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FDA Dietary Supplement Label Review

Dietary Supplements in the United States must follow the labeling requirements as per outlined in 21 CFR 101.  A label which includes both the outer and inner packaging must contain the following information:

  1. statement of identity ie. the name of the dietary supplement
  2. net quantity of the contents statement
  3. nutritional labeling (supplement facts panel)
  4. ingredient list
  5. name and place of business of the manufacturer, packager or distributor

There is a minimum print size required to ensure the text is prominent and easy to read. 

Health claims are limited to structure/function in nature and cannot be therapeutic or preventative as these are deemed disease treating claims and classify such products as drugs.  

Quality Smart Solutions will review your label as per labeling requirements. We will also review your Supplement Facts Panel to ensure it is of the correct format.  Structure-function claims will be reviewed and rewording suggestions, if required.  If you have not prepared a Supplement Facts Panel (SFP) we can prepare one for you that is print-ready. 

If you have any challenges in having your designer prepare your dietary supplement art file our graphic designer can prepare a print-ready, FDA compliant dietary supplement label with a supplement facts panel (provided you provide us with the adobe illustrator file and all fonts and images associated with your design file).

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