Decoding Hair Dye Safety: Does Hair Dye Have to Be FDA Approved?

Coloring your hair can be a fun way to change your look, but have you ever wondered about the safety of hair dye? Specifically, does hair dye have to be FDA approved? The answer is more complex than a simple yes or no. This article breaks down the Food and Drug Administration’s (FDA) role in regulating hair dye, explores the difference between FDA-approved and FDA-regulated products, and examines the potential risks associated with hair dyes and cancer. We’ll also look at the use of hair dyes and relaxers, and delve into color additive regulations to help you make informed decisions about the products you use on your hair. This fact sheet will help you to understand the regulations surrounding hair dye.

What is the FDA’s Role in Regulating Hair Dye?

The FDA regulates cosmetics, including hair dye, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, the FDA’s authority over cosmetics is different from its authority over drugs or medical devices. Unlike drugs, cosmetic products and ingredients (except for color additives) do not require FDA premarket approval. This means that hair dye manufacturers are not required to obtain FDA approval before selling their products. However, the FDA can take action against products or ingredients that are deemed unsafe or adulterated.

While the FDA doesn’t approve hair dye products before they go on the market, they do have regulations in place regarding color additives. All color additives used in cosmetics must be approved by FDA for their intended use. The FDA also has the authority to inspect cosmetic manufacturing facilities and take action against products that violate the FD&C Act. The FDA has a responsibility to ensure that products are safe for consumers to use. Many consumers are interested in hair dye safety.

Understanding Coal-Tar Hair Dyes and Their Regulation

Coal-tar hair dyes are a specific category of hair dye that are subject to different regulations than other cosmetic ingredients. Coal-tar is a byproduct of coal processing and contains a complex mixture of chemicals. Coal-tar dyes are commonly used in darker shades of permanent hair dye. They are often used to color your hair darker.

Under the FD&C Act, coal-tar hair dyes are exempt from certain adulteration provisions that apply to other cosmetics, provided they meet specific requirements. These requirements include a cautionary statement on the label warning about potential skin irritation and instructions to perform a patch test before every use. The label must also warn against dyeing the eyebrows or eyelashes with the product, as this can hurt your eyes. It is important to be aware of these warnings. It is recommended that you patch test before every use.

Color Additives: What Does “FDA Approved” Mean?

Color additives are a crucial component of many cosmetic products, including hair dye. The FDA plays a significant role in regulating their use. Color additives must be approved by FDA before they can be used in cosmetics marketed in the U.S. There is a specific list of color additives approved for use in cosmetics.

FDA approval for color additives means that the agency has evaluated scientific data and determined that the color additive is safe for its intended use under specified conditions of use. The FDA establishes regulations that specify the types of cosmetics in which a color additive may be used, the maximum amount allowed, and any other restrictions. Some color additives must be batch certified by FDA. This involves the FDA testing a sample from each batch of the color additive to ensure it meets the required specifications. You can search for approved additives in Title 21 of the Code of Federal Regulations (21 CFR).

Are All Hair Dye Ingredients FDA Approved?

While color additives in hair dye must be FDA approved, other ingredients in hair dye formulations do not require premarket approval. This means that ingredients in hair dyes other than color additives do not need FDA approval before being used in products. This has led to some concerns about the safety of certain hair dye ingredients. The FDA does not require approval for products and ingredients.

However, the FDA can take action against a cosmetic product if it contains a poisonous or deleterious substance that makes it harmful to users under the intended conditions of use. The FDA also prohibits the use of any ingredient that would cause the cosmetic to be adulterated or misbranded in any way. They also prohibit products from being produced in unsanitary conditions. This helps to protect consumers.

What are the Different Types of Hair Dyes?

Hair dyes can be broadly classified into three main types of hair dyes:

• Permanent Hair Dyes: These dyes use a combination of ammonia (or a similar alkalizing agent) and hydrogen peroxide to open the hair cuticle and deposit color deep within the hair shaft. They provide long-lasting color that does not wash out, but they can be more damaging to the hair.
• Demi-Permanent Hair Dyes: These dyes contain a low volume of peroxide and do not contain ammonia. They can blend grays and enhance color, but they cannot lighten hair. The color gradually fades over several weeks. This makes them a gentler option than permanent dyes.
• Semi-Permanent Hair Dyes: These dyes do not use peroxide and do not penetrate the hair shaft. Instead, they coat the hair with color that typically washes out after 6-8 shampoos. They are the least damaging type of hair dye but also the least permanent.

In addition, there are temporary hair coloring products, such as hair mascaras, sprays, and gels, that wash out with the next shampoo. These products are often used for special occasions or to experiment with different looks. They are not designed for long-term use.

What are the Potential Risks Associated with Hair Dye?

While hair dye is generally considered safe for most people when used as directed, there are some potential risks associated with its use:

• Skin Irritation: Hair dye can cause allergic contact dermatitis, which is an allergic reaction to certain ingredients in the dye. Symptoms can include redness, itching, swelling, and blistering of the scalp, face, or neck. It is important to carry out a patch test before using any new hair dye.
• Hair Damage: Permanent hair dyes, in particular, can damage the hair by weakening the hair shaft and making it more prone to breakage and dryness. This is due to the chemicals used in the dyeing process.
• Eye Irritation: Hair dye can cause severe eye irritation or even permanent damage if it comes into contact with the eyes. This is why it’s crucial to avoid dyeing the eyebrows or eyelashes with hair dye products. You should never dye your eyebrows or eyelashes with hair dye.
• Potential Carcinogenicity: Some studies have suggested a possible link between hair dye use and an increased risk of certain cancers. However, the evidence is not conclusive, and more research is needed. This is discussed further in the next section.

It’s important to follow the instructions on the hair dye package carefully and to perform a patch test before each use to minimize the risk of adverse reactions. You should always patch test before every use.

Hair Dyes and Cancer: What Does the Research Say?

The question of whether hair dyes cause cancer has been a topic of research and debate for many years. The International Agency for Research on Cancer (IARC), which is part of the World Health Organization, has classified some chemicals found in hair dyes as probable or possible human carcinogens. However, the overall evidence linking hair dye use to an increased risk of cancer is mixed and inconclusive. There is still a debate about whether hair dyes and cancer are linked.

Some studies have suggested a possible association between hair dye use and certain types of cancer, such as bladder cancer, non-Hodgkin lymphoma, and leukemia. However, other studies have found no such link. The results of these studies may be influenced by various factors, including the type of hair dye used, the frequency and duration of use, and the study population. There have been suggestions that hair dyes and hair straighteners might be linked to cancer.

In 2022, there was a prospective cohort study completed by the National Institutes of Health. The Sister Study is still ongoing. This was published in the International Journal of Cancer. It found that there was a link between the use of hair dye and an increased risk of cancer in women.

It’s important to note that many older hair dye formulations contained chemicals that are no longer used today. Modern hair dye products are generally considered safer, but more research is needed to fully understand the long-term health effects of hair dye use. There are concerns over the ingredients used in hair dyes. The National Center for Health Research has expressed concerns about the safety of hair dye.

The Truth About Eyebrow and Eyelash Dyeing

The FDA strictly prohibits the use of hair dye for dyeing the eyebrows or eyelashes, even in salons. This is because hair dye can cause severe eye irritation, injury, or even blindness if it gets into the eyes. There are currently no color additives approved for dyeing the eyebrows and eyelashes. Some salons may offer eyebrow and eyelash tinting using other types of dyes, but the safety of these products is not always clear. Many of these products are not FDA-regulated products.

It’s essential to avoid using any product on your eyebrows or eyelashes that is not specifically formulated and approved for that purpose. If you’re considering having your eyebrows or eyelashes tinted, it’s best to consult with a dermatologist or ophthalmologist to discuss the safest options. You should never use hair dye on your eyebrows or eyelashes. This is not an approved for use.

How to Use Hair Dye Safely

If you choose to dye your hair, here are some tips for safe use:

• Follow the Instructions: Carefully read and follow the instructions on the hair dye package. Pay attention to the recommended processing time and any safety precautions.
• Perform a Patch Test: Before using a hair dye for the first time, perform a patch test to check for allergic reactions. Apply a small amount of the dye to a small area of skin (usually behind the ear or on the inner elbow) and wait 48 hours to see if any reaction occurs.
• Wear Gloves: Always wear gloves when applying hair dye to protect your hands from staining and irritation.
• Don’t Mix Different Products: Avoid mixing different hair dye products or brands unless specifically instructed to do so. This could cause an adverse reaction.
• Don’t Leave Dye on Longer Than Recommended: Leaving hair dye on for longer than the recommended time can increase the risk of hair damage and skin irritation. It will not make the color more intense.
• Rinse Thoroughly: After the processing time is complete, rinse your hair thoroughly with cool water until the water runs clear.
• Don’t Use Hair Dye on Eyebrows or Eyelashes: As mentioned earlier, using hair dye on eyebrows or eyelashes can cause severe eye injury.
• Ventilate the Area: Apply hair dye in a well-ventilated area to minimize inhalation of fumes.
• Store Dye Properly: Keep hair dye products out of reach of children and pets. Store them in a cool, dry place.

By following these safety tips, you can minimize the risks associated with hair dye use. If you experience any adverse reactions, such as severe itching, burning, or swelling, rinse the dye out immediately and consult a doctor. If you have concerns, you should tell FDA.

Reporting Adverse Reactions to the FDA

The FDA encourages consumers and healthcare professionals to report any adverse reactions or problems experienced with hair dye or other cosmetic products. If you have a negative reaction to a hair dye, you can report it to the FDA by using MedWatch. This helps the agency monitor the safety of products on the market and take action if necessary. The FDA can then investigate the issue.

You can report an adverse reaction to the FDA online through the MedWatch website or by phone. When reporting a problem, provide as much information as possible, including the product name, manufacturer, lot number, where and when the product was purchased, and a detailed description of the reaction. This helps the FDA to investigate the problem.

Key Takeaways:

• The FDA regulates cosmetics, including hair dye, under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• Cosmetic products and ingredients (except for color additives) do not require FDA premarket approval, but the FDA can take action against unsafe or adulterated products. The FDA can also take action against misbranded products.
• Coal-tar hair dyes are subject to specific regulations and must carry a cautionary statement and instructions for a patch test. They must carry the statement: “Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”
• Color additives used in cosmetics, including hair dye, must be approved by FDA for their intended use.
• Not all ingredients in hair dye are FDA approved; only color additives require premarket approval.
• There are three main types of hair dyes: permanent, demi-permanent, and semi-permanent.
• Potential risks associated with hair dye use include skin irritation, hair damage, eye irritation, and a possible link to certain cancers.
• Research on the link between hair dyes and cancer has yielded mixed results, and more research is needed.
• The FDA strictly prohibits the use of hair dye for dyeing the eyebrows or eyelashes due to the risk of severe eye injury. You should not dye your eyebrows or eyelashes using hair dye.
• To use hair dye safely, follow the instructions, perform a patch test, wear gloves, don’t mix products, don’t leave the dye on longer than recommended, rinse thoroughly, don’t use it on eyebrows or eyelashes, and ventilate the area.

By understanding the FDA’s role in regulating hair dye, the different types of hair dyes, the potential risks, and how to use hair dye safely, you can make informed decisions about coloring your hair. If you experience any adverse reactions to a hair dye, you can report it to the FDA to help the agency monitor the safety of these products. The FDA has a responsibility to protect consumers. They have provided guidance on the safe use of hair dye. If you color your hair, you should follow the instructions carefully. The use of hair dye is common, but many people are unaware of the risks. There is concern over hair dyes and cancer. The use of lead acetate in hair dye is now banned in the U.S. The FDA issued a final rule to amend the color additive regulations. This was after a petition was filed in 2022. This removed the approval for lead acetate in hair dye. Hair dyes and relaxers are now more closely regulated. This is partially due to a study by the National Institutes of Health. The International Agency for Research on Cancer has also highlighted the dangers of certain chemicals used in hair dye. The Centers for Disease Control and Prevention also offer advice on hair dye. You can access their resources online. This includes advice on regulatory issues related to hair dye. There is a push for safer hair dye products. Many companies now offer safer alternatives to traditional hair dye. These products often contain fewer harsh chemicals. They may also be made with more natural ingredients. However, it’s important to remember that even natural ingredients can cause reactions in some people. Always do a patch test before using a new product, even if it’s labeled as natural or organic. If you experience any adverse reactions, stop using the product and consult a doctor. You should also report the reaction to the FDA. This helps them to monitor the safety of cosmetic products. The FDA offers a viscous gel product for reporting adverse reactions.