Upcoming FDA Registration Renewal: Why Should You Start Preparing Now?

In addition to keeping the information in the food establishment registry up to date and protecting it from the FDA, companies should be aware that a new biennial renewal cycle is approaching.

The Agency’s regulations stipulate that food establishments required to register must renew their registration every two years, during the period from October 1 to December 31 of each even-numbered year. For the current cycle, this means that businesses must renew their registration this year to cover the period from 2026 to 2028.

Preparing in advance allows you to check whether the facility information is up to date, verify contact information, confirm product categories, verify the Registered Agent's information, and avoid errors that could delay the process.

What can happen if a company doesn't renew?

Failure to renew within the official period may pose risks and have an impact on the continuity of exports to the United States. The FDA states that facilities required to register must comply with the biennial renewal within the established deadline; otherwise, the registration may be considered expired if it is not renewed in a timely manner.

For an exporting company, this may mean:

  • Expiration of Registration
  • Delays in Export Operations
  • Difficulties in Submitting Information to the FDA
  • Potential Findings During the Introduction of Products to the U.S. Market
  • Additional steps are required to restore the registration status.

For this very reason, the renewal must be processed in advance, before the end of the period; this means beginning the review of the documents well in advance.

How can AGEXPORT help?

AGEXPORT, through its Market Intelligence Department and in partnership with its affiliate Export Americas in the United States, provides support to Guatemalan companies that need to apply for or renew their food facility registration with the FDA.

Support may include:

  • review of the facility's current information;
  • guidance on forms and required information;
  • Verification of account-related information FDA;
  • review of product categories;
  • coordination with the U.S. Agent, when applicable;
  • support throughout the renewal process;
  • Submission of supporting documentation upon completion of the process.

For companies that export food, beverages, or dietary supplements to the United States, having a well-organized process mitigates risks and ensures that their registration with the Agency remains up to date.

At AGEXPORT, we continue to support Guatemalan companies to ensure this process is carried out in an orderly and proactive manner, in accordance with FDA requirements. Follow the link below to get started now https://www.export.com.gt/regulacion-fda/

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