FDA Cosmetics Regulation and Safety

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For more than 80 years, the cosmetics industry largely regulated itself. That era ended with a bang on December 29, 2022, when the Modernization of Cosmetics Regulation Act (MoCRA) became law – the most significant expansion of FDA authority over cosmetics since the Great Depression.

The U.S. Food and Drug Administration now has unprecedented power to ensure the safety of lipsticks, shampoos, moisturizers, and thousands of other products Americans use daily. Companies must register facilities, list products, report serious side effects, and prove their products are safe. The FDA can now force recalls and access company safety records.

This transformation affects every cosmetic sold in America, from drugstore basics to luxury brands. Whether you’re a consumer wondering what’s in your makeup or a business owner navigating new rules, this guide explains everything you need to know about how the FDA regulates cosmetics in the modern era.

The Magic Words: How Marketing Claims Determine Everything

The single most important concept in FDA cosmetics regulation is “intended use.” A product’s legal classification – whether it’s a cosmetic, drug, or both – isn’t determined by its ingredients, formulation, or perceived strength. It’s determined entirely by the claims manufacturers make about what the product does.

This distinction controls everything from pre-market approval requirements to labeling rules. A company’s marketing department can have more impact on regulatory requirements than its research and development team.

What Makes Something a Cosmetic

Under federal law, cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

This broad definition covers products millions of Americans use daily:

• Skin moisturizers, creams, and lotions
• Perfumes and fragrances
• Lipsticks, nail polishes, and makeup
• Shampoos and conditioners
• Hair colors and styling products
• Deodorants

With the crucial exception of color additives, cosmetic products don’t require FDA approval before sale. The manufacturer has historically held responsibility for ensuring safety.

When Products Become Drugs

Federal law defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles intended to affect the structure or any function of the body.”

Unlike cosmetics, drugs face rigorous pre-market review. New drugs must receive FDA approval through a New Drug Application or conform to established Over-the-Counter drug guidelines. The FDA reviews safety and effectiveness data before drugs can be legally sold.

The Combination Zone: Products That Are Both

Many familiar products meet legal definitions of both cosmetics and drugs. These combination products must comply with regulatory requirements for both categories.

Anti-dandruff shampoo is a cosmetic because it cleanses hair and a drug because it treats dandruff.

Makeup with SPF is a cosmetic because it alters appearance and a drug because sunscreen prevents skin damage.

Antiperspirant deodorants combine cosmetic deodorizing with drug-like antiperspirant effects that reduce perspiration.

Fluoride toothpaste cleanses teeth and freshens breath (cosmetic) while preventing tooth decay (drug).

Combination product labels reflect this dual nature. Drug components must be listed first under “Active Ingredients,” followed by cosmetic components under “Inactive Ingredients” in descending order.

How Words Create Legal Reality

Companies can unintentionally market cosmetics as unapproved drugs simply through language used in advertising, websites, or product labels. The words chosen to describe benefits establish “intended use” in FDA eyes.

Consider anti-aging creams:

Cosmetic claim: “Reduces the appearance of fine lines and wrinkles” suggests temporary, superficial change through hydration – altering appearance.

Drug claim: “Increases skin’s collagen production” or “structurally removes wrinkles” suggests changing skin structure or function – requiring FDA drug approval.

This principle applies across categories. An essential oil marketed as fragrance to “promote attractiveness” is cosmetic. The same oil marketed with claims it will “help you quit smoking” or “relieve muscle pain” becomes a drug because it’s intended to treat conditions or affect body functions.

The FDA actively enforces this distinction through Warning Letters to companies making illegal drug claims for cosmetic products.

The Special Soap Exception

A narrow category of products legally defined as “soap” are exempt from cosmetic regulations. To qualify, products must be composed primarily of alkali salts of fatty acids (traditional soap-making process) and their labeling must only refer to cleansing properties.

If products are marketed as “moisturizing” or “deodorizing,” they become cosmetics. Claims to treat skin conditions like eczema make them drugs. Most modern bar and liquid “soaps” are made with synthetic detergents, so they don’t meet the FDA’s narrow soap definition and are regulated as cosmetics.

MoCRA: The Game-Changing Law

The Modernization of Cosmetics Regulation Act represents the most significant expansion of FDA cosmetics authority in American history. This landmark legislation fundamentally reshapes industry responsibilities and provides the agency with powerful new enforcement tools.

MoCRA creates a uniform national regulatory framework, bringing U.S. standards more in line with international practices while ending the era of largely voluntary compliance.

Mandatory Facility Registration

Old system: Companies could voluntarily register manufacturing facilities through the Voluntary Cosmetic Registration Program (VCRP). Most chose not to participate.

New requirement: Any facility that manufactures or processes cosmetic products for U.S. distribution must register with the FDA. Registration must be renewed every two years using the FDA’s existing Establishment Identifier (FEI) system.

Mandatory Product Listing

Old system: Listing individual products and ingredients was voluntary. The FDA had incomplete visibility into the marketplace.

New requirement: A designated “responsible person” – the manufacturer, packer, or distributor whose name appears on the product label – must submit listings for each cosmetic product marketed in the U.S. Listings must include ingredient lists and be updated annually.

This creates the first comprehensive database of all cosmetic products in the U.S. market, giving the FDA unprecedented oversight.

Safety Documentation Requirements

Old system: Manufacturers had legal responsibility for product safety but no formal documentation requirements.

New requirement: The responsible person must maintain records providing “adequate substantiation” of product safety. The law doesn’t prescribe specific tests – companies can use any relevant, scientifically robust safety data. Animal testing is not required for marketing cosmetics in the U.S.

Mandatory Adverse Event Reporting

Old system: Reporting health reactions to cosmetics was voluntary for companies.

New requirement: Responsible persons must report serious adverse events to the FDA within 15 business days of receiving information. “Serious adverse events” include reactions resulting in:

• Death
• Life-threatening experiences
• Inpatient hospitalization
• Persistent or significant disability
• Birth defects
• Infections
• Significant disfigurement (serious rashes, second/third-degree burns, significant hair loss)

Companies must maintain internal records of all adverse events (serious and non-serious) for six years (three years for some small businesses). The FDA can access these records during inspections.

New FDA Enforcement Powers

MoCRA grants the FDA powerful authorities previously unavailable:

Mandatory Recall Authority: Before MoCRA, the FDA could only request voluntary recalls. Now, if the agency determines a cosmetic is adulterated or misbranded with “reasonable probability” of causing “serious adverse health consequences or death,” it can order mandatory recalls if companies refuse voluntary action.

Records Access: If the FDA has reasonable belief that a cosmetic is adulterated or poses serious harm threats, the agency can access and copy company records related to that product, including safety substantiation files.

Facility Registration Suspension: The FDA can suspend facility registration if it determines products manufactured there have reasonable probability of causing serious health consequences. Suspension makes it illegal to distribute any cosmetic products from that facility in the U.S.

Small Business Exemptions and Federal Preemption

Companies with average gross annual U.S. sales under $1 million over the previous three years are generally exempt from new Good Manufacturing Practices, facility registration, and product listing requirements. Exemptions don’t apply to companies manufacturing products that are injected, intended for internal use, regularly contact eyes, or alter appearance for more than 24 hours.

MoCRA’s preemption clause establishes single, national standards for key regulatory areas. State and local laws differing from federal requirements on registration, product listing, Good Manufacturing Practices, records access, recalls, adverse event reporting, and safety substantiation are preempted.

However, states retain authority to prohibit or restrict specific cosmetic ingredients. This creates a nuanced power balance: regulatory processes are federalized while product content can still be shaped by state actions.

Reading Cosmetic Labels Like an Expert

In a system where most cosmetics don’t undergo pre-market approval, product labels become the primary tool for consumer information and FDA enforcement. Labeling rules are exceptionally detailed and strict, governed by the Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act.

Label violations can render products “misbranded” – as serious under federal law as selling unsafe or “adulterated” products.

The Two Faces of Your Product

Cosmetic labeling requirements divide between two main package areas:

Principal Display Panel (PDP): The part most likely displayed or examined by consumers at purchase – essentially the front of the product.

Information Panel: Other label parts, typically back or side panels, where additional required information like ingredient lists and manufacturer addresses appear.

All required information must be prominently displayed in English (unless products are distributed solely in territories like Puerto Rico where other languages predominate).

Front Panel Requirements

Two key pieces of information must appear on every cosmetic product front:

Statement of Identity: Clear statement of what the product is, using common or usual names (shampoo, moisturizer, lipstick).

Net Quantity of Contents: Product amount in the container, stated in both U.S. customary units (ounces, fluid ounces) and metric units (grams, milliliters). This must be placed on the bottom 30% of the PDP.

Cracking the Ingredient Code

The ingredient declaration is one of the most important label parts for safety-conscious consumers, typically found on information panels following specific rules.

Order of Ingredients: With few exceptions, ingredients must be listed in descending order of predominance by weight. The first few ingredients make up the largest portions of product formulas.

The 1% Rule: Ingredients present at 1% concentration or less may be listed in any order after ingredients present at concentrations greater than 1%. This gives manufacturers flexibility in listing minor ingredients like preservatives, fragrances, or colorants.

Ingredient Names: Manufacturers must use established names for ingredients, typically International Nomenclature of Cosmetic Ingredients (INCI) names, ensuring industry consistency.

The Fragrance Loophole Gets Closed: For decades, federal regulations allowed manufacturers to simply list “fragrance” or “flavor” without disclosing specific chemical components, protecting proprietary formulas as trade secrets. MoCRA addresses this by mandating cosmetic labels must now disclose each fragrance allergen contained in products. The FDA is creating and publishing a list of specific allergens that must be declared.

Color Additives: All color additives must be listed at the ingredient declaration end in any order after other ingredients. Crucially, all color additives must be FDA-approved for their specific intended cosmetic use.

Other Required Information

Information panels must also include:

Name and Place of Business: Labels must state the manufacturer, packer, or distributor name and address. If the listed company isn’t the actual manufacturer, the relationship must be clarified with phrases like “Manufactured for” or “Distributed by.”

MoCRA’s Contact Information: Labels must provide domestic addresses, phone numbers, or electronic contact information (websites, email) through which responsible persons can receive consumer adverse event reports.

Warning Statements: If cosmetics have potential harm when used as directed, they must bear clear warning statements. Aerosol products must include warnings like “Warning – Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate.” If cosmetics haven’t had safety adequately substantiated, labels must state: “Warning–The safety of this product has not been determined.”

Country of Origin: Imported cosmetics must be marked showing their country of origin, complying with U.S. Customs and Border Protection requirements.

The Evolution of U.S. Cosmetics Law

Current cosmetic regulation results from long, often reactive history. Unlike proactive systems, major U.S. cosmetic law advancements have typically followed public tragedies and outrage, with long legislative inertia periods between. MoCRA represents the latest, most significant example of this event-driven pattern.

The Wild West Era

At the 20th century’s turn, America’s cosmetics market was truly unregulated. As makeup and personal care use grew, manufacturers operated without federal oversight. Products often contained dangerous substances like lead-based face powders linked to severe health problems and death.

When Congress passed the landmark Pure Food and Drugs Act of 1906, revolutionizing food and medicine safety, cosmetics were deliberately excluded as they weren’t considered serious public health threats.

Tragedy Sparks Change: The 1938 Law

Public sentiment shifted in the 1930s. The FDA created an exhibit of dangerous products a reporter dubbed the “American Chamber of Horrors.” But tragedy provided the final catalyst.

In 1937, a drug manufacturer created liquid sulfanilamide using diethylene glycol – a toxic industrial antifreeze solvent – as the base. “Elixir Sulfanilamide” killed more than 100 people, many children. Combined with reports of eyelash products causing blindness, this disaster pushed Congress to act.

In 1938, President Franklin D. Roosevelt signed the Federal Food, Drug, and Cosmetic Act – the first granting FDA authority over cosmetics and medical devices. It established foundational legal concepts of “adulteration” (unsafe products) and “misbranding” (falsely labeled products) that remain cosmetic regulation cornerstones today.

Eight Decades of Self-Regulation

For the next 84 years, the 1938 Act’s core cosmetic tenets remained largely unchanged. FDA authority was significantly more limited than its authority over drugs or food. Key oversight functions were managed through voluntary rather than mandatory programs.

The Voluntary Cosmetic Registration Program (VCRP), established in 1971, allowed companies to register facilities and file product ingredient lists with the FDA, but they weren’t required to do so. The agency lacked power to order mandatory recalls of dangerous cosmetics or access company safety records, creating effectively industry self-regulated systems.

Modern Push for Reform

Beginning in the early 2000s, consumer awareness and advocacy grew. Groups like the Campaign for Safe Cosmetics and Environmental Working Group highlighted potentially harmful chemicals in personal care products and drew attention to significant gaps between U.S. regulations and European Union standards, where over 1,300 chemicals are banned from cosmetics compared to the FDA’s short list.

High-profile safety incidents, such as discovering asbestos contamination in talc-based powders and makeup, further fueled public concern and reform calls. This mounting pressure culminated in bipartisan efforts to pass MoCRA, enacted in late 2022 as direct legislative response to perceived weaknesses in the eight-decade-old 1938 law.

Good Manufacturing Practices: From Guidelines to Law

The FDA’s primary cosmetic safety role is post-market surveillance – monitoring products after consumer introduction. This enforcement relies on facility inspections, product testing, and responding to problem reports. A cornerstone of preventing safety issues before they arise is adherence to Good Manufacturing Practices (GMPs).

The Shift to Mandatory Standards

For decades, the FDA operated with GMP guidelines for the cosmetics industry – detailed best practice recommendations that weren’t legally binding or enforceable. This has changed under MoCRA.

The FDA is now mandated to establish and enforce legally binding GMP regulations for all facilities manufacturing or processing cosmetic products. This represents a fundamental shift from recommendation to requirement. The FDA is expected to issue proposed GMP rules in late 2025, widely anticipated to align with international standard ISO 22716:2007 already used by many global manufacturers.

Inside Compliant Facilities

GMPs are comprehensive standards and procedures ensuring products are consistently manufactured to be safe, pure, and high quality. Deficiencies in these practices are primary root causes of product safety failures, particularly microbial contamination leading to adulteration and triggering FDA enforcement actions like Warning Letters and recalls.

Moving to mandatory GMPs directly attempts to break this causal chain at its source through prevention focus.

Buildings and Facilities: Physical plants must be suitably sized and designed to prevent mix-ups or cross-contamination between raw materials and finished products. Surfaces must be smooth and easy to clean, with adequate pest control, ventilation, and lighting.

Equipment: All manufacturing equipment must be properly designed, made of appropriate materials, and regularly calibrated, cleaned, and maintained to prevent product adulteration.

Personnel: Employees must have necessary training and experience to perform duties. They must follow strict personal hygiene protocols, including wearing appropriate clean clothing and protective gear, to prevent product contamination.

Raw Materials: There must be procedures for proper storage, handling, and testing of all incoming raw materials ensuring they meet specifications and are contamination-free before production use.

Production and Records: The entire manufacturing process, from weighing ingredients to packaging final products, must be controlled and documented. Each batch must be assigned unique lot numbers, and detailed records must be kept allowing full traceability in problem or recall events.

When Products Go Wrong: Adulterated and Misbranded Cosmetics

FDA enforcement authority is built around two key legal concepts:

Adulterated Cosmetics

Cosmetics are considered adulterated if they:

• Contain substances that could make them harmful under normal use conditions
• Are manufactured or held in unsanitary conditions where they may have become contaminated
• Contain unapproved color additives

Microbial contamination is a frequent adulteration cause.

Misbranded Cosmetics

Cosmetics are considered misbranded if their labeling is false or misleading in any way, fails to include legally required information (like ingredient lists or net quantity of contents), or if containers are made or filled deceptively.

Under federal law, it’s illegal for companies to introduce adulterated or misbranded cosmetics into interstate commerce.

FDA’s Enforcement Arsenal

When the FDA identifies violations, it has several tools:

Inspections: The FDA can conduct cosmetic manufacturing facility inspections and review procedures and records.

Warning Letters: Often the FDA’s first step is issuing public Warning Letters detailing specific violations (illegal drug claims, prohibited ingredients, or adulteration from poor GMPs) and demanding corrective action.

Recalls: When products pose health risks, they may be recalled from markets. MoCRA now gives the FDA mandatory recall authority for the most serious situations. The FDA classifies recalls by health hazard level:

• Class I: Reasonable probability of causing serious health consequences or death
• Class II: May cause temporary or reversible health problems
• Class III: Adverse health consequences unlikely

The FDA maintains a public database of all ongoing and recent recalls at FDA Recalls.

Banned, Restricted, and Scrutinized Ingredients

A common consumer confusion point is which ingredients are and aren’t allowed in cosmetics. Except for color additives, the FDA doesn’t approve individual cosmetic ingredients before sale. However, law prohibits marketing cosmetics containing substances making them harmful when used as intended.

The stark difference between the FDA’s short prohibited substances list and the European Union’s 1,300+ banned ingredients reflects fundamentally different regulatory philosophies. The U.S. historically operates on a “safety responsibility” model where products are generally acceptable until proven risky, with safety burden on manufacturers. The EU often employs a “precautionary principle” where substances may be banned from caution if harm is suspected, even without definitive proof.

FDA’s Official Prohibited and Restricted List

Color Additives: Special Pre-Market Approval

Color additives are the one cosmetic ingredient category subject to strict pre-market FDA approval. Color additives cannot be legally used in cosmetics unless specifically approved by the agency for intended use (eye area use, general cosmetic use). Some color additives must come from batches certified by FDA laboratories for purity before use.

Common Consumer Concerns

Many ingredients subject to public debate and concern aren’t on the FDA’s prohibited list. The agency’s positions are based on ongoing scientific review:

Parabens: These preservatives prevent bacteria and mold growth in cosmetics. While some studies raise concerns about potential endocrine disruption links, the FDA’s current position, based on available science review, is that paraben levels used in cosmetics aren’t concerning.

Phthalates: These chemicals are often used in fragrances to make scents last longer. The FDA continues monitoring scientific literature on phthalates but hasn’t found sufficient evidence concluding that types and levels used in cosmetics pose consumer safety risks.

Formaldehyde: A known carcinogen, formaldehyde can be an ingredient in some nail hardeners and is released by certain preservatives or during some professional hair smoothing treatments. The FDA continues monitoring products and safety data related to cosmetic formaldehyde.

Addressing Hidden Dangers: MoCRA’s New Contaminant Mandates

Some of the greatest cosmetic health risks come not from intentional ingredients but from unintentional contaminants. MoCRA gives the FDA new, direct authority to address two prominent concerns.

Asbestos in Talc

Asbestos is a known human carcinogen often found in nature near talc deposits. If talc isn’t mined carefully and purified properly, it can become contaminated with asbestos, posing serious health risks when used in products like face powders or eye shadows.

MoCRA now requires the FDA to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This process is currently underway through federal rulemaking.

PFAS: “Forever Chemicals”

Per- and polyfluoroalkyl substances, often called “forever chemicals,” are a class of thousands of chemicals used in some cosmetics to increase durability and water resistance. Growing concerns exist about their potential health effects.

MoCRA mandates the FDA assess scientific evidence regarding PFAS safety in cosmetics and publish public reports on findings.

Your Role in Cosmetics Safety

While the FDA and cosmetics industry have legal product safety responsibilities, consumers play vital roles in the nation’s post-market surveillance system. By reporting problems and using products safely, you can help the FDA identify and address potential health risks.

When Bad Reactions Happen

If you experience negative reactions to cosmetic products – rashes, infections, hair loss, or other health issues – the FDA recommends two steps:

First: Stop using the product immediately and contact your doctor or healthcare provider for medical advice and treatment.

Second: Report the problem to the FDA. Your report provides valuable information helping the agency monitor product safety on the market.

MedWatch: FDA’s Safety Reporting Program

MedWatch is the FDA’s safety information and adverse event reporting program – the official channel for consumers and health professionals to report problems with medical products, dietary supplements, and cosmetics.

While consumer reporting is voluntary, it’s a crucial FDA data source. Single reports or similar report patterns can be critical first signals alerting the agency to potential product safety issues, sometimes triggering investigations, recalls, or other regulatory actions.

MoCRA has created a new, two-tiered surveillance system combining broad, voluntary consumer reporting with new mandatory industry reporting requirements. While consumers can report any problems – from minor irritations to contamination suspicions – companies are now legally required to report only the most serious adverse events directly to the agency.

These information streams work together, giving the FDA more comprehensive and robust real-time product safety views than ever before. Consumer reports act as wide, early-warning nets while mandatory industry reports provide direct, high-priority channels for the most critical health threats.

How to File Reports

The FDA has made it easy to file reports through its MedWatch program. You should report not only adverse health reactions but also product quality issues you observe, such as bad smells, color changes, or foreign material presence, which could signal contamination.

Online: The fastest, most encouraged method is using the electronic MedWatch Online Voluntary Reporting Form.

Mail or Fax: Download paper form versions, complete them, and mail to the FDA or fax toll-free to 1-800-332-0178.

Phone: Call the FDA’s Food and Cosmetics Information Center toll-free at 1-888-SAFEFOOD (1-888-723-3366) to report problems over the phone.

Practical Safety Tips

You can reduce personal risk by following FDA-recommended safety tips:

Don’t share cosmetics: Sharing products like mascara, eyeliner, or lipstick can easily transfer germs and lead to infections.

Don’t add water or saliva: Adding liquids to products like mascara can introduce harmful bacteria and dilute preservatives designed to keep products safe.

Store properly: Keep products away from direct sunlight and high humidity, as heat and moisture can cause preservative breakdown and encourage microorganism growth.

Keep containers and applicators clean: Wash hands before applying cosmetics, especially when dipping fingers into jars or pots.

Pay attention to recalls and safety alerts: The FDA publishes recalled product information. Stay informed by checking the FDA’s recall database or following the agency’s social media channels.

Read labels: Be aware that if manufacturers haven’t conducted testing to substantiate product safety, labels are required by law to include: “Warning–The safety of this product has not been determined.”

The New Regulatory Landscape

MoCRA represents a watershed moment in American cosmetics regulation, ending an 84-year era of industry self-regulation and ushering in comprehensive federal oversight. Companies now face mandatory registration, product listing, safety documentation, and adverse event reporting requirements. The FDA has gained unprecedented enforcement powers including mandatory recall authority and records access.

For consumers, this means greater transparency through improved labeling requirements, better safety monitoring through mandatory adverse event reporting, and stronger regulatory response capabilities when problems arise. The new law creates a modern regulatory framework more aligned with international standards while preserving the innovation and diversity that characterizes the American beauty industry.

Whether you’re applying mascara, shampooing your hair, or moisturizing your skin, you’re now protected by the most comprehensive cosmetics safety system in U.S. history. The combination of strengthened industry accountability, enhanced FDA authority, and continued consumer vigilance creates multiple layers of protection ensuring the products you use daily are as safe as possible.

Our articles make government information more accessible. Please consult a qualified professional for financial, legal, or health advice specific to your circumstances.