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U.S. Department of Health and Human Services

Tobacco Products

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Small Business Assistance

 

Civil Money Penalties FAQ

CTP recently published a guidance titled “Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.”  The guidance provides information in response to frequently asked questions from retailers and other interested stakeholders regarding the issuance of CMPs for violations of Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements relating to tobacco products in retail outlets.  The guidance explains what a CMP is, why one may be issued, and what a retailer should do upon being served a CMP complaint.  Additionally, it describes the factors that determine the amount of each penalty.   Finally, the guidance describes the options available to a retailer, and details the processes for each.  


 

Potential Tobacco Product Violations Reporting Form (Form 3779) 

CTP has added a new option for reporting potential violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related regulations. In addition to the paper form, Potential Tobacco Product Violations Reporting form (Form 3779), you may now report potential tobacco product violations using the web form available at Youth & Tobacco – Report Potential Tobacco Product Violations.  The web-based form gives the public a user-friendly interface and allows you to submit your observations to CTP via the website.  You no longer need to submit the form via electronic or regular mail, and you can receive instant notification that FDA has received your form.  You may report potential violations such as sales to minors or sales of flavored cigarettes among other potential retail, advertising, marketing, and promotion violations.

The downloadable PDF Potential Tobacco Product Violations Report Form (Form 3779) will remain available if you prefer to print and send by standard mail.

 

Can I make my report anonymously? 
Yes.  You are free to make your report anonymously, and FDA will evaluate your report, which will remain private.

How will I know that my report has been received?
When using the web form, you may choose to receive email notification that CTP has received your report.  Please note, all reports may be made anonymously.  However, if you choose to receive an email receipt that your form was submitted, you must provide a name and email address.   

What happens to a report once submitted to FDA?
FDA evaluates the reports and determines what follow-up action, if any, is appropriate.  Reports may be helpful in identifying possible violations of the FD&C Act and related regulations that FDA enforces.  All reports to FDA remain private to the extent allowed by law, as explained in FDA’s Privacy Policy.

Can you check the status of a report once submitted?
While FDA does not provide information regarding ongoing investigations, information can be obtained pursuant to a Freedom of Information Act (FOIA) request once an investigation is closed.   Certain compliance check inspection information is posted online in a searchable database and does not require a FOIA request.

 


 

Retailer Training Guidance

CTP recently published a guidance titled “Tobacco Retailer Training Programs,” which is intended to assist retailers implement training programs for employees to learn about, and comply with, Federal laws and regulations restricting the sale, distribution, advertising, and promotion of cigarettes, cigarette tobacco, and smokeless tobacco.  Retailers are not required by Federal law to implement a training program, though such a program may be taken into account when accessing penalties for subsequent violations.  This guidance summarizes the relevant restrictions on the sale, distribution, advertising, and promotion of tobacco products and explains applicable penalties for violating such restrictions.  Further, it sets forth recommendations for elements to be included in a retailer training program, such as applicable laws and penalties, training curriculum, and recommended hiring, training and management practices. 

We recommend that you contact your state or local authorities to determine if they have enacted more strict requirements than FDA. 


21 CFR 1140 Guidance

CTP recently published a guidance titled “Regulations Restricting the Sale of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,” which sets forth FDA’s current thinking regarding 21 CFR 1140.  The Guidance is intended to assist manufacturers, distributors, retailers and others in understanding how to comply with the regulations, which currently apply to cigarettes, roll-your-own tobacco, cigarette tobacco, and smokeless tobacco.  The guidance defines relevant terms, gives advice on complying with the regulations, answers some commonly asked questions, and specifies which provisions of the regulation FDA is currently enforcing.

We recommend that you contact your state or local authorities to determine if they have enacted more strict requirements than FDA.  


Tobacco Product Review and Evaluation Pathways

FDA has created a new section on our website to provide information about the criteria for review and evaluation of new and modified risk tobacco products, before they are marketed, to determine their impact on public health.  FDA created the Tobacco Product Review and Evaluation content to provide:

  • Centralized information on the three pathways to legally market new tobacco products;
  • An interactive tool to provide greater understanding about which pathway may be appropriate for a new tobacco product; and
  • Information on how to legally market a tobacco product with an explicit or implicit modified risk claim.

Visit the Tobacco Product Review and Evaluation page to learn more.  


 

Final Rule: Substantial Equivalence Exemption

On July 1, 2011, FDA issued a final rule  to establish procedures for requesting an exemption from the substantial equivalence requirements of the Food, Drug, & Cosmetic Act. Exemptions from demonstrating substantial equivalence are limited to modifications of additive levels. 

 

Sale and Distribution 

Who is covered, or impacted, by the Youth Access and Advertising regulations?
The regulations apply to manufacturers, distributors, importers, retailers, and others who sell cigarettes and/or smokeless tobacco.

 

Registration and Product Listing

Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

  

Rotational Warning Plans

Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products

  

Low, Light and Mild or Similar Descriptors

Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products

 

Listing of Ingredients in Tobacco Products

Final Guidance for Industry: Listing of Ingredients in Tobacco Products 

 

Tobacco Health Document Submission

 

 

Contact Us

Small Businesses may contact CTP by email at smallbiz.tobacco@fda.hhs.gov or by phone at 1-877-CTP-1373.