Cosmetic Safety Obligations are important in keeping consumers, the environment and the general population safe. In this series, we will delve into the safety obligations across the globe.
Safety Obligations of Cosmetic Products Series
To learn more about the differences in safety obligations across regional regulations, explore our safety obligations of cosmetic products series:
FD&C Act Safety Obligations
The Federal Food, Drug, and Cosmetic Act (FD&C Act), enacted in 1938, is the primary law that regulates cosmetic safety in the United States. Administered by the U.S. Food and Drug Administration (FDA), the FD&C Act establishes legal safety obligations for cosmetics, ensuring they are safe, properly labeled, and not misbranded or adulterated.
Prohibition of Adulterated or Misbranded Cosmetics
A cosmetic is considered adulterated under Section 601 if:
- It contains harmful or toxic substances that may pose a risk to consumers when used as intended.
- It has been contaminated due to improper manufacturing, storage, or handling, leading to microbial growth, chemical degradation, or unintended impurities.
- It has been produced, packed, or stored under unsanitary conditions, increasing the risk of contamination with bacteria, mold, or other hazardous materials.
- It includes prohibited or restricted ingredients such as mercury compounds, certain color additives, or unapproved preservatives.
- Its composition has been altered, making it unsafe for use.
Example: A face cream that contains excessive lead levels or a lotion contaminated with bacteria due to poor manufacturing practices would be classified as adulterated.
A cosmetic is considered misbranded under Section 601 if:
- It contains drug claims.
- The product packaging does not provide a full ingredient list, or it hides certain active ingredients used in the formulation.
- The label does not include the name and address of the manufacturer, packer, or distributor.
- A cream contains alpha hydroxy acids (AHAs) but does not warn about increased sun sensitivity, which is required for products containing AHAs.
Example: an exfoliating body cream which doesn’t state lactic acid on the ingredient list and doesn’t warn consumers of the risk associated with it.
No Pre-Market FDA Approval (Except for Color Additives)
Unlike drugs, cosmetics do not require FDA pre-market approval before they are introduced to consumers. This means that cosmetic manufacturers are not required to submit their products for FDA review or obtain approval before selling them. Instead, it is the responsibility of the manufacturer to ensure that their products are safe for consumer use under the intended conditions.
However, there is an exception to this general rule: color additives used in cosmetics (except those in coal-tar hair dyes) must receive FDA approval before they can be legally used. This is because certain color additives may pose health risks, such as allergic reactions, skin irritation, or systemic toxicity, if not properly regulated. Approved color additives are listed in 21 CFR Part 73, 74, and 82, and must be used in compliance with FDA guidelines.
FDA’s Enforcement Authority
If a cosmetic product violates the Federal Food, Drug, and Cosmetic Act (FD&C Act)—whether due to adulteration, misbranding, or safety concerns—the U.S. Food and Drug Administration (FDA) has several enforcement mechanisms to protect public health.
Issuing Warning Letters
- The FDA may send a warning letter to the manufacturer, distributor, or retailer, notifying them of the violation and requiring corrective action.
- A warning letter does not impose immediate penalties, but failure to respond or correct the violations can lead to further enforcement actions.
- Example: If a company falsely claims that a face cream “permanently removes wrinkles”, suggesting it has drug-like effects, the FDA may issue a warning letter for misbranding.
Seizing Adulterated or Misbranded Products
- The FDA can request a court order to seize cosmetic products that fail to comply with the FD&C Act (adulterated or misbranded products)
- Seizure actions prevent the sale, distribution, and use of non-compliant products.
- Example: If a contaminated eye shadow is found to contain bacteria due to poor manufacturing conditions, the FDA can seize the product to prevent further sales.
Working With the Department of Justice (DOJ) to Pursue Legal Action
If a company ignores FDA warnings or continues to violate the FD&C Act, the agency can collaborate with the DOJ to take legal action.
This may involve:
- Injunctions: A court order preventing the company from manufacturing or distributing the product until compliance is achieved.
- Civil penalties: Financial fines imposed on the company.
- Criminal prosecution: If a company knowingly sells harmful or fraudulent cosmetics, responsible individuals (such as company executives) may face fines or imprisonment.
Example: A company selling skin-lightening creams with illegal mercury levels could face DOJ-led prosecution, leading to product bans, financial penalties, and even criminal charges.
Other FDA Actions for Non-Compliant Cosmetics
Although the FDA cannot mandate cosmetic recalls, it can urge manufacturers to voluntarily recall dangerous products. The FDA can block unsafe cosmetics from entering the U.S. if they fail to meet regulatory standards. The FDA may publicly warn consumers about harmful products through safety alerts or press releases.
MoCRA Safety Obligations
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law on December 29, 2022, represents the most significant update to U.S. cosmetic regulations since the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938. It strengthens FDA oversight of cosmetic products by introducing new safety, manufacturing, and reporting requirements for cosmetic companies.
Mandatory Facility Registration and Product Listing
Before MoCRA, cosmetic manufacturers were not required to register their facilities or list their products with the FDA.
After MoCRA:
- Facilities that manufacture or process cosmetics must register with the FDA and renew registration every two years.
- Companies must submit a list of cosmetic products, including ingredients, to the FDA.
- Small businesses (annual sales under $1 million) may qualify for exemptions.
Mandatory Adverse Event Reporting
Before MoCRA, reporting adverse reactions (e.g., skin rashes, burns, infections) was voluntary for cosmetic companies.
After MoCRA:
- Companies must report serious adverse events (hospitalization, disfigurement, or death) to the FDA within 15 days.
- Records of all adverse events must be kept for six years.
Good Manufacturing Practices (GMPs) for Cosmetics
Before MoCRA, the FDA had no authority to establish mandatory Good Manufacturing Practices (GMPs) for cosmetics.
After MoCRA:
- The FDA will create enforceable GMP regulations to ensure cosmetics are produced in a clean, safe, and controlled environment.
- Facilities that fail to follow GMPs may face FDA enforcement actions.
FDA’s Expanded Recall Authority
Before MoCRA, the FDA could not mandate recalls of harmful cosmetics—it could only request voluntary recalls.
After MoCRA, the FDA has the power to order recalls of cosmetics that are misbranded or adulterated.
Safety Substantiation Requirement
Before MoCRA, cosmetic companies were not required to provide proof that their products were safe.
After MoCRA:
- Manufacturers must maintain safety records demonstrating that a cosmetic product is safe for consumer use under normal and foreseeable conditions.
- The FDA can request this data to ensure compliance.
Regulation of Talc and Per- and Polyfluoroalkyl Substances (PFAS)
Before MoCRA, there was no specific FDA oversight of talc-containing products or PFAS chemicals in cosmetics.
After MoCRA:
- The FDA will conduct new safety assessments on talc-containing cosmetics to check for asbestos contamination.
- The agency is evaluating PFAS chemicals, which are linked to health risks, for potential future regulation.
FPLA Safety Obligations
The Fair Packaging and Labeling Act (FPLA), passed in 1966, is a key law that complements the Federal Food, Drug, and Cosmetic Act (FD&C Act) in regulating the labeling and packaging of consumer goods, including cosmetics. While the FD&C Act primarily addresses safety, adulteration, and misbranding, the FPLA focuses specifically on labeling requirements to ensure that consumers are provided with clear, truthful, and accurate product information.
Clear Ingredient Disclosure
The FPLA mandates that cosmetic products must list ingredients on the packaging. Knowing the ingredients in a cosmetic product is essential for consumers to avoid potential allergens, irritants, or harmful chemicals. It also allows consumers with sensitivities or health conditions to assess whether the product is safe for their use.
Example: A shampoo with sulfate-based surfactants must clearly list “Sodium Lauryl Sulfate” so consumers who are sensitive to sulfates can avoid it.
Manufacturer and Distributor Information
The FPLA requires that cosmetics display the name and address of the manufacturer, packer, or distributor. This provides consumers with a means of identifying the company responsible for the product. If an issue arises, such as an allergic reaction or product recall, consumers need to be able to contact the manufacturer for guidance or to report adverse events.
Example: If a consumer experiences a rash or irritation after using a facial cream, they can contact the company listed on the label for guidance or to report the adverse event.
Avoiding False or Misleading Claims
The FPLA mandates that all product labeling be truthful and not misleading in any way. Misleading or false claims about the product’s benefits or safety can be dangerous. Consumers might unknowingly use a cosmetic that could cause harm or may not perform as promised.
Example: claiming that a product can treat or cure a medical condition (which would make it a drug) is illegal unless it meets FDA drug approval standards. “FDA-approved for acne treatment” without evidence would be misleading and could result in consumers using a product they believe is safe, but may not actually be FDA-approved as a treatment.
Warnings & Precautions
The FPLA also requires that certain products carry warnings when they contain ingredients that may pose potential risks. For cosmetics containing potentially harmful ingredients like formaldehyde, mercury, or hydroquinone, clear warning labels alert consumers to potential health risks, thereby protecting those who might be sensitive or at higher risk from harmful effects.
Example: Hair dyes that contain ammonia should display a warning about possible skin irritation or allergic reactions.
State Safety Obligations
California
California Safe Cosmetics Act (2005)
The California Department of Public Health (CDPH) oversees the implementation of the California Safe Cosmetics Act and manages the reporting system.
Cosmetic companies selling products in California must report if their products contain ingredients that are recognized as harmful under the following regulations:
- California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act)
- National Toxicology Program (NTP) reports
- International Agency for Research on Cancer (IARC) classifications
The CDPH ensures that cosmetic manufacturers comply with the law and provides oversight to prevent the sale of products containing undisclosed harmful ingredients.
The reported information is made available to the public through the California Safe Cosmetics Program (CSCP) database. This database allows consumers, researchers, and health professionals to access data on cosmetic products and their potential risks. The goal is to increase consumer awareness and encourage manufacturers to reformulate products to remove or reduce harmful chemicals.
California proposition 65 (1986)
California Proposition 65 mandates that cosmetic products containing chemicals known to cause cancer, birth defects, or reproductive harm must include clear warnings to inform consumers of potential health risks. These requirements apply to various toxic cosmetic ingredients, including formaldehyde, which is often found in hair straightening treatments, and lead, which has been detected in some lipsticks and eyeliners. By enforcing labeling requirements, this regulation helps increase consumer awareness and encourages manufacturers to reformulate products with safer alternatives, ultimately promoting public health and safety.
California Cruelty-Free Cosmetics Act (2018)
California Cruelty-Free Cosmetics Act enforced as of January 1, 2020, the sale of cosmetics tested on animals is banned, ensuring that only cruelty-free products are available in the market. However, there are exemptions for products that have undergone animal testing when required by law, such as in certain foreign markets like China, where such testing may still be mandated for regulatory approval. This law encourages companies to adopt alternative testing methods while aligning with the global movement toward ethical and sustainable beauty products.
Toxic-Free Cosmetics Act (2020)
Toxic-Free Cosmetics Act prohibits the use of harmful chemicals in cosmetics, ensuring that products sold to consumers are safer and free from toxic ingredients. The ban includes substances such as formaldehyde, a known carcinogen often found in hair treatments; mercury, which can cause neurological damage; and certain parabens and phthalates, which have been linked to hormonal disruptions and reproductive harm. The law applies to all cosmetic products, including those specifically marketed to children, who may be more vulnerable to the effects of toxic chemicals.
New York
New York Cruelty-Free Cosmetics Act (2022)
The New York Cruelty-Free Cosmetics Act (2022) prohibits the sale and manufacturing of cosmetic products that have been tested on animals within the state of New York. This law, which went into effect on January 1, 2023, aligns with similar cruelty-free legislation in other states, such as California.
Toxic-Free Children's Product Act (2019)
The New York Toxic-Free Children’s Product Act (2019) is a law aimed at protecting children from exposure to hazardous chemicals in products designed for their use. It requires manufacturers to disclose harmful chemicals in children’s products and bans the use of certain toxic substances. The New York Department of Environmental Conservation (DEC) maintains a list of these chemicals and updates it as new scientific research emerges. This regulation applies to toys, clothing, car seats, pacifiers, and other products intended for use by children under 12 years old. It does not cover food, drugs, medical devices, or packaging.
Prohibition of Cosmetic Products and Personal Care Products Containing 1,4-Dioxane or Mercury (2023)
1,4-Dioxane, a potential human carcinogen and environmental contaminant, is restricted in cosmetics and personal care products. The regulation sets strict limits on allowable levels: 0.1 ppm by December 31, 2023. This regulation applies to products such as shampoos, body washes, lotions, and other personal care items that may contain trace amounts of 1,4-Dioxane as a byproduct of certain manufacturing processes (e.g., ethoxylation).
This regulation prohibits the sale of cosmetics containing mercury, which is toxic to the nervous system and can cause skin rashes, kidney damage, and other serious health effects. Applies to products such as skin-lightening creams, anti-aging treatments, and mascaras, which have historically contained mercury compounds as preservatives or active ingredients.
Other State Regulations
New Jersey Animal Testing Ban (2022)
- Bans the sale of cosmetics tested on animals.
- Contains exemptions for regulatory testing where required.
Nevada Cruelty-Free Cosmetics Act (2019)
- Prohibits the sale of animal-tested cosmetics.
- Enforced as of January 1, 2020.
Illinois Cruelty-Free Cosmetics Act (2019)
- Similar to California’s ban, effective January 1, 2020.
- Prohibits the sale of cosmetics tested on animals.
Hawaii Animal Testing Ban (2021)
- Restricts the sale of animal-tested cosmetics in the state.
Maryland Animal Testing Ban (2021)
- Prohibits animal-tested cosmetics from being sold in the state.
Virginia Cruelty-Free Cosmetics Act (2021)
- Bans the sale of newly animal-tested cosmetic products.
Minnesota Toxic-Free Kids Act
- Regulates toxic chemicals in children’s products, including cosmetics marketed for children.
Washington Safer Products for Washington Act (2019)
- Authorizes restrictions on harmful chemicals in consumer products, including cosmetics.
- Targets substances like phthalates and PFAS (per- and polyfluoroalkyl substances).
Oregon Toxic-Free Kids Act
- Focuses on reducing toxic chemicals in children’s cosmetics.
Colorado Toxics-Free Cosmetics Act (2022)
- Bans certain harmful ingredients in cosmetics, such as formaldehyde, mercury, and certain phthalates.
- Takes effect in 2025.
Maine PFAS Ban (2021)
- Restricts per- and polyfluoroalkyl substances (PFAS) in cosmetics.
- One of the strictest PFAS regulations in the U.S.
Maine Toxic Chemicals in Children's Products Law (2008)
- Identifies priority chemicals harmful to children.
- Applies to children’s personal care products, including cosmetics.
Massachusetts Toxic-Free Cosmetic Act (Proposed)
- Aims to ban toxic chemicals like formaldehyde, mercury, and PFAS in cosmetics.
