Resources for You
Nail Care Products Safety & Regulatory Information
How Nail Products Are Regulated
Nail Product Ingredient Safety
Some Common Nail Product Ingredients
Toluene in Nail Polishes and Other Products
Reporting Adverse Nail Product Reactions
There are many nail products on the market. It is important to know how to use them safely. As with any cosmetic product, follow the labeled directions carefully and pay careful attention to any warning statements. The following information will answer commonly asked questions about some nail products and ingredients.
Nail products for both home and salon use are regulated by the Food and Drug Administration. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are cosmetics [FD&C Act, section 201(i)].
By law, nail products sold in the United States must be free of poisonous or deleterious (harmful) substances that might injure users when used as labeled or under the usual or customary conditions of use (see Key Legal Concepts: Interstate Commerce, Adulteration and Misbranding). Many nail products contain potentially harmful ingredients, but are allowed on the market because they are safe when used as directed. For example, some nail ingredients are harmful only when ingested, which is not their intended use.
The labels of all cosmetics, whether marketed to consumers or salons, must include a warning statement whenever necessary or appropriate to prevent a health hazard that may occur with use of the product (21 CFR 740.1). Cosmetics sold on a retail basis to consumers also must bear an ingredient declaration, with the names of the ingredients listed in descending order of predominance. The requirement for an ingredient declaration does not apply, for example, to products used at professional establishments or samples distributed free of charge. However, the requirement does apply if these products are also sold at retail, even if they are labeled "For professional use only" (see Cosmetic Labeling: An Overview).
Under the law, cosmetic products and ingredients, including nail products, are not subject to FDA premarket approval authority, with the exception of most color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law (See FDA Authority Over Cosmetics).
While FDA regulates the nail products intended for use at home and in salons, the operation of nail salons and the licensing of their technicians are regulated by state and local authorities. Also, the Occupational Safety and Health Administration has addressed the safety of employees in nail salons.
Artificial nail removers consist primarily of acetonitrile. Child-resistant packaging is required for all household glue removers in liquid form containing more than 500 milligrams of acetonitrile in a single container [16 CFR 1700.14 (18)]. The Consumer Product Safety Commission (CPSC) enforces this requirement under authority of the Poison Prevention Packaging Act [15 U.S.C. 1471-1476]. However, the fact that a product is in "child-resistant" packaging does not mean that a child could not open it.
Like any cosmetic product that may be hazardous if misused, it is important for these artificial nail removers to carry an appropriate warning on the label, along with directions for safe use.
Formaldehyde is used in many different products, some of which are regulated as cosmetics. For example, formaldehyde is an important component of nail hardeners. Formaldehyde and formaldehyde-releasing ingredients are often used in other cosmetics as preservatives to protect against harmful bacteria, and formaldehyde also has been used in certain hair-smoothing or hair-straightening products. Different forms of formaldehyde have different names, such as "formalin" and "methylene glycol."
The Cosmetic Ingredient Review (CIR) Expert Panel concluded in December 2011 that formaldehyde and methylene glycol are safe for use in cosmetics when formulated to ensure use at the minimal effective concentration, but in no case should formalin concentration exceed 0.2% by weight. (This would be 0.074% by weight calculated as formaldehyde or 0.118% by weight calculated as methylene glycol.) CIR also found that formaldehyde and methylene glycol are safe under present practices of use and concentration in nail hardening products, where the concentration of formaldehyde is typically higher than the 0.2% level noted for cosmetics generally. "Present practices of use" include instructions to avoid skin contact. However, CIR found that formaldehyde and methylene glycol are unsafe in the present practices of use and concentration in hair smoothing products; see FDA, OSHA Act on Brazilian Blowout and the related Warning Letter.
Nail hardeners that contain formaldehyde may cause an irritation or allergic reaction to those sensitized to this compound. There is also some evidence that certain individuals may become allergic to toluene sulfonamide–formaldehyde resin, a common ingredient in nail preparations. If you are allergic to formaldehyde, have previously experienced an allergic reaction to nail preparations, or for any other reason wish to avoid this ingredient, be sure to read the product ingredient statement on the label to determine whether formaldehyde or related ingredients, such as formalin and toluene sulfonamide-formaldehyde resin, are present.
Artificial nails are composed primarily of acrylic polymers and are made by reacting together acrylic monomers, such as ethyl methacrylate monomer, with acrylic polymers, such as polymethylmethacrylate. When the reaction is completed, traces of the monomer are likely to remain in the polymer. For example, traces of methacrylate monomers remain after artificail nails are formed. The polymers themselves are typically quite safe, but traces of the reactive monomers could result in an adverse reaction, such as redness, swelling, and pain in the nail bed, among people who have become sensitive (allergic) to methacrylates.
Ethyl methacrylate monomer is commonly used today in acrylic nails, although methyl methacrylate monomer may still be found in some artificial nail products. In the early 1970s, FDA received a number of complaints of injury associated with the use of artificial nails containing methyl methacrylate monomer. Among these injuries were reports of fingernail damage and deformity, as well as contact dermatitis. Unlike methyl methacrylate monomer, methyl methacrylate polymers were not associated with these injuries. Based on its investigations of the injuries and discussions with medical experts in the field of dermatology, the agency chose to remove from the market products containing 100 percent methyl methacrylate monomer through court proceedings, which resulted in a preliminary injunction against one firm as well as several seizure actions and voluntary recalls. No regulation specifically prohibits the use of methyl methacrylate monomer in cosmetic products.
The CIR Expert Panel determined in 2002 that ethyl methacrylate is safe as used when application is accompanied by directions to avoid skin contact because of its sensitizing potential (that is, the possibility that a person might develop an allergy to this material).
Despite the similar names, methacrylic acid is different from methacrylate monomers. It also is used differently and raises different safety concerns. Methacrylic acid (MAA) has been used in nail primers to help acrylic nails adhere to the nail surfaces. In response to cases of poisoning and injury, the CPSC issued a regulation [16 CFR 1700.14 (29)] requiring child-resistant packaging for household products containing MAA. A number of serious injuries have occurred to children who ingested such products or spilled them, receiving burns to their skin.
Nail primers that contain MAA are most commonly distributed through wholesale suppliers to nail salons and retail beauty supply stores, and they usually are labeled "For Professional Use Only." However, some of these retail stores sell to both professionals and consumers.
The CPSC regulation, established in accordance with the Poison Prevention Packaging Act, requires child- resistant packaging for liquid household products containing more than 5 percent MAA, weight to volume, in a single retail package. That means that it applies, for example, to a product containing more than 5 grams of MAA per 100 milliliters.
MAA products applied by means of absorbent material in a dispenser, such as a pen-like marker, are exempt from this requirement if there is no free liquid in the device and if, under any reasonably foreseeable conditions of use, the methacrylic acid will emerge only through the tip of the device. For more information regarding the child-resistant packaging requirements for MAA, contact the Office of Compliance, CPSC, at (301) 504-0608.
Phthalates are a group of chemicals used in a wide variety of products, from toys to carpeting and medical tubing. In nail polishes, they are used primarily at concentrations of less than 10% as plasticizers, to reduce cracking by making them less brittle. Dibutylphthalate (DBP) is used most commonly in nail polishes, but dimethylphthalate (DMP) and diethylphthalate (DEP) are used occassionally. For information on health questions related to phthalates in cosmetics, please see Phthalates and Cosmetic Products.
Toluene in Nail Polishes and Other Products
Toluene is used as a solvent in a variety of nail products, such as nail polish, nail hardeners, and polish removers. Toluene was reviewed by the CIR Expert Panel in 1987, when the Panel determined that it was safe for cosmetic use in nail products when limited to concentrations no greater than 50 percent. The Panel re-evaluated the safety of toluene in 2005 and confirmed its original conclusion.Reporting Adverse Nail Product Reactions
* The Cosmetic Ingredient Review (CIR) Expert Panel is an independent, industry-funded panel of medical and toxicology experts that meets quarterly to conduct safety assessments of cosmetic ingredients and publishes its findings in peer-review journals. FDA participates in the CIR in a non-voting capacity. FDA takes the results of CIR reviews into consideration when evaluating safety, but the results of FDA safety assessments may differ from those of CIR.
February 29, 2000; Updated December 13, 2006, March 9, 2010, December 6, 2012, and March 11, 2013