Definition / Cosmetics that are also Drugs / Regulations

• Definition
  
  The FD&C Act defines cosmetics as "articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions."
  Examples include products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants.
  
  
• Cosmetics that are also Drugs
  
  Products that are cosmetics but are also intended to treat or prevent disease, or otherwise affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law.
  
  Examples that are both drugs and cosmetics are anticaries toothpastes (e.g., "fluoride" toothpastes), hormone creams, sun-tanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos. Most currently marketed cosmetics, which are also drugs, are over-the-counter drugs.
  
  
• Regulations
  
  Cosmetic products must comply with labeling regulations (all labels and other written or graphic matter) and ingredient declaration. All color additives must be approved by the FDA; many cannot be used unless certified in the FDA's own laboratories. If the product is both a drug and a cosmetic, it must comply with the requirements for drugs.
  
  Among the most common reasons for import refusals of cosmetics are labeling violations, the illegal use of color additives, and the presence of poisonous or deleterious substances, such as pathogenic microorganisms.
  
  In addition, two of the FDA's Import Alerts for drugs address cosmetic-type products marketed with therapeutic claims that cause them to be considered unapproved new drugs under the law: one for certain skin care products labeled as anti-aging creams and another for various unapproved new drugs promoted in the U.S.
  
  The FDA also has an Import Alert for decorative contact lenses. Contrary to the common view, getting a drug approval for cosmetic-type drug products involves a relatively short process time and lower cost, compared to that of a new molecular formula.