Using Ingredients with Foreign-Language Labels – Is It FDA Compliant?

Hello everyone. My question is about an ingredient I would receive that has minimal English language on the packaging.

Most of the information is in another language.

It would be used as an ingredient and not sold in the original package directly.

Most of the labeling guidelines I found are for sales direct to customers.

It would be regulated under FDA.

We would receive it from a supplier inside the United States. We will not be the ones importing it.

No allergens, very few ingredients. Low risk.

Can we use this? My thought is an inspector would not like being unable to read the package during a visit.

I'm thinking if we use this product, every shipment will need translated to ensure allergen, nutrition data, etc. has not changed.

This would be recorded and kept on file with the original spec sheet that is in English.

Would love to hear your thoughts. 

Yes to use an yes to translation.

It sounds as though you are in the United States. If not, please disregard.

21 CFR 101.15©(1) [https://www.ecfr.gov...5#p-101.15©(1)] says, "All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English."

Import Alert 99-39 (https://www.accessda...alert_1144.html) includes articles alleged to be misbranded for lack of English labeling. For example, I believe the statement of identity and net weight must be in English. That is why the IA sometimes cites the lack of those attributes.

However, it sounds like the importer, not you, would need to address any potential misbranding.