Overview

Curious about which ingredients are prohibited or restricted in cosmetics? Below, you’ll find detailed information on the regulations and safety standards set by the FDA regarding cosmetic ingredients.

Are Harmful Ingredients Allowed in Cosmetics?

No, it is illegal for a cosmetic to contain any ingredient that would make the product harmful when used as directed on the label, or in the expected manner. This applies even if there isn’t a specific regulation prohibiting the ingredient.

An exception exists for coal-tar hair dyes, which are treated differently under the law. The FDA cannot take action against a coal-tar hair dye for safety reasons as long as it includes a special warning statement and directions for a skin test. The required caution statement is:

*Caution – This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.*

Additionally, some cosmetics that are safe when used correctly can be unsafe if misused. Therefore, appropriate directions and warnings are required to ensure safe use. For example, ingredients safe in rinsed-off products may be harmful in leave-on products. Similarly, ingredients suitable for hair or nails might be unsafe for skin or eyes.

In the U.S., cosmetic products and ingredients, excluding color additives, do not need FDA approval before being marketed. However, cosmetic manufacturers are legally responsible for the safety and labeling of their products. The FDA can and does take action against non-compliant cosmetics.

Ingredients Prohibited or Restricted by FDA Regulations

Despite the general prohibition against harmful ingredients, the FDA has specific regulations that prohibit or restrict the following ingredients in cosmetics:

– Bithionol: Prohibited due to potential for causing photocontact sensitization (21 CFR 700.11).

– Chlorofluorocarbon Propellants: Prohibited in cosmetic aerosol products intended for domestic use (21 CFR 700.23).

– Chloroform: Prohibited because it causes cancer in animals and is harmful to human health, with exceptions for residual amounts (21 CFR 700.18).

– Halogenated Salicylanilides: Prohibited due to risk of serious skin disorders (21 CFR 700.15).

– Hexachlorophene: Restricted to a concentration not exceeding 0.1% and only when no other preservative is as effective, not to be used on mucous membranes (21 CFR 250.250).

– Mercury Compounds: Limited to eye area products at no more than 65 parts per million (0.0065%) unless trace amounts are unavoidable (21 CFR 700.13).

– Methylene Chloride: Prohibited due to carcinogenicity (21 CFR 700.19).

– Prohibited Cattle Materials: Restricted to prevent BSE, excluding certain derivatives like purified tallow (21 CFR 700.27).

– Sunscreens: Subject to drug regulations if labeled for sun protection, unless specified as protecting product color (21 CFR 700.35).

– Vinyl Chloride: Prohibited in aerosol products due to cancer risk (21 CFR 700.14).

– Zirconium-Containing Complexes: Prohibited in aerosols due to toxic effects on lungs and potential for skin granulomas (21 CFR 700.16).

Color Additives

Color additives in cosmetics require FDA approval for their intended use. Some must come from certified batches. For more information, see “Color Additives and Cosmetics.”

Drug Ingredients

Products intended for therapeutic purposes, such as treating or preventing disease, are classified as drugs and must comply with drug regulations, including premarket FDA approval. The FDA assesses these products on a case-by-case basis. For more details, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”

International Regulations

Different countries have varying regulations for cosmetics. In the U.S., the FDA does not mandate cosmetic manufacturers to submit safety data, and the burden of proof lies on the FDA to demonstrate that a product is harmful. The FDA may consider decisions from other countries but operates within its own legal framework.