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Ensuring Compliance with the Tobacco Control Act and Enforcing the Law

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This information will help the public and those who work with CTP understand what FDA’s Center for Tobacco Products (CTP) is doing to ensure compliance with the Tobacco Control Act. 

 

“There may be other ways for kids to get their hands on a pack of cigarettes, but if we’re doing our job as regulators they won’t be getting them over the counter at retail outlets.”

Mitch Zeller

September 2, 2013

- Kansas Health Institute (KHI) News Service 

 

Importance of Complying with the Law

CTP’s rigorous compliance and enforcement program aims to ensure that the tobacco industry follows the law and regulations designed to reduce the health burden of tobacco use. 

 

Helping the Industry Understand the Law

CTP takes a 3-pronged approach to help industry comply with the law by:

  • developing and giving training, presentations, and guidance on how to comply,
  • monitoring compliance, and
  • taking action when necessary

 

Training, Presentations, and Guidance

Because federal tobacco law and regulations are new to many of those who must comply, we provide several ways to learn about them:

Training sessions and webinars
Since March 2011, CTP has been hosting live, public webinars to help educate those who must comply with federal tobacco law and regulations. Topics include Substantial Equivalence reporting requirements, warning letters, civil money penalties, and what to expect during a tobacco retail inspection.  Access a list of tobacco compliance webinars.

Conferences and other presentations 
A thumbnail of a Center for Tobacco Product Guidance Document.  Click here to view actual CTP guidance documents.CTP has given presentations to public health partners as well as manufacturers, distributors, importers, and retailers.  We have also provided in-person meetings, teleconferences, and one-on-one compliance education at our exhibit booths at conferences. For example, we have raised awareness about our strategic goals, extended critical outreach to important groups and provided trainings at regional and national Synar workshops, the National Conference on Tobacco or Health disclaimer icon  and the Food & Drug Law Institute Conference disclaimer icon .

Guidance documents
CTP issues guidance documents to help everyone understand and comply with the law and regulations.  Access a list of guidance documents.

Help for small businesses
CTP‘s Office of Small Business Assistance gives technical assistance to small tobacco product manufacturers and retailers to help them understand their responsibilities under the Tobacco Control Act.  It works with FDA’s subject matter experts to give small businesses accurate and timely responses to their questions.

 

Monitoring Compliance

To ensure that regulated industry complies with the requirements of the Tobacco Control Act and regulations, CTP

Inspects places where tobacco is sold
CTP contracts with states and territories to inspect places where tobacco is sold.

CTP will be conducting inspections in all states and territories.

Tobacco retail inspections include ensuring that the clerk checks the photo ID of everyone under age 27 who tries to buy tobacco products we regulate (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco). Retailers cannot sell these products to anyone under age 18.

In addition, among other things, retailers may not give away free samples of cigarettes. They must not open packages of regulated products to sell smaller amounts, such as single cigarettes (called loosies). And they may not sell flavored cigarettes or flavored cigarette tobacco (other than menthol flavored products).
 

Monitors manufacturing and marketing practices
CTP monitors what manufacturers of tobacco products do by

•  reviewing pre-market applications

•  inspecting manufacturing facilities

•  inspecting “qualified adult only facilities” that are permitted under limited circumstances to provide free samples of smokeless tobacco products to adults

•  approving required plans for warning labels on smokeless tobacco products and advertisements

•  monitoring advertisements in the media, such as magazines and Internet sites, and other promotional activities

•  evaluating complaints and conducting targeted monitoring of publications, advertising, and tobacco retailer's websites to see if they comply with restrictions on promoting and advertising tobacco products.

 

Reviews required registrations and lists
The owner or operator of any business that compounds, manufactures, prepares, or processes tobacco products must register with FDA every year and include a list of their regulated tobacco products. CTP reviews these registrations and lists to ensure efficient oversight of the tobacco industry.

Inspects tobacco product businesses
On a biennial basis, FDA inspects tobacco product manufacturers to ensure they are complying with the Tobacco Control Act. Inspections are a collaborative effort between representatives from CTP and investigators from FDA's Office of Regulatory Affairs. 

Handles Complaints
CTP receives and evaluates complaints of potential violations from the public and others interested in this issue and takes action as appropriate. When CTP finds a manufacturer, distributor, importer, or retailer has violated the law, we respond with advisory or enforcement actions.

One type of advisory action is a warning letter. In a warning letter, CTP notifies a retailer or tobacco product business that it violated the law. The purpose of the warning letter is to encourage the retailer or other business to comply with the law voluntarily. If the retailer or other business continues to not comply even though they received a warning letter, CTP may move to enforcement actions.

To enforce compliance with the Tobacco Control Act, CTP may seek a civil money penalty (a fine) or order the retailer to stop selling any tobacco. Enforcement might also mean criminal prosecution, seizing tobacco products, or an injunction against distribution or sale of tobacco products.

CTP has already taken action against tobacco product retailers and businesses for violations of the Tobacco Control Act.  Warning Letters and fines issued to tobacco retailers can be found here


Help Us

If you think someone is violating the law, report it.

Contact the Center for Tobacco Products in any of these ways:

Send us a letter at

Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 
 

When you report a violation or potential violation, you do not have to give your name.

However, giving us your name and contact information can help because we sometimes need more information. 


 

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Other Key Areas of Focus

  • Overview of the Center for Tobacco Products
    CTP is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act. This law – commonly called the Tobacco Control Act – gives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products.
  • Policy, Rulemaking, and Guidance
    This information describes how FDA’s Center for Tobacco Products (CTP) sets policy and develops rules (regulations) and guidance under the Tobacco Control Act.
  • Public Education Campaigns
    As part of this approach, FDA’s Center for Tobacco Products (CTP) is investing in a number of tobacco prevention public education campaigns that directly support our mission by educating the public about the dangers of regulated tobacco products.
  • Research
    This information describes how FDA’s Center for Tobacco Products (CTP) funds and uses scientific research to better understand tobacco products, how they cause death and disease, and how to best reduce the harm from these products.
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