Integrative Medicine as an Adjunct to Orthopaedic Surgery

James R. Ficke, MD; Nathan M. Moroski, MD; Steven D. Ross, MD; Ranjan Gupta, MD

Disclosures

J Am Acad Orthop Surg. 2018;26(2):58-65. 

In This Article

Regulation and Marketing

In 1994, the Dietary Supplement Health and Education Act (DSHEA) classified dietary supplements as food.[12] This classification prevents the US FDA from regulating supplements strictly as drugs with respect to their efficacy, safety, or marketing claims. The passage of DSHEA also eliminated the requirement that the FDA review efficacy and safety data for these products, provided that no manufacturer claims were made by the product or manufacturers to diagnose, treat, cure, or prevent disease. The United Nations also supports what is referred to as the "highest attainable health," concluding that it is a state's responsibility to refrain from prohibiting or impeding traditional preventive care and healing practices unless on an exceptional basis.[12]

With regard to marketing regulations for supplements, a supplement's label may not claim to treat a specific disease or condition. However, marketing statements that suggest an effect on the "structure or function of the body" are allowed. For example, Echinacea products can be promoted as supporting immune health (as a function) but not as preventing or curing colds.[12]

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