Cosmetics

Cosmetic Ingredient Suppliers: Fact Sheet

Raw material suppliers who provide bulk ingredients to cosmetic product manufacturers often ask how FDA’s regulations apply to them. The legal definition of “cosmetic” includes finished products and their components. While the basic requirements for safety and labeling are generally the same, there are some differences. Here are links to resources that respond to common questions:

  • Color Additives and Cosmetics: Color additives must be approved by FDA for the intended use. Misuse makes cosmetics adulterated, misbranded, or both. Read an overview of the color additive requirements that apply to cosmetics, and find links to more resources.
  • “Cosmeceutical”: This is a marketing term with no legal definition. It will not help you avoid requirements that apply to drugs, including drug ingredients.
  • Exporting Cosmetics:  FDA does not issue export certificates for cosmetics manufactured outside the United States, or for raw or bulk materials. Read answers to common questions on exporting cosmetics and obtaining cosmetic export certificates.
  • FDA Authority Over Cosmetics: Read an overview of the legal requirements enforced by FDA that apply to cosmetics.
  • Good Manufacturing Practice/Inspection Checklist and Good Manufacturing Practice Draft Guidance: Careful manufacturing of raw materials and proper equipment maintenance are just a few of the steps that help keep cosmetics safe. Learn more here.
  • Import Surveillance: Find resources on FDA’s surveillance and enforcement activities related to imported cosmetic products and ingredients.
  • Incidental Ingredients: Find out how the cosmetic regulations define an incidental ingredient (also known as a “nonfunctional constituents”) and what that means for cosmetic ingredient labeling. For related information, see “Products & Ingredients,” below.
  • Information for Cosmetics Importers: Learn about importing cosmetics, including bulk raw materials. Cosmetic companies importing products and raw materials considered to be solely cosmetics in the United States are not required to register with FDA.
  • Ingredient Names: Cosmetic products marketed on a retail basis to consumers must bear a list of ingredients, using their common or usual names. Trade names are not acceptable. Learn how your customers need to identify ingredients on cosmetic labels.
  • Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?): Not all “personal care products” are cosmetics. Are your raw materials intended for use as cosmetic or drug ingredients? Read an overview of the differences in intended use and requirements that apply to each category.
  • Label Claims: Find information on claims that are sometimes made for cosmetic products and ingredients, such as “aromatherapy” and “organic.”
  • Nanotechnology: Find links to information and resources from FDA and elsewhere. In particular, see FDA’s Guidance for Industry: Safety of Nanomaterials in Cosmetics Products.
  • Products & Ingredients: Find information on selected cosmetic products and ingredients, as well as potential contaminants.
  • Registration (Voluntary Cosmetic Registration Program, or VCRP): FDA’s VCRP is only for manufacturers, packers, and distributors of finished cosmetic products, not raw material suppliers. Read an overview of the VCRP and related resources.
  • Science & Research FDA scientists conduct cosmetic safety research and stay abreast of research by scientists elsewhere
  • "Trade Secret” Ingredients: FDA rarely grants “trade secret” status for cosmetic ingredients. Learn more here.

 

Page Last Updated: 03/08/2018
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