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Help FDA Keep Kids from Using Tobacco

Your report may help us identify possible violations of the laws that we enforce, such as not selling regulated tobacco products to anyone under age 18. FDAs Center for Tobacco Products (CTP) recently published a comprehensive report on its compliance and enforcement efforts from its inception in 2009 through September 30, 2013. Of the more than 18,000 violations during this time, more than half were for selling tobacco products to minors, and more than a third were for failure to verify a purchasers age with a photo ID.

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How You Can Help FDA

FDA needs the eyes and ears of consumers nationwide to help ensure that federal tobacco laws are being followed in your communities. We have developed several ways to report a potential tobacco product violation and it should only take a few minutes. You can:

  • report online;
  • call the FDA Center for Tobacco Products Call Center at 1-877-CTP-1373; or
  • download and mail a form to FDA Center for Tobacco Products c/o Document Control Center, 9200 Corporate Boulevard, Rockville, MD 20850-3229.

When reporting a potential violation, provide as much information as you can to assist FDA with a possible follow-up investigation, such as the date, location, product type, product brand, and/or type of violation. You can report a variety of things that you think may be a potential violation, including, but not limited to:

  • sales of cigarettes or smokless tobacco to minors
  • sales of flavored cigarettes or flavored cigarette tobacco (except menthol)
  • providing free samples of cigarettes
  • sales of single cigarettes
  • providing free samples of smokeless tobacco, unless in a qualified adult-only facility

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Taking a Second Look

FDA reviews all complaints that it receives. Complaints can be submitted anonymously, but if contact information is included, we first acknowledge receipt of the complaint. Before determining the appropriate actions or investigation, we will check to see if the product named in the complaint is a product regulated by FDA and if the complaint is a possible violation of the laws we enforce.

If the product in the complaint is regulated by a different federal or state agency, or different part of FDA, we will forward the complaint, as appropriate, to the applicable entity for evaluation. For example, a complaint about a tobacco retailer selling cigarettes to minors would fall under FDA jurisdiction, whereas a complaint about the lack of tax stamps on packages of cigarettes would not.

FDA performs its own investigation related to the complaint and does not rely solely on what was submitted to take enforcement action. After reviewing a complaint, we may, among other things:

  • perform an inspection of a tobacco product manufacturer, distributor, or importer;
  • conduct a compliance check inspection of a tobacco retailer; or
  • initiate monitoring and surveillence of a tobacco product manufacturers or retailers website.

During our investigation, FDA may determine there is no evidence of a violation, or we may find evidence of the reported violation or of other potential violations that will require additional surveillence, monitoring, and/or inspections.

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Results of FDA's Work Near You

The time it takes FDA to complete an investigation varies with the complexity of the observed violations and the evidence collected. Information about an investigation cant be made public until the case is closed. Any information about a case that has been closed may be obtained by filing a Freedom of Information request. We generally issue a Warning Letter to a company for first-time violations. Companies who continue to violate the law are subject to fines, seizures, injunctions or criminal prosecution.

A list of tobacco retailers inspected, as well as any Warning Letters or fines assessed against a tobacco retailer, is located in this searchable database. Other FDA Warning Letters issued, such as to tobacco manufacturers or distributors, can be found on the FDA website.

By sending FDA complaints of potential tobacco product violations, you are helping the agency monitor industry compliance with the laws and reduce the health impact of tobacco use.

This article appears on FDAs Consumer Updates page, which features the latest on all FDA-regulated products.

May 9, 2014

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