Structural functional theory
These two sections define what types of claims are structure/function claims and what types of claims are disease claims.
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#STRUCTURAL FUNCTIONAL THEORY CODE#
The regulation added ยง101.93(f) and (g) to Title 21 of the Code of Federal Regulations, Part 101. These requirements were published as final rules in the Federal Registers of Septem(62 FR 49826), J(63 FR 30615), and (62 FR 2218) (access via (see Title 21 of the Code of Federal Regulations (21 CFR) Parts 101 and 111) (1). It should be noted that other regulations also cover labeling and packaging requirements for dietary supplements. This guidance discusses only the requirements that apply to determining whether a claim is a structure/function claim or a disease claim. Disease claims require prior approval by FDA and may be made only for products that are approved drug products or for foods under separate legal provisions that apply to claims called "health claims." The regulation also provides criteria to assist you in determining when a statement about a dietary supplement is a disease claim, that is, a claim to diagnose, cure, mitigate, treat, or prevent disease. Called structure/function claims, these claims are statements that describe the effect a dietary supplement may have on the structure or function of the body. On January 6, 2000, the Food and Drug Administration (FDA) published a final rule in the Federal Register defining the types of statements that may be used on the label and in the labeling of dietary supplements without prior review by the agency (65 FR 1000) ( ). An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
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However, this guidance document represents the agency's current thinking on this subject and does not, itself, create or confer any rights for or on any person and does not operate to bind FDA or the public. The regulations are binding and have the force and effect of law.
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This is a Level 2 guidance document published for immediate implementation in accordance with FDA's good guidance practices (21 CFR 10.115). This guidance document restates in plain language the legal requirements set forth in a regulation concerning labeling claims for dietary supplements. The Food and Drug Administration has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (P.L. Center for Food Safety and Applied Nutrition