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                Cosmetic Products

Cosmetic Products

                        Aromatherapy
          Cosmetic Tanning Products
          Disposable Wipes
          Hair Products
          Makeup
          Nail Care Products
          Soaps & Lotions
          Tattoos, Temporary Tattoos & Permanent Makeup Home
          Cosmetics
          Cosmetic Products & Ingredients
          Cosmetic Products
          Hair Smoothing Products That Release Formaldehyde When HeatedCosmetic Products Hair Smoothing Products That Release Formaldehyde When Heated
  
  	
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Hair smoothing products are used to straighten hair or to smooth out curls. A hair straightening or smoothing solution is usually applied to human hair followed by a heat treatment that seals the solution in. These products often contain formaldehyde, also known as formalin and methylene glycol. When the solution is heated, the formaldehyde in the products is released into the air as a gas. If the salon is not properly ventilated, both the salon professionals and their clients are at risk of inhaling the released formaldehyde.

Formaldehyde is a colorless, strong-smelling gas that presents a health hazard when breathed into the lungs, or when it gets into the eyes or onto the skin. According to the National Cancer Institute, when formaldehyde is present in the air at levels exceeding 0.1 ppm, some individuals may experience adverse effects such as watery eyes; burning sensations in the eyes, nose, and throat, coughing, wheezing, nausea, and skin irritation. Some people are very sensitive to formaldehyde, whereas others have no reaction to the same level of exposure. Formaldehyde has also been classified as a human carcinogen by the International Agency for Research on Cancer because at high levels or prolonged exposure, formaldehyde has been linked to certain types of cancers.

As hair smoothing products increased in popularity in the late 2000’s, the FDA began receiving inquiries from consumers and salon professionals about the safety of products containing formaldehyde or related ingredients. In response to these concerns, in 2010, the agency began communicating with the public to provide information about the potential health effects of these products and how to recognize products containing formaldehyde or its liquid forms, formalin and methylene glycol.

**What Should Consumers Know?**

Skin sensitization or allergic dermatitis can develop after repeated contact with formaldehyde-related ingredients. When formaldehyde is released into the air, it can cause serious irritation of your eyes, nose, and lungs. The greater the exposure, in terms of both duration and concentration, to products that contain formaldehyde-related ingredients, the higher the potential health risks. Possible reactions that have been reported include eye problems or irritation, nervous system problems (for example, headaches and dizziness), respiratory tract problems (sore or scratchy throat, cough, wheezing), nausea, chest pain, vomiting, and rash.

Here are some steps consumers can take when considering hair smoothing products:

**Read the label.** If you're purchasing a product on a retail basis, whether at a store or by mail order, including on the Internet, the product is required to have a list of the ingredients. If it doesn't, we recommend that you do not purchase the product. Also, please let the FDA know. The list of ingredients is required under the Fair Packaging and Labeling Act. To identify products containing formaldehyde-related ingredients, look for:

	Formaldehyde
		Formalin
		Methylene glycol
	**Ask your salon professional.** Ask your salon professionals if they know whether a product contains formaldehyde-related ingredients. If they are unsure if formaldehyde is present, you may not want to use the product, especially if you have had a reaction in the past. Products that are marketed only to salon professionals may not have a list of ingredients, because the Fair Packaging and Labeling Act applies only to products marketed on a retail basis to consumers. Professional use products, however, are required to have directions for safe use and any necessary warning statements. In addition, the Occupational Safety and Health Administration (OSHA) requires products with hazardous chemicals to have a Safety Data Sheet (SDS), (also called a Material Safety Data Sheet) which lists the hazards associated with those products.
	**Report bad reactions.** Consumers are one of the FDA's most important sources of information. If you experience a bad reaction to a hair smoothing product, please report your symptoms to the FDA as well as to your health care provider. Below are links to the FDA to help you:
	Report by phone to the Consumer Complaint Coordinator at your nearest FDA district office. Phone numbers are posted on the FDA's Web page, Consumer Complaint Coordinators.
		Report online to FDA's MedWatch adverse event reporting system. You also may call MedWatch at 1-800-332-1088 to request a reporting form by mail. Salon workers also can file complaints about unsafe workplaces with OSHA, as stated in OSHA’s Hazard Alert.**How Are These Products Regulated?**

FDA's Role

The FDA regulates cosmetics, including hair smoothing products, under the authority of the Federal Food, Drug, and Cosmetic Act and, if they are marketed on a retail basis to consumers, under the Fair Packaging and Labeling Act. Under these laws, cosmetics are not approved by the FDA.

However, cosmetics must not be unsafe under the intended conditions of use and must be properly labeled, and companies and individuals who manufacture or market them are responsible for the safety and labeling of their products and ingredients. The FDA can take action against cosmetics on the market that do not comply with the law. To learn more, see FDA Authority Over Cosmetics.

OSHA’s Role

The FDA does not have authority over the operation of salons or the practice of cosmetology. However, workplace safety in general, including air quality issues, is regulated by OSHA. Salons are also generally subject to state and local authorities, which may specify safety practices such as assuring proper ventilation.

OSHA issued a Hazard Alert to hair salon owners and workers about potential formaldehyde exposure from working with these hair smoothing products and set a formaldehyde standard 29 CFR 1910.1048 limiting the allowable levels of formaldehyde in the air. This standard applies to all employers who use formaldehyde, and products that contain or release formaldehyde. OSHA has also published a Formaldehyde Fact Sheet.

**FDA Actions**

As part of its authority, the FDA issues warning letters to notify firms or individuals that they have been found to be in violation of the laws the FDA enforces. A warning letter also outlines what violations need to be corrected in order to comply with the law.

To date, the FDA has issued two warning letters to GIB, LLC dba Brazilian Blowout and to Van Tibolli Beauty Corp. citing both safety and labeling violations. The warning letters noted that hair smoothing products containing formaldehyde have been associated with reactions such as eye problems, nervous system problems (for example, headaches and dizziness), respiratory tract problems, nausea, chest pain, vomiting, and rash. Labeling violations included, for example, failure to warn consumers of potential health risks. Both GIB, LLC dba Brazilian Blowout and Van Tibolli Beauty Corp. took steps to correct the violations listed in the FDA warning letters.

These warning letters should not be interpreted as a broad evaluation of the safety of hair smoothing products in general. Other hair smoothing products may vary with respect to composition, intended conditions of use, and other factors. That is why we recommend that consumers ask their salon about ingredients in hair smoothing products. Or, if you’re purchasing a product for home use, read the product label carefully, to check if formaldehyde is an ingredient.

In addition, from 2016 to 2017, the FDA conducted a series of focus groups with salon owners, stylists, consumers and customers to determine their perceptions of formaldehyde hair smoothing products. The questions focused on potential hazards associated with use of these products and the participants’ reactions to different types of warning labels.

Findings indicated that salon owners and stylists try to be well-informed about hair smoothing products by taking the training that product manufacturers may provide and learning about short-term and long-term risks from using these products. Salon customers were less knowledgeable about possible risks: some reported they did not receive any information on the risks before stylists applied these products, while others reported side effects during treatment.

The FDA continues to communicate with consumers about the potential risks associated with use of these products and evaluates products for safety and labeling on a case-by-case basis.

**Where to Learn More**

For information on workplace exposure to formaldehyde, see Formaldehyde on OSHA’s website. The National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention also has published resources on formaldehyde on its website under Formaldehyde: NIOSH Resources.

The FDA will continue to monitor safety issues regarding hair smoothing products and will update its information as appropriate.

**Resources For You**

OSHA Hazard Alert: Hair Smoothing Products That Could Release Formaldehyde
	GIB, LLC dba Brazilian Blowout Warning Letter
	Van Tibolli Beauty Corp. Warning Letter

                                                                                  Content current as of:
      02/25/2022
              
              
Regulated Product(s)
		 CosmeticsCosmetic Products

          
                        Aromatherapy
          Cosmetic Tanning Products
          Disposable Wipes
          Hair Products
          Makeup
          Nail Care Products
          Soaps & Lotions
          Tattoos, Temporary Tattoos & Permanent Makeup
 
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