FDA often receives questions about the safety and regulation of hair dyes. Most of these products belong to a category called “coal-tar” hair dyes.
Color additives, with the exception of coal-tar hair dyes, need FDA approval before they’re permitted for use in cosmetics.
FDA’s ability to take action against coal-tar hair dyes associated with safety concerns is limited by law. It’s important to follow the directions on the label. It is also important to be an informed consumer and understand the risks.
The term “coal-tar colors” dates back to the time when these coloring materials were by-products of the coal industry. Today, most are made from petroleum, but the original name is still used. Coal-tar hair dyes--those coal-tar colors used for dyeing hair--include permanent, semi-permanent, and temporary hair dyes.
Coal-tar colors are also called “synthetic-organic” colors. That’s because, to a chemist, a “synthetic” compound is one formed from simpler compounds and an “organic” compound is one that contains carbon atoms
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a law passed by Congress, color additives must be approved by FDA for their intended use before they are used in FDA-regulated products, including cosmetics. Other cosmetic ingredients do not need FDA approval. FDA can take action against a cosmetic on the market if it is harmful to consumers when used in the customary or expected way and used according to labeled directions.
How the law treats coal-tar hair dyes:
But there are limits to this exception:
While many people use coal-tar hair dyes, FDA is aware of the following problems:
Eye injuries: Hair dyes have caused eye injuries, including blindness, when used in the eye area. Eyebrow and eyelash dyeing are not permitted uses of coal-tar hair dyes.
Allergic reactions: Some coal-tar hair dyes can cause allergic reactions or sensitization that may result in skin irritation and hair loss. People can develop sensitivities with repeated exposure. In addition, formulations may change over time. So, it’s possible to have a reaction even if you have dyed your hair in the past, without a problem. That’s why it’s important to follow the instructions and do the skin test before every use. Even if you don’t see a reaction to the skin test, it’s still possible to have a reaction when you dye your hair.
One hair dye ingredient, p-phenylenediamine, or “PPD,” has been implicated more prominently in leading to allergic reactions. Some people may become allergic to PPD from other exposures, including occupational exposures. This is called “cross-sensitization.” Here are some examples;
Temporary tattoo artists who use coal-tar hair dyes to color people’s skin are misusing these products and ingredients, because coal tar hair dyes are not intended to be used for staining the skin. While FDA regulates cosmetics products on the market, professional practice is generally subject to state and local authorities, not FDA. To learn more, see “Temporary Tattoos, Henna/Mehndi and ‘Black Henna.’”
If you have a reaction to a hair dye or tattoo, ask your healthcare provider about treatment. If you know what ingredient caused the problem, you may be able to find a product that doesn’t contain that ingredient. If you color your hair yourself, check the list of ingredients on the label for any you wish to avoid. If you have your hair colored at a salon, your stylist may be able to tell you the ingredients, or you may wish to check with the manufacturer.
FDA reminds you to get the facts before using hair dyes and hair relaxers.
Questions about hair dyes and cancer: In the 1980s, some coal-tar hair dyes were found to cause cancer in animals. FDA published a regulation requiring a special warning statement for all hair dye products containing these two ingredients:
The cosmetic industry has since reformulated coal-tar hair dye products, and we are no longer seeing these two ingredients in hair dyes.
FDA continues to monitor research on hair dye safety. We do not have reliable evidence showing a link between cancer and coal-tar hair dyes on the market today. We are collecting adverse event data which helps us assess the safety of this class of ingredients. If you experience an adverse event or bad reaction, please report that to the FDA (see below).
Color additives approved for use on hair include henna (from the Lawsonia plant) as well as lead acetate and bismuth citrate, both of which are used in “progressive” hair dyes that darken hair gradually with repeated applications. Of note, temporary tattoos marketed as “black henna” contain PPD and may increase your risk of allergy to hair dyes. Hair dyes are not meant to be used for staining your skin. (See above.)
People sometime ask whether unusual colors such as pink, orange, blue, and green are regulated differently from other hair dyes. How a hair dye is regulated depends on whether it is a coal-tar hair dye or is made from plant or mineral materials, not on the shade.
If you have a reaction to a hair dye—or any other cosmetic—first contact your health care provider for any necessary medical help.
Then, please tell FDA. The law doesn’t require cosmetic companies, including hair dye manufacturers, to share their safety data or consumer complaints with FDA. So, the information you report is very important to help FDA monitor the safety of cosmetics on the market.
You can report a problem with a cosmetic to FDA in either of these ways:
To learn more, see “Adverse Event Reporting: How to Report a Cosmetic-related Problem to FDA.”