he cosmetics industry has seen unprecedented growth over recent decades, bringing a flood of new cosmetic products and ingredients to the market. With this rise, today’s consumers have access to a vast range of cosmetic options tailored to every beauty goal, from skincare and anti-aging products to hair care and fragrances. Advances in technology and formulation have enabled the development of highly specialized treatments, with innovations such as personalized skincare regimens and smart beauty devices becoming more accessible. The influence of social media and celebrity endorsements has further fueled this boom, creating a culture where beauty products are more than just personal care items—they have become status symbols and lifestyle statements. However, as the industry expands, safety concerns also escalate.

The sheer volume of new products entering the market has led to a lack of standardized regulations and quality control across different regions, creating confusion and uncertainty for consumers. In addition, the growing complexity of ingredients—ranging from chemical compounds to natural extracts—has raised questions about their long-term effects on health and the environment. While many brands highlight the use of “clean” or “sustainable” ingredients, the absence of a clear, universally accepted definition for these terms only adds to the confusion. Furthermore, the increasing prevalence of allergies, sensitivities, and adverse reactions to certain cosmetics ingredients has prompted calls for more stringent safety protocols and greater transparency in product labeling.

As consumers demand more information and accountability, the beauty industry faces a critical challenge: balancing innovation and consumer demands with the need for greater oversight and safety. This evolving landscape will likely continue to shape the future of beauty, with both consumers and regulators seeking to ensure that the pursuit of beauty doesn’t come at the expense of health or ethical practices.

Issues such as the use of potentially harmful ingredients (like parabens and sulfates), counterfeit products, and insufficient ingredient transparency necessitate a systematic approach to consumer safety. Thus enters “cosmetovigilance,” a field designed to monitor, assess, and mitigate risks associated with cosmetic products and ensure they are safe for global consumers.

Cosmetovigilance operates similarly to pharmacovigilance in the pharmaceutical industry. It involves the collection and analysis of data regarding undesirable effects linked to cosmetic products, identifying potential health risks, and ensuring regulatory compliance. This proactive safety monitoring is vital as cosmetics—ranging from skincare and makeup to fragrances—are in daily contact with the body, making even minor risks potentially impactful over exposure time.

Cosmetovigilance: Scope and Need

Cosmetic ingredients range from natural extracts to synthetic compounds. As beauty products incorporate more innovative ingredients, the complexity of these products also increases and makes safety oversight more crucial. Key concerns in today’s beauty landscape include:

Counterfeit Products

Counterfeit cosmetics have emerged as a rapidly expanding issue in recent years, fueled by the ease and anonymity of online sales. These counterfeit products are often designed to look identical to popular, trusted beauty brands, but they pose serious risks due to the harmful and unregulated ingredients they contain. Manufactured primarily in regions with weak regulatory oversight, such as China, India, and Southeast Asia, counterfeit cosmetics often flood global markets, from online platforms to physical retail stores. These fake products frequently contain dangerously high levels of heavy metals—such as lead, mercury, and arsenic—as well as toxic chemicals and bacteria like E. coli and Staphylococcus aureus.

The dangers associated with counterfeit makeup are substantial. Consumers who use these products may experience a range of health issues, including allergic reactions, skin infections, eye damage, respiratory problems, and, in severe cases, long-term organ toxicity from prolonged exposure to harmful substances. The risk extends beyond individual health, as counterfeit cosmetics not only undermine consumer safety but also damage the integrity of legitimate beauty brands. The growing prevalence of these imitations has made it increasingly difficult for consumers to discern what is safe and authentic.

To combat this issue, regulatory bodies such as the US FDA and the European Medicines Agency (EMA) are stepping up efforts to reduce the sale of counterfeit cosmetics through stricter import checks, increased consumer education, and greater collaboration with eCommerce platforms. However, the availability of counterfeit products remains alarmingly high, with online marketplaces being one of the most significant sources for these dangerous items. Counterfeiters often go to great lengths, including using fake packaging and deceptive marketing tactics, to convince consumers they are purchasing genuine products at a lower price.

For consumers, staying vigilant is key. Purchasing only from reputable retailers and authorized distributors is the best way to avoid these dangerous counterfeit goods. With the continued growth of the online marketplace, increased awareness and caution are essential to ensuring that beauty remains safe and trustworthy.

Chemical Ingredients and Potential Risks

While cosmetics ingredients must meet safety standards before they reach the market, certain chemicals have been linked to adverse health effects. For example:

Parabens: Widely used as preservatives in cosmetics, parabens prevent the growth of bacteria and mold. However, they have also been linked to hormone disruption and are suspected of contributing to reproductive and developmental issues. Some studies suggest that parabens can mimic estrogen, potentially increasing the risk of breast cancer.

Phthalates: Often used to increase flexibility and softness in products, phthalates are commonly found in fragrances, nail polishes, and lotions. Yet, phthalates are known endocrine disruptors and may affect human reproductive health.

Formaldehyde: A common preservative, formaldehyde is found in products like nail polish, hair treatments, and other personal care items. It is a known carcinogen and can cause respiratory irritation, skin allergies, and other health problems.

Triclosan: Used for its antibacterial properties, triclosan is found in some soaps and deodorants. It is an endocrine disruptor and can negatively affect the thyroid and other hormone-related functions.

Lead: While not added intentionally, lead can be found as a contaminant in certain lipsticks, eyeliners, and other colored cosmetics. FDA has guidelines for acceptable lead levels, but prolonged exposure still poses risks of organ toxicity, especially in children and pregnant women.

Due to these concerns, the call for “clean” beauty has grown louder, with consumers pushing for products free from synthetic preservatives, fragrances, and other potentially harmful additives.

Regulatory Actions, Industry Responsibilities

In response to these concerns, regulatory bodies worldwide have tightened oversight on cosmetics. The US FDA and the EMA in Europe have introduced new frameworks to monitor adverse reactions, ensure transparency, and enforce safety standards.

The US Modernization of Cosmetics Regulation Act (MoCRA)

The US Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major step toward strengthening cosmetics safety in the United States. Key provisions of MoCRA include:

Mandatory Adverse Event Reporting: Cosmetics companies are now required to report serious adverse reactions to the FDA within 15 days of receiving the report. This ensures a rapid response to potential health risks.

Ingredient Transparency: Companies must disclose all ingredients in their products, including fragrance components, allowing consumers to make informed decisions.

Product Recalls: The FDA now has greater authority to mandate recalls if a cosmetic product is deemed unsafe or misbranded, providing another layer of consumer protection.

European Union Cosmetics Regulation

Europe has long maintained stringent cosmetics regulations, and the EU Cosmetic Products Regulation (Regulation EC No 1223/2009) is considered one of the most comprehensive globally. The regulation includes:

Cosmetic Product Safety Report (CPSR): Before any cosmetic product enters the EU market, it must undergo a safety assessment documented in the CPSR, which evaluates its toxicological profile, microbiological quality, and stability.

Responsible Person Requirement: Every company must appoint a responsible person within the EU to ensure compliance with safety and labeling standards.

Serious Undesirable Effect (SUE) Reporting: The regulation mandates reporting of serious adverse reactions, which are then shared among EU member states, creating a cross-border network of safety monitoring.

These regulations aim to maintain high standards for consumer safety and encourage transparency within the industry.

Empowering Consumers Through Awareness and Choice

As consumers become more aware of these safety issues, they increasingly demand products that prioritize transparency, sustainability, and minimal synthetic additives. Here are several ways consumers can make safer choices:

Read Ingredient Labels: Consumers should familiarize themselves with common ingredients, including those they may wish to avoid, like parabens, phthalates, and formaldehyde.

Support Transparent Brands: Consumers can patronize companies that disclose their full ingredient lists and are clear about their sourcing and manufacturing practices.

Verify Products and Retailers: Purchasing from reputable retailers or directly from brand websites can reduce the risk of buying counterfeit products.

Consider “Clean” Beauty Options: Many brands now offer products free from synthetic fragrances, artificial dyes, and potentially harmful chemicals, often labeled as “clean” or “organic.”

Future Cosmetovigilance

The rise of cosmetovigilance represents a shift towards a more transparent and consumer-focused beauty industry. It empowers regulators, companies, and consumers to address potential risks proactively. While there is still room for progress in global standardization and enforcement, the industry’s future looks increasingly oriented toward health, safety, and sustainability.

For consumers, the evolution of cosmetovigilance offers the assurance that their beauty routines can enhance well-being without compromising health. As the industry continues to innovate, a vigilant approach to safety will be essential in maintaining trust, meeting consumer demands, and setting a new global standard for beauty care.

Learn more about this topic in the regional sessions at DIA’s 2025 Global Annual Meeting.

Cosmetovigilance session panelists (left to right): John Praveen, Thirumalai Velu Swaminathan, Renu Sharma, Fahd Khan, and Umesh Suryawanshi.