Shelf Extension Regulations

Hello, 

I practice in the realm of dietary supplement manufacturing and we have an ingredient that comes from the supplier with no expiration date on the CoA.  This ingredient is required to meet our spec at 96% purity.  It was said to be best by 3 years, however, the product was tested and is still within spec.  Is it plausible to extend the shelf based off of a third party test showing that it is still in fact free of contamination and meeting product specs? If so for how long? I believe I read somewhere this can be done for a year at a time with a max of two years? Not sure how valid this information is. 

Hello, 

 

I practice in the realm of dietary supplement manufacturing and we have an ingredient that comes from the supplier with no expiration date on the CoA.  This ingredient is required to meet our spec at 96% purity.  It was said to be best by 3 years, however, the product was tested and is still within spec.  Is it plausible to extend the shelf based off of a third party test showing that it is still in fact free of contamination and meeting product specs? If so for how long? I believe I read somewhere this can be done for a year at a time with a max of two years? Not sure how valid this information is. 

Hi Sarah,

What is meant by "Purity" ? Analysis of some particular chemical entity ? eg analysis of chloride content in salt ?

Does this mean that product has no other significant BCPA/organoleptic characteristics which may change with time and affect slelf life ?  .

It is an amino acid.  Our purity or potency is 96 percent plus.   The lots that we tested are still within spec.  We have a lot of this material.

You can extend the shelf life based upon organoleptic properties or lab testing.  If you can show the product is within spec, you can extend the shelf life internally.  Just be sure you document the extension and the basis on which it was extended.  I would recommend 3-6 months at a time.