Label Compliance
Basic required label formatting is as follows:
Principal Display Panel (PDP)
Must have:
- Statement of Identity (e.g. Herbal Supplement or Dietary Supplement) - MUST include the word “supplement”
- Net Quantity of Contents (in numerical count [e.g., 30 capsules], or if in volume or weight, both in metric and US Customary System terms)
May have:
Other information
Information Panel:
Must be directly to the right of PDP.
Must have (in order):
-SFP
-Ingredients
-Major Food allergens
-Company information
-Distributed by/Manufactured for:
- Name and place of business
-Mailing address (no PO boxes)
-Phone number
There should be no intervening material appearing between the information above, e.g., barcodes, logos, directions for use, claims, etc. This may all be placed either above the SFP or below the Company Information.
May have:
-Other information
Any panel:
Must be located somewhere on the label:
Full domestic street address or phone number for receiving adverse event reports (this may be included in the company information section). Websites are acceptable if the mailing address or phone number are easily found on the website. Email is allowed but must not be the only listed contact information.
May be located somewhere on the label:
Directions for use (voluntary, unless necessary for safe use)
Warnings (voluntary, unless necessary for safe use)
Country of origin (voluntary. FTC regulations apply for “made in USA” type statements)
DSHEA/FDA disclaimer (voluntary, unless structure/function/health claims are made)