Canned Foods and FDA Regulation

Food & Beverages | Canned Foods

Canned foods (low acid canned foods, or LACF products, and acidified food canned food products) are subject to special FDA permit controls, which are implemented through FDA Food Canning Establishment (FCE) regulations and FDA Scheduled Process Identification (SID) filings. The FDA canned food regulations are in addition to the Bioterrorism Act (BTA) food facility registration, U.S. Agency, Prior Notice, and FDA food ingredient regulations and FDA food processing and food label requirements.

Before exporting canned foods or beverages or acidified foods or drinks to the United States, contact FDAImports.com, LLC and let us show your company The Way Through the FCE registration and SID filing process. Our experts have direct and inside the FDA experience, having regulated the canned food and beverage industries and in some cases even supervised FDA’s aseptic processing program for a number of years.

FCE Registration

All low acid canned food (LACF) and acidified canned food manufacturers must submit a Food Canning Establishment (FCE) Registration with FDA before exporting to or distributing canned foods in the United States. The FDA FCE Registration is in addition to FDA’s Bioterrorism Act Food Facility Registration requirement. When the FCE Registration is submitted to FDA, the manufacturer must also submit to FDA its Scheduled Process filings for all of its commercially sterile, acidified and low-acid canned foods to obtain a Scheduled Process Identification (SID) Number from FDA for each specific canned food and aseptic or acidified food process.

Although only canned food manufacturers and processors are required to obtain an FCE Number for their facility and SID Numbers for their scheduled processes, U.S. importers, wholesalers, distributors, and brokers must ensure their suppliers have correctly filed their Scheduled Processes and that the food they are importing is actually subject to the SID Number. Failing to take into account the accuracy and applicability of the FCE and SID information can result in very expensive FDA import detentions and FDA import refusals that cannot be overcome by simply filing some paperwork after the fact or by correcting some labeling violations. FDA will refuse admission to any imported LACF or acidified food or beverage processed by a manufacturer lacking the required FCE Number and an SID Numbers.

FDAImports, LLC can save your company time and money by assisting in preparing, evaluating and submitting your FCE and SID scheduled process filings for your canned foods and beverages.

Scheduled Process Identification

Any low acid canned food processor, which is required to submit an FDA FCE registration must also submit to FDA a scheduled process filing form. The canned food manufacturer’s Scheduled Process must be electronically transmitted to and reviewed (and accepted) by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) before any canned food import shipments occur.

The Scheduled Process form will contain necessary information about the manufacturer’s aseptic or acidification processes for producing commercially sterile low-acid canned foods or properly acidified food and eliminating the risk of botulism poisoning in the food product. Ordinarily, a separate process filing form must be submitted for each separate acidified food or LACF canned or bottled product. However, FDAImports.com, LLC is often able to legally justify filing related products and processes under the same Scheduled Process filing. This saves our client’s time and money while ensuring compliance with FDA regulations governing the importation and distribution of canned foods.

Modifications in the manufacturing process or changing the container type used (e.g. glass, metal, etc.), or acidulators or aseptic processing equipment will require the FCE manufacturer to submit updated SID forms.

There are other important food manufacturing details that are required in order to obtain proper SID Number compliance. At FDAImports.com, LLC we assist low acid canned food and acidified food processors to acquire an SID Number and to comply with all FDA regulations related to Scheduled Process updates.

Need Help?

FDAImports.com, LLC works with international and domestic companies to assure FDA compliance with canned food products, facilities and registration. Let FDAImports.com, LLC find The Way Through for you and your company. Get Started.