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Guidance for Industry and FDA Staff

General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors

This guidance document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance document. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance document.

Introduction
The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes that is effective on September 22, 2009. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The issues identified in this guidance document represent those that we believe are frequently asked regarding the ban of cigarettes that contain certain characterizing flavors. In developing the guidance document, we carefully considered the relevant statutory criteria regarding the ban.

General Questions and Answers:

1.
What is the significance of today’s announcement on flavored cigarettes?
Smoking is the leading cause of preventable death in the United States, claiming over 400,000 lives each year. An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as are smokers over the age of 25. In addition to being more attractive to young people, flavored products make it easier for new smokers to start smoking by masking the unpleasant flavor of tobacco. Studies have also demonstrated that young people believe that flavored tobacco products are safer than unflavored tobacco products.
Flavored cigarettes are just as addictive and have the same types of harmful effects as regular cigarettes. Removing these flavored products from the market is important because it removes an avenue that young people can use to begin regular tobacco use. Congress specifically enacted the ban on sale of cigarettes and their component parts, such as filters and papers, which contain certain characterizing flavors. The removal from the market of cigarettes that contain certain characterizing flavors is an important step in the Nation’s efforts to reduce the burden of illness and death caused by tobacco products as authorized by the FSPTCA, signed by President Obama on June 22, 2009.

2.
What products are covered?
Several key definitions in the law define which products are covered.
The ban applies to all tobacco products that meet the definition of a cigarette in section 900(3) of the FDCA even if they are not labeled as cigarettes or are labeled as cigars or as some other product.
Specifically, section 900(3) defines cigarettes as:
‘‘(3) CIGARETTE.—The term ‘cigarette’— ‘‘(A) means a product that— ‘‘(i) is a tobacco product; and ‘‘(ii) meets the definition of the term ‘cigarette’ in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and ‘‘(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco. ‘‘(4) CIGARETTE TOBACCO.—The term ‘cigarette tobacco’ means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter shall also apply to cigarette tobacco.”
This definition refers to a provision of the Federal Cigarette Labeling and Advertising Act which defines the term ‘cigarette’ as:
“(1) The term “cigarette” means— (A) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and (B) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in subparagraph (A).”

3.
Does the special rule for cigarettes in section 907(a)(1)(A) of the FDCA, banning cigarettes containing an artificial or natural flavor that is a characterizing flavor, apply to loose tobacco intended to be used in cigarettes or as roll-your-own tobacco?

Yes. The special rule for cigarettes in section 907(a)(1)(A) of the FDCA bans all cigarettes containing an artificial or natural flavor that is a characterizing flavor. Section 900(3) of the FDCA defines “cigarette” as including “tobacco, in any form . . . that is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.” Loose tobacco intended to be used in cigarettes or as roll-your-own tobacco fits this definition of “cigarette” and therefore may not be flavored with a characterizing flavor.

4.
Does the special rule for cigarettes in section 907(a)(1)(A) of the FDCA, banning cigarettes containing an artificial or natural flavor that is a characterizing flavor, apply to rolling paper or filters intended for use in roll-your-own cigarettes?
Yes. The special rule for cigarettes in section 907(a)(1)(A) of the FDCA prohibits the component parts of a cigarette (including the filter or paper) from containing an artificial or natural flavor that is a characterizing flavor. Section 900(3) of the FDCA defines “cigarette” as a tobacco product that “meets the definition of the term ‘cigarette’ under section 3(1) of the Federal Cigarette Labeling and Advertising Act,” which states that a cigarette is any wrapped roll of tobacco. A consumer rolled, roll-your-own cigarette is a cigarette under section 900(3) because it is a wrapped roll of tobacco. Rolling paper or filters intended for use in roll-your-own cigarettes are component parts of a rolled, roll-your-own cigarette and therefore may not be flavored with a characterizing flavor.

5.
Under what, if any, circumstances would FDA consider cigars, including little cigars, to be in violation of the ban in section 907(a)(1) of the FDCA?
The ban applies to all tobacco products with certain characterizing flavors that meet the definition of a “cigarette” in section 900(3) of the FDCA even if they are not labeled as “cigarettes” or are labeled as cigars or as some other product.
We encourage members of the public to submit any information relevant to compliance with the prohibition of cigarettes containing characterizing flavors, including information concerning consumer perception of tobacco products not labeled as cigarettes, but because of their appearance, the type of tobacco used in the filler, or their packaging and labeling, are likely to be offered to, or purchased by, consumers as cigarettes. Please submit any information to Docket No. FDA-2009-N-0294.

6.
Does the ban apply to bona fide pipe tobacco?
No. The ban does not apply to bona fide pipe tobacco. However, as noted above in question 5, the ban applies to all tobacco products with certain characterizing flavors that meet the definition of a “cigarette” in section 900(3) of the FDCA. The definition of a “cigarette” includes “tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.”
We encourage members of the public to submit any information relevant to compliance with the ban of cigarettes containing characterizing flavors regarding any tobacco product that may meet the definition of a “cigarette.” Please submit any information to Docket No. FDA-2009-N-0294.
Contains Nonbinding Recommendations

7.
How will this ban be enforced?
As of September 22, 2009, cigarettes and their component parts that contain characterizing flavors (other than tobacco or menthol) or an herb or spice are illegal. FDA has a range of enforcement and regulatory tools to address violations of the ban by, among others, manufacturers, importers, distributors, and retailers. Before taking enforcement action, it is the agency’s general practice to issue Warning Letters to firms to notify them that they or their products are in violation of the law and to give them the opportunity to come into compliance. As always, when circumstances are appropriate, FDA may take enforcement action to protect the public health without first issuing a Warning Letter.

8.
Will FDA provide a comprehensive list of products that are illegal?
No. All products that meet the description in section 907(a)(1)(A) of the FDCA below are banned. Section 907(a)(1)(A) states:
“…a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.”
The agency plans to make available Warning Letters it has issued and information about enforcement actions it has taken to notify the public about violative products.

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FDA’s Flavored Cigarette Ban Kicks In

Fruit, candy, clove products affected, but not menthol…yet

WASHINGTON — The U.S. Food & Drug Administration (FDA) said that the ban on flavored cigarettes went into effect September 22. The ban, which affects cigarettes with flavors characterized as fruit, candy or clove, was authorized by the new Family Smoking Prevention & Tobacco Control Act.

The FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes, it said.

“Almost 90% of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our nation’s public health.”

U.S. Department of Health & Human Services Assistant Secretary for Health Howard K. Koh, M.D., M.P.H., said, “The FDA’s ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily.”

The FDA is taking several steps to enforce the ban. A letter recently sent to the tobacco industry provided information about the law, and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.

The FDA has also made available an advisory to parents on the risks associated with flavored tobacco products.

Officials are encouraging consumers to notify authorities of any potential violations of the ban, reported the Associated Press.

Executives from leading health groups urged the FDA last month to take a closer look at alleged attempts to sidestep the ban by making superficial changes that turn a cigarette into a small cigar in order to keep selling flavored products.

In June, President Barack Obama signed the law that allows the FDA regulate the industry. Its authority includes the ability to ban certain products, reduce nicotine in tobacco products and block labels such “low tar” and “light.” Tobacco companies also will be required to cover their cartons with large, graphic warnings. The law won’t let the FDA ban nicotine or tobacco outright, but the agency will be able to regulate what goes into tobacco products, make public the ingredients and prohibit marketing campaigns, especially those geared toward children.

Richmond, Va.-based Altria Group Inc., owner of market-leading Philip Morris USA, supported the legislation, while its chief rivals—No. 2 Reynolds American Inc. and No. 3 Lorillard Inc., both based in North Carolina—opposed it. The latter two have joined in a lawsuit with other smaller tobacco companies challenging specific marketing regulations of the law.

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September 22, 2009 – WASHINGTON — Additional information was provided by the Food and Drug Administration (FDA) in regards to the ban on cigarettes containing “certain characterizing flavors” that went into effect Sept. 22, including the implication of rolling papers, roll-your-own tobacco and little cigars.

The FDA stated the “special rule” prohibits a cigarette or its component parts — including the tobacco, filter or paper — from containing ingredients, additives, herbs, spices, and artificial or natural flavors other than tobacco or menthol. Such flavors that are banned include strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry and coffee.

According to a statement released yesterday by the FDA, this ban applies to loose tobacco to be used as cigarette and roll-your-own tobacco, as well as cigarette rolling papers and filters.

“A consumer-rolled, roll-your-own cigarette is a cigarette under section 900(3) [of the Federal Food, Drug, and Cosmetic Act] because it is a wrapped roll of tobacco,” the FDA said in a statement. “Rolling paper or filters intended for use in roll-your-own cigarettes are component parts of a rolled, roll-your-own cigarette and therefore may not be flavored with a characterizing flavor.”

As a result, Republic Tobacco issued a statement to retailers and wholesalers, stating that the sale of certain products has ceased, including Golden Wrap flavored tobacco wraps, Top flavored papers and Wildfire flavored papers. It also asked its customers to halt the sale of these products, and instead, return the products by Oct. 30, for a full credit of the purchase price.

The ban does not apply to flavored pipe tobacco, and it is not immediately clear if the ban applies to little cigars. In its statement to the tobacco industry, the FDA said the ban applies to all tobacco products with certain characterizing flavors that meet the definition of a “cigarette” in section 900(3) of the Federal Food, Drug, and Cosmetic Act, even if they are not labeled as “cigarettes” or are labeled as cigars or as some other product.

In a separate statement, the FDA stated it is examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes. And when asked during a press conference about the application of the ban to little cigars, the head of the FDA’s tobacco committee, Dr. Lawrence Deyton, said the issue of a ban on other flavored tobacco products will be studied by the FDA in the near future, according to reports by the National Association of Tobacco Outlets (NATO), which said, “The lack of a definitive ‘yes’ or ‘no’ in the FDA advisory … plus the statement by Dr. Deyton about the need to study the issue further, can lead a reasonable person to conclude that flavored little cigars are not banned at this time.”

Kretek International Inc., which imports Djarum-brand tobacco products from Indonesia, recently began importing cigars similar to the size of a cigarette and contain flavors such as clove and vanilla, in efforts to circumvent the ban, according to a report in The Wall Street Journal. Kretek did not immediately return a call from the Journal for comment.

An FDA lawyer told the paper the FDA would look at “little cigars” and similar products on a “case-by-case basis.”

If a retailer, manufacturer, importer or wholesaler is found to violate this ban, the FDA said its general practice is to issue warning letters to firms before taking enforcement action, to notify firms that they or their products are in violation of the law, and to give them an opportunity to comply. However, the FDA added, “when circumstances are appropriate, FDA may take enforcement action to protect the public health without first issuing a warning letter.”

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Burned on Flavor

FDA further defines flavored-clove-cigarettes ban; retailer reacts

OAK BROOK, Ill. — With just under a week left before the sales of flavored clove cigarettes become illegal, the U.S. Food & Drug Administration (FDA) has issued a letter providing the industry with more specific direction, its first action in regulating tobacco since given the task in July.

As the letter explains, “An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. Congress has stated that flavors make cigarettes more appealing to youth and often result in exposure to additional carcinogens and other toxic constituents. The removal from the market of cigarettes that contain certain characterizing flavors is an important step in FDA’s efforts to reduce the burden of illness and death caused by tobacco products.”

According to the letter, retailers have until September 22 to completely remove a cigarette or any of its component parts (including the tobacco, filter or paper) that contains any artificial or natural flavor (other than tobacco or menthol) or an herb or spice…that is a characterizing flavor of the tobacco product or smoke. Retailers who fail to do so will be subject to seizure and the “full range of enforcement tools within the agency’s authority” to ensure compliance. “In addition, manufacturers, distributors and retailers may be subject to injunction actions, civil money penalties and/or criminal prosecution.”

The information was both news and a source of frustration to at least one small retailer, Lancaster, Ohio-based Pipe Emporium Inc. dba Smokers Emporium Downtown. Maria Williams, assistant manager at the store, said she heard about clove cigarettes through customers buying up her stock and did her own research to confirm it. She didn’t know about other flavors being hit until a conversation with CSP Daily News. “It’s a little bit frustrating actually, because we don’t even really get a heads up on this stuff unless somebody says something to us.”

Details of the regulation, as clarified this week from a letter from the director of the FDA’s new Center for Tobacco Products, Lawrence Deyton, specifically state the following flavors as being “adulterated”: strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee.

As both a consumer and somebody running a store, she said, the law is an annoyance. “I see it as too much emphasis is put on regulation and not enough on personal responsibility,” Williams said.

She added that her store’s clove cigarette consumers tend to be women, who smoke three of them a day maximum, or just as an occasional treat. And while she does understand why marketing of such products should be watched to ensure it doesn’t encourage children to smoke, the regulation is also taking away choice for adults. “Everybody has their own choices in flavors; I didn’t suddenly develop old-people taste buds,” she said, adding that she occasionally likes her chocolate-mocha Dreams cigarettes. “It’s the option of choice, I guess, that is the biggest reason why some people get so frustrated with it.”

And with only a couple of clove cigarette packs on her store’s shelf, she said she will likely just buy them herself if they don’t find a home. “For us personally, I don’t see it affecting us majorly, just because we are really a relatively small tobacco store,” she said. “It’s more of a disappointing sign of the times.”

Click here to view the full FDA letter.

Meanwhile, September 18, representatives from the National Association of Tobacco Outlets (NATO) will participate in a “Listening Session” conference call scheduled by the FDA, the group said. The purpose of the conference call is for the FDA to listen to industry retailers with comments on how to implement the FDA tobacco regulations.

One area that NATO representatives will comment on is the ban on color tobacco advertising in all retail stores and the requirement that only “tombstone” advertising consisting of black letters on a white background be allowed in retail stores, said NATO. Since a lawsuit has been filed against the FDA seeking to declare the advertising restrictions unconstitutional, NATO representatives will direct comments to the FDA regarding the unconstitutionality of the advertising ban, it said.

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The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that effective September 22, 2009, cigarettes that contain certain characterizing flavors are considered adulterated under the Federal Food, Drug, and Cosmetic Act (FFDCA or the Act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Smoking is the leading preventable cause of death in the United States. An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. Congress has stated that flavors make cigarettes more appealing to youth and often result in exposure to additional carcinogens and other toxic constituents. The removal from the market of cigarettes that contain certain characterizing flavors is an important step in FDA’s efforts to reduce the burden of illness and death caused by tobacco products.

The FSPTCA provides FDA with regulatory authority over the manufacture, marketing, and distribution of tobacco products. Specifically, section 907(a)(1)(A) of the Act, as amended by the FSPTCA, establishes a tobacco product standard special rule for cigarettes that states in part:

…a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.

This standard applies to all tobacco products that meet the definition of a “cigarette” in section 900(3) of the Act even if they are not labeled as “cigarettes” or are labeled as cigars or as some other product.

As of the September 22, 2009, effective date, cigarettes and their component parts that fail to comply with the special rule established under section 907 are deemed adulterated under section 902 of the Act. Under the Act, adulterated products sold or held for sale in the United States may be subject to seizure under section 304 of the Act. In addition, manufacturers, distributors, and retailers may be subject to injunction actions, civil money penalties, and/or criminal prosecution for violating the requirements of the Act (FFDCA, sections 301, 302, 303). FDA intends to use the full range of enforcement tools within the Agency’s authority to ensure compliance with the new requirement.

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TORONTO — At first glance, it looks like cigarettes have disappeared from Canadian stores.

There are no advertisements or signs for cigarettes in retail outlets in most of the nation’s provinces. And the behind-the-counter racks of various cigarette brands, so familiar in the United States, are nowhere to be seen.

While cigarettes are still sold, they have largely disappeared from view — an effort by the nation’s provincial governments to discourage smoking among young people and help adults quit.

“The principle is indeed out of sight, out of mind,” said Rob Cunningham, senior policy analyst with the Canadian Cancer Society.

Canada’s move to hide cigarettes at their point of sale is being watched closely by U.S. anti-tobacco advocates as a potential weapon in the just-starting federal regulation of tobacco products.

“In convenience stores in the United States, we are bombarded with tobacco branding images,” said Paul Billings, vice president for national policy and advocacy at the American Lung Association in Washington. “These measures to reduce the attractiveness and reduce the availability of tobacco products do have a positive impact on reducing tobacco use.”

The new anti-smoking law passed by the U.S. Congress this year gives the federal Food and Drug Administration the authority to minimize tobacco-marketing tools that may affect consumption of the product, particularly by youths, said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

“Much of the rest of the world is ahead of us in taking steps to minimize exposure to tobacco marketing,” he said. “All of the issues concerning marketing and displays in convenience stores are appropriate for FDA’s consideration.”

Concealing cigarettes ends a subtle but powerful form of advertising, said Michael Perley, director of the Ontario Campaign for Action on Tobacco.

“If you have this product next to the candy, the gum, pop and newspapers in every store on every corner in every city and town in the province, young people wonder how can it be harmful — because it’s everywhere,” Perley said. “Removing that message in large part is extremely important.”

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On September 22, in accordance to the Eshoo law, all flavored cigarettes will be illegal. This includes fruit flavored cigarettes, vanilla, chocolate, cinnamon, and clove. But now menthol? Of course not.

Of course not. Major tobacco industries have been lobbying to rid the nation of flavored and clove cigarettes for years because well, they are losing money to them. Major companies like Phillip Morris don’t distribute flavored cigarettes in the U.S, except menthol flavors. However, clove cigarettes are imported mainly from Indonesia.

The reason cited for the bill is to discourage underaged smoking. The lawmakers say they feel that flavored cigarettes appeal more to underaged smokers and people who never smoked before. If this is true, then why are menthol cigarettes still legal? Because menthol cigarettes make up about a quarter of $52 billion in annual sales for Phillip-Morris alone. It’s pocket change to lobby for this bill to be passed in order to protect their interests. Aside from that, the U.S has their own hind-ends to look after. Even though Congresswoman Virginia Foxx clearly stated that this is a vialation of WTO.

“According to WTO rules…an imported ‘good’ (clove cigarettes) should receive treatment that is ‘no less favorable than that provided to a domestic good.’ “

Well now what? The law is passed, and really there isn’t much that we can do. Let’s just hope the right decisions are made not based on the interests of certain people’s wallets. What do you think about the ban? Is it right or wrong? Should the government ban flavored cigarettes, or is this law unethical? Post your

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