The U.S. Food and Drug Administration (FDA) has amended the color condiment regulations to no longer provide for the use of atomic number 82 acetate in cosmetics intended for coloring pilus on the scalp. This amendment was based on FDA'southward determination that the available information no longer demonstrates a "reasonable certainty of no harm" – the safety standard for a color condiment used in cosmetics – rather than on a determination that atomic number 82 acetate in cosmetics intended for coloring the hair on the scalp has been shown to cause harm under the conditions of use set along 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 apply of atomic number 82 acetate in cosmetics intended for coloring pilus on the scalp. On April ane, 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 bureau has reviewed the objections and has adamant that they did not raise issues of cloth fact that justify a hearing. Therefore, on January 6, 2022, the final rule was made effective. We intend to exercise 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 lead acetate.

For more information, please see the Constituent Update.

The FDA frequently receives questions well-nigh the safety and regulation of hair dyes. Most of these products belong to a category called "coal-tar" hair dyes.

Colour additives, with the exception of coal-tar hair dyes, demand FDA approval before they're permitted for use in cosmetics.

The FDA's ability to take action against coal-tar hair dyes associated with safety concerns is limited by police force. It's of import to follow the directions on the label. It is also important to be an informed consumer and understand the risks.

Acquire more here:

  • What are Coal-tar Hair Dyes?
  • What the Police force Says Most Coal-tar Pilus Dyes
  • Condom Bug
    • Hair dyes and eye safety
    • Hair dyes and allergic reactions
    • Using pilus dyes and pilus straighteners together
    • Questions about pilus dyes and cancer
  • Other Types of Hair-coloring Products
  • Unusual Colors
  • Hair Dye Safe Checklist
  • How to Written report a Problem

What Are Coal-tar Pilus Dyes?

The term "coal-tar colors" dates back to the fourth dimension when these coloring materials were by-products of the coal industry. Today, most are made from petroleum, just the original name is still used. Coal-tar hair dyes--those coal-tar colors used for dyeing pilus--include permanent, semi-permanent, and temporary hair dyes.

Coal-tar colors are also called "synthetic-organic" colors. That's considering, to a chemist, a "synthetic" compound is one formed from simpler compounds and an "organic" compound is one that contains carbon atoms.

What the Law Says About Coal-tar Hair Dyes

Under the Federal Food, Drug, and Cosmetic Act (FD&C Deed), a police force passed by 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 take action against a cosmetic on the market place 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 confronting a coal-tar pilus dye on the footing that it is or contains a poisonous or deleterious ingredient that may make information technology harmful to consumers, every bit long as the label includes a special caution statement and the product comes with adequate directions for consumers to do a skin test before they dye their hair. This is the caution statement:
    Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary exam co-ordinate to accompanying directions should beginning be made. This product must not exist used for dyeing the eyelashes or eyebrows; to do so may crusade blindness. (FD&C Act, 601(a))
  • Coal-tar hair dyes, different color additives in general, do not need FDA approving. (FD&C Human action, 601(e)).

But there are limits to this exception:

  • FDA may have action against a coal-tar hair dye production if—
    • it does not have the caution statement on its characterization or come with acceptable directions for a pare test, or
    • an ingredient other than the coal-tar hair dye itself is harmful., or
    • it is otherwise adulterated or misbranded.
  •  "Coal-tar hair dyes" are not countenance or eyelash dyes. Color additives intended for dyeing the eyebrows or eyelashes need FDA blessing for that use. No color additives are approved for dyeing the eyebrows or eyelashes.

Safety Issues

While many people use coal-tar hair dyes, FDA is aware of the post-obit bug:

Center injuries: Pilus dyes accept caused center injuries, including incomprehension, when used in the eye surface area. Eyebrow and eyelash dyeing are not permitted uses of coal-tar hair dyes. To learn more, see "What does the police say about coal-tar hair dyes?"

Allergic reactions: Some coal-tar pilus dyes can cause allergic reactions or sensitization that may result in skin irritation and pilus loss. People can develop sensitivities with repeated exposure. In addition, formulations may modify over time. So, it's possible to take a reaction even if you have dyed your hair in the past, without a problem. That'southward why it'southward important to follow the instructions and practice the skin test before every use. Even if you lot don't meet a reaction to the pare test, it'southward notwithstanding possible to have a reaction when you dye your pilus.

One hair dye ingredient, p-phenylenediamine, or "PPD," has been implicated more prominently in leading to allergic reactions. Some people may go allergic to PPD from other exposures, including occupational exposures. This is called "cantankerous-sensitization." Hither are some examples;

  • Some temporary tattoo inks, sometimes marketed as "black henna"
  • Certain cloth dyes, ballpoint pen inks, some colour additives used in foods and drugs, and other dyes used in semi-permanent and temporary hair dyes
  • Rubber 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 acid (PABA), a naturally occurring compound used in some sunscreens and in some cosmetics.

Temporary tattoo artists who use coal-tar hair dyes to color people's skin are misusing these products and ingredients, considering coal-tar pilus dyes are not intended to be used for staining the peel. While FDA regulates cosmetics products on the market, professional practice is by and large subject field to state and local authorities, not FDA. To learn more, encounter "Temporary Tattoos, Henna/Mehndi and 'Black Henna.'"

If you have a reaction to a hair dye or tattoo, enquire your healthcare provider about treatment. If you lot know what ingredient caused the problem, y'all may be able to find a production that doesn't contain that ingredient. If you color your hair yourself, bank check the listing of ingredients on the label for any you wish to avert. If y'all have your pilus colored at a salon, your stylist may be able to tell you the ingredients, or you may wish to check with the manufacturer.

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 alarm argument for all hair dye products containing these two ingredients:

  • four-methoxy-m-phenylenediamine 2,4-diaminoanisole
  • 2, 4-methoxy-thousand-phenylenediamine sulfate 2,4-diaminoanisole sulfate

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 inquiry on pilus dye safe. Nosotros do non accept reliable evidence showing a link between cancer and coal-tar hair dyes on the marketplace today. Nosotros are collecting adverse effect data which helps us appraise the safety of this class of ingredients. If you feel an adverse event or bad reaction, please report that to the FDA (see beneath).

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Other Types of Hair-coloring Products

Pilus coloring materials made from plant or mineral sources are regulated the same as other colour additives. They must be approved past FDA and listed in the color condiment regulations.

Color additives approved for employ on pilus include henna (from the Lawsonia plant) and bismuth citrate, which are used in pilus dyes that may darken hair gradually with repeated applications. On Oct thirty, 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 increment your gamble of allergy to hair dyes. Hair dyes are non meant to be used for staining your skin. (Encounter to a higher place.)

Unusual Colors

People sometime ask whether unusual colors such equally pink, orangish, blue, and dark-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.

Coal-Tar Hair Dye Safety Checklist:

  • Follow all directions on the label and in the parcel.
  • Practice a patch test on your skin every fourth dimension before dyeing your pilus.
  • Go along hair dyes away from your eyes, and do not dye your eyebrows or eyelashes. This can hurt your eyes and may even cause blindness.
  • Wear gloves when applying hair dye.
  • Do not leave the product on longer than the directions say you should. Proceed track of time using a clock or a timer.
  • Rinse your scalp well with water after using hair dye.
  • Go on hair dyes out of the reach of children.
  • Exercise not scratch or brush your scalp iii days before using pilus dyes.
  • Practice not dye or relax your hair if your scalp is irritated, sunburned, or damaged.
  • Wait at least 14 days after bleaching, relaxing, or perming your hair 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 non nowadays.
  • If you have a problem, tell your healthcare provider. Then, please report it to FDA.

How to Report a Trouble

If you lot take a reaction to a hair dye—or any other corrective—commencement contact your wellness care provider for any necessary medical help.

Then, please tell FDA. The law doesn't require corrective companies, including hair dye manufacturers, to share their safe information or consumer complaints with FDA. So, the information you lot report is very important to assistance FDA monitor the safe of cosmetics on the market place.

Y'all tin report a problem with a corrective to FDA in either of these ways:

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

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

Related Resources

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