What are the Labeling Requirements for Dietary Supplements?
Principal Display Panel
The principal display panel is the part of the label that is most likely to be viewed and read by the consumer. This is traditionally the "front" of the labeling. There is specific information that must appear on the principal display panel unless exempt. These are:
- Statement of Identity
- Net Contents/Quantities
The information panel is the panel immediately to the right of the principal display panel, in most cases. If the panel immediately to the right is too small to accomodate all the mandatory labeling requirements then the information may be divided between two or more panels. The mandatory information required on the information panel, unless exempt is:
- Directions for Use:
- Name and Address of Manufacturer, Packer or Distributor: A qualifying statement such as "Manufactured by:" or "Manufactured for:" is required to identify what operations the labeler is conducting. The street address may be omitted leaving only the city, state and zip code if the labeler's contact information appears in the local telephone directory.
- Supplement Facts: There are specific regulations regarding the size of the font, separation of hairlines, rounding rules for any nutrients identified, etc. All these regulations must be complied with unless exempt.
- Country of origin: This is required in the event that the product is manufactured outside the United States. If the labeler chooses to add "Made in USA" there are specific regulations based on where the ingredients came from, packaging, etc.
- Expiration date: Expiration date is optional on dietary supplements, however if an expiration date does appear on the labeling of a dietary supplement then the date must be based on scientific studies, commonly referred to as stability studies.
- Warnings: Any warnings necessary to ensure the safety of the dietary supplement must appear on the labeling.
- Disclaimer: If the labeling contains any structure/function claims the disclaimer "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." must appear on the labeling within a contrasting box.