Starting February 28, 1997, new FDA rules prohibited retailers from selling cigarettes, loose cigarette tobacco, and smokeless tobacco to anyone under age 18, and required retailers to verify by means of photo identification the age of anyone under age 27 who wishes to purchase these products. This document answers the questions most frequently asked by retailers, consumers and others about the age and ID restrictions.
Age & ID
FDA rules prohibit retailers from selling cigarettes, loose cigarette tobacco, or smokeless tobacco to anyone under the age of 18, and require retailers to check the photo ID of customers under the age of 27.Q: Who is responsible under the new regulations, the employer or the salesclerk?
A: Under the Federal Food, Drug, and Cosmetic Act (the Act), the employer is held responsible for violations of regulations. This result is similar to an employer's responsibilities in other situations involving health and safety requirements. For example, the retailer generally is responsible when an employee's failure to follow health or sanitary codes results in a citation. Similarly, some states and localities revoke a retailer's license to sell tobacco products when a store has a certain number of violations. The penalty against the retailer results from illegal sales made by the store clerks.
Q: Why not penalize the kids who try to buy these products?
A: Some states and localities impose penalties on children under the age of 18 for purchasing, possessing or using tobacco products. FDA's regulations address those responsible for the sale and distribution of these products. FDA believes that it has chosen the most appropriate focus for these regulations.
Q: What is the legal age for
purchasing cigarettes or smokeless tobacco?
A: Under FDA regulations, a retailer must not sell cigarettes or smokeless tobacco to anyone under 18. Therefore, purchasers must be 18 or older. However, state laws may differ. It is possible that as a result of a companion rulemaking, FDA may permit states to enforce a higher age requirement for the purchase of these products.
Q: Why did FDA decide that retailers must require
customers under the age of 27 to present a photo ID?
A: It is very difficult to judge the age of many teenagers and young adults simply from their appearance, partly because young people mature at different rates. To ensure that older-looking teenagers are asked for ID, it makes common sense to set the requirement to check identification somewhere above 18. This reasoning is reflected in a report prepared by twenty-six State Attorneys General recommending that the age for photo ID should be significantly higher than the minimum age of sale. In addition, materials developed and distributed to retailers by the tobacco industry and leading retailer organizations specifically recommended that retailers card anyone who appears to be under 26.
Q: Does a retailer have to check the ID
of regular customers who are known to be at least 18 years old
every time they buy one of these products?
A: No. Retailers must check a customer's photo ID at least once to ensure that the customer is at least 18 years old.
Q: Some states do not require photographs on their driver's licenses.
What type of ID should purchasers present in such states?
A: The rule does not require that customers present a driver's license. While any form of ID which contains a photograph and the birth date of the bearer is acceptable, the agency suggests that retailers request a government-issued photo ID, such as a driver's license, passport, or military ID, because they are more reliable and more difficult to alter.
Q: What should a salesclerk do when the clerk suspects
that a customer's ID is fake or has been altered?
A: If a retailer suspects that an ID is unreliable, the retailer should refuse the sale. Selling to an underage customer violates the rule. However, if an underage customer presents a fake or altered ID, and the retailer reasonably relies in good faith on the ID, FDA will not bring a compliance action. Fake ID cards may be difficult to detect, but many fake cards are obvious due to their poor quality. There are also some companies that sell manuals showing pictures of current, valid driver's licenses for each state. These manuals may help the retailer to determine whether or not an ID card is valid.
Q: Can a retailer accept an out-of-state driver's license
if it has the customer's picture and date of birth?
A: Yes. The rule states that any photo ID with a birth date is acceptable.
Q: Can a retailer sell to a child whose parent sends the
child into a store to buy these products for the parent?
A: No. FDA's rule prohibits retailers from selling to anyone under 18, and requires retailers to demand proof-of-age. So parents need to purchase tobacco products for themselves.
Q: Is a retailer responsible for preventing parents or other adults
from purchasing tobacco products for minors?
A: No. While the retailer is free to refuse the sale, the rule only requires that the retailer verify the age of the purchaser.
Q: Does a salesclerk have to be at least 18 years old to sell cigarettes?
A: No. FDA's regulations do not address the age of the salesclerk, although some state laws may require a minimum age for salesclerks.
Products Covered
The new regulations apply to cigarettes, loose cigarette tobacco and smokeless tobacco.Q: Why don't the regulations apply to cigars and pipe tobacco?
Given the recent cigar-smoking fad, isn't this an oversight?
A: Unlike the evidence relating to cigarettes and smokeless tobacco, FDA had insufficient evidence at the time the agency proposed these rules that cigars and pipe tobacco are drug delivery devices under the Act. Therefore, the agency did not include cigars or pipe tobacco.
Q: Are retailers required to card customers under the age of 27 who want to buy rolling papers?
A: No. At this time, retailers are required to card customers under the age of 27 who wish to buy cigarettes, loose cigarette tobacco, or smokeless tobacco, not rolling papers.
Litigation
Cigarette and smokeless tobacco manufacturers, trade associations representing advertising agencies and convenience stores, and others sued FDA in Federal Court arguing that FDA lacked the authority to regulate cigarettes and smokeless tobacco. Court rulings and related documents can be found on FDA's Children and Tobacco: Court Opinions and Briefs Page.Q: What was the recent court ruling in the suit against FDA?
A: On April 25, 1997, Judge William Osteen of the Federal District Court in Greensboro, North Carolina, ruled that FDA has jurisdiction under the Federal Food, Drug, and Cosmetic Act (the Act) to regulate nicotine-containing cigarettes and smokeless tobacco. The Court held that tobacco products fit within the Act's definitions of 'drug' and 'device,' and that FDA can regulate cigarettes and smokeless tobacco products as drug delivery devices under the combination product and restricted device provisions of the Act.
With respect to the tobacco rule, the Court upheld all restrictions involving youth access and labeling, including the two access provisions that went into effect Feb. 28. The Court also upheld access and labeling restrictions originally scheduled to go into effect Aug. 28, 1997, including the prohibition on self-service displays and the placement of vending machines where children have access to them. The Court also upheld the ban on distribution of free samples, the sale of so-called kiddie packs of less than 20 cigarettes, and the sale of individual cigarettes. However, the Court delayed implementation of the provisions that have not yet gone into effect pending further action by the Court.
The Court invalidated on statutory grounds FDA's restrictions on the advertising and promotion of cigarettes and smokeless tobacco. Judge Osteen found that the statutory provision relied upon by FDA, section 520(e) of the Act, does not provide FDA with authority to regulate the advertising and promotion of tobacco products. Specifically, the Court found that the authority in that section to set "such other conditions" on the sale, distribution, or use of a restricted device does not encompass advertising restrictions. Because Judge Osteen based his ruling on the advertising provisions on purely statutory grounds, he declined to consider the First Amendment challenge to those parts of the rule.
Both sides filed appeals with the U.S. Court of Appeals for the Fourth Circuit. On Aug. 14, 1998, a majority of a three-judge panel of the Fourth Circuit in Richmond, Va., ruled that FDA lacks the jurisdiction to regulate tobacco products, reversing the decision of the U.S. District Court for the Middle District of North Carolina. Because the majority found that the agency lacked jurisdiction, it invalidated FDA's Aug. 28, 1996, regulations that restricted the sale and distribution of cigarettes and smokeless tobacco to children and adolescents.
In the Fourth Circuit, the majority opinion held that FDA's jurisdiction to regulate drugs and devices does not include cigarettes and smokeless tobacco. The court, however, did not reject FDA's conclusion that these products fall within the Act's definitions of "drugs" and "devices." Instead, the majority opinion concluded, based on several sources of evidence, that Congress did not intend the Act to apply to these products. This evidence included what the court viewed as a lack of regulatory tools in the act appropriate for the regulation of tobacco products; prior statements by FDA that it lacked authority to regulate tobacco products in the absence of express claims; congressional inaction on bills to grant FDA explicit jurisdiction over tobacco products; and tobacco-specific legislation approved by Congress such as the Federal Cigarette Labeling and Advertising Act, the Comprehensive Smokeless Tobacco Health Education Act, and the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992.
Judge Hall agreed with FDA on all issues and dissented from the majority opinion. He concluded that tobacco products fit comfortably within the Act's "drug" and "device" definitions, and that the evidence falls far short of demonstrating that Congress intended to deny FDA jurisdiction over tobacco products. He wrote that he would have found that not only does FDA have jurisdiction to regulate tobacco products, but that all of FDA's regulations, including the advertising restrictions, are within the agency's authority. He explained that how FDA has chosen to regulate tobacco products has no bearing on the question of whether the agency has the authority to regulate them at all.
On November 10, 1998, the Fourth Circuit denied the government's Petition for Rehearing of the August 14, 1998, decision.
On January 19, 1999, the Solicitor General filed a Petition for a Writ of Certiorari that requests the Supreme Court to review the August 14, 1998 decision of the United States Court of Appeals for the Fourth Circuit which reversed the decision of the United States District Court for the Middle District of North Carolina. Filing the Petition stays the issuance of the Fourth Circuit's mandate while the Supreme Court considers the government's request. The age and identification provisions of FDA's tobacco rule in effect since February 1997 therefore remain in effect pending Supreme Court review.
FDA is continuing to enforce the age and picture ID provisions of the tobacco regulations, which prohibit retailers from selling cigarettes and smokeless tobacco to persons younger than 18 years of age, and require retailers to examine the photo ID of persons younger than age 27 before selling these products to them. FDA will continue to disseminate an advertising campaign in states where contracts for enforcement are active, and will continue to bring civil money penalty actions against retailers who violate the provisions now in effect.
(information added or amended Jan. 22, 1999)
Enforcement
To ensure that the federal rule is followed, FDA will contract with the states to carry out compliance checks during which adolescents, accompanied by state or local officials commissioned by FDA, will attempt to purchase cigarettes and smokeless tobacco from retailers.Q: How does a compliance check work?
A: FDA will train state officials and provide them with a manual that defines how compliance checks are to be conducted. Generally, a minor accompanied by a commissioned state or local official will enter a retail establishment and attempt to purchase cigarettes or smokeless tobacco. All results will be reported to FDA.
Q: What happens to retailers who do not card someone between 18 and 27
before selling them cigarettes or smokeless tobacco?
A: If FDA receives a complaint that a retailer is not checking IDs for young people under 27, it will not result in a monetary penalty. However, FDA will use these complaints for scheduling retailers for a compliance check, using a minor to ensure that the retailer is not selling to minors.
Q: Why don't you cite a violator on the spot?
A: First, FDA chose not to issue letters on the spot out of concern for the safety of the adolescent and official conducting the compliance check. Second, FDA believes the compliance checks will be more effective if they are unannounced. If letters were given on the spot, retailers in the community would get word that compliance checks were underway in their area.
Q: How many times will FDA visit a retailer to conduct a compliance check?
A: Once we have determined that a retailer has violated the regulations, we'll keep going back until the retailer demonstrates compliance with the regulations. Therefore, retailers that have a record of noncompliance with FDA's requirements should expect to be investigated more frequently than those who have a history of complying with the regulations.
Q: When did the enforcement operation begin?A: The first compliance checks began in Summer 1997. (information added or amended Jan. 22, 1998)
Q: Can any non-government group conduct compliance checks for FDA?
A: No. Only those state or local officials authorized by FDA will be able to conduct compliance checks for FDA.
Q: What can a state or local law enforcement officer do if the officer witnesses an illegal sale?
A: State or local officers can enforce their state or local law, depending on the officer's jurisdiction, and can report to FDA any violation of FDA's rules. However, an officer can only conduct compliance checks for FDA if the officer has been commissioned by FDA.
Q: How much time will there be between the first letter notifying a retailer
that a violation has occurred, and the second or follow-up compliance check?
A: FDA will give retailers a reasonable amount of time to come into compliance before scheduling a follow-up visit, but the exact amount of time is likely to depend on a number of variables and will vary from state to state.
Q: What can a customer do if the customer continues to see repeated offenses?
A: First, a customer could complain directly to the retailer, reminding the retailer of the new federal rule. Second, the customer could report the retailer to FDA's hotline and to state and local authorities.
Q: How will FDA guard against false complaints?
A: As with any hotline, it will not be possible for FDA to determine whether a false complaint was filed. However, the complaint itself is not sufficient to trigger a letter notifying a retailer of a violation or a penalty proceeding. A complaint prompts FDA to schedule a compliance check as soon as practicable and, if the store is not selling to minors, it will not be subject to any sanctions.
Q: If FDA conducts a compliance check based on a report of an alleged violation and finds that the retailer is in compliance, how many times will FDA continue to investigate the retailer?
A: If FDA finds a retailer in compliance, the retailer would be randomly selected for its next investigation, unless FDA received another complaint.
Enforcement Procedures (This section on Enforcement Procedures was added Jan. 22, 1998.)
State officials will send the results of the tobacco compliance checks to FDA. Depending upon the retailer's compliance history with the age and photo ID provisions currently in effect, FDA will initiate correspondence and/or administrative actions. The Safe Medical Device Act of 1990 authorized FDA to seek civil money penalties for violations of the Federal Food, Drug, and Cosmetic Act related to devices. Therefore, FDA will seek civil money penalties for violations observed and documented during compliance checks conducted by or for FDA..
Q: Will FDA notify retailers who are found to be in compliance?
A: Yes. We intend to notify retailers who refuse to sell tobacco products to the minors that participate in our compliance checks. We plan to send a letter stating that the retailer was found to be in compliance with the final rule. Those letters will be publicly available and communities will be able to recognize retailers that refuse to sell to minors.
Q: What action will FDA take for a first violation?
A: The first time FDA finds a retailer to be in violation, FDA will send a letter explaining the new regulation, describing the violation, and informing the retailer that another compliance check will be scheduled. FDA intends to mail letters as soon after receiving reports from commissioned officials as is practicable. In addition, retailers may also receive correspondence from state or local officials for violations of state or local law.
Q: Will the employee making the sale be identified in the letter?
A: No. However, FDA will mail to retailers a copy of the form that will contain the date and time of the violation and the gender of the salesclerk who sold to the adolescent.
Q: What will happen if a retailer sells cigarettes or smokeless tobacco
to a minor in the follow-up compliance check?
A: The second time a violation is found, FDA will seek civil money penalties in the amount of $250.00.
Q: What will the penalties be for third and subsequent violations?
A: The table below shows the actions the Agency will take, including the amount of civil money penalties FDA will seek, as a result of all tobacco checks at retail establishments.
| ENFORCEMENT STRATEGY |
|---|
| In Compliance ----------------------------------> Letter 1st violation -------------------------------------> Notice of Violation 2nd violation ------------------------------------> $250 civil money penalty 3rd violation ------------------------------------> $1,500 civil money penalty 5th violation ------------------------------------> $10,000 civil money penalty subsequent -------------------------------------> determined on a case-by-violations-case basis |
Q: Do the penalties always continue to escalate
no matter how long it has been since the last violation documented by FDA?
A: No, a retailer has an opportunity to avoid escalating civil money penalties if thirty-six months have passed without the retailer's being cited by FDA for a violation. For example, if a retailer was found selling to a minor a fourth time, FDA would seek a $5,000.00 civil money penalty if that violation occurred less than thirty-six months from the third violation. However, if more than thirty-six months had passed since the third violation, FDA then would seek the lowest civil money penalty of $250.00.
Q: Please explain the civil money penalty process.
A: For the second and subsequent violations, FDA may serve an Administrative Complaint for Civil Money Penalties. The Complaint is filed with the Dockets Management Branch at FDA and initiates a legal proceeding before an Administrative Law Judge. The retailer may pay the penalty to end the proceeding, or the retailer may instead choose to file an Answer to the Complaint and request a hearing.
Q: How does the retailer receive the Administrative Complaint for Civil Money Penalties?
A: FDA will serve the Complaint together with a cover letter on the retailer by certified or registered mail or personal delivery. The letter explains that the retailer is entitled to a hearing according to the procedures established in FDA's regulations on civil money penalty proceedings in 21 Code of Federal Regulations (CFR) Part 17. The CFR is available at many libraries, on the Internet at http://www.access.gpo.gov/, or can be obtained by calling 1-888-FDA-4-KIDS for a copy.
Q: How long does a retailer have to respond to the Complaint?
A: The retailer may request a hearing by filing an answer with the Dockets Management Branch at FDA within 30 days of service of the complaint. In the response, the retailer should:
- admit or deny each of the allegations made in the Complaint;
- state all defenses on which the retailer intends to rely;
- state all reasons why the retailer contends the penalty should be less
- than the requested amount; and
- state the name, address, and telephone number of the retailer's counsel, if any.
If the retailer requests a hearing, a date will be scheduled with the Administrative Law Judge.
Q: Can the retailer pay the penalty without having to respond to the Complaint?
A: Yes. If the retailer chooses to pay the assessed penalty without contest, a check or money order, payable to the United States Treasury, must be mailed to FDA within thirty days of the service of the complaint.
Q: What happens if a retailer fails to pay the penalty?
A: If a retailer does not respond in writing or offer payment within 30 days of the service of the Complaint, the Administrative Law Judge shall assume the facts alleged in the Complaint to be true and can impose the amount asked for in the Complaint. If, after a civil money penalty assessment becomes final, the retailer refuses to pay, the U.S. Department of Justice may sue the retailer in federal court under the Federal Food, Drug, and Cosmetic Act for the amount of the penalty plus interest.
Q: Does FDA keep the funds collected from penalties?
A: No. All civil money penalties collected by FDA, as with most fines paid to the U.S. government, are deposited as miscellaneous receipts in the Treasury of the United States.
Q: Why doesn't FDA suspend or revoke a retailer's right to sell tobacco products for repeated violations?
A: Some states and localities have issued licenses to sell tobacco products and revoke licenses for repeated violations. This has been shown to be an effective means of enforcing tobacco control laws. However, historically, these programs have been under state or local jurisdiction.
Q. Will the agency seek penalties against chain stores with a particularly poor compliance record?
A: FDA believes that corporations and franchises have an important role in ensuring that their stores understand and comply with the new rules. Therefore, FDA currently is considering an enforcement strategy for these organizations that will both recognize a high rate of compliance among the stores in an organization and seek penalties against the corporation or franchisor for a low rate of compliance among their stores.
Q: If FDA contracts with state or local agencies to conduct compliance checks,
can the state or local authority use that information to take action under their own laws?
A: Yes. As is sometimes the case, a single act may violate local, state and federal law. Therefore, even though FDA will mail a letter for a first violation, the state or local authority may impose state or local sanctions. Similarly, FDA may seek civil money penalties for a violation that is also subject to state or local sanctions.
Tobacco Shops, Wholesalers & Indian Reservations
The age and ID requirements apply to retailers who sell cigarettes or smokeless tobacco to consumers for their personal use.Q: How do the regulations affect those retailers who sell only tobacco products?
A: Retailers that sell only tobacco products are subject to the same age and photo identification requirements as other retailers.
Q: If a wholesale operation delivers to a store or gas station, and the only employee present
at the time of delivery is someone under 18, can the delivery be made?
A: Yes. The wholesaler is selling to a retailer, not to a consumer. Therefore, under FDA's rule, a person of any age can sign or pay for the delivery on behalf of the retailer, and that would not constitute a violation. However, state or local laws may prohibit the delivery of tobacco products to persons younger than a certain age.
Q: Do FDA's tobacco regulations apply to sales of cigarettes and smokeless tobacco on Indian reservations?
A: As a general rule, statutes that by their terms apply to everyone generally are presumed to apply to Indian reservations. This general rule can be altered by specific treaties with individual tribes. FDA's Compliance Policy Guide provides that "FDA considers Indian Reservations to be possessions of the United States within the meaning of [the Act]." Therefore, FDA presumes that the tobacco regulations apply to sales of cigarettes and smokeless tobacco on Indian reservations unless a specific treaty with an individual tribe alters FDA's jurisdiction over such sales.
Although this guidance document does not confer any rights for or on any person and does not operate to bind FDA or the public, it does represent the agency's current thinking on the regulations involving the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents at 21 CFR Part 897. Alternative methods that comply with the tobacco regulations are acceptable. If a regulated company or person wishes or chooses to use an approach other than that set forth in this guidance document, FDA will, upon request, discuss with that company or person alternative methods of complying with the regulations.
FDA is accepting public comment on this document. You can submit written comments to: Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., Room 1-23, Rockville, MD 20857.
Comments should be identified with docket number 97D-0261 and will be available for viewing at the Dockets Management Branch from 9 a.m. to 4 p.m., Monday through Friday.
(Hypertext updated 1999-JAN-22)