How U.S. Law Defines Cosmetics

The Federal Food, Drug & Cosmetic Act defines cosmetics as “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.” Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpaste, and deodorants, as well as any material intended for use as a component of a cosmetic product.

Authorities of FDA on cosmetics


Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. Rather, FDA has consistently advised manufacturers to use whatever testing that is deemed necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that “the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information.” (Federal Register, March 3, 1975, page 8916).


Provision FDA Quality System Consulting Services:
  • Mock-up Audit (on-site or online)

  • Draft SOP

  • SOP Implementation

  • Training

  • Management

  • Representative Role Upon Audit

  • Personnel Qualification and Staffingl

  • Investigations

  • CAPA

  • Document Management

  • Electronic Quality Management Systems

  • Process Validation

  • Cleaning Validation

  • Equipment Qualification and Validation

©Copyright 2020 Provision Consulting Group, Inc. | All Rights Reserved.

Address: 100 N Barranca St. Suite 700, West Covina, CA 91791 | Phone: +1-909-493-3276 (office) | Email: