How to File with FDA for a Shelf-Stable or Acidified Product (FCE + SID Explained)

18 Feb How to File with FDA for a Shelf-Stable or Acidified Product (FCE + SID Explained)

If you’re developing a shelf-stable or acidified product, understanding how to file with the FDA is crucial to legally sell your product in the U.S. market. From tomato sauces to pickled vegetables, the FDA requires certain filings and process documentation to ensure food safety. Two key components in this process are the FCE (Food Canning Establishment) registration and the SID (Scheduled Process Identifier).

What Is a Shelf-Stable or Acidified Product?

Shelf-stable foods are those that can be safely stored at room temperature without refrigeration. Common examples include:

• Canned vegetables, fruits, or meats

• Jams and jellies

• Pickled or acidified products like salsa or hot sauce

Acidified foods are low-acid foods that have been acidified (pH ≤ 4.6) to prevent the growth of harmful bacteria such as Clostridium botulinum. Examples include:

• Pickled cucumbers

• Acidified salsa

• Hot sauces

FDA Filing Requirements

When you manufacture a shelf-stable or acidified product, you must comply with FDA regulations under 21 CFR Part 113 for low-acid canned foods (LACF) and 21 CFR Part 114 for acidified foods.

The two most critical filings are:

1. Food Canning Establishment (FCE) Registration

Any facility that processes low-acid canned foods must register with the FDA as a Food Canning Establishment (FCE).

Key points:

• Registration must be renewed every two years

• Assigns a unique FCE number to your facility

• Required for both domestic and foreign facilities

The FCE ensures the FDA knows which facilities are producing shelf-stable products and allows inspection when needed.

2. Scheduled Process Identifier (SID)

Every acidified or low-acid canned food requires a Scheduled Process Identifier (SID). This is essentially a detailed description of the thermal process used to ensure product safety.

What SID includes:

• Product formulation and pH level

• Container type (glass jar, can, pouch)

• Fill weight and headspace

• Processing temperature and time

The SID must be kept on file at the manufacturing facility and updated if any part of the process changes. While you don’t submit the SID directly to the FDA for routine filing, it is reviewed during inspections and must be accessible.

Step-by-Step Filing Process

1. Determine if your product is shelf-stable or acidified

   • Conduct pH and water activity testing to classify your product correctly.

2. Register your facility with the FDA (FCE)

   • Use the FDA FCE registration portal

   • Provide facility details and contact information

   • Receive your FCE number

3. Develop a Scheduled Process (SID)

   • Work with a certified process authority (CPA)

   • Document the thermal process, container, and formulation

   • Ensure the process meets FDA requirements for lethality and safety

4. Keep all documentation on-site

   • Maintain SID records for inspection

   • Update whenever there’s a formulation or process change

5. Labeling Compliance

   • Ensure your product labels meet FDA regulations for acidified or low-acid canned foods

   • Include required allergen information and nutrition facts

Why FCE and SID Are Important

Failing to properly register as an FCE or maintain an SID can result in:

• FDA warning letters

• Product recalls

• Legal penalties and halted distribution

Having proper documentation demonstrates compliance and ensures your products are safe for consumers.

Partnering With a Certified Process Authority

Many food entrepreneurs partner with a Certified Process Authority (CPA) to develop their scheduled process. A CPA:

• Reviews your product formulation

• Determines the proper thermal process

• Prepares the SID for your records

Working with a CPA simplifies FDA compliance and reduces risk of product safety issues.

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Filing with the FDA for a shelf-stable or acidified product may seem complicated, but understanding the roles of the FCE and SID will simplify the process. With proper registration, documentation, and testing, you can safely bring your products to market while meeting all regulatory requirements.