Structure Function Claim Dietary Supplement

Health claims describe a relationship between a food food component or dietary supplement ingredient and reducing risk of a disease or health related condition.

Structure function claim dietary supplement. The label of a dietary supplement or food product may contain one of three types of claims. The dietary supplement health and education act of 1994 dshea established some special regulatory requirements and procedures for using structure function claims and two related types of dietary. Structure function claims are not subject to fda pre authorization.

21 cfr 101 14. A structure function claim describes the role of a substance intended to maintain the structure or function of the body. We reviewed the claims to determine the extent to which they complied with fda regulations.

A health claim nutrient content claim or structure function claim. Depending on the ingredients different rules come into play. Competent and reliable scientific evidence adequate to substantiate a claim would consist of scientific and reliable data derived primarily from human studies.

A structure function claim describes the product s role in maintaining the structure or function of the body or general well being labeling rules are detailed. We reviewed substantiation provided by manufacturers to describe the quantity and nature of the evidence. Small entity compliance guide on structure function claims questions and answers regarding the labeling of dietary supplements as required by the dietary supplement and nonprescription drug.

Structure function claims do not require preapproval by fda. The dietary supplement health and education act of 1994 dshea established some special regulatory requirements and procedures for structure function claims and two related types of dietary. In contrast to health claims structure function claims within the broader category of statements of nutritional support refer to representations about a dietary supplement s effect on the structure or function of the body for maintenance of good health and nutrition.

Dietary supplements can make structure function claims for example calcium builds strong bones.