The short answer
Shelf-stable fruit pulps and purées in cans, pouches or drums may be acidified foods or low-acid canned foods under FDA rules. If they are, you need two extra filings on top of normal food facility registration: FCE registration and a process filing (SID).
| Requirement | What it means | Who |
|---|---|---|
| FDA food facility registration | Every facility that makes, packs or holds the food for the US registers with FDA and renews every two years (Oct–Dec of even years) | Your facility |
| U.S. Agent | Foreign facilities name a U.S. Agent on the registration | Your facility |
| FDA-compliant label | English label, ingredients, Nutrition Facts, allergens, net quantity, responsible business | Your facility / brand |
| FCE + SID (if acidified or low-acid canned) | Form FDA 2541 registration, then process filing such as Form FDA 2541e, before you ship | Your facility |
| Prior Notice | Filed with FDA before every shipment arrives | Exporter, importer, broker or Orionex |
| FSVP | The US importer verifies your food safety | FSVP importer (your buyer or Orionex) |
Is my product an acidified food?
Under 21 CFR 114.3, an acidified food is a low-acid food to which acids or acid foods are added, with a water activity above 0.85 and a finished equilibrium pH of 4.6 or below. A low-acid food has a pH above 4.6 and water activity above 0.85.
- Acid foods — naturally at pH 4.6 or below — are treated differently from acidified foods.
- Products stored, distributed and sold under refrigeration are excluded from the acidified food rules.
- Many tropical fruits are naturally acidic, but blends, added low-acid ingredients or added acid can change the answer. Measure the finished pH and document how the product is made.
FCE registration and SID process filing
- 1Register the establishment (FCE) — Form FDA 2541Foreign processors must register before offering acidified foods for import into the US (21 CFR 108.25(c)(1)).
- 2File the scheduled process (SID) — Form FDA 2541e for acidified foodsWithin 60 days of registration and before packing a new product. FDA says filing does not mean approval.
- 3Trained supervisionAcidification, pH control and heat treatment must be supervised by someone who completed a course at an FDA-approved school (21 CFR 108.25(f)).
Low-acid canned foods (pH above 4.6, sealed and heat-processed) follow a similar route under 21 CFR Part 113, with their own process filing forms.
Labels
- Name that describes the product — “mango pulp”, “sweetened guava purée”.
- Ingredients including sugar, acids (e.g. citric acid) and preservatives; Nutrition Facts with added sugars.
- Net quantity, and the name and address of the manufacturer, packer or distributor.
Example
A mango pulp processor in India or Mexico that adds citric acid to bring a blend to pH 4.2 registers its facility with FDA, registers as an FCE on Form 2541, files its process on Form 2541e, and has a trained supervisor control acidification. Its US importer gets the filing confirmations with the FSVP documents, and Prior Notice is filed for each container.
Step by step: getting your fruit pulp and purée into the US
- 1Register your facility with FDAEvery facility that makes, packs or holds the product for the US registers, and renews between October 1 and December 31 of each even-numbered year. Foreign facilities name a U.S. Agent.
- 2Make the label US-readyEnglish text, the right name, ingredients, the correct facts panel, allergens, net quantity and the responsible business — plus the product-specific points above.
- 3Agree the import roles with your buyerWho is the importer of record, who is the FSVP importer, and which customs broker files the entry. See who does what.
- 4Send your food safety documentsYour FSVP importer needs evidence that hazards are controlled — food safety plan, certificates, test results.
- 5File Prior Notice for every shipmentFDA must receive it before arrival — at least 8 hours by sea, 4 hours by air or rail, and 2 hours by road.
Checklist
- Finished pH and water activity measured and documented
- Classification decided: acid, acidified, low-acid canned, or refrigerated
- If acidified or low-acid canned: FCE (Form 2541) and SID filed before shipping
- Trained supervisor for critical factors
- FDA food facility registration, U.S. Agent, label, Prior Notice and FSVP documents
Tell us your product — we send your US requirements in writing, free.
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Frequently asked questions
Does mango pulp need FCE and SID?
It depends on the product. If a low-acid ingredient is acidified to a finished pH of 4.6 or below (with water activity above 0.85), it is an acidified food and the processor must register on Form FDA 2541 (FCE) and file its process on Form FDA 2541e (SID). Naturally acid products and refrigerated products may not be covered. The finished pH and the process decide.
Is FCE the same as FDA food facility registration?
No. Food facility registration is required for all food facilities. FCE registration and process filing are additional requirements for processors of acidified and low-acid canned foods.
Does FDA approve my process filing?
No. FDA states that filing a scheduled process does not mean FDA has approved it. The processor is responsible for using an adequate, properly established process.
Who must supervise an acidified food process?
Under 21 CFR 108.25(f), operations that control critical factors such as acidification and pH must be supervised by a person who has completed a course at a school approved by FDA.
Who files Prior Notice for my shipments?
Anyone with the required information can file it — the exporter, the US importer, the customs broker or a consultant such as Orionex. It must reach FDA before the shipment arrives: at least 8 hours by sea, 4 hours by air or rail and 2 hours by road.
Sources
- FDA — Registration of Food Facilities and Other Submissions
- FDA — Prior Notice of Imported Foods
- FDA — FSVP Final Rule At-A-Glance
- FDA — Import Alerts (search by product, country and firm)
- 21 CFR 114.3 — Acidified foods definitions (Cornell LII)
- 21 CFR 108.25 — Acidified foods: registration and process filing (Cornell LII)
- FDA — Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.