Dietary Supplement:

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a dietary supplement is defined, in part, as “a product taken by mouth that is intended to supplement the diet and that contains one or more dietary ingredients.” The dietary ingredients in these products can include vitamins, minerals, herbs and other botanicals, amino acids, other dietary substances intended to supplement the diet, and concentrates, metabolites, constituents, extracts, or combinations of the preceding types of ingredients.  Dietary supplements can be found in many forms such as tablets, capsules, softgels, liquids, or powders.

Food:

Section 201(f) of the FD&C Act (21 U.S.C. 321(f)) defines a food as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” 

Cosmetic:

Section 201(i) of the FD&C Act (21 U.S.C. 321(i)) defines a cosmetic as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”  With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA.

Whether an IND is needed for a clinical investigation evaluating a dietary supplement, food, cosmetics, or other substance, is determined by the intent of the clinical investigation.

If the clinical investigation is intended to evaluate its ability to diagnose, cure, mitigate, treat, or prevent a disease or condition, an IND is required, and it must be listed on the drug/biologics subform in the IRB application. If it is not, then is goes on the supplement/food/cosmetic/other subform within the IRB application. In rare circumstances, an IDE is required for certain cosmetics that may be regulated as a device, instead of a drug, and should be listed on the medical device subform. If you are unsure, our supplement/foods/cosmetics/other subform asks questions to help us determine whether an IND is required and will direct you to the Drugs/Biologics subform, if necessary.

See FDA guidance on INDs – Determining Whether Human Research Studies Can Be Conducted Without an IND.  Becoming familiar with this guidance and our subform during the early stages of project planning will help you to determine whether an IND is required and allow you to plan for the time required to submit an IND application.

Dietary Supplements: An IND should not be required if all the following are met. For purposes of the dietary supplement labeling requirements, a “‘disease’ is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases  resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition” (21 CFR 101.93(g)(1)).

  • The supplement will only be used to study/evaluate its effect on the structure or function of the body.
  • The supplement is not intended to be used for therapeutic purposes.
  • The supplement is not intended to evaluate its ability to diagnose, cure, mitigate, treat, or prevent a disease.
  • The supplement is not intended to treat or mitigate symptoms of a disease.
  • The supplement is not, or does not contain, an article FDA previously authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.

Food: An IND should not be required if all the following are met:

  • The food is not intended to be used in the diagnosis, cure, mitigation, treatment, or prevention of a disease.
  • The food is not intended to evaluate its effect on the signs or symptoms of a disease.
  • The study is not intended to evaluate the effects of a medical food on a disease.
    • Intended Uses: IND generally not required if the study is limited to the following:
      • A clinical study to evaluate the safety of a food ingredient (even if the ingredient is known to influence bodily structure and function in addition to its taste, aroma, or nutritional effect).
      • A clinical study of food tolerability in a susceptible population, including individuals with a disease.

Cosmetic: An IND (or IDE in some products) should not be required if all the following are met.

  • The cosmetic is not being studied for use to affect the structure or function of the body.
  • The cosmetic is not being used to prevent, treat, mitigate, cure, or diagnose a disease.
  • The cosmetic does not include ingredients of a drug or components of a medical device.

Other Substance/Product: An IND may not be required if all the following are met. The IRB may ask additional questions during its review process to determine whether an IND or IDE is required.

  • The item is not intended to evaluate its ability to diagnose, cure, mitigate, treat, or prevent a disease.
  • The item is not intended to treat of mitigate symptoms of a disease.

You must notify the IRB when this occurs and not enroll subjects until you receive a formal determination from the FDA and submit that determination to the IRB for review. If an IND is required, you will add the substance to the drug/biologics subform and provide the IND information. See the Drugs/Biologics FAQs for additional information regarding the IRB review process. Some cosmetics that are considered medical devices may require an IDE, and that determination must also be communicated to the IRB. The cosmetic would need to be listed on the medical device subform instead.

The determination of whether an IND is required does not depend on whether you commercially market the substance. Please refer to FDA Guidance on requirements. 

The clinical condition of study subjects (e.g., the presence or absence of disease) has no bearing on whether the study is subject to the IND/IDE requirements.  The definition of clinical investigation refers only to subjects involved in an experiment.  It makes no distinction between healthy subjects or those with a disease.

Package insert, device brochure or an equivalent information sheet. All information and documents submitted to the FDA will need to be uploaded.

If your intended use of the supplement/food/cosmetic/other is not to diagnose, cure, mitigate, treat or prevent a disease, make sure that all the documents and information provided to the IRB are in alignment with this intention so there is no ambiguity about the intended use.

If the supplement/food/cosmetic/other you are researching requires an IND or IDE, it needs to be disclosed as having FDA oversight, an IND/IDE application, and that it’s considered an investigational drug (or medical device) in the clinical investigation. It needs to be clear the investigational substance/product does not have FDA approval and it is being tested in this study.

If an IND or IDE is not required, FDA regulation language is not required to be included unless other substances/products in the clinical investigation are FDA regulated.