[D122.0000] ORI Dietary Supplement Study FAQs Dietary supplements are regulated as drugs when intended to test their ability to diagnose, cure, mitigate, treat, or prevent disease.

• A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet.
• The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, glandulars, and metabolites.
• Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.

Under the National Institutes of Health (NIH) Dietary Supplement Health and Education Act (DSHEA) of 1994, a dietary supplement is not considered a drug and is not subject to the premarket approval requirements for drugs if the intended use is only to affect the structure or any function of the body (i.e., not for a therapeutic purpose). 

FDA Dietary Supplements

According to the FDA 2013 IND Determination Guidance (page 12), whether an IND is needed for a study evaluating a dietary supplement is determined by the intent of the clinical investigation.

• No, an IND is not required if the clinical investigation is intended only to evaluate the dietary supplement’s effect on the structure or function of the body or reduce the risk of a disease, intended to support a new or expanded health claim, and conducted in healthy individuals over 12 months of age.
• Yes, an IND is required if the clinical investigation is intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease. An IND may also be needed if clinical investigations are intended to evaluate whether a food substance/supplement may reduce the risk of a disease in individuals less than 12 months of age, those with altered immune systems, and those with serious or life-threatening medical conditions.

See FDA IND guidance for revised information on which supplement studies require an IND. 

Examples of structure/function vs. therapeutic effects: 

Refer to the FDA Guidance: Small Entity Compliance Guide on Structure/Function Claims for examples, as the distinction between treatment and structure/function effects can be unclear.

A sponsor or sponsor-investigator (S-I) for an investigator-initiated study may make an initial determination regarding the need for an IND and document on the IRB application (Form O). The IRB will review and, if unsure, may require the S-I to seek an IND determination from the FDA. If an FDA determination is required, the S-I may:

• Submit an FDA inquiry to obtain a written response from the FDA that an IND is not needed.
• Submit an IND to the FDA. Provide the IRB with FDA correspondence indicating an IND was not needed or confirming the IND was approved by the FDA.

If only evaluating structure or function, the FDA does NOT consider a dietary supplement to be a drug.
An investigator would not need to include FDA language in the consent form as long as the study evaluates the supplement’s effect on the structure or function of the body and not therapeutic effects.

_{Source: “What is a Drug?” Section of FDA 2013 IND Determination Guidance}

No, if an IND is otherwise required, purchasing the supplement off the shelf does not exempt the study from IND requirements.

FDA regulations (21 CFR 56.102) define a Human Subject as “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.” An IND may be required in studies including healthy subjects or patients.

Studies designed to evaluate whether a conventional food or dietary supplement reduces the risk of a disease, effects a structure or function of the body or intended to support a new or expanded health claim, may only be conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions. Such studies in these vulnerable populations would require an IND.

FDA Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
FDA IND Applications for Clinical Investigations: Regulatory and Administrative Components

Unlike drugs, dietary supplements do not undergo a phased FDA approval process before they are marketed. 

Under DSHEA, FDA requires a manufacturer or distributor only to notify FDA if it intends to market a dietary supplement that contains a "new dietary ingredient." If the supplement contains a new dietary ingredient, a pre-market review for safety data and other information is required by law. If the supplement does not contain a new dietary ingredient, there is no requirement for the manufacturer to provide the FDA with evidence of safety or effectiveness before or after marketing its products.

FDA Questions and Answers on Dietary Supplements

No, a product sold only as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention, or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the National Institutes of Health (NIH) Dietary Supplement Health and Education Act (DSHEA) of 1994.

*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.