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Dietary Supplement Panel Requirements


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#1 Sarahb3339

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Posted 10 October 2018 - 04:49 PM

Good morning, 

 

Our company manufactures dietary supplements containing Creatine Hydrochloride.  We have a brand name that we call our Creatine Hydrochloride, .  My question is when I go to design the dietary supplement panel how would I list this. 

 

Creatine Hydrochloride (BRAND NAME HCl)   750mg?

 

or 

 

Brand name (as creatine hydrochloride)  750 mg

 

Or neither?



#2 lengland

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Posted 10 October 2018 - 05:49 PM

Hi Sarah,

Most of the US FDA rules state that you use the common or usual name for ingredients.  21 CFR 101.36 is Nutrition labeling of dietary supplements.  The website to find this is https://www.ecfr.gov...CFR?page=browse

 

 

Part (d)(1) of 21 CFR 101.36 says:

"(1) Source ingredients shall be identified in accordance with §101.4 (i.e., shall be listed by common or usual name, and the listing of botanicals shall specify the part of the plant from which the ingredient is derived) regardless of whether they are listed in an ingredient statement or in the nutrition label." 

 

I don't see anything about brand names in parenthesis so I'm not sure if that's ok or not.  Maybe try looking at FDA warning letters and see if there is anything about brand names for ingredients.  Reading through the warning letters is a good way to learn how the FDA interprets labeling and issues.

 

Hope this helps!

L


Edited by lengland, 10 October 2018 - 05:49 PM.


#3 Sarahb3339

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Posted 10 October 2018 - 06:14 PM

Yes, this is a tricky one. I will try the warning letters.  Good idea!  Thank you so much.






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