Cause 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 Dyes
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.
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."
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 Level
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.