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Additional Requirements for Producing Dietary Supplements

dietary supplement FDA GMPs

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#1 JackieD

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Posted 12 December 2018 - 07:08 PM

Hello all,

 

I work for a co-manufacture that produces acidified and acid food/beverage. We were approached by a client that wants to produce a dietary supplement (acidified "shot") made from herbs and coffee. I did some preliminary research into the requirements for producing dietary supplements and found that the main difference from our cGMPs and the DSGMPs are stringent label requirements and end product testing. The client is having their labeled reviewed by a third party specializing in dietary supplements. 

 

My question is what do we need to put in place in order to produce this product under compliance. All the ingredient inputs are whole foods (herbs and coffee) and no claims are made on the label pertaining to input quantity. Is end product testing required for this variety of dietary supplement?

 

Thank you so much for your feedback!



#2 Scampi

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Posted 13 December 2018 - 08:46 PM

Have you read through this link

 

https://www.fda.gov/...s/ucm238182.htm

 

or

https://www.registra...ry-supplements/


Because we always have is never an appropriate response!


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