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                Cosmetics Laws & Regulations

Cosmetics Laws & Regulations

                        Key Legal Concepts for Cosmetics Industry: Interstate Commerce, Adulterated, and Misbranded
          Regulations Related to Cosmetics from Title 21 of the Code of Federal Regulations (21 CFR)
          Prohibited & Restricted Ingredients in Cosmetics
          Cosmetics & U.S. Law


                        Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Home
          Cosmetics
          Cosmetics Guidance & Regulation
          Cosmetics Laws & Regulations
          Prohibited & Restricted Ingredients in CosmeticsCosmetics Laws & Regulations Prohibited & Restricted Ingredients in Cosmetics
  
  	
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    PrintWhat ingredients are prohibited or restricted from use in cosmetics? You can find the information on what the law and FDA regulations say about cosmetic ingredients and safety below.

Are harmful ingredients allowed in cosmetics?
	What ingredients are prohibited or restricted by regulation?
	What about color additives?
	What about drug ingredients?
	Why are different ingredients prohibited in some other countries?
	More Resources**Are harmful ingredients allowed in cosmetics?**

It’s against the law for a cosmetic to contain any ingredient that makes the product harmful when consumers use it according to directions on the label, or in the customary or expected way. This is true whether or not there is a regulation that specifically prohibits or restricts the use of the ingredient in cosmetics.

The one exception is for coal-tar hair dyes, which the law treats differently. Under the law, FDA cannot take action against a coal-tar hair dye for safety reasons as long as it has a special warning statement on the label and directions for a skin test. The caution statement reads as follows:

*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 may cause blindness.*

It’s also important to understand that some cosmetics that are safe when people use them correctly may be unsafe when used the wrong way. Cosmetics must have any directions for use or warning statements needed to make sure people use the products safely. For example, some ingredients may be safe in products such as cleansers that we wash off the skin immediately, but not in products that we leave on the skin for hours. Similarly, ingredients that are safe for use on the hair or nails may be unsafe when used on the skin or near the eyes.

Under U.S. law, cosmetic products and ingredients, other than color additives, do not need FDA approval before they go on the market**.**Cosmetic manufacturers have a legal responsibility for the safety and labeling of their products.  FDA can and does take action against cosmetics on the market that do not comply with the law.

**What ingredients are prohibited or restricted by FDA regulations?**

Although it’s against the law to use any ingredient that makes a cosmetic harmful when used as intended, FDA has regulations that specifically prohibit or restrict the use of the following ingredients in cosmetics:

**Bithionol.** The use of bithionol is prohibited because it may cause photocontact sensitization (21 CFR 700.11).
	**Chlorofluorocarbon propellants.** The use of chlorofluorocarbon propellants in cosmetic aerosol products intended for domestic consumption is prohibited (21 CFR 700.23).
	**Chloroform.** The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to be harmful to human health, too. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18).
	**Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide).** These are prohibited in cosmetic products because they may cause serious skin disorders (21 CFR 700.15).
	**Hexachlorophene.** Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when no other preservative has been shown to be as effective. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips (21 CFR 250.250).
	**Mercury compounds.** Mercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body. They may cause allergic reactions, skin irritation, or neurotoxic problems. The use of mercury compounds in cosmetics is limited to eye area products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available. All other cosmetics containing mercury are adulterated and subject to regulatory action unless it occurs in a trace amount of less than 1 part per million (0.0001 percent) calculated as the metal and its presence is unavoidable under conditions of good manufacturing practice (21 CFR 700.13).
	**Methylene chloride.** It causes cancer in animals and is likely to be harmful to human health, too (21 CFR 700.19).
	**Prohibited cattle materials.** To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials. These materials include specified risk materials*****, material from nonambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and hides and hide-derived products, and milk and milk products****** (21 CFR 700.27).
	**Sunscreens in cosmetics.**Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products.
	**Vinyl chloride.** The use of vinyl chloride is prohibited as an ingredient of aerosol products, because it causes cancer and other health problems (21 CFR 700.14).
	**Zirconium-containing complexes.** The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin (21 CFR 700.16).**What about color additives?**

Color additives are permitted in cosmetics only if FDA has approved them for the intended use. In addition, some may be used only if they are from batches that FDA has tested and certified. To learn more, see “Color Additives and Cosmetics.”**What about drug ingredients?**

If a product is intended for a therapeutic purpose, such as treating or preventing disease, it’s a drug under the law and must meet those requirements, such as premarket approval by FDA, even if it affects the appearance. The presence of certain ingredients with a therapeutic use that is well-known to the public and industry is one factor that can determine whether a product is intended for use as a drug. FDA makes these decisions on a case-by-case basis. To learn more, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”

**Why are different ingredients prohibited in some other countries?**

Different countries and regions regulate cosmetics under different legal frameworks.

Under U.S. law, FDA does not have the authority to require cosmetic manufacturers to submit their safety data to FDA, and the burden is on FDA to prove that a particular product or ingredient is harmful when used as intended. We make these decisions based on reliable scientific information available to us. FDA can take other countries’ decisions into consideration, but we can only take action within the legal and regulatory framework for cosmetics in the United States.

**More Resources**

Color Additives and Cosmetics
	FDA Authority Over Cosmetics
	Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
	Key Legal Concepts: Interstate Commerce, Adulteration, and Misbranding
	Regulations Related to Cosmetics
	Science & Research***** "Specified risk material" means the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older and the tonsils and distal ileum of the small intestine of all cattle.

****** Tallow must be produced from tissues that are not prohibited cattle materials or must contain not more than 0.15 percent insoluble impurities as determined by the method entitled "Insoluble Impurities" (AOCS Official Method Ca 3a-46), American Oil Chemists' Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from AOCS, 2211 W. Bradley Ave. Champaign, IL 61821

                                                                                  Content current as of:
      02/25/2022
              
              
Regulated Product(s)
		 CosmeticsCosmetics Laws & Regulations

          
                        Key Legal Concepts for Cosmetics Industry: Interstate Commerce, Adulterated, and Misbranded
          Regulations Related to Cosmetics from Title 21 of the Code of Federal Regulations (21 CFR)
          Prohibited & Restricted Ingredients in Cosmetics
          Cosmetics & U.S. Law


                        Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
 
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