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HomeFood and BeveragesFCE (Food Canning Establishment) and SID (Process Filings)FCE Samples › FDA FCE-SID Dietary Supplement Regulations

U.S. FDA FCE-SID Dietary Supplement Requirements



Food canning establishments in the United States and foreign establishments that process and export foods to the United States are subject to regulations that require registration of the establishments (FCE) and filing of scheduled processes (SIDs). The FCE registration and SID regulations for thermally processed low-acid and acidified foods packaged in hermetically sealed containers are found in Title 21 CFR 113 and 114. Typical hermetically sealed products include:

  - Canned Dietary Supplement   - Dietary Supplement in Water
  - Bottled Dietary Supplement   - Dietary Supplement in Oil
  - Jarred Dietary Supplement   - Dietary Supplement in Brine
  - Dietary Supplement in Pouch   - Dietary Supplement in Sauce
  - Dietary Supplement in Tetra Pak   - Dietary Supplement in Syrup
  - Dietary Supplement in Dressing   - Dietary Supplement in Spring Water
  - Marinated Dietary Supplement   - Dietary Supplement in Vinegar

Registrar Corp assists Dietary Supplement companies with: 

  • FDA Dietary Supplement FCE Registration
  • FDA Dietary Supplement SID Process Filing
  • FDA Dietary Supplement FCE-SID Exceptions
  • FDA Dietary Supplement Label Requirements
  • FDA Dietary Supplement Import Information
  • FDA Dietary Supplement Detentions / Dietary Supplement Entry Refusals
  • General U.S. Food and Drug Administration Guidelines for:
       - Dietary Supplement Manufacturers
       - Dietary Supplement Suppliers
       - Dietary Supplement Processors
       - Dietary Supplement Exporters
       - Dietary Supplement Importers

In addition to Dietary Supplement FCE-SID regulations, Dietary Supplement businesses are typically subject to FDA Bioterrorism Act Registration and U.S. Agent requirements (when applicable). For more information about Dietary Supplement rules, simply click one of the buttons below:



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Applicable U.S. Regulations:

FDA FCE/SID: 21 C.F.R. sections 108, 109, 113, 114


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