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Fish Allergen

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Posted 08 September 2017 - 08:50 AM

Dear Sirs,

Currently, we design the lable of milk product for US export. This product is fortified DHA from fish oil (tuna). For FDA regualtion about allergen warning in label claim, woud you please advise us how about this claim? and what document for references.

Thanks so much,



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Posted 08 September 2017 - 06:47 PM

Guidance document here: https://www.fda.gov/...n/ucm059116.htm


Highly refined oils where all allergenic proteins are removed do not typically require an allergen declaration to cover the source material. However you need to be certain that the oil does not carry any allergenic protein.

Austin Bouck
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Posted 14 September 2017 - 04:17 AM

Get information from your supplier of the fish oil.  I've been in a company where we did the exact same thing and the Omega-3 oil was derived from fish, but the supplier couldn't guarantee it to be free of fish allergen.  So....we discontinued that experiment.  This was 15 years ago so it was a bit new back them.  Now, dairies in the US will use other sources of omegas such as flax.

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