CENTER FOR TOBACCO PRODUCTS

Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy.

August 2021

WHAT A BRICK AND MORTAR

RETAILER SHOULD DO AFTER 

RECEIVING A WARNING LETTER

Presented by:

Office of Compliance and Enforcement

Center for Tobacco Products

FDA
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AGENDA

• What is a Warning Letter?

• What is a Compliance Check Inspection Notification? 

• What does a Warning Letter include?

• What should I do if I receive a Warning Letter?

• How do I respond to a Warning Letter?

• What happens next? 

• FDA resources for retailers
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• Brick and Mortar Retailers

- This webinar provides information to tobacco product brick 

and mortar retailers about Warning Letters that FDA may 

issue as a result of a tobacco retailer inspection. 

- This webinar does not cover Warning Letters FDA may issue 

to other regulated entities, including online tobacco product 

retailers.

- For more information about online tobacco retailer 

enforcement please visit our website at: 

https://www.fda.gov/tobacco-products/complianceenforcement-training.

AGENDA NOTE 
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WHAT IS A WARNING LETTER?

• A Warning Letter is the Agency’s advisory action that alerts a retailer, and 

provides notice, that their establishment is not in compliance with Federal laws 

and regulations regarding the sale and distribution of regulated tobacco products.

• The first time FDA finds violation(s) during a tobacco retailer inspection, FDA 

typically issues a Warning Letter. 

• The Warning Letter prompts the retailer to address current violations and provides 

information for the retailer to help prevent future violations.
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• If a sale to an underage purchaser is documented during a tobacco retailer inspection, a 

Compliance Check Inspection Notification (CCI) is typically mailed to the retail 

establishment. 

• The CCI is not a Warning Letter. The FDA sends CCI notices as a courtesy to retailers 

shortly after a potential violation(s) for selling tobacco products to a person under 21 years 

of age. 

• The CCI provides the retailer with detailed information about the inspection, including a 

photo of the establishment taken at the time of the inspection, the date and time of the 

inspection, and a description of the clerk (if available) who made the sale. 

• No response is required for a CCI. However, if the establishment identified in the CCI is 

not your establishment, you should contact FDA. 

WHAT IS A COMPLIANCE CHECK INSPECTION 

NOTIFICATION? 
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WHAT DOES THE WARNING LETTER INCLUDE?

• FDA will review the evidence obtained during the inspection at the retail 

establishment to determine whether there was a violation of Federal laws and 

regulations. 

• If FDA determines a violation occurred and you receive a Warning Letter, the 

Warning Letter will include the following information:

 The inspection date

 The approximate time of inspection

 Description of the specific violation(s) observed 

 Relevant Federal tobacco laws and regulations

 Information on how to submit a written response

 Statement that violations listed in the Warning Letter may not be a complete list of 

violations at the establishment 

 Reminder to comply with all applicable laws and regulations
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WHAT SHOULD I DO IF I RECEIVE A WARNING LETTER?

• After receiving a Warning Letter, you should:

– Carefully review the listed violation(s)

– Review the Warning Letter to ensure the establishment information is correct

 If the establishment information is incorrect, you should notify FDA

– Respond to the Warning Letter in writing within fifteen (15) working days of 

receipt

– Take action to address the listed violations in order to ensure future compliance

– Preserve any evidence or information relevant to this Warning Letter in the 

event FDA takes regulatory action at a later date
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HOW DO I RESPOND TO A WARNING LETTER? 

• Directions on how to respond will be included in the Warning Letter. These directions 

request your response within 15 working days by either: 

• E-mail to: CTP-WL@fda.hhs.gov (scanned responses are acceptable)

• Phone: contact the Center for Tobacco Products at 1-877-CTP-1373, or

• Mail to:

Food and Drug Administration

Center for Tobacco Products

Document Control Center

Building 71, Room G335

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

• Your Warning Letter Response should include: 

• Your current contact information, including address, telephone number, and e-mail address.

• The reference number listed at the top of your Warning Letter.

• An explanation of the steps you will take to address the violation(s) and prevent future 

violations (e.g., retrain your employees, remove the problematic items, etc.).
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• If your Warning Letter comes with a voluntary Warning Letter response document, you 

may use it to respond or you can submit your own written response. 

– A voluntary Warning Letter response document may be sent via mail or e-mail to FDA.

– Voluntary Warning Letter response document example:

HOW DO I RESPOND TO A WARNING LETTER?
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• No. Generally FDA will NOT contact you after receipt of a Warning Letter 

response. 

• FDA may contact you if additional information or clarification is needed regarding 

your response.

WILL FDA CONFIRM RECEIPT OF MY WARNING LETTER 

RESPONSE?
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• FDA will conduct follow-up inspections at your establishment. These inspections will not be 

scheduled or pre-announced. 

• You must continue to comply with all applicable tobacco laws and regulations. 

– More detailed information available at: www.fda.gov/tobacco-products/retail-sales-tobaccoproducts/selling-tobacco-products-retail-stores

• If violations are observed during a follow-up inspection it may result in FDA taking 

additional enforcement action without notice, including a Civil Money Penalty or NoTobacco-Sale Order.

• Inspection results will be added to our Compliance Check Inspection database, which is 

updated monthly. 

– To access this database, go to: 

https://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm

WHAT HAPPENS NEXT?
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• For additional questions, you can contact FDA:

– CTP General E-mail: AskCTP@fda.hhs.gov

– Call: 1-877-287-1373 (9am EST-4pm EST)

– Small Business E-mail: SmallBiz.Tobacco@fda.hhs.gov

WHAT IS THE BEST WAY TO CONTACT FDA WITH 

ADDITIONAL QUESTIONS?
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• Retail Sales of Tobacco Products

https://www.fda.gov/tobacco-products/compliance-enforcement-training/retail-sales-tobaccoproducts

• Summary of the Federal Rules for Selling Tobacco Products 

https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/selling-tobacco-products-retailstores

• “This is Our Watch” Campaign for Retailers 

https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/our-watch

• Social Media Links (E.g.: Twitter, Facebook, YouTube)

https://www.fda.gov/tobacco-products/contact-ctp/connect-ctp

• Sign up for CTP E-mail updates

www.fda.gov/tobacco-products/ctp-newsroom

FDA RESOURCES FOR RETAILERS
CONCLUSION