Dual Language Labels

Dietary Supplement Contract Manufacturer

We have a customer that wants to use as their contract manufacturer. They want to make the same product but with 2 different labels. One that can be used to sell the product both in the U.S. AND France and one just be exclusively sold in France.

1. Can we do that?

2. For the dual language label what information do we need to list?

3. For the one exclusively sold in France, is there a document or disclaimer that needs to be on the label since we are a U.S. based manufacturer?

If anyone knows they CFR's that address this or any guidance documents that would be greatly appreciated as well!

First you'd have to look at the regulations for both countries, it may seem straight forward but some ingredients may be banned or have to be used in a reduced quantity. The FDA versus EU Regs are different.