Aug. 11, 2025
Beauty & Personal Care
Below are frequently asked questions and our answers to them. We have also provided links to learn more information about each of the specific topics identified below. Feel free to contact the FDA - CFSAN - Outreach and Information Center (salesforce-sites.com) for general cosmetic questions or for specific questions regarding Modernization of Cosmetics Regulation Act of (MoCRA), please contact .
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1. Does FDA regulate cosmetics?
2. How do I know if my products are regulated as cosmetics, and not as drugs or some other product category?
3. Do I need to have my cosmetic products or ingredients approved by FDA?
4. What do I need to know about using color additives in cosmetics?
5. Do I need to register my cosmetic product facility or list products with FDA?
6. Can I manufacture cosmetics in my home or salon?
7. Can I label my cosmetics “natural” or “organic”?
8. Must I test my products and ingredients?
9. Using available safety data
10. Doing additional testing
11. Can I use a Post Office (P.O.) box or website for the address on the label?
12. Where can I learn more about labeling requirements?
13. What are the local requirements for starting a cosmetics business?
14. Do I need to get a license from FDA to manufacture or market cosmetics?
15. Where can I find more information on FDA requirements I need to know about?
Yes. FDA regulates cosmetics under the Federal Food, Drug and Cosmetic Act (FD&C Act). Under MoCRA, which expanded FDA’s authority under the FD&C Act law, cosmetics must not be adulterated or misbranded. For example, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled. Any color additives they contain must be approved for the intended use, and some must be from batches certified in FDA’s own labs. Packaging and labeling must not be deceptive. If you manufacture or market cosmetics, you have a legal responsibility for the safety and labeling of your products.
To learn more, see “Resources for You: Industry” and “Cosmetics: Guidance and Regulations,” where you will find overviews of the laws, links to the laws and regulations themselves, and more.
A product’s intended use is determined by factors such as product claims, consumer expectations, and certain ingredients. A product is a cosmetic if it is intended for uses such as cleansing the human body, making a person more attractive, or changing a person’s appearance. Here are some examples of products marketed as cosmetics:
If a product is intended to affect the way a person’s body works, or to treat or prevent disease, it’s a drug, but sometimes it is both a cosmetic and a drug depending on its claims. Drugs must meet different requirements.
Some “personal care products” are regulated by FDA as medical devices or as dietary supplements, while others, including some soaps, are regulated by the Consumer Product Safety Commission (CPSC). To learn more about these product categories, including how FDA determines a product’s intended use, see Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).
Here are some more resources:
The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded. This means that they must be safe for consumers when used according to the labeling, or as people customarily use them, and they must be properly labeled. To learn more, see Key Legal Concepts: Interstate Commerce, Adulterated, and Misbranded.
With the exception of color additives and ingredients that are prohibited or restricted by FDA regulations, you may use any ingredient in your cosmetic, as long as it does not cause the product to be adulterated in any way. You are legally responsible for making sure your cosmetics are safe and properly labeled, in compliance with all the laws and regulations that apply to them.
Remember, however, that not all “personal care products” are regulated as cosmetics under U.S. law. For example, some are regulated as drugs. If your product is a drug under U.S. law, it must meet the requirements for drugs, such as premarket approval. For more information about how some “personal care products” are regulated by FDA as medical devices, while others are regulated by the CPSC, see #2 above.
A color additive, other than coloring materials intended for use as coal-tar hair dyes, must be approved by FDA for the intended use. These color additives are listed in regulations called “listing regulations.” Some may be used only if they are from batches certified in FDA’s own labs. Here are some resources to help you learn more:
Yes, you may need to register your facility and list your cosmetics products. Please see our Draft Guidance that describes the Modernization of Cosmetics Regulation Act of (MoCRA) requirements for facility registration and product listing, and the exemptions under MoCRA for certain small businesses.
MoCRA exempts certain small businesses from facility registration and product listing.
However, such exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products:
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices (For ex. Class 1 and Class II Device Exemptions).
If, however, your products are drugs, or both cosmetics and drugs, they must meet the requirements for drug registration. Similarly, importers of cosmetic ingredients that are also classified as food products must meet the registration requirements of the Bioterrorism Act of .
It’s not against the law to manufacture cosmetics in your home. Keep in mind, however, that it’s your responsibility to manufacture products in an environment that will not cause them to become adulterated.
Here are some of the ways in which a cosmetic can become adulterated:
FDA intends to conduct rulemaking as part of the implementation of MoCRA, which requires FDA to establish good manufacturing practices (GMP) that, to the extent practicable and appropriate, are consistent with national and international standards. If you manufacture homemade cosmetics or own a salon, exemption from GMP requirements may apply. For more information on GMP, please see:
The same requirements for safety and labeling apply to all cosmetics, no matter what their source. This includes, for example, making sure that all your labeling is truthful and not misleading.
FDA has not defined the term “natural” and has not established a regulatory definition for this term in cosmetic labeling.
FDA also does not have regulations for the term "organic" for cosmetics. The U.S. Department of Agriculture (USDA) regulates the use of the term “organic” for agricultural products under the National Organic Program (NOP). If you have questions about the use of the term “organic,” contact USDA. Answers to some common questions about "organic" cosmetics are available on our website under “‘Organic’ Cosmetics.”
Don’t use terms such as “natural” as part of an ingredient statement, because ingredients must be listed by their common or usual names, without additional description.
And remember, choosing ingredients from sources you consider “organic” or “natural” is no guarantee that they are safe. You are still responsible for making sure your ingredients are safe when used according to the labeling, or as they are customarily used, no matter what kinds of ingredients you use.
In general, a manufacturer, packer or distributor whose name appears on the label of a cosmetic product is required to ensure adequate substantiation of safety of their cosmetic product and to maintain records that support substantiation. Adequate substantiation of safety means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe. Animal testing is not a requirement. It’s important, however, that all data used to support the safety are derived from scientifically robust methods.
FDA does not require specific tests to demonstrate the safety of individual cosmetic products or ingredients. Nor does FDA require cosmetic companies to share their safety information with FDA prior to marketing of their products. However, if certain conditions are met, FDA can access and copy records, including safety substantiation data for cosmetic products and their ingredients.
FDA has consistently advised manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that "the safety of a product can be adequately substantiated through:
Additionally, there are regulations that prohibit or restrict the use of several ingredients in cosmetic products. (See 21 CFR 700.11-700.35.)
For more resources on cosmetics safety substantiation, please see Product Testing of Cosmetics.
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Manufacturers can use relevant safety data that is already available to support the safety of their products.
Here are some examples:
The Cosmetic Ingredient Review (CIR) website has information on the safety of cosmetic ingredients that they have reviewed. (CIR is an industry-funded panel of scientific and medical experts who review the safety of cosmetic ingredients. FDA participates in CIR meetings, but does not vote, and we may agree or disagree with CIR conclusions. However, we do take CIR reviews into consideration when we evaluate cosmetic ingredient safety.)
You may also need to do toxicological testing to fill in any gaps in the information that’s available. Toxicology or other testing methods may be necessary to determine the safety of each ingredient and the finished product. And don’t forget microbiological safety. Cosmetics do not have to be sterile, but they must not contain any harmful microorganisms, and the number of aerobic microorganisms per gram must be low. To learn more, see “Microbiological Methods for Cosmetics.”
Many factors can affect how your product may become contaminated, including use by consumers, such as dipping one’s fingers into a jar. If you do not have the technical expertise to determine the best way to ensure that your product is protected from contamination, you may want to work with a consultant.
For more resources on cosmetics safety substantiation, please see Product Testing of Cosmetics.
A post office box or website address is not adequate for this labeling requirement.
The FD&C Act requires cosmetic labels to identify the name and place of business of the manufacturer, packer, or distributor. By regulation, this includes the street address, city, state, and ZIP code, although you may omit the street address if your firm is listed in a current city or directory. You may use the main place of business instead of the actual place where the cosmetic was manufactured, packed, or distributed, unless such a statement would be misleading.
If you use the distributor’s address, you must use a phrase such as "Distributed by" or "Manufactured for," followed by that firm's name and place of business. The name of the firm must be the corporate name. See the regulation on name and place of business at 21 CFR 701.12.
Cosmetic labeling is not subject to premarket approval by FDA. It’s your responsibility to make sure your labeling meets all requirements. For specific labeling questions, please contact the FDA - CFSAN - Outreach and Information Center (salesforce-sites.com) or for specific questions regarding Modernization of Cosmetics Regulation Act of (MoCRA), please contact .
Here are some useful resources:
Some cosmetic labeling requirements are regulated by other federal agencies. For example, the U.S. Federal Trade Commission regulates claims of “Made in USA.” Other country of origin labeling is regulated by U.S. Customs and Border Protection (see “Chapter 13-Country of Origin Marking”).
You may wish to work with a labeling consultant. FDA, as a government agency, does not provide referrals to private consultants.
You will need to contact your state and local authorities for that information. The Small Business Administration can also help.
FDA does not license cosmetics firms. However, state or local authorities may require licensing or have other requirements you need to know about. You will need to contact your state or local authorities directly. Again, the Small Business Administration may be able to help.
Drivers Impact Analysis
Driver (~) % Impact on CAGR Forecast Geographic Relevance Impact Timeline Growing emphasis on personal grooming and aesthetics +1.2% Global; stronger in North America and Europe Medium term (2-4 years) Sustainability and clean beauty preferences +0.8% Global; stronger in Europe and North America Long term (≥ 4 years) Influence of social media platforms and beauty influencers +1.5% Global; stronger in Asia-Pacific and North America Short term (≤ 2 years) Innovation in product formulation and applicators +0.9% Global; stronger in North America and Europe Medium term (2-4 years) Increasing disposable income boosting premium product adoption +0.8% Global; stronger in Asia-Pacific & Latin America Medium term (2-4 years) Growing popularity of e-commerce platforms for beauty products +0.9% Global; strongest in Asia-Pacific Short term (≤ 2 years) Source: Mordor IntelligenceGrowing Emphasis on Personal Grooming and Aesthetics
The growing emphasis on personal appearance has shifted eye makeup from an occasional accessory to a daily necessity for many consumers. This change is particularly pronounced among younger demographics, who perceive makeup as a means of self-expression rather than solely a beauty product. The rise of virtual meetings and online interactions has heightened the relevance of eye makeup, as eyes have become the primary focus of communication during mask-wearing periods. This behavioral shift has proven resilient, with L'Oréal reporting that consumers continue to prioritize eye makeup even after the lifting of mask mandates. Furthermore, the trend is expanding beyond traditional consumer segments, with men's eye makeup emerging as a key growth area, particularly in Asian markets where gender-fluid beauty concepts are gaining widespread acceptance. In response, brands are introducing specialized formulations and launching targeted marketing campaigns to address this growing market segment.
Sustainability and Clean Beauty Preferences
The rising demand for natural pigments and cruelty-free testing protocols is driving growth in the natural/organic sub-segment of the eye makeup market, surpassing historical growth rates. Ingredient transparency dashboards, now a standard feature on brand websites, are bridging the information gap between manufacturers and consumers. Furthermore, regulatory tightening, once viewed as a cost challenge, has become a strategic advantage for early adopters who comply with or exceed regulatory standards. Companies embracing clean beauty practices are also reporting lower product return rates, indicating improved consumer satisfaction. For instance, in January , Maybelline New York launched a new Conscious Together sustainability initiative, under which it just launched its Green Edition makeup line, including an eye makeup range made without animal-derived ingredients and containing 95% bio-based formulations and 70% natural-origin ingredients.
Influence of Social Media Platforms and Beauty Influencers
Platforms like TikTok and Instagram have become the go-to channels for consumers to discover, evaluate, and purchase eye makeup products. The influence of these platforms is evident: Gen Z shoppers have made eye makeup purchases based solely on TikTok influencer endorsements. In , 94% of households in the European Union had internet access, underscoring the significant role of increasing internet penetration in driving the influence of social media platforms and beauty influencers on consumer behavior and market trends [1]Eurostat, "Digital Economy and Society Statistics - Household and Individuals," ec.europa.eu. Beyond merely raising product awareness, these influencers also shape application techniques, with tutorial videos boosting demand for products that achieve trending looks. The importance of perceived influencer credibility on consumer attitudes, highlighting trustworthiness as the paramount attribute. Consequently, brands are shifting their strategy, prioritizing long-term collaborations with influencers to forge deeper, more authentic connections with their target audiences.
Innovation in Product Formulation and Applicators
Research and Development teams are integrating color and care by incorporating actives like peptides into mascaras and liners, offering lash-strengthening benefits. The use of precision applicators and AI-driven shade-matching tools is driving the convergence of hardware and software in the eye makeup market. This shift highlights a transition in value creation from solely focusing on pigment intensity to enhancing the overall user experience. As a result, manufacturers are forming cross-functional teams comprising chemists and UX designers. Additionally, innovations such as stabilized applicators are enabling access for consumers with limited hand mobility, thereby expanding the market's potential customer base.
Restraints Impact Analysis
Restraint (~) % Impact on CAGR Forecast Geographic Relevance Impact Timeline Consumer concerns over product safety and ingredients -0.7% Global; stronger in Europe and North America Medium term (2-4 years) Counterfeit products affecting brand reputation -0.3% Global; stronger in Asia-Pacific and emerging markets Short term (≤ 2 years) High product costs limiting consumer adoption -0.2% Global Short term (≤ 2 years) Stringent regulatory standards impacting market growth -0.2% Global; stronger in Europe Long term (≥ 4 years) Source: Mordor IntelligenceConsumer Concerns Over Product Safety and Ingredients
Heightened safety concerns are emerging as a significant restraint in the eye makeup market, driven by growing consumer awareness of health risks linked to specific ingredients and formulations. The FDA has identified key risks in eye cosmetics, including microbial contamination and the presence of harmful substances such as lead and asbestos. A FDA survey reported that 8% of eye area cosmetics contained microorganism levels exceeding recommended thresholds, raising questions about the effectiveness of preservation systems, particularly in products marketed as "preservative-free" [2]U.S. Food & Drug Administration, “Cosmetics Recalls and Alerts,” fda.gov. Beyond microbial contamination, safety concerns also include allergic reactions and ocular irritation, with studies indicating that eye cosmetics can disrupt tear film stability and contribute to dry eye symptoms. In response to these challenges, the regulatory environment is evolving.
Counterfeit Products Affecting Brand Reputation
Counterfeit eye makeup products are disrupting the cosmetics market, diminishing brand equity and revenue while eroding consumer confidence. According to a report by the EUIPO, counterfeiting costs the European cosmetics industry an annual loss of EUR 3 billion, accounting for 4.8% of the industry's total sales [3]EUIPO, "Economic Impact of Counterfeiting in the Clothing, Cosmetics, and Toy Sectors in the EU," euipo.europa.eu. Eye makeup, known for its high value-to-weight ratio and strong brand recognition, is particularly susceptible. The health risks associated with counterfeit eye products are significant, as these items often contain hazardous substances such as lead and mercury, which can result in severe eye infections and allergic reactions. The issue is further intensified by e-commerce platforms, where third-party sellers frequently list counterfeit products alongside genuine ones, making it challenging for consumers to differentiate. A report from the U.S. Government Accountability Office revealed that all cosmetic samples obtained from reputable online sellers were counterfeit, emphasizing the scale of the problem. In response, brands are adopting anti-counterfeiting measures, including QR codes, holograms, and blockchain-based verification systems. However, these initiatives increase production costs, which may lead to higher prices for consumers.
By Product Type: Eye Liner Dominates, Eyeshadow Accelerates
In , eye liner captured a dominant 33.61% share of the eye makeup market, underscoring its foundational role across diverse price points. This consistent demand has led brands to prioritize innovations in applicator ergonomics over radical formula changes. Notably, even minor enhancements, like faster-drying vegan formulas, significantly bolster brand loyalty, as consumers tend to stick with their preferred liner once satisfied.
Forecasted to grow at a 4.83% CAGR from to , eye shadow is set to outpace the broader eye makeup industry's growth. The introduction of cream-to-powder textures addresses fallout concerns, appealing to novice users. Furthermore, the segment's heightened colour intensity suggests a shift in consumer perception: natural aesthetics and bold artistry are no longer seen as opposites. Instead, consumers fluidly navigate between the two, creating a richer palette diversity.
By Category: Mass Products Lead, Premium Accelerates
In , mass products will account for 64.71% of the eye makeup market size, driven by extensive supermarket distribution and affordable pricing. Enhanced pigment stability has reduced the performance gap with premium products, enabling mass brands to retain customers who are considering an upgrade. Promotional strategies, such as 'buy-one-get-one' offers, have proven effective in driving unplanned purchases, thereby increasing overall sales during peak holiday periods.
The premium product segment is projected to grow at a 5.32% CAGR through , leveraging experiential retail formats and subscription boxes that lower barriers to product trials. Hybrid formulations combining skincare and color justify higher price points, shifting revenue share toward the premium segment despite a smaller unit share. The segment's accelerated growth reflects a rising trend of consumers spending more on self-reward occasions.
By Ingredient: Conventional/Synthetic Dominates, Natural/Organic Rises
Conventional/Synthetic ingredients maintain market leadership with a 74.61% share in , benefiting from established supply chains, consistent performance, and cost advantages. These formulations are advancing through innovations focused on enhancing longevity, pigmentation, and ease of application.
Conversely, the natural/organic segment is experiencing rapid growth, with a projected CAGR of 5.71% from to , reflecting increasing consumer demand for clean beauty products. This growth is fueled by heightened awareness of potential health risks associated with certain synthetic ingredients, particularly in products applied near sensitive areas like the eyes. The FDA has raised concerns about ingredients such as carbon black and heavy metals in eye makeup, further accelerating the transition toward natural alternatives.
By Distribution Channel: Specialty Stores Lead, Online Retail Accelerates
Specialty stores currently dominate the eye makeup distribution landscape with a 41.61% market share in , leveraging their curated product selections and personalized customer experiences. These stores, such as Sephora, leverage curated product assortments and personalized customer engagement to drive sales. Trained staff enhance the shopping experience by offering expert application advice and tailored product recommendations. Sephora exemplifies this strategy, generating approximately 75% of its net sales through its online platform while maintaining a strong physical presence that provides services like virtual try-ons and personalized consultations. In contrast, online retail stores are anticipated to experience the highest growth, with a projected CAGR of 6.13% from -, fueled by convenience, expanded product availability, and advanced digital shopping experiences.
Supermarkets and hypermarkets continue to hold a significant position, particularly in the mass-market eye makeup segment, benefiting from high customer footfall and impulse purchasing behavior. The "other distribution channels" category, which includes direct-to-consumer models and subscription services, is gaining momentum by offering unique value propositions such as personalized product curation. Retailers are increasingly adopting omnichannel strategies, blurring the lines between distribution channels to align with evolving consumer preferences.
In , Asia-Pacific commands the eye makeup market with a 32.63% share and is set to lead with a projected growth rate of 7.61% CAGR from -. This surge is attributed to the region's vast population, rising disposable incomes, and heightened beauty consciousness. China's beauty landscape is rapidly evolving, with domestic brands carving a niche through innovative formulations and culturally attuned marketing. In China, the eye makeup trend leans towards products that not only accentuate natural features but also offer skincare benefits, echoing the nation's longstanding emphasis on skin health. Meanwhile, Japan and South Korea are at the forefront of innovation, especially in product formulations and packaging. Notably, Korean brands are broadening their global reach, capitalizing on distinctive product concepts and savvy digital marketing.
North America, while boasting a mature market, is a hotbed for innovation, especially with premium and masstige products. Digital platforms, especially social media and influencer marketing, are pivotal in shaping product discovery and consumer purchasing habits. As consumers become more discerning about ingredient transparency and corporate environmental practices, sustainability and clean beauty emerge as dominant market drivers. Regulatory changes, like Washington State's Toxic-Free Cosmetics Act set to take effect in January , are reshaping the landscape by banning certain chemicals in cosmetics, potentially altering formulation strategies nationwide.
Europe, bolstered by contributions from both its Western and Eastern regions, remains a key player in the eye makeup arena. The continent's stringent regulatory standards, especially around ingredient safety and sustainability, have hastened the shift towards clean beauty. European consumers' preference for natural ingredients and eco-friendly packaging is spurring innovation. There's also a rising demand for eye makeup that marries skincare benefits with cosmetic appeal. Brands are increasingly turning to augmented reality and virtual try-on technologies, reshaping online shopping experiences. L'Oréal's growth in Europe, outpacing the broader beauty market, underscores the region's enduring allure for eye makeup products, even amidst economic headwinds.
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