Research using Dietary Supplements

IRB Standard Operating Procedure

Definition

The term “dietary supplement” is defined as a product that contains a “dietary ingredient” and is intended to supplement the diet. [FD&A Act, section 201(ff)] The “dietary ingredients” in these products may include: (1) vitamins, (2) minerals, (3) herbs or other botanicals, (4) amino acids, (5) dietary substances to supplement the diet by increasing the total dietary intake, and (6) concentrates, metabolites, constituents, extracts, or combinations of the substances identified in (1)-(5).  Dietary supplements may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.  

Dietary Supplement Regulation

The Food and Drug Administration (FDA) regulates dietary supplements under a different set of rules than those covering prescription and over-the counter drug products. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling dietary supplements.

Investigator's Responsibilities

In preparing the IRB application, the investigator is responsible for providing comprehensive information concerning the supplement:

  • Ensuring that extensive research has been completed to ascertain whether the study falls under FDA regulation.*
    • If required, submitting an NDA application to the FDA and including the final letter in the IRB application.
    • In cases where there is a question about whether an IND is applicable, providing evidence that the supplement sponsor or the PI has consulted with the FDA for advice about need for an IND.
  • Providing available evidence of use of the substance in humans and/or animals in previous research studies.
  • In the case of "medicinal" herbs, providing evidence regarding methods of cultivation and processing (purity, consistency, potency, etc.).
  • Stating all known contraindications, risks, and side effects, including frequency of occurrence, especially for serious side effects.
  • Stating any possible interactions with drugs, medications, and other supplements.
  • Providing all information about potential conflicts of interest, including the source of the supplements to be used and funding for the research.
  • Performing a health history/screening of potential participants to reduce risks, identify special precautions and warnings, and exclude those at high-risk and vulnerable populations.

*Research involving dietary supplements may require that an Investigational New Drug (IND) application be submitted to the FDA.  Whether or not an IND is required is determined by the intent of the investigation.

  • If the investigation is intended only to evaluate the dietary supplement’s effect on the structure or function of the body, an IND is not required.
  • If the investigation is intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease, an IND is required.

For example, a clinical investigation designed to study the relationship between a dietary supplement’s effect on normal structure or function in humans (e.g., guarana and maximal oxygen uptake) or to characterize the mechanism by which a dietary supplement acts to maintain such structure or function (e.g., fiber and bowel regularity) would not need to be conducted under an IND. However, a clinical investigation designed to evaluate a dietary supplement’s ability to prevent osteoporosis or to treat chronic diarrhea or constipation would need to be conducted under an IND.

Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND, 2013, p 12.

In cases where there is a question about whether an IND is required, the PI must contact the FDA and submit evidence of the determination to the IRB.

IRB Review

The IRB may seek consultation with a pharmacist, pharmacologist or other health professional to obtain needed expertise concerning the use of dietary supplements.

IRB Approved:  October 13, 2017