Dietary Supplement Facility Registration and Renewal

Our team can help make your dietary supplement facility registration and renewal quick, easy and cost-effective. Our US regulatory team provides businesses with proper assistance in registering or renewing food or dietary supplement facilities with the FDA and all compliance matters related to facility registration.

FDA Registration and Renewal

The Food and Drug Administration (FDA) requires every facility that manufactures, processes, packages or holds foods for consumption in the US to register their facility with the FDA.  This also applies to beverages or dietary supplements for importation or distribution in the US. Biennial registration renewal is required. Any imported beverages or foods failing to comply with the FDA facility registration requirements are not allowed for commercial sale in the US.

FDA registration number

US Agent Designation

Like domestic facilities (within the US), foreign facilities must also register with the FDA before they begin shipping foods or dietary supplements into the US. They must designate a US Agent for FDA Communication at the time of registration.

  • A US Agent can be an individual or entity in the US
  • They play the role of the domestic representative for the foreign facility
  • All communication with the FDA takes place through the US Agent.

FDA Registration and Renewal Date

Registration renewals are done every other year during the period from October 1 to December 31 each even-numbered year, irrespective of when they initially registered. For instance, if a facility registers with the FDA in August 2019, it will still need to renew its registration between October 1 and December 31, 2019.

FDA registration and renewal form
FDA Registration and Renewal

Don’t Want To Navigate The Requirements On Your Own?

Is the process for registering with the FDA still unclear? Are you not aware of all key factors and documents that need to be kept ready? Fret not!  Quality Smart Solutions makes the process of registering food or dietary supplement facilities simple and cost-effective.

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