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HomeU.S. FDA Tobacco Product Regulations › U.S. FDA Tobacco Product Labeling Requirements

U.S. FDA Tobacco Product Labeling Requirements


U.S. FDA Tobacco Product Labeling Regulations Can Be Complicated

Registrar Corp's team of Regulatory Advisors can provide a Free Assessment of how U.S. FDA tobacco product labeling regulations apply to your particular tobacco product. Simply click below to receive information about tobacco product labeling requirements.

Learn how U.S. FDA tobacco product labeling regulations apply to you >>


The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines "labeling" as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.

Registrar Corp's Tobacco Product Labeling and Ingredient Review service helps companies determine their tobacco product's likely classification and compliance with applicable labeling requirements. Registrar Corp cross references your tobacco product labeling against thousands of pages within the Code of Federal Regulations as well as the Federal Register, Guidance Documents, and Warning Letters issued by U.S. FDA. Registrar Corp's label review service provides:

  • A detailed report (typically 30-40 pages) prepared by our team of regulatory specialists who scrutinize each element of your tobacco product labeling (including inner packaging, outer packaging, website, etc.).
  • A print-ready graphic file of your revised tobacco product label which incorporates our recommended changes.
  • A generous revision policy providing additional reports for your revised tobacco product label within 90 days at no extra cost.

Learn how U.S. FDA tobacco product labeling regulations apply to you >>






 
U.S. FDA Regulations:

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


Fee:

Tobacco Labeling Review:
US$ 1495/product

Discounts are available for multiple products.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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