Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Potential Contaminants in Cosmetics

Potential Contaminants in Cosmetics

                        1,4-Dioxane in Cosmetics: A Manufacturing Byproduct
          Bovine Spongiform Encephalopathy (BSE) and Cosmetics
          Lead in Cosmetics
          Microbiological Safety and Cosmetics Home
          Cosmetics
          Cosmetic Products & Ingredients
          Potential Contaminants in Cosmetics
          Lead in CosmeticsPotential Contaminants in Cosmetics Lead in Cosmetics
  
  	
    Share
    Post
    Linkedin

    Email
    PrintCause for Concern?

Questions sometimes arise about the presence of lead in cosmetics. Lead is an element that occurs naturally in the earth. Trace amounts of lead may occur in the foods we eat and the water we drink. FDA works hard to limit consumers’ exposure to lead in all FDA-regulated products, including cosmetics.

The following information provides some background on what the law says about the safety of cosmetics. It also describes some cosmetic products and ingredients that FDA has looked at closely with regard to lead content..

Cosmetic Safety and U.S. Law
	Color Additives
	Kohl, Kajal, Al-Kahal, Surma, Tiro, Tozali, or Kwalli
	Lipstick, Other Cosmetic Lip Products, and Externally Applied Cosmetics
	Progressive Hair DyesCosmetic Safety and U.S. Law

FDA regulates cosmetics under a law passed by Congress: the Federal Food, Drug, and Cosmetic Act. This law does not require cosmetic products or most ingredients to have FDA approval before they go on the market. The only exception is for the color additives used in cosmetics. But cosmetics must be safe when consumers use them following directions on the label, or in the customary or expected way.

If a cosmetic contains an ingredient or impurity that may make the product harmful to consumers when they use it according to the labeling or in the customary or expected way, that product is considered “adulterated” under the law. Misuse of color additives also makes a cosmetic adulterated. It’s against the law to market an adulterated cosmetic.

FDA can take action when we find out about a cosmetic with a safety problem. But first, we need to have reliable scientific information proving that the product is adulterated under the law.

Color Additives

The law treats color additives differently from other cosmetic ingredients. Except for coal-tar hair dyes, color additives need FDA approval before they may be used in cosmetics, foods, drugs, or many medical devices. Each color additive that FDA approves is listed in a regulation, called a “listing regulation.” That regulation describes the color additive, tells how it is permitted to be used, and provides limits on impurities. Typically, lead (when present as an impurity) for color additives used in cosmetics is limited to 10 to 20 parts per million (ppm).

To learn more about how FDA regulates color additives for use in cosmetics, see "Color Additives and Cosmetics." For a quick-reference list of the color additives that FDA has approved for use in cosmetics, as well as a link to the listing regulation for each one, see "Color Additives Permitted for Use in Cosmetics."

Kohl, Kajal, Al-Kahal, Surma, Tiro, Tozali, or Kwalli

These traditional eyeliners, popular in many parts of the world, are a serious health concern because they commonly contain large amounts of lead, as well as other heavy metals. Products containing kohl and similar ingredients have been linked to lead poisoning, especially among children, and are not allowed to be sold in the U.S. Nevertheless, these products sometimes make their way into specialty markets in this country.

FDA has an Import Alert advising import inspectors to be on the lookout for shipments of these products, and we’ve posted information to alert consumers to the dangers of using them.

To learn more, see "Kohl, Kajal, Surma, Tiro, Tozali, or Kwalli: By Any Name, Beware of Lead Poisoning."

Lipstick, Other Cosmetic Lip Products, and Externally Applied Cosmetics

Over the years, there have been reports alleging dangerous levels of lead in lipstick. FDA has analyzed hundreds of lipsticks and other cosmetic lip products, such as lip glosses, for lead. We found that levels of lead in these products were from below the detection limit to about 7 ppm. We published the method we developed for analyzing lipstick for lead.

FDA has also analyzed hundreds of externally applied cosmetics (cosmetics applied to the skin, such as eye shadows, blushes, shampoos, and body lotions) for lead and other impurities. The levels of lead we found were from below the detection limit to 14 ppm.

Our data show that over 99% of the cosmetic lip products and externally applied cosmetics on the U.S. market contain lead at levels below 10 ppm.

We have issued guidance to industry on limiting lead as an impurity in cosmetic lip products and externally applied cosmetics to a maximum of 10 ppm. This recommended maximum supports the public health goal to limit consumers’ exposure to lead in FDA-regulated products.

To learn more, see:

Limiting Lead in Lipstick and Other Cosmetics
	FDA's Testing of Cosmetics for Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content
	Guidance for Industry: Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum LevelProgressive Hair Dyes

Under the law, coal-tar hair dyes don’t need FDA approval, unlike color additives in general. But hair dyes from plant or mineral sources do.

In 1980, lead acetate was permanently listed as safe for use as a color additive in cosmetics intended for coloring hair on the scalp (“progressive” hair dyes). However, in 2017, FDA received a color additive petition requesting that the FDA repeal the lead acetate listing due to safety concerns. After reviewing the available data, the FDA concluded that these data no longer support the safe use of lead acetate as a color additive in hair dyes. This amendment was based on FDA’s determination that the available information no longer demonstrates a “reasonable certainty of no harm” – the safety standard for a color additive used in cosmetics – rather than on a determination that lead acetate in cosmetics intended for coloring the hair on the scalp has been shown to cause harm under the conditions of use set forth in 21 CFR 73.2396. On October 30, 2018, the FDA published a final rule to amend the color additive regulations to no longer provide for the use of lead acetate as a color additive. On April 1, 2019, the final rule was stayed because the agency received objections to its decision and a public hearing was requested within the allowable timeframe. The agency has reviewed the objections and has determined that they did not raise issues of material fact. As of January 6, 2022, lead acetate is no longer allowed as a color additive in “progressive” hair dyes. We intend to exercise enforcement discretion for 12 months following the effective date to provide industry with the opportunity to deplete their current stock and reformulate their hair dye products containing lead acetate.

To learn more, see "FDA to Repeal Color Additive Approval for the Use of Lead Acetate in Hair Dyes" and "Lead Acetate in Progressive Hair Dye Products".

                                                                                  Content current as of:
      02/25/2022
              
              
Regulated Product(s)
		 CosmeticsPotential Contaminants in Cosmetics

          
                        1,4-Dioxane in Cosmetics: A Manufacturing Byproduct
          Bovine Spongiform Encephalopathy (BSE) and Cosmetics
          Lead in Cosmetics
          Microbiological Safety and Cosmetics
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop