Policy on Dietary Supplements

Preface

FDA definition from Dietary Supplement Health and Education Act (1995): composed of essential nutrients, such as vitamins, minerals, and proteins, herbs or similar nutritional substances (such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these).

1) It is intended to supplement the diet and bears or contains one or more of the following ingredients: a vitamin; a mineral; an herb or other botanical (excluding tobacco); an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total daily intake (e.g., enzymes or tissues from organs or glands); a concentrate, such as energy bars; or a metabolite, constituent, or extract.

2) It is intended for ingestion in pill, capsule, tablet, food substance, or liquid form, or administered by another route (e.g., patch).

3) It is not represented for use as a conventional food or as the sole item of a meal or diet.

4) It is labeled as a “dietary supplement”.

FDA regulates dietary supplements as foods, and not as drugs.

Dietary Supplement Health and Education Act (www.cfsan.fda.gov/~dms/dietsupp.html)
National Institutes of Health Office of Dietary Supplements (dietary-supplements.info.nih.gov)

Disclaimer: The information provided by the investigator to research participants is for informational purposes and should not be construed as medical advice. Participants should consult with a qualified health care professional for advice about their specific health or medical needs before taking any dietary supplement.

Introduction

Review of dietary supplement research will be on a case-by-case basis, based upon valid reports in the existing, established and mainstream literature of risks encountered with the formulation and suggested dose of the supplement, the population proposed for the research, and the actual research procedures. For supplements and/or a subject population and/or a procedure deemed to be higher risk, the review will be more stringent and the committee may require consultation with or oversight or co-investigation by a health care professional. The committee reserves the right to prohibit research deemed too risky, either because of the supplement itself, or the population to be studied, or the actual procedures or any combination.

Policy

a) As well as the existing requirement for a brief (1 – 2 paragraphs), current, scholarly review of relevant literature that supports the purpose of the research study, the researcher must include a review of the clinical research detailing the presence/absence of the side effects associated with use of this supplement, particularly when administered to a population and in a dose and duration similar to those which the researcher is using. This should include both minor and major side effects, and frequency. Inclusion of brand-names may be relevant if some brands have been associated with side effects, but not others.

(b) The committee can request a validation of the literature by either the Office for the Protection of Human and Animal Subjects, if appropriate personnel are available, or by an outside consultant.

(c) All possible side effects should be stated in lay terms [e.g., hypotension (low blood pressure], and frequency of occurrence included, especially for serious side effects.

(d) A signed, adequate health history/screening questionnaire will be required to reduce the risk to subjects by screening out potential high risk subjects.

(e) Certain medications being taken by a potential participant may result in their exclusion from the study. These medications should be pre-determined by the researcher by a thorough review of the relevant clinical research literature and they should be specifically listed on the health history/screening questionnaire.

(f) The researcher should demonstrate an understanding and knowledge of the side effects and how serious they are.

(g) Subjects should be told to seek medical or emergency treatment for side effects, as appropriate, as well as notifying the researcher. Obviously, things such as severe headaches, fainting or extensive bleeding require immediate medical attention.

(h) Subjects should be advised that these supplements may interfere with other supplements or medications they are taking. Also, they should be advised to tell their physician that they are taking/have taken this supplement when they meet with him/her.

(i) The researcher must stay abreast of current literature and studies and notify the Committee for the Protection of Human Subjects (CPHS) immediately if any additional risks are identified for this supplement. The committee will then determine if the study needs to be altered or terminated, or if the consent documents need to be changed to reflect these additional risks.

2. Study design:

(a) Although the committee usually does not require changes to a researcher’s study design, it does have the prerogative to do so when the design contributes to the risk encountered by the subject. For dietary supplement research, the committee may request changes in the design to either (1) reduce the risk to the subject or (2) increase the benefit of the research to justify additional risk.

(b) To avoid any appearance that the researcher may be seen to be "dispensing" supplements, we have adopted a procedure similar to that used at the University of California, San Francisco. This procedure involves having the supplements and the placebos and their directions out on the table, and potential participants are told they may choose to take the supplements, if they wish.

(c) Disclaimers should be included on consent forms for (1) the fact that the supplement has not been approved by the FDA and (2) "this study is not affiliated with a medical center treatment or trial (and drug or supplement company, if appropriate.

(d) Any personnel associated with the study should not be identified as “Dr.” unless they are a medical doctor to avoid confusion on the part of a participant.

3. Participants:

Research with vulnerable or patient populations would require more stringent review by the committee than research on normal volunteers. The committee may require additional literature review that addresses this population. The committee may require consultation with or oversight or co-investigation by a medical health professional.

4. Health questionnaire/screen:

(a) The health history/screening questionnaire is paramount in reducing risk to the study subjects. Whenever possible, all subjects with any pre-existing condition or symptom that may put them at risk when taking this supplement should be excluded. If this is not possible (e.g., the need for a special category of subjects,), the committee may require a health care professional to oversee the medical history, provide clearance for the subject’s participation, etc. The cost of this oversight would be the responsibility of the researcher.

(b) If the risks associated with the supplement are minor or rare, then a signed, self questionnaire should be adequate. If the risks are of more concern, either because of the supplement or the population, we may require a health care professional to oversee the medical history or provide clearance for the subject’s participation. The cost of this oversight would be the responsibility of the researcher.

5. Supplement itself:

(a) Is the supplement routinely available to the public over-the-counter? Research where the supplement has been made available to the researcher specifically for this project may require more stringent review, if there is conflict of interest. If the production of this product is under the quality control of, e.g., a pharmaceutical company, this may lessen the stringency of review.

(b) Subjects should be told what the role of the dietary supplement supplier is in the research—uninvolved (in which case, the researchers would be providing the supplement themselves), providing the supplement as a courtesy/convenience to the researcher, or sponsoring the research.

(c) Details of the placebo also need to be included.

(d) While the CPHS recognizes that the supplement industry does not always conduct expensive controlled trials and may instead rely upon “testimonials”, research on supplements that have not undergone controlled clinical testing may not be able to be approved by the CPHS. Evidence documenting the effects of individual components of the supplement may not be acceptable unless clinical data about their interaction with the other components in the product is available.

Last Updated: December 2007