2 replies to this topic

[Sarahb3339]

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?

[olenazh]

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. 

[sqflady]

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