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ACTION ON SMOKING AND HEALTH (ASH)
A National Legal-Action Antismoking Organization 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310 |
The first of the FDA's rules regulating the sale of cigarette to children goes into effect Friday.
To help insure that there is widespread compliance with the rules, ASH has prepared an easy-to-duplicate 1-page FDA WARNING LEAFLET which sets forth the requirements in lay language drafted by the FDA.
The leaflet also contains an easy-to-remember toll-free phone number to which violations can be reported. It is: 1 - 888 - FDA - 4 - KIDs.
Copies of the leaflet are being mailed to most national, state, and local antismoking organizations across the country, together with a simple set of suggestions for using the leaflet.
If your ANTISMOKING ORGANIZATION does not receive a leaflet by March 7th, please call ASH at: (202) 659-4310.
The leaflets are designed to be used in a variety of ways, including giving them to local organizations for distribution to their members, distribution to local merchants to put them on notice of what the law requires, and as part of a citizens' army to help the FDA enforce the rules.
To assist other US readers of this Web Site, ASH reprints the text of the FDA WARNING LEAFLET below, along with the suggestions for its use.
Users may distribute this information in whatever form they wish, including in their own newsletters, or to other sites on the World Wide Web.
However, since web users may not be able to format the text to produce the leaflet itself, readers may also write to ASH-FDA LEAFLET, 2013 H St., NW, Washington, DC to receive an original of the leaflet which can then be easily copied.
TEXT OF THE FDA WARNING LEAFLET: Excerpts from The Small Entity Compliance Guide U.S. Food and Drug Administration 5600 Fishers Lane, Rockville, MD 20857 FORMAL LEGAL NOTICE FEDERAL REGULATORY REQUIREMENTS IMPOSED ON RETAILERS CONCERNING THE SALE OF CIGARETTES AND OTHER TOBACCO PRODUCTS PLEASE READ AND FOLLOW CAREFULLY TO AVOID: * FEDERAL PROSECUTION * SEIZURE OF STOCK * CIVIL PENALTIES Beginning Feb. 28, 1997, you may be liable if you: þ fail to check photo IDs þ sell tobacco to children REMEMBER: The retailer is legally responsible for the acts of all of its employees. SUMMARY OF LEGAL REQUIREMENTS The primary purpose of this document is to provide retailers þ including drug, convenience, and food stores, gasoline stations, restaurants, etc.) þ with full legal notice of their obligations under new regulations issued by the U.S. Food and Drug Administration (FDA) relating to the sale of cigarettes and other tobacco products. The document also describes the penalties which may be imposed for noncompliance, and contains information about how antismoking, civic, parent, and other organizations þ as well as concerned individuals þ can officially report violations. Retailers, to avoid legal liability, MUST: * not sell cigarettes or smokeless tobacco to anyone under 18. * verify that anyone buying cigarettes or smokeless tobacco is at least 18 years old or older. This will involve checking identification of anyone under 27 show- ing the buyer's picture and date of birth. * sell cigarettes or smokeless tobacco only in a direct, face-to-face exchange between you and your customer, without the help of any electronic or mechanical device. * not break open any cigarette or smokeless tobacco package or sell any number or quantity of cigarettes or smokeless tobacco that is less than the smallest package distributed by the manufacturer for individual consumer use. For cigarettes, the minimum package size is 20 cigarettes. * remove or bring into compliance any violative items, such as self-service displays, advertising, and labeling, that are in the retail establishment. This applies to items that you, the retailer, own, as well as to items that are in your retail establishment (whether you own them or not). REPORTING VIOLATIONS Retailers are advised that a coalition of antismoking, health, parent, civic, and other organizations, as well as tens of thousands of their individual members, will be watching for violations of the FDA rules regarding the sale of cigarettes and other tobacco products after February 28, 1997. To assist them in reporting possible violations, a national TOLL-FREE phone number has been established. That number is: 1 - 888 - FDA - 4 - KIDs or 1 - 888 - 332 - 4 - 544 Violations may also be reported by writing to the FDA, Office of Policy (HF-23), 5600 Fishers Lane, Room 14-72, Rockville, MD 20857. Written and phone complaints should contain the name and location of the offending retail establishment, as well as the date and other details of the alleged violation. ADDITIONAL RESPONSIBILITIES OF RETAILERS If you are a retailer, 897.14 is perhaps the most important section that applies to you. This is the section that specifies your obligations to ensure that the cigarettes and smokeless tobacco that you or your employees sell are not sold to persons under age 18. In brief, your obligations, as a retailer, are to: * not sell cigarettes or smokeless tobacco to anyone under 18; * verify that anyone buying cigarettes or smokeless tobacco is at least 18 years old or older. This will involve checking identification of anyone under 27 years of age showing the buyer's picture and date of birth; * sell cigarettes or smokeless tobacco only in a direct, face-to-face exchange between you and your customer, without the help of any electronic or mechanical device. In other words, you should see the customer with your own eyes and physically give the product to him or her. Exception: The face-to-face exchange requirement does not apply if the retailer is using a vending machine or self- service display in a facility where no one under 18 is present or permitted to enter at any time or where mail order sales are involved. * not break open any cigarette or smokeless tobacco package or sell any number or quantity of cigarettes or smokeless tobacco that is less than the smallest package distributed by the manufacturer for individual consumer use. For cigarettes, the minimum package size is 20 cigarettes; * remove or bring into compliance any violative items, such as self-service displays, advertising, and labeling, that are in the retail establishment. This requirement applies to items that you, the retailer, own, as well as to items that are in your retail establishment (whether you own them or not). SOME COMMON ISSUES FACING RETAILERS : How do I check proof of age? The rule requires retailers to verify a consumer's age by checking photographic identification that shows the person's date of birth. The regulation does not specify the type of photographic identification that is accept- able for verifying a person's age, but the most reliable forms of identification are cards issued by the national governments (such as military identification cards if they contain the bearer's date of birth and a photograph and passports), State governments (such as driver's licenses), and local governments (such as employee identification cards that contain the bearer's date of birth and photograph). Some private companies also publish guides containing photographs and descriptions of valid licenses; these guides may be helpful in distin- guishing valid or genuine identification cards from fraudulent ones. The regulations specify that you do not need to check the ID of customers who are 27 or older. But, guessing someone's age by his or her looks can be difficult. Some people simply look older than they really are. To protect you and your customers--especially your underage customers--you must ask for ID from anyone you're not sure about. However, you do not need to ask for ID from every customer every time he or she wants to purchase a tobacco product if you have already verified by means of photo ID that the customer is at least 18. In other words, if you have a regular customer whom you know is 18 or over because he or she has presented a valid photo ID in the past, you do not need to ask for proof of age every time the customer wants to buy a tobacco product. What does FDA mean by a "direct, face-to-face exchange?" Cigarettes and smokeless tobacco are products that present serious health hazards that frequently result in premature death. As a result, one theme in the "access" provisions is to emphasize the health risks associated with these products and to make the sales transaction more "formal." These products kill hundreds of thousands of Americans each year and lead to health problems for their users (and, in some cases, nonusers, such as fetuses of smokers). So, a transaction for a product with serious adverse health effects should not be taken lightly. The rule accomplishes this goal by requiring retailers to physically hand the product to the consumer. This means that, if you are a retailer, you and your employees must be able to: * see the customer directly, without the use of electron- ic aids (such as a television screen) or mechanical devices (such as an intercom), and, when necessary, verify that he or she is at least 18 years old; * obtain the product for the customer, and * hand the product to the customer. This requirement has other purposes, such as helping you verify the customer's age and reducing shoplifting. What is a "self-service display" under the rule? A self-service display" is any item that permits a consumer to remove a cigarette or smokeless tobacco product without the retailer's direct assistance. Self- service displays, which are also sometimes known as "merchandisers," come in many different shapes and sizes, ranging from free-standing, multi-shelf kiosks to small display stands that are placed next to a cash register. Regardless of the type or size, a self-service display is not permitted in any pharmacy, convenience store, grocery store, gasoline station, restaurant, or any other place where anyone under 18 can enter or is present at any time. Am I responsible for the actions of my employees? Generally, Federal courts have held that employers are responsible for their employees' actions. This is true even if the employer did not know about the employee's actions or where the employee failed to take corrective action as requested by his or her employer. As an employer, you are generally responsible for the actions of your business, whether it is in the manufacturing, distributing, or retail sector, and this includes being responsible for the acts of people who work for you. So, to avoid causing unintended violations, you should take appropriate steps to train or educate your employees to check photographic identification for proof of age and to know that the rule prohibits sales to anyone under 18 and to inform them of the other requirements in the rule. If your State or local government has additional require- ments, you might want to add them to your training program, too. [DISTRIBUTION OF FREE SAMPLES] Similarly, if you are a retailer, and a manufacturer or distributor asks you to distribute free samples of cigarettes or smokeless tobacco (which violates 897.16(d)), then you would be subject to regulatory action for violating the restriction against the distri- bution of free samples, even though the manufacturer or distributor asked you to distribute those samples. [PENALTIES FOR VIOLATIONS] Simply put, this means that if you fail to comply with a regulatory requirement that applies to you, the ciga- rettes or smokeless tobacco that you manufacture, distribute, or sell becomes misbranded. The act specifi- cally prohibits misbranding as well as the introduction of a misbranded product into interstate commerce, and you and the product may then be subject to regulatory action by FDA, including actions to: * issue a warning to you and encouraging you to take voluntary corrective action before the agency begins formal legal actions to obtain compliance with the rule; * obtain an injunction or a restraining order from a federal district court to prevent you from taking or continuing any action that would misbrand the product; * seize the misbranded tobacco products; and/or * seek civil money penalties against you and/or your firm * recommend prosecution of the individuals and organiza- tions responsible for engaging in a prohibited act and violating federal law. Excerpts from The Small Entity Compliance Guide On: Regulations to Restrict the Sale and Distribution of Cigarettes and Smokeless Tobacco in Order to Protect Children and Adolescents (21 CFR Part 897), Food and Drug Administration (FDA). ********** Instructions/Suggestions For Using the FDA WARNING LEAFLET The purpose of the FDA WARNING LEAFLET is to help empower individuals and organizations to save lives in their communities by helping to prevent young children from becoming addicted to nicotine. The key is new regulations by the federal Food and Drug Administration (FDA) which require all retailers þ including stores, gas stations, restaurants, bars, etc. þ which sell cigarettes to do so: * only in face-to-face transactions with no vending ma- chines, except in adult-only areas [effective 8/28/97]; and then * only after requiring everyone under 27 years of age to show a photo ID as they now must to purchase beer, wine, and other alcoholic beverages [effective 2/28/97]. These new regulations were passed because survey after survey found that state and local laws designed to prevent the sale of cigarettes to youngsters were routinely violated. Even when violations were reported to the police or other authorities by concerned citizens, the callers were often met with bored indifference or even hostility. Thus it's no surprise that 90% of children said in a recent federal survey that it is "fairly easy" or "very easy" for them and their classmates to buy cigarettes. When underage children are sent out to try to purchase cigarettes in police sting operations, they frequently succeed in 70% to 100% of their attempts. As a result, children smoke over 10 billion cigarettes a year! Even more astounding, every day the number of children addicted to nicotine grows by at least 3000. Of that 3000, at least 1000 will die as a result of a stupid and careless decision they made when they were only 14, or 12, or 10, or even 8. Moreover, more than half of the cigarettes smoked by kids are those they buy themselves, from merchants who don't bother to check their ages, or from vending machines which can't. That's why cracking down on the sale of cigarettes to kids will definitely help to reduce consumption. The FDA WARNING LEAFLET will make it possible to assure that merchants comply with these new federal regulations, at least in YOUR community. For the first time it provides a powerful new weapon for parents, neighbors, grandparents, god-parents, teachers, princi- pals, adult leaders of student groups, and other con- cerned citizens who may previously have felt powerless because state and local laws were difficult to enforce, and local authorities lacked interest in enforcing them. The FDA has only 1000 inspectors for the entire country. So, without assistance from concerned citizens and public spirited organizations, merchants in your community may not be aware of the new rules, nor have much incentive to comply with them. That's where the FDA WARNING LEAFLET becomes important. It explains in simple lay language written by the FDA itself what the new rules require. The leaflet also provides an easy-to-remember toll-free phone number to which violations can be reported to the FDA. This information is important to every concerned citizen. On the other side of this sheet are some of the many ways in which the leaflet þ and the valuable information it contains þ can be used. You may think of others. 1. Individuals should keep the leaflet for reference, as well as make copies to give to friends, neighbors, co- workers, and others. They are also urged to send copies of the leaflet AND the instructions to local antismoking, parent-teacher, scouting, and other groups, to local schools, and clubs of which they are members. Point out that there is space on the leaflet for the group to print its own name, address, etc., and even to identify itself as a "Participating" or "Sponsoring" organization. 2. Organizations can inform their members of this important information about the FDA rules by summarizing it in newsletters, letters, and other means of communica- tion with their membership. Better yet, organizations may wish to duplicate the leaflet and give or mail copies to their members for their own use. 3. Schools which receive copies of the leaflet should make it available for children to take home to their parents. The school can also arrange to deliver or mail it to merchants in the vicinity of the school where young children now probably purchase their cigarettes. This will help to keep the school and its students smoke free. 4. The leaflets are designed to be given to local mer- chants, including gas stations, restaurants, and bars, to make sure each knows what it is required to do. While the leaflets can be mailed, hand delivery by an individu- al or members of a group is preferred. It provides a personal touch, and lets the merchant know that local citizens will be visiting his store to check for compli- ance. This is an excellent project for any club or public service organization, including groups like the Rotary, Elks, etc. 5. At the very least, individuals and members of organizations should be alert when they shop in estab- lishments where cigarettes are sold to observe any apparent violations: e.g., selling cigarettes to anyone under 27 without checking a photo ID, or selling ciga- rettes through a vending machine. Violations should then be promptly reported to the FDA using this toll-free number: 1þ888þFDAþ4þKIDs (1þ888þ332þ4þ544). 6. Clubs and other organizations may wish to also conduct "sting" operations; a technique the federal government and many state groups have found is the most effective way to insure compliance. In the past, conducting a sting operation could lead to legal complications, since such programs involved having minors seeking to purchase tobacco products. However, under the FDA rules, adults 18-26 can be sent into stores to try to purchase ciga- rettes. If a pack is sold without checking the purchaser's photo ID, a clear violation of the FDA's rules has occurred which can then be reported. 7. Needless to say, every effort should be made to publi- cize the new FDA rules þ as well as citizen enforcement initiatives þ through the local media, including press releases or letters to the editor of local papers, calls to local talk shows, and other appropriate means. The FDA WARNING LEAFLET and instructions were prepared as a public service by Action on Smoking and Health (ASH), 2013 H St., N.W., Washington, DC 20006, a national legal- action antismoking organization entirely supported by tax-deductible contributions. ASH encourages others to make additional copies, to distribute them in person or by mail to retailers, schools, clubs, and other groups in their area, and to report any violations.
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ACTION ON SMOKING AND HEALTH (ASH)
A National Legal-Action Antismoking Organization 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310 |