July 1, 2014

FDA Asks for Help From Consumers to Assist in Crackdown on Illegal Tobacco Sales to Minors

Health Letter, July 2014

By Sarah Sorscher, J.D., M.P.H.

In May, the Food and Drug Administration (FDA) publicized a comprehensive report on its efforts to enforce tobacco laws and at the same time called on consumers nationwide to help ensure that local retailers stop selling tobacco products to children under 18.[1],[2] The sale of tobacco products to minors is an enormous public health concern in the United States. Each day, more than 3,200 children smoke their first cigarette, and the vast majority of first-time users of tobacco are under 18, the minimum legal age to purchase such products.[3]

Current FDA inspections of tobacco retailers

It may come as a surprise to most consumers that the FDA now inspects and monitors tobacco retailers — including small businesses, such as the local corner store — for violations of federal tobacco laws, particularly those prohibiting sales to minors.

The FDA first began regulating cigarettes and other tobacco products in 2009, when President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act. This law gave the FDA authority to inspect tobacco manufacturing facilities, require warning labels and monitor advertising, activities consumers readily associate with the FDA. But the law also did something more unusual: It empowered the FDA to inspect local retailers and issue fines to those who sell cigarettes to minors and break other federal tobacco laws.

Here are just a few of the illegal activities the FDA specifically looks for when inspecting and monitoring tobacco retailers:[4]

• Selling cigarettes, tobacco and smokeless tobacco (chewing tobacco or snuff) to anyone younger than 18;
• Failing to “card” (request photo identification from) anyone younger than age 27 before selling that person a tobacco product;
• Selling flavored cigarettes (with the exception of menthol-flavored products);
• Selling cigarettes from vending machines, self-service displays or other non-face-to-face exchanges (except mail-order sales and sales in adult-only facilities);
• Selling single cigarettes or any package containing fewer than 20 cigarettes;
• Sponsoring athletic, musical or other social or cultural events using a tobacco brand name;
• Selling or giving away nontobacco items (such as hats or T-shirts) with a tobacco brand name; and
• Giving out free samples of cigarettes or smokeless tobacco, except in adult-only facilities.

During many inspections, the FDA uses minors (ages 16-17) to detect violations by having them attempt to buy tobacco products in order to test whether the retailer will request photo identification to confirm the teens are over 18.[5]

If a business is caught violating the law, the FDA can issue a warning letter or impose a civil fine.[6] Typically, the FDA will issue a warning letter for the first confirmed violation, after which it usually conducts an unannounced follow-up inspection. Further violations result in civil fines, and companies who continue to violate the law are subject to fines, seizures, injunctions or criminal prosecution.[7]

The FDA has detected almost 19,000 violations of federal law since 2010. The vast majority of these — more than 16,000 — involved selling cigarettes to minors or failing to ask for identification before selling tobacco products.[8]

As of 2013, the FDA had conducted over 200,000 inspections and issued over 10,000 warning letters.[9] The number of these warnings that resulted in civil fines has been low; for example, in fiscal year 2012, the agency issued 4,107 warning letters but only 382 civil fines.[10]

The reason for this is unclear. The number of penalties may be low because companies generally correct violations after receiving a warning letter, or it may be low because the FDA fails to follow up with additional inspections.

Consumer reports to the FDA

Following the release of its report, the FDA asked consumers nationwide to help it step up enforcement even further by serving as the agency’s eyes and ears, reporting apparent violations of tobacco laws to support further investigations.

The FDA can initiate inspections either on its own or after receiving a consumer complaint about a potential violation. The number of consumer reports concerning potential violations of tobacco law has nearly doubled since fiscal year (FY) 2011, the year that the FDA started tracking complaints.[11]

Yet overall, complaints remain a small part of the FDA’s enforcement effort: The agency received only 301 complaints concerning potential violations in FY 2013 but conducted approximately 100,000 inspections that year.[12],[13]

It is likely that few consumers consider contacting the FDA after witnessing a local retailer break tobacco laws, because the agency’s authority to monitor retailers for tobacco law violations is new and most consumers are not aware of the FDA’s new role.

Reports can be submitted anonymously. However, reports accompanied by names and contact information are helpful when the agency needs to follow up for more information. The FDA must independently verify each report before confirming an actual violation of the law.

The FDA may or may not decide to follow up on a complaint. If you have a concern about a local business, you can view inspections, warning letters and civil penalties for that business by looking it up in the FDA’s searchable online database, located at www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm.

By sending in complaints, you can help the FDA crack down on businesses that break federal tobacco laws and help ensure that fewer children become lifelong smokers.

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References

[1] Food and Drug Administration, Center for Tobacco Products, Office of Compliance and Enforcement. Compliance and Enforcement Report; June 22, 2009 through September 30, 2013. Undated. http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM396614.pdf. Accessed May 20, 2014.

[2] Food and Drug Administration. Help FDA Keep Kids from Using Tobacco. May 9, 2014. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm392886.htm. Accessed May 20, 2014.

[3] Food and Drug Administration, Center for Tobacco Products, Office of Compliance and Enforcement. Compliance and Enforcement Report; June 22, 2009 through September 30, 2013. Undated. http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM396614.pdf. Accessed May 20, 2014.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

[9] Food and Drug Administration, Center for Tobacco Products, Office of Compliance and Enforcement. Compliance and Enforcement Report; June 22, 2009 through September 30, 2013. Undated. http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM396614.pdf. Accessed May 20, 2014.

[10] Data reporting number of civil penalties can be downloaded online, at: http://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm. Accessed May 20, 2014.

[11] Food and Drug Administration, Center for Tobacco Products, Office of Compliance and Enforcement. Compliance and Enforcement Report; June 22, 2009 through September 30, 2013. Undated. http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM396614.pdf. Accessed May 20, 2014.

[12] Ibid.

[13] Data reporting number of civil penalties can be downloaded online, at: http://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm. Accessed May 20, 2014.