. . . .
In sum, the Court concludes that Plaintiffs have little likelihood of success on the merits of their facial First Amendment challenge to the MRTP provision except on the theory that it operates as a prior restraint on speech and lacks a reasonable time limit for FDA review. . . .
Having considered each of the required factors, the Court finds that the “extraordinary remedy” of a preliminary injunction is unwarranted.
29
III. CONCLUSION
For the foregoing reasons, Plaintiffs’ motion is DENIED.
A federal judge has turned down a request by the nation's No. 2 cigarette-maker and others to immediately halt enforcement of new federal regulations on tobacco products.
Their challenge to new U.S. Food and Drug Administration powers to regulate what tobacco firms say about their products has little likelihood of success, except on one point, Judge Joseph H. McKinley Jr. of the U.S. District Court in Bowling Green, Ky., ruled yesterday.
Because of that, and because the businesses couldn't show they faced irreparable harm, McKinley rejected tobacco companies' request for a preliminary injunction stopping FDA enforcement of rules limiting what they say about products they believe reduce the risk of using tobacco.
In a clear victory for public health, a federal judge in Kentucky today rejected a motion by tobacco companies to block key provisions of the new law giving the U.S. Food and Drug Administration (FDA) the power to regulate tobacco products. Specifically, today's decision strongly supports the government's authority to prevent the industry from making health claims about its products without FDA approval.
We applaud the federal court's decision to quickly and decisively reject the latest attempt by Big Tobacco to frustrate the intent of the new FDA law and allow the agency to get on with its role in putting an end to deceptive and dangerous tobacco marketing.
Eleven public health and consumer advocacy groups joined in the legal effort to thwart the industry's challenge to the law based on the claim that its First Amendment rights were violated.
By the time you're done reading this column, combustible tobacco smoking will claim four more American lives — and a total of 440,000 lives this year.
Electronic cigarettes — battery-operated products that deliver an inhalable nicotine vapor — offer a much needed alternative. . . .
Electronic cigarettes are not drugs, nor are they sold to cure any disease or affliction. Therefore, the FDA has no authority to regulate or ban them as drug-delivery devices.
But by attempting to mislabel them as medical devices, the FDA wants to force manufacturers to spend as much as $1.5 billion on clinical research, drug trials and FDA fees for potential marketplace approval. We are not large drug companies capable of this type of investment, and the FDA knows it.
President Obama just signed a landmark law giving the FDA authority to regulate virtually all aspects of tobacco products. We understand that to protect the public, some form of regulation may be necessary and would welcome regulation under the new and more reasonable authority. This process wouldn't take us off the shelf or cost hundreds of millions of dollars, and would still provide necessary safeguards. Our goal is to guarantee access for committed smokers who want the freedom of the clear alternative that e-cigarettes offer and ensure that minors do not have access to our products.
The companies, including two of the industry's three largest, are challenging provisions of a law that gave the U.S. Food and Drug Administration new authority over tobacco. In a 29-page decision, McKinley outlined the arguments in the lawsuit and found that blocking the provisions was not warranted. . . .
The companies say the law, which takes full effect over three years, prohibits them from using "color lettering, trademarks, logos or any other imagery in most advertisements, including virtually all point-of-sale and direct-mail advertisements." Their complaint also says the law prohibits tobacco companies from "making truthful statements about their products in scientific, public policy and political debates."
The tobacco makers say new mandated warnings for cigarettes would relegate their branding to the bottom half of cigarette packaging and make it "difficult, if not impossible, to see."
In its response to the lawsuit, the FDA said the new marketing rules do not restrict free speech and serve a greater public health interest.
R.J. Reynolds Tobacco Co.'s bid to carve out a "free speech" marketing niche for innovative products was dealt a blow today.
A U.S. District Court judge in Richmond denied a motion for a preliminary injunction sought by Reynolds and other tobacco manufacturers regarding The Family Smoking Prevention and Tobacco Control Act.
A lawsuit was filed Aug. 31 against the federal government and the Food and Drug Administration by Reynolds, Conwood Co. LLC, a sister company with Reynolds American Inc., Lorillard Inc. and Commonwealth Brands Inc.
The companies had sought a preliminary injunction against The Family Smoking Prevention and Tobacco Control Act. They said they are trying to "protect their First Amendment right to communicate with adult tobacco consumers about their products."
But Judge Joseph McKinley ruled that the "plaintiffs have little likelihood of success" in their challenge to the modified risk tobacco products provision in the law.
As the debate heats up concerning the use of electronic cigarettes, Electronic Cigarette Association (ECA) President Matt Salmon today encouraged those involved in this discussion to carefully and honestly study how these devices work and recognize that the more than one million adult committed smokers, who use electronic cigarettes, are seeking an alternative to combustible cigarettes that contain a multitude of toxic, harmful chemicals.
The debate on these devices has intensified in recent months as events have fueled and focused attention on electronic cigarettes, including a front-page story last week and a follow-up editorial in yesterday's edition of USA Today and stories or editorials in other major newspapers such as the New York Times and Los Angeles Times. Governor Schwarzenegger's veto of a bill that would have denied California citizens the right to purchase electronic cigarettes and a warning by the Food and Drug Administration (FDA) based on a flawed, narrow study have also contributed to the growing debate.
"Unfortunately, many of the arguments we've seen recently against electronic cigarettes have been driven by fear of the unknown, insufficient evidence, political agendas, and ignorance about our members' products," said Salmon. "As in the case of California Governor Schwarzenegger, we've found that reasonable people, when willing to honestly and intellectually evaluate the information about electronic cigarettes, find that these products provide smokers a viable alternative to combustible tobacco cigarettes."
With the enactment of the Family Smoking Prevention and Tobacco Control Act on June 22, the United States entered a new era in tobacco control and prevention. . . .
This issue of the NCI Cancer Bulletin highlights several important tobacco control research studies supported by NCI. In the largest trial of its kind to date, researchers from the Fred Hutchinson Cancer Research Center found that telephone counseling using motivational interviewing and cognitive behavioral approaches significantly improved 6-month cessation rates in older teens. Given that 20 percent of American high school seniors smoke cigarettes, and that few strategies have been effective at promoting cessation among teen smokers, this finding is very significant. This issue also highlights a study of mobile phone technology provided to DC Tobacco Quitline callers and the expansion of Smokefree.gov, including new links to social media, such as Facebook, that take advantage of interactive Web technologies to reach new audiences for smoking cessation.
NCI's tobacco control research cannot be limited to the United States, where, as in most high-income countries, tobacco use is slowly declining. By 2030, global mortality from tobacco use is expected to rise to 8 million deaths per year. About 80 percent of those deaths will occur in low- and middle-income countries, where tobacco use is still increasing. Research will be critical to averting this global epidemic, which threatens to reverse hard-won improvements in global health and which economically developing countries with overburdened health care systems can ill afford.
The U.S. Food and Drug Administration is moving quickly to use its sweeping new tobacco powers despite facing swift legal action from cigarette makers, the agency's tobacco chief told Reuters on Tuesday.
Dr. Lawrence Deyton said lawsuits from companies such as Reynolds American Inc (RAI.N), Lorillard Inc (LO.N) and others are not slowing his work to set up the FDA's tobacco unit or take action against products that harm the public, especially children.
"Congress is very clear what it wants me to do, I'm moving ahead. Nobody's told me not to," Deyton said in an interview at his office in suburban Maryland.
Burned by the recent US ban on kretek cigarettes, Trade Minister Mari Pangestu said government officials would soon meet with their US counterparts in an effort to alleviate smoldering tension over the issue.
Kretek cigarettes were banned by the US Food and Drug Administration on Sept. 21 on the grounds that their sweet flavor encouraged young people to take up smoking.
“We will arrange a meeting and will be having consultations to seek a fair solution to this matter,” Mari told the Jakarta Globe on Tuesday.
The discussions, Mari said, are a preliminary response, but if no solution is found, then “at the end, it will be taken to the World Trade Organization.”
Mari said previously that the ban was highly detrimental to this country’s clove farmers and was in breach of WTO rules. . . .
Kretek International is apparently not going to take the issue lying down and is now seeking a declaratory ruling from the US District Court in Washington that its cigars are not cigarettes and can therefore be freely sold.
In its petition, it accused the FDA of “deliberately obfuscating” the definition of cigarette,” adding that “If a product is a cigar, it is not a cigarette, and vice versa.”