ABSTRACT

This chapter provides an overview of the federal legal systems that govern alternative medicine. It explains the legal difficulties and limitations confronting alternative medicine as it grows within a regulatory system designed around conventional care. Employing alternative medical therapies usually requires the purchase or sale of articles regulated by the United States Food and Drug Administration (FDA). When using FDA-regulated products in patient care, practitioners should fully understand how those products are regulated at the federal level. The consequences of "drug" regulation are significant. Prescription drugs can generally be marketed only with premarket approval through the FDA. The chapter describes the means by which practitioners can lawfully develop and use those regulated therapies in their practices and during patient care; the permissible scope of physician advertising. It also describes that the legal changes recommended to encourage medical innovation and growth in medical fields like alternative services and personalized medicine.