Taking care of your nails is an important part of personal grooming for many. From manicures and pedicures to simply maintaining healthy nail beds, various products are used to achieve desired looks and maintain nail health. However, it’s crucial to understand the safety aspects of nail care, especially concerning the products we use. This guide will explore the regulations surrounding nail products and provide essential information to ensure safe nail care practices.
The Regulatory Landscape of Nail Products
In the United States, nail products, whether for home use or professional salon application, are regulated by the Food and Drug Administration (FDA). Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these items are generally classified as cosmetics. This broad category includes items intended for cleansing, beautifying, promoting attractiveness, or altering the appearance. It’s important to note this cosmetic classification as it dictates the regulatory pathway and safety standards these products must adhere to.
Products marketed to treat medical nail conditions, such as fungal infections, fall under a different category – drugs. This distinction is critical because drugs undergo a more rigorous pre-market approval process. The information presented here focuses specifically on nail products regulated as cosmetics. To understand the nuanced differences between cosmetics and drugs, resources like the FDA’s guide, “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” offer valuable clarity.
The law mandates that nail products available for sale in the U.S. must be safe for consumers when used as directed on the label or in a customary manner. This doesn’t mean all ingredients are inherently harmless. Many nail product components could be potentially harmful if misused. However, their presence in products is permitted because they are deemed safe under intended usage. For instance, certain nail product ingredients might be harmful if ingested but pose no risk when applied to nails due to the nail’s barrier function, which prevents absorption.
Labeling is a critical aspect of nail product safety. All cosmetic labels, whether for consumer or professional use, must include warning statements whenever necessary to prevent potential health hazards associated with product use. This requirement is codified in regulations like 21 CFR 740.1.
For cosmetics sold directly to consumers in retail settings, including online, a comprehensive ingredient list is mandatory. Ingredients must be listed in descending order of predominance. Interestingly, this ingredient declaration isn’t always required for products exclusively used in salons or for free samples. However, if a product, even labeled “For professional use only,” is also sold at retail, it must bear an ingredient list. Further details on cosmetic labeling can be found in resources like the FDA’s “Cosmetic Labeling: An Overview.”
It’s crucial to understand that cosmetic products and ingredients, including nail products, generally do not require FDA pre-market approval, with the exception of most color additives. Instead, the FDA has post-market authority to take action against products, companies, or individuals that violate cosmetic safety laws. More information on the FDA’s regulatory authority can be found in “FDA Authority Over Cosmetics.”
While the FDA oversees nail product safety, the operation of nail salons and the licensing of manicurists and nail technicians fall under the purview of state and local authorities. Additionally, the Occupational Safety and Health Administration (OSHA) addresses workplace safety in nail salons, with resources like “Health Hazards in Nail Salons” available on their website.
Using Nail Products with Safety in Mind
Safe nail care starts with informed consumer practices. It is paramount to carefully read nail product labels and diligently follow all warning instructions. As previously noted, some ingredients can be harmful if ingested. Furthermore, certain nail products are flammable and should be kept away from open flames, lit cigarettes, or heat sources like curling irons. Eye contact should also be avoided. Infections and allergic reactions are potential risks associated with some nail products. Adequate ventilation is essential when using these products. If you experience an adverse reaction to a nail product, it’s important to report it to the FDA.
Common Ingredients in Nail Products: What to Know
Consumers often have questions about specific ingredients found in nail products, particularly those that raise safety concerns. Let’s examine some of these common ingredients:
Acetonitrile in Artificial Nail Removers
Acetonitrile is a primary component in artificial nail removers. Due to its potential hazards, child-resistant packaging is mandated for liquid household glue removers containing over 500 milligrams of acetonitrile per container, as per 16 CFR 1700.14 (18). The Consumer Product Safety Commission (CPSC) enforces this regulation under the Poison Prevention Packaging Act. However, “child-resistant” does not equate to “childproof.”
Artificial nail removers containing acetonitrile are required to carry appropriate warnings and safe use directions on their labels, similar to any cosmetic product that could be hazardous if misused.
Formaldehyde in Nail Hardeners and Polishes
Formaldehyde is used in some nail hardeners and polishes. It might be listed as formaldehyde, formalin, or methylene glycol on product labels. In nail hardeners, formaldehyde interacts with nail keratin to increase nail hardness. However, frequent use of formaldehyde-containing hardeners can lead to brittle nails that are prone to breakage and peeling. Formaldehyde can also cause skin irritation and allergic reactions in sensitive individuals.
Toluene sulfonamide/formaldehyde resin (TSFR) is another formaldehyde-based resin found in some nail polishes. TSFR creates a durable and resilient coating, improves polish adhesion and gloss, and enhances product flow during application. However, TSFR can also trigger allergic reactions in some people.
If you are allergic to formaldehyde or wish to avoid it, carefully check ingredient lists for formaldehyde, formalin, methylene glycol, or tolunesulfonamide/formaldehyde resin.
Methacrylate Monomers in Artificial Nails (“Acrylics”)
Artificial nails are primarily made of acrylic polymers, created by reacting acrylic monomers like ethyl methacrylate monomer with acrylic polymers like polymethylmethacrylate. Even after the reaction, trace amounts of monomers may remain. While the polymers are generally safe, these residual monomers can cause adverse reactions, such as redness, swelling, and pain in the nail bed, in individuals sensitized to methacrylates.
In the early 1970s, the FDA received complaints regarding injuries linked to artificial nails containing methyl methacrylate monomer, including nail damage, deformities, and contact dermatitis. Ethyl methacrylate polymers were not associated with these issues. Consequently, the FDA took action to remove products containing 100% methyl methacrylate monomer from the market through legal proceedings.
Currently, no specific regulation bans methyl methacrylate monomer in cosmetics. However, the Cosmetic Ingredient Review (CIR) Expert Panel determined in 2002 that ethyl methacrylate is safe for use when application instructions emphasize avoiding skin contact due to its sensitization potential.
Both methyl methacrylate monomer and ethyl methacrylate monomer are still occasionally found in artificial nail products and sometimes in nail polishes. Avoiding skin contact is crucial to minimize the risk of allergic reactions.
Methacrylic Acid in Nail Primers
Methacrylic acid (MAA), despite the similar name, differs from methacrylate monomers and presents different safety concerns. MAA is used in nail primers to enhance acrylic nail adhesion. Nail primers with MAA are typically distributed to nail salons and beauty supply stores and are labeled “For Professional Use Only.” However, some retail stores sell to both professionals and consumers.
Due to incidents of poisoning and injury, the CPSC mandates child-resistant packaging for household products containing MAA, including nail primers (16 CFR 1700. 14 (29)).
Phthalates in Nail Polishes and Other Nail Products
Phthalates are a group of chemicals used in various products, including nail polishes, where they act as plasticizers at concentrations below 10%. They reduce brittleness and cracking.
Dibutyl phthalate (DBP) was commonly used in nail polishes and nail hardeners, while dimethyl phthalate (DMP) and diethyl phthalate (DEP) were used less frequently. However, in a 2010 FDA survey, DBP was found in only a few nail polishes, and DEP and DMP were not detected in any surveyed nail products. More information on phthalate safety can be found in the FDA’s “Phthalates” resource.
Toluene in Nail Polishes and Other Nail Products
Toluene is a solvent used in nail products like polishes, hardeners, and removers, though its use is decreasing. The CIR, in a 1987 review, deemed toluene safe in nail products at concentrations up to 50%, the highest level found in such products.
A 2005 CIR re-evaluation confirmed the safety assessment, noting that adverse effects occurred only at levels significantly higher than those encountered during nail polish use and that toluene use in nail products had significantly declined.
Reporting Adverse Reactions to Nail Products
If you, as a consumer or nail technician, experience an adverse reaction to a nail product, consult your doctor or healthcare provider and then report it to the FDA. You can report cosmetic-related health issues, including those from nail products, to the FDA using the contact information provided at How to Report a Cosmetic Product Related Complaint | FDA.
Further Resources
For more in-depth information on nail product safety and regulations, refer to the following resources:
- Federal Food, Drug, and Cosmetic Act
- “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”.
- Key Legal Concepts: Interstate Commerce, Adulteration and Misbranding
- 21 CFR 740.1
- Cosmetic Labeling: An Overview
- FDA Authority Over Cosmetics
- Occupational Safety and Health Administration (OSHA)
- “Health Hazards in Nail Salons,”
- 16 CFR 1700.14 (18)
- Cosmetic Ingredient Review (CIR) Expert Panel
- 16 CFR 1700. 14 (29)
- Phthalates
- How to Report a Cosmetic Product Related Complaint | FDA