Cause for Concern?
Questions sometimes arise about the presence of lead in cosmetics. Lead is a mineral that occurs naturally in the earth. There are traces of lead in the food we eat and the water we drink. Usually, these traces are much too small to cause lead to be detected in our bodies. But, if exposures are too high, lead can cause serious problems. How we are exposed to lead also makes a difference. That’s because our bodies handle different kinds of exposures in different ways.
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, Kahal, Al-Kahal, or Surma
- 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 ingredients to have FDA approval before they go on the market. The only exception is for the color additives used in cosmetics.
If a cosmetic contains an ingredient or contaminant that would 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 coloring materials used in coal-tar hair dyes, color additives need FDA approval for their intended use before they may be used in cosmetics, food, drugs, or many medical devices.
Each color additive that FDA approves is listed in a regulation, called a “listing regulation.” That regulation tells what the color additive is made of, how it is permitted to be used, and any limits on contaminants. Typically, these regulations set limits on lead at no more than 20 parts per million. When setting these limits, FDA considers factors such as how a color additive will be used and the likely exposure levels for consumers.
If a cosmetic contains a color additive that does not meet the requirements in its listing regulation, the cosmetic is adulterated under the law.
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.”
This traditional eyeliner, popular in many parts of the world, is a serious health concern because it commonly contains large amounts of lead, as well as other heavy metals. These products have been linked with lead poisoning, especially among children. 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, Kahal, or Surma: By Any Name, a Source of Lead Poisoning.”
Over the years, there have been rumors and reports alleging dangerous levels of lead in lipstick. Some have questioned why FDA has not set the same limits on lead in lipstick as for lead in candy. But licking small amounts of lipstick off our lips is much different from eating candy, which people—especially children—tend to eat in much larger amounts. And even if children play with makeup, it’s very unlikely that they will eat as much lipstick as they do sweet treats.
FDA analyzed hundreds of lipsticks on the market and found that levels of lead were too low to pose a health risk, especially considering the tiny amounts of lipstick that a consumer might ingest.
To learn more, see “Lipstick and Lead: Questions and Answers.” We also published the method we developed for analyzing lipstick for lead.
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. Lead acetate is a color additive that is approved for use in coloring hair. It is used in products that darken the hair gradually over time, with repeated applications. Unlike the limits on lead other color additives, lead is allowed at much higher levels in progressive hair dyes. But because of the dangers of lead exposure if these products are misused, lead acetate hair colorings must have a special warning on the label:
"Caution: Contains lead acetate. For external use only. Keep this product out of children's reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after use."
To learn more, see “Lead Acetate in Progressive Hair Dye Products.”