Who’s Responsible for the
Safety of Cosmetics? Keyport, NJ

FDA does not have the legal authority to approve cosmetic products and ingredients (other than color additives) before they go on the market. We also do not have a list of tests required for any particular cosmetic product or ingredient. However, a manufacturer or distributor of a cosmetic is legally responsible for ensuring that a marketed product is safe when consumers use it according to the directions in the labeling or in the customary or expected way. FDA can take action against the manufacturer of a cosmetic on the market if we have reliable information to show that a cosmetic does not meet the legal requirement for safety.

The law treats color additives differently. Unlike other cosmetic ingredients, color additives, other than coloring materials used in coal-tar hair dyes, must be approved by FDA for the specific intended use before they are permitted in any cosmetic.

Using Available Safety Data to Support the Safety of Your Cosmetic

Manufacturers can use safety data that is already available on individual ingredients and on products with similar formulations. Here are some examples:

• • Cosmetic ingredient suppliers often have safety data on their products.
• • Safety data may be published in scientific journals (sources include PubMed and TOXNET).

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