Dietary Supplement Labeling

Ensuring your dietary supplement follows unique guidelines.

Dietary Supplements are regulated as a special class of foods by the US Food and Drug Administration. While regulated as foods, dietary supplement labeling is subject to a unique set of regulations. Dietary supplement product labels must include Supplement Facts Boxes. These facts boxes are similar to those found on food products but they are not identical. For example, the order for listing nutrients (vitamins and minerals) differs between nutrition facts boxes and supplement facts boxes.

Dietary supplement labels may include structure function claims, which describe the way the product effects the normal, healthy structure or normal, healthy function of the human body and its systems. Structure function claims may not be therapeutic in nature. All such claims must be truthful, not misleading and backed by scientific data. FDA has published guidelines on how to determine when there is sufficient information to back the claims being made. Claims being made must be submitted to the Office of Special Nutritional Products within 30 days of market introduction.

It can also be necessary to submit a New Dietary Ingredient Notification prior to market introduction of certain products. If the ingredient was not marketed in the US prior to October 25, 1994, then FDA must be notified of the intent to market that ingredient 75 days prior to market introduction. In 2011 FDA published a draft guidance document stating that it is the agency’s view that each new dietary supplement should be the subject of an NDIN even if all the ingredients were in use prior to October 25, 1994. It will be interesting to see the public comments and the final guidance on this topic.

View Dietary SupplementĀ resources.

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