FDA Stories #007 — A Mexican Hot Sauce Maker Needed an FCE Number They Had Never Heard Of

A family-owned hot sauce company in Guadalajara made a habanero sauce that was already popular across Mexico. They had a deal with a specialty food distributor in Texas who wanted to bring it into the US market. They came to us for FDA food facility registration.

We registered their facility. Got their DUNS number. Designated ourselves as US Agent. Reviewed the label. Everything was tracking for a smooth entry — until we asked the question that their previous consultant had never asked.

The question

'Is your hot sauce made by adding acid to a low-acid base, or is it naturally acidic from the ingredients?' The owner paused. 'We add vinegar to the chili base to bring the pH down.' That answer changed everything.

A hot sauce made by adding acid (vinegar) to a low-acid food (chili peppers with a natural pH above 4.6) is classified as an acidified food under 21 CFR Part 114. Acidified foods require a Food Canning Establishment (FCE) registration and a Scheduled Process Identifier (SID) filing — both separate from and in addition to the standard FDA food facility registration. Without an FCE number and SID filings, the hot sauce could not legally enter the United States.

What most people miss

The FCE/SID requirement catches more food exporters off guard than almost any other FDA regulation. It applies to any product in a hermetically sealed container where acid is added to achieve a pH of 4.6 or below — including hot sauces, salsas, pickled vegetables, certain marinades, and many condiments. The requirement exists because improperly acidified foods can support the growth of Clostridium botulinum, which produces botulinum toxin — one of the most lethal substances known.

We coordinated the full process: FCE registration, engagement of a qualified process authority to establish the scheduled process, and SID filing for each product-container combination. The process authority conducted pH testing, established the acidification procedure, and validated that the product consistently achieved and maintained the target pH. The entire additional process took three weeks.

What would have happened

Without the FCE and SID, the first shipment would have been detained under Import Alert 99-23, which targets acidified and low-acid canned foods without valid process filings. The detention would have been automatic — no examination needed, no appeal, just a hold until the filings are completed. And completing FCE/SID filings after a detention is more difficult and takes longer than doing it proactively.

If your product is packed in a sealed jar, bottle, can, or pouch and involves adding acid to the recipe — you probably need an FCE number. Ask us before you ship. Visit fdabridge.com/food.