FDA’s Definition of a Little Cigar as a Cigarette

Based on a September 22nd news conference with new Tobacco Center head Dr. Deyton, FDA appears confused as to whether HR 1256 covers flavored little cigars and cigarillos as well as flavored cigarettes, which had to be off the shelves on September 22nd.  It appears that FDA conducted sting operations in Pennsylvania and Alabama and demanded that retailers remove Swisher Sweets and Black and Mild flavored cigars since under FDA’s interpretation of the law consumers could “believe” that these products are like cigarettes and are therefore covered by the law.  The question now is how far can FDA’s interpretation of consumer beliefs go?

15 comments ↓

#1 OTP Kid on 09.24.09 at 1:01 PM

While cigarillos remain a question mark, all indications are little cigars will fall into this ban. Additionally, non-flavored cigars are going to be taxed at cigarette rate.

#2 John Rolfe on 09.28.09 at 1:31 PM

Cigarillos are tobacco whole leaf wrapped, not recon wrapped, and will not be impacted and even if they were recon wrapped like little cigars, the key issue in all of this, based on the FDA definitions of what is a cigarette, is whether it is likely that a consumer would believe the product is a cigarette or not, given that it has a filter, comes 20 to a pack etc., in spite of the fact that the tobacco in all genuine little cigars are low-sugar, air-cured with little or no oriental and flue-cured. Based on the submission to the Regulations.gov file by Cheyenne, in response to the fallacious Campaign for Tobacco Free Kids claim that Cheyenne, like Kretek renamed a cigarette to be a “little cigar, the latter due to the clove ban, Cheyenne never produced a flavored cigarette that is now a flavored little cigar.

#3 Desert Dude on 10.02.09 at 6:10 PM

John Rolfe,

You really think that the FDA gives a rip whether it’s a cigar or a cigarette. Come on now you must be smoking something funky. This is all about giving control to an organization that will take it’s orders from CTFK & Altria.
Get a grip PM has fooled folks and now it’s pretty damn sad that this baby won’t get changed back. I’m so sick of all these folks that took a stance in the past that just said all this couldn’t happen but here it is!

#4 TAZ on 10.03.09 at 12:25 PM

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.

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.

#5 TAZ on 10.03.09 at 12:39 PM

FURTHER INFORMATION – MUST SAY I WARNED FOLKS ABOUT FDA REGULATION AND HOW IT WOULD REACH FURTHER INTO THE INDUSTRY THEN EXPECTED. BUT WHAT DO YOU THINK THIS MEANS.

-EXPCITE-
TITLE 15 – COMMERCE AND TRADE
CHAPTER 36 – CIGARETTE LABELING AND ADVERTISING

-HEAD-
Sec. 1332. Definitions

-STATUTE-
As used in this chapter –
(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).

(2) The term “commerce” means (A) commerce between any State,
the District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway Islands,
Kingman Reef, or Johnston Island and any place outside thereof;
(B) commerce between points in any state, the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, Wake Island, Midway Islands, Kingman
Reef, or Johnston Island, but through any place outside thereof;
or (C) commerce wholly within the District of Columbia, Guam, the
Virgin Islands, American Samoa, Wake Island, Midway Islands,
Kingman Reef, or Johnston Island.
(3) The term “United States”, when used in a geographical
sense, includes the several States, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American
Samoa, Wake Island, Midway Islands, Kingman Reef, and Johnston
Island. The term “State” includes any political division of any
State.
(4) The term “package” means a pack, box, carton, or container
of any kind in which cigarettes are offered for sale, sold, or
otherwise distributed to consumers.
(5) The term “person” means an individual, partnership,
corporation, or any other business or legal entity.
(6) The term “sale or distribution” includes sampling or any
other distribution not for sale.
(7) The term “little cigar” means any roll of tobacco wrapped
in leaf tobacco or any substance containing tobacco (other than
any roll of tobacco which is a cigarette within the meaning of
subsection (1)) and as to which one thousand units weigh not more
than three pounds.
(8) The term “brand style” means a variety of cigarettes
distinguished by the tobacco used, tar and nicotine content,
flavoring used, size of the cigarette, filtration on the
cigarette, or packaging.
(9) The term “Secretary” means the Secretary of Health and
Human Services.

#6 TAZ on 10.06.09 at 12:20 AM

NEW YORK — The Nat Sherman Co. has issued a letter clarifying which of the company’s cigarette brands comply with the new U.S. Food & Drug Administration (FDA) regulations, according to the National Association of Tobacco Outlets (NATO), which published a copy of the letter in its most recent E-News Bulletin.

The letter said:

“Regarding the FDA ban on characterizing flavors which went into effect on September 22, 2009…. The law bans both the manufacturing and sale of all flavored cigarettes (except for regular and menthol brands). This includes our Clove and Mint brand styles, but does not affect any of our other brands. In the last few weeks, we have been actively removing our Clove and Mint brands from the market place as many states have begun delisting them from their approved directories.

Consistent with our obligations as a responsible manufacturer, we have discontinued our ‘A Touch of Cloves’ and all our Mint brands styles. Concerning our ‘Mint’ brands, while many competitors use a synthetic menthol flavoring to treat the tobacco in their products, we have always remained true to our heritage as a manufacturer of only all-natural 100% additive-free cigarettes. Since menthol is derived from nature’s own mint plant, our menthol-flavored cigarettes have always contained pure menthol crystals in our filters to impart a natural menthol flavor. And to differentiate our menthol products, we adopted the descriptor ‘Mint.’ Now, however, we have revised our packaging for these brands and changed the descriptor to ‘Menthol.’ Other than this slight name change, you can be assured the quality and enjoyment you and your adult customers have come to expect from these brands will continue to remain the same. Please note that both the UPC and product code will remain unchanged.”

#7 jancascade on 10.07.09 at 10:32 PM

As a retailer, we have decided to not sell any RYO tobacco. We must pay our state tax on the federal SCHIP tax, so in our state a pound of tobacco has almost $42.00 combined taxes before we make a dime. Too costly to floor for the return on the investment.

We had a small but steady Clove and Sweet Dream clientele. That is gone now too.

The federal government is raiding the states treasuries with these new bans and taxes. The states will have to use their SCHIP allotments to shore up existing children’s health insurance plans, and be unable to add any new kids with insurance coverage.

This is nuts!

#8 OTP Kid on 10.08.09 at 2:16 PM

jancascade:

You should try TubeCut and Superoll from Republic Tobacco. It weighs about half and gives people the same amount of cigarettes. We are selling a lot of it, and it’s about the only RYO we’re selling except Drum, Top and Buglar pouches. We have our retail stores listed on the the website, which they will do for you for free.

http://www.tubecuttobacco.com

#9 jancascade on 10.09.09 at 1:41 AM

OTP Kid,
We are taxed on the wholesale cost, not the weight. RYO was a small part of my business and I do not need it and have no desire to make more money for the state than I make on the product. RYO tobacco is all but impossible to buy in our state now.

As far as I am concerned, government can go pound sand.

#10 OTP Kid on 10.09.09 at 9:55 AM

jancascade – what state a re you in?

Those products weigh less, so an 8 ounce bag has half the federal tax than a one pound bag so it starts off 12 bucks cheaper, and then your state otp % is off a lower base

We are selling a lot of this product and we have a 71% OTP tax in our state!

you ought to check it out, it should work for you

#11 Desert Dude on 10.11.09 at 2:07 AM

Sounds like Jancascade is from a liberal western state like Oregon. Bring on the weed! Pretty interesting.

#12 TAZ on 10.12.09 at 1:11 PM

US Rep. Henry Waxman (D-California), chair of the House Committee on Energy and Commerce, said he sent letters to Cheyenne International of North Carolina and Kretek International of California, noting reports that the companies are allegedly attempting to circumvent the Food and Drug Administration’s ban on flavored cigarettes by repackaging their flavored cigarettes as “little cigars” or as “filtered cigars that share a similar appearance and size,” and asking them to provide information about how they have marketed their flavored tobacco products since the FDA’s rules took effect on September 22nd. (Associated Press – AP 10/06)

#13 John Rolfe on 10.12.09 at 1:43 PM

Yes, Taz you are quite right. Thing is that Waxman’s letter to Cheyenne clearly states that it was public health groups that brought this to his attention and already back on August 27th the Campaign For Tobacco Free Kids made a submission at Regulations.gov citing precisely what their mouthpiece Waxman wrote. What Waxman failed to do, however, prior to his October 8th letters was to review the Cheyenne response to CTFK in their submission at Regulations.gov which made it clear why CTFK had failed to properly characterize Cheyenne’s little cigars e.g., unlike Kretek’s clove flavored little cigars, Cheyenne’s cigarettes were quite different. Now Waxman is reaching out for all data from both including sales data to retailers and wholesalers, all marketing plans, and everything else that will require a team of data gatherers.

This is the first example of the new powers of Bart Stupak, who heads Oversight and Investigations for Waxman’s committee, and of the FDA itself but more importantly it is no doubt being aided and abetted by Altria since their John Middleton group never made cigarettes so Altria believes they would be exempt from the oversight faced by cigarette makers who now make little cigars and fits with Altria’s plan to eliminate all competitors under the guise of doing something for youth, while at the same time selling more Marlboro Lights to youth than all other products combined.

#14 Bill Godshall on 10.13.09 at 6:30 PM

This is a very interesting discussion, and it appears that the FDA and Waxman are trying to expand the scope of the FDA law by reinterpretting definitions of words and phrases.

Regarding little cigars, PA just enacted a new budget on Friday that imposes a $.25/pack tax hike on cigarettes (from $1.35 to $1.60) and a new $1.60/pack tax on little cigars (which were previously untaxed).

PA’s definition (for tax purposes) of a little cigar is under 4 pounds per thousand (instead of the SCHIP definition of under 3 pounds per thousand), which appears to include little cigars that companies recently added a little bit more tobacco to in order to aviod the SCHIP $1/pack tax on little cigars.

What I found interesting is that none of the health groups were urging PA legislators to tax little cigars at the same $1.60/pack rate as cigarettes. Rather, CTFK, ACS, AHA, ALA were advocating a 59% of wholesale price for all OTP (and especially for smokeless). Meanwhile, Smokefree Pennsylvania was urging the legislature to enact Gov. Rendell’s proposed $.036/cigar tax (for all cigars) and a $.36/ounce tax on all smokeless and smoking tobacco.

A Philly Inquirer article indicated that Altria was urging the PA legislature to enact the $1.60/pack tax on all little cigars. If that is true, I suspect that Altria also urged the legislature to define little cigars as being under 4 pounds per thousand (instead of under 3 pounds per thousand).

Interestingly, PA Senate and House Republicans adamantly opposed any tax on smokeless and smoking tobacco or on large cigars (not sure if cigarillos fit the definition of little cigars). So I anticipate that many little cigar smokers will now switch to less expensive large cigars.

Also of interest, during the entire budget process, CTFK, ACS, AHA, ALA criticized Rendell’s more modest and fairer weight and piece based OTP tax proposal by insisting upon a far greater price based OTP tax of 59% of wholesale price, claiming that it would “eliminate the tobacco tax loophole by taxing OTP at the same rate of cigarettes”. These groups have made the exact same claim in urging the Ohio legislature to tax OTP at 59% of wholesale. But even with PA’s new $.25/pack cigarette tax hike, the new $1.60/pack tax is only 29% of the anticipated $5.50/pack cigarette wholesale price.

After I informed PA legislators of this false tax claim by these heatlh groups, the PA House approved a 30% OTP tax (instead of the 59% OTP tax bill that had been introduced and was advocated by these groups), which was subsequently rejected by the PA Senate.

I’m also not aware that CTFK, ACS, AHA, ALA advocated increasing the PA cigarette tax during the entire budget process, which (along with their actions regarding the FDA cigar flavorings) indicates to me that these anti tobacco groups are far more interested in going after OTP, flavored cigarettes and cigars, and electronic cigarettes than in reducing cigarette consumption (which makes no sense to me).

#15 OTP Kid on 10.28.09 at 10:50 AM

Willie,

I will help you out on this one. The reason no health groups were behind the little cigar tax is because they do not understand what Altria understands, which is that little cigars are cigarette substitutes (packed 20, filtered, lights, menthol, etc). That is why PM pushed this through in PA and is working dilligently in Michigan to get a similar measure passed.

Your conclusion that many little cigar smokers will switch to cigarillos is incorrect, as you can see from the previous paragraph these were not cigar smokers to begin with, they were cigarette smokers who converted to little cigars due to price, now they will go back to cigarettes or RYO.

Oh, and by the way, they picked 4 pounds per thousand because Black n Mild weighs slightly more than that and would not fall into the tax. Altria: Looking out For the Industry (which is us).

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