008-U.S. FDA, Cosmetics

Listing and Registration of Cosmetics

  1. Definition of Cosmetics and Drugs of U.S. FDA

Cosmetics

Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].


Drugs

Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

  1. Category of Cosmetic

U.S. FDA has defined cosmetics into 13 categories. These 13 categories break down into 91 specified lists.

List of Cosmetics

  1. VCRP: Voluntary Cosmetic Registration
  • According to Federal Food, Drug, and Cosmetic Act (FD&C Act), section 201(i)6, it is not mandatory to register products that fall meet the definition of “cosmetic”
  • VCRP is not a notification, approval nor certification process of cosmetic products. Importers and distributors are not obliged register their facility nor products
  • Manufacturer and distributors hold all responsibility for safety, labeling, and compliance with regulatory requirements of the cosmetic product.
  • Device which meets the definition of both cosmetic and drug shall follow different regulatory compliance procedure.

  1. Cosmetic registration

Though it is not mandatory, manufacturers and re-packager of cosmetic can register.

  • Form FDA 2511


CPIS (Cosmetic Product Ingredient Statements)

  • Registration: Form FDA 2512
  • Manufacturer, packager, and distributor may submit
  • Upon completion, CPIS No. (Cosmetic Product Ingredient Statement Number) will be appointed and letter of acknowledge of receipt is issued.

  1. Functional Cosmetic? Drugs?

U.S. FDA does not identify such thing as “Functional Cosmetics”. They are simply classified as “Drugs” as they affect to functions and tissues of human body.


  1. Drugs Approval

Drugs shall be approved either by Premarket Approval or by OTC Drug: Over the Counter Drugs registration. Most “Functional Cosmetics” fall into this category.

  • Approval: Subject to NDA and/or Monograph NDA=Premarket approval, Monograph=OTC Drugs
  • GMP: Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211].
  • Labeling: 21 CFR 201.66

  1. Over the Counter Drugs
  • If final monograph exists, products manufactured and labelled as of the monograph can be distributed into U.S. market without pre-approval. However,
  • Facility and the products shall be registered to U.S. FDA’s database
  • Registration of OTC Drugs does not require clinical investigation.
  • The drug shall comply with applicable OTC Monograph.

  1. Monograph
  • There are over 80 OTC Drugs Monographs which defines over 800 active ingredients, doses, formulations, labeling, and testing.
  • Monographs are being updated for new ingredients, labeling etc.
  • Products which comply with applicable monograph may be distributed to U.S. market.
  • Drugs do not satisfy OTC Drug Monograph shall go through NDA procedure before distributed into U.S. market.