The Illinois Council of Health-System Pharmacists (ICHP) adopts the following American Society of Health-System Pharmacists' (ASHP) position statements: #0415 Use of Dietary Supplements, #0811 Regulation of Dietary Supplements, and #2039 Complementary, Alternative, and Integrative Medicine Products.
Background
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines a dietary supplement as “a dietary ingredient. The dietary ingredient can be a vitamin, mineral, herb, amino acid, a substance used to increase total dietary intake (e.g., an enzyme), concentrate, metabolite, constituent, or extract.” DSHEA regulates dietary supplements as a special category of conventional foods. Therefore, pre-market safety approval is not required, and most dietary supplements are subject only to post-marketing regulation.
The FDA and the Federal Trade Commission (FTC) regulate dietary supplement labeling, advertising, and marketing. The FDA assumes primary responsibility for food and supplement labeling, and the FTC regulates food and supplement advertising and marketing.
Key aspects of the three ASHP position statements cited above, which are supported by ICHP
The Illinois Council of Health-System Pharmacists (ICHP) supports FDA regulation of the dietary supplement product industry with adequate resources to do so effectively. ICHP also recommends an addition to DSHEA that would require manufacturers of dietary supplements to provide substantial proof of efficacy and safety prior to marketing approval; that manufacturing standards are met regarding identity, strength, quality, purity, packaging, and labeling; and that post-marketing reporting of adverse events, including drug interactions, be mandatory.
ICHP opposes direct-to-consumer advertising of dietary supplements unless DHSEA is amended, as described above, and unless evidence-based information regarding safety and efficacy is available that allows for informed-decision making by the patient.
ICHP encourages pharmacy practitioners to become adequately educated about dietary supplements. Such supplements should be included in documenting medication histories, during pre-surgery planning, and as part of comprehensive patient counseling. ICHP also supports the regular use of the FDA Safety Reporting Portal for routine monitoring and reporting of dietary supplements defects, adulteration, identified interactions, and adverse effects.
ICHP recommends that the criteria used to evaluate dietary supplements for inclusion in health system formularies should be as rigorous as those established for non-prescription drugs reviewed for formulary status. The increased risks of non-FDA regulated dietary supplements in hospitals and other health-system settings should be recognized by pharmacists and other healthcare providers.
ICHP urges pharmacists and other health care practitioners to integrate awareness of dietary supplement use into everyday practice and encourages pharmacists to increase efforts to prevent interactions between these supplements and prescription and non-prescription medications.
ICHP urges patients not to use dietary supplements for treatment or prevention of disease unless supervised by a prescriber or a pharmacist.
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Revised 9/2021