The U.Due south. Nutrient and Drug Assistants (FDA) has amended the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp. This subpoena was based on FDA'southward determination that the bachelor data no longer demonstrates a "reasonable certainty of no harm" – the rubber standard for a colour 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 damage under the weather condition of apply set up along in 21 CFR 73.2396.

On October 30, 2018, the FDA published a final rule to amend the color condiment regulations to no longer provide for the apply of lead acetate in cosmetics intended for coloring hair on the scalp. On April 1, 2019, the concluding rule was stayed because the agency received objections to its conclusion and a public hearing was requested within the commanded timeframe. The agency has reviewed the objections and has determined that they did not enhance issues of material fact that justify a hearing. Therefore, on January 6, 2022, the final rule was fabricated constructive. We intend to practise enforcement discretion for 12 months following the effective engagement to provide industry with the opportunity to deplete their current stock and reformulate their hair dye products containing atomic number 82 acetate.

For more data, please run across the Constituent Update.

The FDA often receives questions about the safe and regulation of hair dyes. Most of these products belong to a category chosen "coal-tar" hair dyes.

Color additives, with the exception of coal-tar hair dyes, need FDA approval before they're permitted for utilize in cosmetics.

The FDA'south ability to take action against coal-tar hair dyes associated with rubber concerns is limited by law. Information technology's of import to follow the directions on the characterization. Information technology is likewise important to be an informed consumer and sympathise the risks.

Learn more here:

  • What are Coal-tar Hair Dyes?
  • What the Law Says About Coal-tar Hair Dyes
  • Safety Bug
    • Hair dyes and eye rubber
    • Hair dyes and allergic reactions
    • Using hair dyes and hair straighteners together
    • Questions about hair dyes and cancer
  • Other Types of Hair-coloring Products
  • Unusual Colors
  • Hair Dye Condom Checklist
  • How to Report a Problem

What Are Coal-tar Hair Dyes?

The term "coal-tar colors" dates back to the time when these coloring materials were by-products of the coal manufacture. Today, almost are fabricated from petroleum, merely the original proper 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 as well called "synthetic-organic" colors. That's because, to a pharmacist, a "synthetic" chemical compound is one formed from simpler compounds and an "organic" chemical compound is 1 that contains carbon atoms.

What the Law Says Near Coal-tar Hair Dyes

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a law passed past Congress, color additives must be canonical 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 accept action confronting a corrective on the market if information technology contains a poisonous or deleterious ingredient that may make the cosmetic 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:

  • FDA cannot take action against a coal-tar hair dye on the basis that information technology is or contains a poisonous or deleterious ingredient that may make it harmful to consumers, as long equally the label includes a special caution statement and the product comes with acceptable directions for consumers to do a skin exam before they dye their hair. This is the circumspection statement:
    Caution - This product contains ingredients which may crusade skin irritation on certain individuals and a preliminary test according to accompanying directions should first exist fabricated. This production must not exist used for dyeing the eyelashes or eyebrows; to do and so may cause blindness. (FD&C Deed, 601(a))
  • Coal-tar hair dyes, dissimilar colour additives in general, do not need FDA approval. (FD&C Human action, 601(eastward)).

But there are limits to this exception:

  • FDA may have activity confronting a coal-tar hair dye product if—
    • it does not have the caution statement on its label or come up with adequate directions for a skin test, or
    • an ingredient other than the coal-tar hair dye itself is harmful., or
    • information technology is otherwise adulterated or misbranded.
  •  "Coal-tar hair dyes" are not eyebrow or eyelash dyes. Color additives intended for dyeing the eyebrows or eyelashes demand FDA blessing for that employ. No color additives are approved for dyeing the eyebrows or eyelashes.

Safety Issues

While many people apply coal-tar hair dyes, FDA is aware of the following problems:

Eye injuries: Hair dyes have caused heart injuries, including blindness, when used in the eye area. Countenance and eyelash dyeing are not permitted uses of coal-tar pilus dyes. To learn more than, see "What does the law say about coal-tar pilus dyes?"

Allergic reactions: Some coal-tar hair dyes tin can cause allergic reactions or sensitization that may result in peel irritation and hair loss. People tin develop sensitivities with repeated exposure. In addition, formulations may change over time. And so, it's possible to have a reaction fifty-fifty if you have dyed your hair in the by, without a problem. That's why it'south important to follow the instructions and practice the pare test before every apply. Even if y'all don't see a reaction to the peel exam, it'due south still possible to have a reaction when you lot dye your pilus.

I 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;

  • Some temporary tattoo inks, sometimes marketed as "black henna"
  • Certain textile dyes, ballpoint pen inks, some color additives used in foods and drugs, and other dyes used in semi-permanent and temporary hair dyes
  • Condom and other latex products
  • Benzocaine and procaine, local anesthetics used by doctors and dentists
  • Para-aminosalicylic acid, a drug used to treat tuberculosis
  • Sulfonamides, sulfones, and sulfa drugs
  • Para-aminobenzoic acrid (PABA), a naturally occurring compound used in some sunscreens and in some cosmetics.

Temporary tattoo artists who employ coal-tar pilus dyes to color people'south 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 practise is mostly field of study to state and local authorities, not FDA. To acquire more, run across "Temporary Tattoos, Henna/Mehndi and 'Black Henna.'"

If you have a reaction to a pilus dye or tattoo, ask your healthcare provider almost 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 y'all have your hair colored at a salon, your stylist may be able to tell y'all the ingredients, or you may wish to check with the manufacturer.

Questions about pilus 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 argument for all hair dye products containing these ii ingredients:

  • 4-methoxy-chiliad-phenylenediamine two,four-diaminoanisole
  • 2, 4-methoxy-m-phenylenediamine sulfate 2,4-diaminoanisole sulfate

The cosmetic industry has since reformulated coal-tar hair dye products, and we are no longer seeing these ii ingredients in hair dyes.

FDA continues to monitor research on hair dye safety. We do not have reliable testify showing a link betwixt cancer and coal-tar hair dyes on the market today. Nosotros are collecting adverse consequence information which helps u.s.a. assess the safety of this class of ingredients. If you feel an adverse event or bad reaction, delight report that to the FDA (meet below).

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Other Types of Hair-coloring Products

Pilus coloring materials made from institute or mineral sources are regulated the same as other color additives. They must be canonical by FDA and listed in the colour additive regulations.

Colour additives canonical for use on pilus include henna (from the Lawsonia plant) and bismuth citrate, which are used in hair dyes that may darken hair gradually with repeated applications. On Oct xxx, 2018, FDA repealed the regulation which provides for the use of lead acetate in hair dyes because there is no longer a reasonable certainty of no harm from the use of this color additive. Of note, temporary tattoos marketed every bit "black henna" contain PPD and may increase your risk of allergy to pilus dyes. Hair dyes are not meant to be used for staining your pare. (Meet above.)

Unusual Colors

People sometime inquire whether unusual colors such equally pinkish, orange, bluish, and greenish 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 found or mineral materials, not on the shade.

Coal-Tar Hair Dye Safety Checklist:

  • Follow all directions on the label and in the bundle.
  • Do a patch test on your skin every fourth dimension before dyeing your hair.
  • Continue hair dyes away from your eyes, and practise not dye your eyebrows or eyelashes. This tin hurt your eyes and may even cause blindness.
  • Wear gloves when applying hair dye.
  • Exercise not leave the product on longer than the directions say y'all should. Keep track of fourth dimension using a clock or a timer.
  • Rinse your scalp well with water subsequently using pilus dye.
  • Keep hair dyes out of the reach of children.
  • Exercise non scratch or brush your scalp iii days earlier using hair dyes.
  • Do non dye or relax your pilus if your scalp is irritated, sunburned, or damaged.
  • Wait at least 14 days after bleaching, relaxing, or perming your pilus before using dye.
  • Read the ingredient statement to make certain that ingredients that may have caused a problem for you in the past, such equally p-phenylenediamine (PPD) are not present.
  • If you lot have a problem, tell your healthcare provider. And then, please report information technology to FDA.

How to Report a Problem

If y'all have a reaction to a pilus dye—or any other cosmetic—first contact your health care provider for whatsoever necessary medical help.

And so, delight tell FDA. The law doesn't require cosmetic companies, including hair dye manufacturers, to share their safety information or consumer complaints with FDA. Then, the data you report is very important to assist FDA monitor the safety of cosmetics on the market place.

You lot tin can report a problem with a cosmetic to FDA in either of these ways:

  1. Contact MedWatch, FDA'south trouble-reporting program, at 1-800-332-1088 , or file a MedWatch Voluntary written report online
  2. Contact the consumer complaint coordinator in your area.

To larn more, see "Adverse Event Reporting: How to Report a Corrective-related Problem to FDA."

Related Resources

  • Color Additives and Cosmetics
  • Temporary Tattoos, Henna/Mehndi, and "Black Henna"
  • Atomic number 82 Acetate in "Progressive" Hair Dye Products
  • FDA to Repeal Color Additive Approval for the Employ of Lead Acetate in Hair Dyes