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U.S. FDA Tobacco Labeling Requirements

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U.S. FDA has strict labeling requirements for tobacco products, including requiring health warnings on tobacco packaging and advertisements.

For assistance with FDA tobacco labeling requirements, complete the form below:

  I want to verify that my labeling meets current U.S. FDA requirements.
  I have a shipment detained due to labeling violations and need immediate assistance.
  I have not yet designed my product labeling and would like assistance.
Company Name: *
Contact Name: *
Contact Title: *
Facility Street Address: *
City: *
State/Province/Territory:
Country: *
Postal Code:
Phone: *
Mobile Phone:
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Type of Business (Select all that apply): *
Manufacturer - Owns or operates an establishment that manufactures a tobacco product. This term includes, but is not limited to, control laboratories, contract laboratories, contract manufacturers, contract packers, contract labelers, and other entities that manufacture a tobacco product.
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Repacker - Packages finished tobacco products from bulk or repackages tobacco products made by a manufacturer into different containers (excluding shipping containers).
Private Label Distributor - Any company engaged in distributing private label tobacco products (your company name appears on the label).
Other - Contract Testing Lab, Contract Assembler, Fulfillment Packager, and Contract Sterilizer.

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U.S. FDA Regulations:

U.S. FDA Tobacco Regulations: 21 C.F.R.




 


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