FDA: Frequently Asked Questions: Protecting Kids From Tobacco

Frequently Asked Questions: Protecting Kids From Tobacco
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
June 22, 2010, new FDA regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents take effect. This document provides answers to anticipated questions most frequently asked by retailers, consumers, and others about the restrictions.

I.The Family Smoking Prevention and Tobacco Control Act:

  • What is the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act)?
    On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act grants the Food and Drug Administration (FDA) important new authority to regulate the manufacture, marketing and distribution of tobacco products to protect the public health generally and to reduce tobacco use by children and adolescents.
    Among its many provisions, the Tobacco Control Act requires FDA to re-issue its 1996 final regulations restricting the sale and distribution of cigarettes and smokeless tobacco products. The rule contains provisions designed to limit youth access to tobacco products, as well as restrictions on marketing to curb the appeal of these products to youth. Provisions of the new FDA regulations will go into effect on June 22, 2010.

II. Description of the Regulation:

  • How is the Youth Access and Advertising Regulation related to the Tobacco Control Act?
    The Tobacco Control Act requires the FDA to publish these regulations, which the agency previously issued in nearly identical form in 1996. The regulations set forth advertising, access, and marketing restrictions regarding the sale of cigarettes and smokeless tobacco. The Tobacco Control Act contains provisions relating to the manufacture, marketing and distribution of tobacco products.
  • What is the name of the regulation?
    Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.
  • How will FDA inform the retail community and general public about the regulations?
    The regulations will be published in the Federal Register on March 19, 2010. In addition, FDA will use a variety of communication channels, including a dedicated Web page that will contain guidance on how to comply with the new requirements, social media tools, such as pod casts, and other tools to educate retailers and consumers about the new requirements. The Web site can be found at www.fda.gov/protectingkidsfromtobacco.gov.
    In addition, FDA has established a toll-free number (1.877.CTP.1373) for further assistance.
  • Which center in the FDA will regulate tobacco products?
    The Center for Tobacco Products (CTP).
  • What are some of the regulations that go into effect on June 22, 2010?
    The full text of the requirements may be found in 21 CFR Part 1140, which was published in the Federal Register on March 19, 2010.

Age and ID (21 CFR 1140.14, Additional Responsibilities of retailers)

    1. Cigarettes and smokeless tobacco may not be sold to anyone younger than 18 years of age;
    2. Retailers must examine a photographic identification bearing the person’s birth date to verify that any person purchasing cigarettes or smokeless tobacco is at least 18 years old. Verification is not required for purchasers who are over the age of 26.

Packaged or Unpackaged Cigarettes or Smokeless Tobacco (21 CFR 1140.14, Additional Responsibilities of retailers)

    1. Retailers may not sell single cigarettes or packages containing fewer than 20 cigarettes, except in vending machines located in facilities where the retailer ensures that no person younger than 18 years of age is permitted to enter at any time;
    2. Retailers may not sell unpackaged smokeless tobacco or packages of smokeless tobacco that are smaller than packages distributed by the manufacturer for individual use;
    3. Cigarettes and smokeless tobacco may not be sold through vending machines or self-service displays, except in facilities where persons under the age of 18 are prohibited from entering.

Free Samples, Rebates, or Redemption of Coupons by Mail or Retailer for Cigarettes or Smokeless Tobacco (21 CFR 1140.16 Conditions of manufacture, sale, and distribution)

    1. Distribution of free samples of cigarettes is prohibited;
    2. Free samples of smokeless tobacco products may be distributed only in qualified adult-only facilities and no more than 1 package or 0.53 ounces (15 grams) may be distributed to an individual adult consumer per day; however, if the smokeless package contains individual portions, it may contain no more than 8 individual portions and the collective weight of the individual portions may not exceed 0.53 ounces (15 grams);
    3. Free samples of smokeless tobacco may not be distributed to a sports team or entertainment group, or at any football, basketball, soccer, or hockey event;
    4. Mail-order redemption of coupons is prohibited and free samples of cigarettes or smokeless tobacco may not be distributed through the mail;
    5. Manufacturers may not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product unless the trade or brand name was on both the tobacco product and a nontobacco product sold in the United States on January 1, 1995.

Advertising and Labeling (21 CFR 1140.32 Scope of permissible forms of labeling and advertising)

    1. Audio advertisements for cigarettes or smokeless tobacco may not include music or sound effects;
    2. Video advertisements for cigarettes or smokeless tobacco may not use color, but rather are limited to static black text on a white background;
    3. Ads in teen magazines or similar publications may not use color, but rather must use black text on a white background.

Non-Tobacco Gifts or Items (21 CFR 1140.34 Sale and distribution of non-tobacco items and services, gifts, and sponsorship of events)

  1. Manufacturers (and distributors of imported products) are prohibited from selling non-tobacco items, like T-shirts and novelty items, bearing a cigarette or smokeless tobacco brand-name, logo, or selling message;

Trade or Brand-Name (Non-Tobacco For Tobacco and Vice Versa) (21 CFR 1140.34 Sale and distribution of non-tobacco items and services, gifts, and sponsorship of events)

  1. Non-tobacco products and services may not bear a trade- or brand-name, logo, symbol, motto, selling message, recognizable pattern of colors, or any other indicia of product identification that is identical or similar to those used for any brand of cigarettes or smokeless tobacco;
  2. Sponsorship of athletic, musical, artistic, or other social or cultural events in the brand-name, logo, symbol, motto, selling message, recognizable pattern of colors, or any other indicia of product identification of cigarettes or smokeless tobacco is prohibited.

Black Text on White Background (“tombstone” provision) (21 CFR 1140.32 Format and content requirements for labeling and advertising)

Labeling and advertisements for cigarettes or smokeless tobacco may not use color, but rather must use black text on a white background.

The only exceptions to this requirement are advertising:

    1. In any facility where vending machines and self- service displays are permitted, provided that the advertising is not visible from outside the facility and that it is affixed to a wall or fixture in the facility; or
    2. Appearing in any publication (whether periodic or limited distribution) that the manufacturer, distributor, or retailer demonstrates is an adult publication. An adult publication is a newspaper, magazine, periodical, or other publication:
      (i) Whose readers younger than 18 years of age constitute 15 percent or less of the total readership as measured by competent and reliable survey evidence; and
      (ii) That is read by fewer than 2 million persons younger than 18 years of age as measured by competent and reliable survey evidence.
  • Why don’t the regulations include restrictions on outdoor advertising?
    In the Tobacco Control Act, Congress directed FDA to review the restrictions on outdoor advertising that were included in the 1996 rule in light of recent First Amendment case law. FDA did that and determined that it was appropriate in light of governing First Amendment case law to solicit additional information regarding outdoor advertising in order to determine what modifications to the previous outdoor advertising provision, if any, are appropriate.
    FDA published an advance notice of proposed rulemaking (ANPR) in the Federal Register on March 19, 2010, requesting comments and information on outdoor advertising. By issuing this ANPR, the agency will obtain comments and data, research, or other information that may have developed since the 1996 rule. FDA intends to use the information submitted in response to the advance notice of proposed rulemaking, along with information in the existing record and other information developed since the publication of the 1996 final rule, to inform its regulation of outdoor advertising of cigarettes and smokeless tobacco. Consequently, FDA has reserved the outdoor advertising section of the rule.
  • What is FDA’s position concerning the tombstone (black and white text) provision in the 1996 rule in light of the Commonwealth decision?
    FDA believes this is a very important provision of the 1996 rule. The district court ruled in the Commonwealth case that this provision violates the First Amendment. FDA disagrees with the court’s ruling on this provision, and the government has appealed this part of the court’s decision.
  • While the case is being appealed, does FDA intend to enforce this provision against companies not involved in the lawsuit?
    The regulation becomes effective on June 22, 2010. FDA intends to consider what further steps, if any, should be taken with regard to this provision and to provide further information before the effective date.

     

III. Who is Covered and Contact Information:

  • Who is covered, or impacted, by the Youth Access and Advertising regulations?
    The regulations apply to manufacturers, distributors, importers, retailers, and others who sell cigarettes and/or smokeless tobacco.
  • How do I know if I am a retailer?
    You are a retailer for purposes of these regulations if you sell cigarettes or smokeless tobacco to individuals for their own use or operate a facility where vending machines or self-service displays are permitted under the regulations. The regulations apply to all types of retail establishments, such as, for example, grocery stores, pharmacies, convenience stores, gas stations, bars, restaurants, bowling alleys, and hotels.
  • Do the regulations affect consumers?
    Retailers are prohibited from selling cigarettes or smokeless tobacco to persons under the age of 18. All purchasers, except for persons over the age of 26, are subject to age verification via a photograph identification bearing his/her birth date. It is a violation of some state laws for persons under the age of 18 to purchase these products.
  • Are these regulations applicable to Tribal lands?
    Yes. These regulations apply to sales of cigarettes and smokeless tobacco on Tribal lands unless a specific treaty with an individual tribe alters FDA’s jurisdiction over such sales
  • If I have questions about the regulations, whom do I contact?
    Call: Starting March 19, 2010, those with questions about the regulations may call 1.877.CTP.1373 for assistance.
    Go Online: You may also go to www.fda.gov/protectingkidsfromtobacco1 for additional information.

IV. Product Categories :

  • What are tobacco products?
    The Federal Food, Drug, and Cosmetic Act, section 201(rr)(1), defines the term
    “tobacco product” as any product made or derived from tobacco that is intended for human consumption. The term includes components, parts, or accessories of tobacco products, except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product. The term does not include an article that FDA regulates under the Food, Drug, and Cosmetic Act as a drug, a medical device, or a combination product.
  • What tobacco products are covered by these regulations?
    Cigarettes and smokeless tobacco.
  • What is a cigarette?
    Under the Federal Food, Drug, and Cosmetic Act, section 900(3), the term cigarette:
  1. means a product that–
    (A) is a tobacco product; and
    (B) meets the definition of the term ‘cigarette’ in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and
  2. (2) 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.
  • What is smokeless tobacco?
    Under the Federal Food, Drug, and Cosmetic Act, section 900(18), the term “smokeless tobacco” means any product that consists of cut, ground, powdered, or leaf tobacco and that is meant to be placed in the oral or nasal cavity (i.e., in the mouth or the nose).
  • Do the regulations apply to cigars, pipe tobacco, and hookah tobacco?
    No, the regulations apply to cigarettes and smokeless tobacco products only.
  • Do the regulations apply to roll-your-own (RYO) cigarette tobacco?
    Yes. Cigarette tobacco is defined in the Tobacco Control Act and the regulations as any product that consists of loose tobacco that is intended for use by consumers in a cigarette. The regulations provide that, unless otherwise stated, the requirements applicable to cigarettes also apply to cigarette tobacco.

V. Age and ID:

  • What is the legal age for purchasing cigarettes or smokeless tobacco?
    The regulations prohibit the sale of cigarettes and smokeless tobacco to anyone under the age of 18. However, the Tobacco Control Act does not pre-empt State or local laws relating to access to tobacco products that are in addition to, or more stringent than, the access provisions in the Tobacco Control Act. Therefore, a state could establish 19 years of age or older as the minimum age for purchasing these products in that state. Some states and localities do, in fact, have more stringent age requirements. As of March 1, 2010, four states (Alabama, Alaska, New Jersey, and Utah) have established 19 years of age as the minimum legal age for purchasing tobacco products in those states.
  • Are persons under the age of 18 who attempt to buy these products subject to action for violating this law?
    FDA’s regulations apply to persons who manufacture, sell, distribute, and advertise these products. However, some states and localities impose penalties on underage children for purchasing, possessing, or using tobacco products.
    Why did FDA decide that retailers must require all customers who are not over the age of 26 to present a photo ID?
    Research has shown that it is very difficult for retailers to accurately determine the age of a customer and that older youth (those who are 16 or 17 years old) are more successful in purchasing tobacco products in retail establishments than are younger youth. Therefore, in order to ensure that older-looking teenagers are asked for identification, FDA concluded that it is important for retailers to request and examine photographic identification from anyone who is not over the age of 26.
    This recommendation was reiterated in a report issued by a Working Group of State Attorneys Generals, who studied the problem of illegal tobacco sales to minors and concluded that, in order to prevent illegal sales of tobacco products to youth, photographic identification must be requested for persons who are significantly older than the minimum legal age to purchase these products. To address this issue, retailer training programs developed by states, retailer groups, and the tobacco industry typically train retailers to request photographic identification from any customer seeking to purchase tobacco who appears to be under the age of 27.
  • Does the age requirement apply to the purchase of rolling papers?
    No. The requirement applies to purchases of cigarettes and smokeless tobacco products only.
  • Does the retailer have to be 18 years old to sell the products?
    The FDA regulations do not address the age of the salesclerk. However, some state laws may set a minimum age for clerks selling tobacco products.
  • Can a retailer accept an out-of-state driver’s license if it has the customer’s picture and date of birth?
    Yes, this would be a photographic identification containing the bearer’s date of birth.
  • Can a retailer sell to a child whose parents (or other adults) have sent him/her into a store to purchase these products for the adult’s use?
    No. The regulations prohibit retailers from selling to anyone under the age of 18.
  • Is the retailer responsible for preventing parents and other adults from purchasing these products for minors?
    No. The regulations require only that the retailer verify the age of the purchaser.
  • How do the regulations affect retailers who sell only tobacco products?
    The regulations apply equally to retailers that sell only tobacco products and those that sell tobacco products in addition to other things.

VI. Free Samples, Rebates, Coupons, and Proofs-of-Purchase:

  • What are free samples?
    Cigarettes or smokeless tobacco that the manufacturer, distributor or retailer offers or distributes for free.
    Can a manufacturer, distributor or retailer distribute free samples of smokeless tobacco?
    Yes, a manufacturer, distributor or retailer may distribute free samples of smokeless tobacco in a qualified adult-only facility.
  • What is a qualified adult-only facility?
    The regulations, section 1140.16(d)(2)(iii), define the term “qualified adult-only facility” as a facility or restricted area that:
     
  • requires each person present to provide to a law enforcement officer (whether on or off duty) or to a security guard licensed by a governmental entity government-issued identification showing a photograph and at least the minimum age established by applicable law for the purchase of smokeless tobacco;
  • does not sell, serve, or distribute alcohol;
  • is not located adjacent to or immediately across from (in any direction) a space that is used primarily for youth-oriented marketing, promotional, or other activities;
  • is a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of smokeless tobacco adhering to this subparagraph;
  • is enclosed by a barrier that–
    • is constructed of, or covered with, an opaque material (except for entrances and exits)
    • extends from no more than 12 inches above the ground or floor (which area at the bottom of the barrier must be covered with material that restricts visibility but may allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); and
    • prevents persons outside the qualified adult-only facility from seeing into the qualified adult-only facility, unless they make unreasonable efforts to do so; and
    • does not display on its exterior—
      • any tobacco product advertising;
      • a brand name other than in conjunction with words for an area or enclosure to identify an adult-only facility; or
      • any combination of words that would imply to a reasonable observer that the manufacturer, distributor, or retailer has a sponsorship that would violate section 1140.34(c).
  • Can coupons be redeemed by mail?
    No. The regulations prohibit the sale of cigarettes or smokeless tobacco through redemption of coupons by mail.
  • What are some examples of “evidence of a purchase?”
    Examples include credits, proofs-of-purchase, and coupons.
     

IX. Advertising

  • Are vendor posters and displays placed in a retailer’s window or placed in other locations throughout a retailer’s facility in violation of the law if they are in color or contain imagery?
    Yes, advertising and labeling with imagery and color are prohibited under the regulations.
  • What are the advertising restrictions for “qualified adult-only facilities?”
    Under section 1140.16(d)(2)(C) of the regulations, qualified adult-only facilities are not permitted to display on the exterior of the facility tobacco product advertisements; a tobacco product brand name except for purposes of identifying an area or enclosure as an adult-only facility; or words that imply that the manufacturer, distributor, or retailer has a sponsorship that violates section 1140.34(c).
  • What is the manufacturer’s responsibility concerning point of sale displays, advertising and labeling?
    Under section 1140.12 of the regulations, manufacturers must remove from each point of sale all self-service displays, advertising, labeling, and other items that the manufacturer owns that do not comply with the regulations.
  • What is the retailer’s responsibility concerning point of sale displays, advertising and labeling?
    Under section 1140.14(e) of the regulations, each retailer must ensure that all self-service displays, advertising, labeling, and other items located in its establishment that do not comply with the regulations are removed or are brought into compliance.

X. Labeling

  • What is labeling?
    The term “labeling” is defined in the Federal Food, Drug, and Cosmetic Act, section 201(m), as all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
  • What is a label?
    The term “label” is defined in the Federal Food, Drug, and Cosmetic Act, section 201(k), as a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

XI. Enforcement:

  • How will FDA enforce the regulations?
    In addition to doing inspections on its own, the Tobacco Control Act requires FDA to contract with states to inspect retail establishments within the state, to the extent feasible.
  • Who will conduct these inspections?
    Tobacco retail inspections will be performed by FDA, as well as by state officials and employees commissioned by FDA to do these inspections.
  • When will enforcement of the Youth Access and Advertising regulations begin?
    The regulations become effective on June 22, 2010, and FDA intends to enforce the requirements as soon as they are in effect.
  • Will FDA enforce the regulations in all 50 states and U.S. Territories at the same time?
    Yes. As required by the law, FDA will be entering into contracts with state agencies to conduct inspections of retail establishments in their states. FDA will enter into these contracts on a rolling basis, but in the interim, FDA intends to conduct its own investigations using FDA personnel and to take enforcement action when appropriate.
  • Will there be training programs for retail establishments to help them comply with the new requirements?
    Retail establishments are responsible for providing training to their employees. FDA intends to publish guidance to assist retailers in complying with the law.
  • What will be covered during an inspection?
    Inspectors will be checking for compliance with the requirements of the regulations, as well as the requirements of the Tobacco Control Act, such as the ban on certain characterizing flavors in cigarettes.
  • What happens if a retailer is found to be in violation of these regulations?
    FDA has a variety of enforcement tools to address retailers who violate the regulations, including civil money penalties, warning letters, seizures, injunctions, and/or criminal prosecution. Retailers who violate the regulations may also be in violation of state law and subject to a variety of state remedies.

XII. Consumers:

  • Why is FDA regulating cigarettes and smokeless tobacco products?
    On June 22, 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, providing FDA with authority to regulate tobacco products. FDA is a science-based regulatory agency that has a mission to protect the public’s health. The Tobacco Control Act required FDA to issue these regulations, which it had previously issued in nearly identical form in 1996. FDA’s priorities in implementing the new law and these regulations are to: prevent youth from purchasing tobacco products; help adults who use tobacco to quit; provide accurate information to the public regarding the content of tobacco products and the effects the products have on the public health; and use the regulatory tools contained in the Tobacco Control Act, including tobacco product standards, to reduce the public health consequences of tobacco use in the United States.
  • How can the general public help enforce these rules?
    Members of the general public can report violations to FDA’s Center for Tobacco Products through our website (http://www.fda.gov/TobaccoProducts/default.htm), by e-mail (AskCTP@fda.hhs.gov), or by phone (1-877-CTP-1373). In addition, you can cooperate with clerks and retailers by providing your photographic ID when buying cigarettes and smokeless tobacco.
  • Will tobacco products still be available for purchase?
    Yes. These products may legally be sold to persons who are 18 years of age or older. They are not being removed from the marketplace.