IRB: Dietary Supplements

Dietary Supplements

Overview

According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, 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, organ tissues, glandulars, and metabolites. Some examples are ginseng, garlic, fish oils, psyllium, enzymes or combinations of these. Dietary supplements can be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also appear 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. Whatever their form, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

Regulations Involving Dietary Supplements

While the Food and Drug Administration (FDA) regulates dietary supplements, it does so 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. Many studies involving the ingestion of dietary supplements may not be subject to FDA oversight. In contrast, if a researcher proposes to study a dietary supplement with the intent of diagnosis, cure, mitigation, treatment or prevention of disease in humans, the supplement would be need to be treated as a drug and would be subject to FDA oversight. In such a case, the manufacturer or researcher would need to submit an Investigational New Drug (IND) application to the FDA.

Studies involving the ingestion of dietary supplements that are not subject to FDA oversight are still covered by Office of Human Research Protections (OHRP) regulations, and therefore must be reviewed by the Institutional Review Board (IRB).

Researcher's Responsibilities

• The researcher needs to ensure that s/he has done extensive research to ascertain whether the study substance is subject to FDA regulations. If it is, FDA regulations need to be followed. http://www.fda.gov/
• The researcher must provide available evidence of use of that substance in humans and/or animals in previous research studies.
• In the case of "medicinal" herbs, the researcher is responsible for providing evidence regarding methods of cultivation and processing (purity, consistency, potency, etc.).
• Participants must undergo a health history/screening to reduce risks and screen out potential high-risk participants.
• All possible side effects must be stated, including frequency of occurence, especially for serious side effects.
• The IRB may seek consultation with a pharmacist or pharmacologist to obtain needed expertise about potential drug and herb interactions.