Product’s Intended Use determines regulation as Drug, Cosmetic, or Both 

  • Drugs:  Diagnosis, cure, mitigation, treatment, or prevention of disease and affect structure/function of body
  • Cosmetics: Rubbed, poured, sprinkled, sprayed on, introduced into, applied to human body for cleansing, beautifying, promoting attractiveness, or altering the appearance
  • Drug + Cosmetic:  Example – antidandruff shampoo
  • FDA does not recognize the term “cosmeceutical”

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