The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as products (other that tobacco) intended to supplement the diet and meet at least one of the following criteria:
- Contains one or more of the following: vitamin; mineral; herb or other botanical; amino acid; dietary substance to supplement the diet by increasing the total dietary intake; concentrate, metabolite, constituent, extract; or combination of any of the previously described ingredients
- Intended for ingestion in a tablet, capsule, powder, softgel, gelcap, or liquid form
- Labeled as a dietary supplement
- Cannot be represented for use as a conventional food or as a sole item of a meal or diet
- Cannot include an article that is approved as a drug or biologic
All dietetics professional should consider the following guidelines when making the decision to recommend or sell dietary supplements. The guidelines are intended to address the scientific, legal, ethical and business aspects of recommending or selling dietary supplements:
- All patients/clients should receive a complete assessment of diet and dietary supplement use as a routine component of their nutritional status assessment. Assessment should include:
- List of supplements
- Brand/chemical form Rationale for use (patient/client perspective)
- Evaluation of diet and supplement adequacy
- Recommendations for dietary supplements should be based on a thorough review of the currently available scientific evidence with consideration for:
- Level of currently available scientific evidence (see Appendix "A").
- Demographic characteristics (age, gender, ethnicity, economic status, etc.)
- Disease states
- Clinical parameters (blood pressure, weight, biochemistries, etc)
- Medications (prescription and over-the-counter)
- Risk and/or benefits
- Dietary supplementation should be complementary to diet (ie, efforts to improve diet to meet nutrient needs should be made prior to, or in conjunction with, dietary supplementation).
- All recommendations should be made in the patient/client's best interest and should be safe to use, including reasonable assurance of freedom from product toxicity as well as not causing harm with respect to ongoing disease states.
- The dietetics professional is responsible for reporting any adverse reactions by utilizing available Food and Drug Administration (FDA) documentation procedures:
- Adverse reactions can be reported to the FDA (link below)
- Referring health care professionals should be notified of any adverse reactions.
- All recommendations for dietary supplementation should be documented in the patient/client's medical record. Documentation should include:
- Listing of current supplements
- Dosage/frequency of use
- Rationale for recommendation
- Plan for outcomes monitoring
- Purchases/dispensed volume for each supplement
- Adverse reactions
- The dietetics professional assumes responsibility and accountability for personal competence in practice (based on Principle #2 of the Code of Ethics) and therefore, should participate in continuing professional education in this area.
- The dietetics professional may make dietary supplements available to patients/clients with respect to the unique nutrition needs of the individual (based on Principle #8 of the Code of Ethics). The dietetics professional needs to:
- Avoid bias to ensure patient/client's choice in selection and use of dietary supplement.
- Provide appropriate educational materials to patients/ clients about dietary supplements (see Appendix "A").
- The dietetics professional provides disclosure of any financial relationship regarding the sale of dietary supplements to patients/clients (based on Principle #12 of the Code of Ethics). The dietetics professional must disclose any financial arrangements with specific manufacturer(s) or supplier(s) to sell dietary supplements.
- Disclosure should be accomplished through face-to-face communication or by posting a written notification that is easy to comprehend in a prominent location that is accessible by all patients/clients.
- Dietetics professionals should inform patients on the availability of products being recommended as well as equivalent products on the market.
- The dietetics professional provides factual information regarding the availability of dietary supplements for purchase and does not advertise in a false or misleading manner (based on Principles 13 and 14 of the Code of Ethics).
- The dietetics professional maintains current knowledge regarding the regulation of dietary supplements such as (see Appendix: "A"and "B"):
- Labeling issues (Food and Drug Administration)
- Health claims,structure/function claims,disease claims (Federal Trade Commission, see Dietary Supplements: An Advertising Guide for Industry, linked below)
- Standards for identity, strength, quality and purity (ie, US Pharmacopoeia, NSF International)
- Definition of Dietary Supplements (Food and Drug Administration)
- The dietetics professional understands the potential legal issues and complies with legal restrictions related to selling dietary supplements to patients/clients. Knowledge of the following issues is critical:
- Authorized scope of practice in the business locale
- Institutional policies (hospital, clinic, etc.)
- Federal/state/local laws and regulations, including zoning and any ordinance issues, business licenses, scope of practice of other health care professionals, inconsistencies between states, etc.
- Dietetics professionals choosing to sell dietary supplements need to investigate all aspects of business practice. Any sales should be based on sound business practices. The following should be considered (see appendix for further information):
- Pricing and profit issues
- Liability concerns, including product liability
- Retail policies (products returned by customers, method of payment, etc.)
- Follow-up sessions related to use of products
The guidelines are currently under evaluation and will remain in effect until new guidelines are published. These guidelines are meant to provide direction and recommendations for best practice. They are not enforceable except in regards to the Academy/CDR Code of Ethics.
David M. Eisenberg, MD, Presenter of the President’s Lecture “Alternative and Complementary Medicine, an International Focus,” October 21, 2001, St. Louis, MO (FNCE); Director, Division for Research and Education in Complementary and Integrative Medical Therapies, Harvard Osher Institute Harvard Medical School, Boston, MA