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Dietary Supplement Shelf Life

Started by , Oct 05 2021 02:45 PM
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Hello, 

 

I was wondering if anyone could weigh in the topic of shelf life justification for new dietary supplements. Is it plausible to use an expiration date on a supplement going by the expiration date of the CoA of the raw materials in the supplement?  I had spoke to an FDA inspector and was told this and thought it sounded odd.  Has anyone heard of this before?

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It sounds nonsense to me: say, if one of my yogurt ingredients has shelf life of 365 days - the product itself should have the same shelf life? You should establish your new product shelf life basing on product  organoleptic/chemical/physical properties (e.g. pH, fat level, moisture, solids, etc.) and behavior (e.g. acidification, syneresis, gelatinization, etc.) as well as microbial resistance. 

You will also want to evaluate potency and at what point in time the potency becomes unacceptable.  

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