FDA Label Review and Registration for Dietary Supplements Intended for Import into the United States

Bringing dietary supplements compliant with FDA standards to the American market requires the FDA registration of the manufacturing company and a review of the labels.

Specifically, you must notify the FDA of the text of the claims on the labels of dietary supplements to be exported and sold in America. This notification must be made within 30 days of the start of sales in the American market.

It is therefore crucial to proceed with the review of the labels of dietary supplements to be imported and sold in America to determine whether or not there is an obligation to notify the FDA of the labels according to the terms provided for their introduction to the U.S. market.

Structure and function claims have always appeared on the labels of food products and dietary supplements intended for the American market, as well as on drugs. The 1994 U.S. regulation on the marketing of dietary supplements in America established certain requirements and special regulatory procedures for claims related to structure and/or function and for two related types of claims that may appear on the labels of dietary supplements:

• claims related to overall well-being, and
• claims related to nutrient deficiency diseases.

Structure/function claims can describe:

• the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones."
• Additionally, they can characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function.

Claims related to the general well-being of individuals describe the benefit derived from consuming a nutrient or dietary ingredient.

Claims related to diseases due to nutrient deficiency, finally, describe a benefit related to a nutrient deficiency disease, but such claims are allowed only if they also specify the prevalence of that disease in the United States.

These three types of claims are not pre-approved by the FDA, but the manufacturer must substantiate that the claims on the labels of dietary supplements to be sold in the American market are truthful and not misleading, and must submit a notification to the FDA with the text of the claim no later than 30 days after the dietary supplement with the claim in question is marketed in the United States. If the label of a dietary supplement includes one of the claims mentioned in this article, the supplement's label must also contain a disclaimer stating that the FDA has not evaluated the claim on the label.