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Is an Existing Precautionary Allergen Statement Sufficient?

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shwetakumari

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Posted 11 March 2026 - 05:40 PM

If one of our ingredient specifications states “may contain traces of peanuts and tree nuts,” but our finished product label already includes the statement “processed in a facility that also processes peanuts and tree nuts,” is the existing statement sufficient, or should the supplier’s “may contain” advisory also be added to the finished product label?


Edited by shwetakumari, 11 March 2026 - 05:42 PM.

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MDaleDDF

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Posted 11 March 2026 - 06:52 PM

Both of those statements are dubious to me....at best.   They're not regulated by any law, so I just find them dubious.   No idea what's behind a statement like that, or why it's being made.    Is a company just using it as a buffer for bad GMP's and allergen control?   I dunno.   Lots of threads on the forum about that.  To me they're pretty much the same statement.

They're both voluntary so I don't see legalities having any say in the matter.   


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jfrey123

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Posted 11 March 2026 - 06:56 PM

FDA's guidance on these statements is crap, other than to specify that they're not intended to be used as a legal protection and should only be used where cross-contact cannot be adequately controlled based upon a risk assessment.  In short, it is not a substitute for proper PC's under FSMA, their misuse can be considered misleading labeling.

 

Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)

 

Skim through that and take a look at D.15 as well.  "May contain" is not suitable as a replacement for good basic GMPs and effective sanitation.  My take would be that if your supplier is properly using that statement (and not just inappropriately trying to CYA themselves), then your statement is almost a downplay of the hazard.  But then again, FDA is not actually regulating the use or actual wording of these statements, other than to say they aren't supposed to be used on everything just because you have the same allergen in the building.


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G M

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Posted 11 March 2026 - 09:28 PM

Should it be done -- probably not.  "In a facility that also" seems like a much lower risk level than "may contain".  Neither of them really mean anything, and won't protect you if someone has a reaction and takes you to court.

 

Will you get away with it, and worse -- probably.  The FDA is kind of a joke.  


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MDaleDDF

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Posted 12 March 2026 - 12:24 PM

 Neither of them really mean anything, and won't protect you if someone has a reaction and takes you to court.

This says it all.....  There's no room for 'maybe' in food safety nowadays.   I can't believe companies still lean into statements like these, but whateva.....   I would never do it.


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GMO

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Posted 12 March 2026 - 02:48 PM

The intent is to avoid people eating that who have a food allergy.

 

The reality is it stops nobody because it's used too widely. It's like a wet floor sign being left out long after the floor is dry. People so often see that warning when it's unnecessarily it makes them blind to it when it's needed.

 

Would I include it? Ah possibly (and I think either are fine for the intent of the statement) but as others said, it means nothing in reality.

What I'd do first is to go to the supplier and understand the risk of their process. Whether the risk was genuine and real or just a** covering BS. That might make you feel more confident to not have it and have due diligence reasons on why.


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