Registrar Corp LinkedIn Registrar Corp Twitter Registrar Corp Facebook Registrar Corp Google+ Registrar Corp Youtube Channel Registrar Corp FDA News Blog
HomeU.S. FDA Tobacco Product Regulations › Establishment Registration & Listing Requirements

U.S. FDA Tobacco Product Establishment Registration & Listing Requirements

U.S. FDA Tobacco Product Establishment Registration & Listing Requirements The U.S. FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import tobacco products sold in the United States. Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of tobacco products must register their establishments with the U.S. FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers of tobacco products must also designate a U.S. Agent.

If you are not registered with U.S. FDA

Registrar Corp's team of Tobacco Product Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:
  • Help determining whether tobacco product establishment registration exclusions apply and, if not, we will prepare and submit your tobacco product establishment registrations with U.S. FDA and make changes, updates, and cancellations as needed at no extra cost.
  • Assistance determining if U.S. FDA tobacco product user fees are required for your tobacco product establishment registration and, if so, help prepare and submit your payment per U.S. FDA's requirements.
  • Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.

Register Your Tobacco Product Establishment With The U.S. FDA  ››

If you are already registered with the U.S. FDA
Select one of the following options:

  
Option 1:  Order a Certificate of Registration
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their registration. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with the registration requirement of the U.S. Food, Drug and Cosmetic Act.
  • The Certificate helps assure your customers and suppliers that your tobacco products have been properly listed with U.S. FDA.
  • Sending a copy of your Certificate along with each shipment may help to avoid errors and delays.
  • Once a Certificate has been ordered, you will periodically receive simplified forms enabling us to quickly update your information on file with U.S. FDA. Such reminders help ensure that your U.S. FDA registration data remains accurate and prevents the accidental loss of your critical information.

Order a Certificate of Registration for Your Tobacco Product Establishment ››

  
Option 2:  If You Have Lost Your U.S. FDA Registration Information
Companies often misplace their registration information. If you do not have your U.S. FDA Tobacco Product Establishment information, you will not be able to update your tobacco product registration information as required by U.S. FDA. For assistance recovering your U.S. FDA registration information, click below.

Recover U.S. FDA Registration Information for Your Tobacco Product Establishment  ››

  
Option 3: List Additional Tobacco Products With U.S. FDA
Most tobacco product establishments that are required to register with the U.S. FDA are also required to list the tobacco products and the activities that are performed on those tobacco products. Registrar Corp's team of Tobacco Product Regulatory Specialists provides guidance as to required elements, formats and particularities of tobacco product listings such as:
  • Assisting you in determining your tobacco product's likely classification
  • Preparing and submiting your tobacco product listings to U.S. FDA and make changes, updates, and cancellations as needed
  • Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.

List Additional Tobacco Products With U.S. FDA  ››






 
U.S. FDA Regulations:

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





















































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.

Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco