Regulating the Gray Zone: Comparative Review of Cosmeceutical Policy Evolution and Harmonization Challenges in India, USA, and South Korea

Abstract

Cosmetics are the sector of the beauty industry that is expanding at the fastest rate. Herbs utilized for their medicinal qualities to treat a range of systemic diseases are also used to alter one's look. Many commercially available products in the cosmetics industry promise to provide skin-benefitting (antiaging, for example) properties when applied topically. Given the abundance of these materials and the wide range of skin appearance effects they cover, this little contribution must inevitably be selective in terms of the quantity of materials addressed and the depth with which each specific material is overviewed. With the introduction of the BB cream, also known as blemish balm or beauty balm, in 2011, Korean beauty made its debut in the West. This skincare product was promoted as a multipurpose product that could be used as a foundation, moisturizer, and sunscreen. Since then, Korean cosmetics have become increasingly well-liked by customers throughout the world and are still well-established in the US, which is the country's third-largest export market. With an emphasis on guaranteeing the safety, effectiveness, and stability of these goods, this comparative analysis looks at the regulatory frameworks for cosmeceuticals in South Korea, the United States, and India, noting variations and difficulties in policy change and harmonization.

Keywords

Introduction

Feature	India	USA	South Korea
Primary legislation	Drug and Cosmetics Act,1940 and New Cosmetics Rules,2020	Federal Food, Drug , and Cosmetic Act and the Fair Packaging and Labelling Act [FPLA], significantly updated by the Modernization of Cosmetics Regulation Act [MoCRA] of 2022	Cosmetics Act , supplemented by the Pharmaceutical Affairs Act for quasi-drugs
Regulating Authority	Central Drugs Standard Control Organization [CDSCO] for import registration; State Licensing Authorities [SLAs] for manufacturing licenses	U.S. Food and Drug Administration [FDA]	Ministry Of Food And Drug Safety [MFDS] and the Korea Pharmaceutical Traders Association [KPTA]
Pre-market Approval	Required for all imported cosmetics with each brand requiring registration with the CDSCO. Manufacturing licenses are required for domestic producers	Only for color additives and over the counter drugs MOCRA, requires manufacturers to register facilities and list all products with the FDA before marketing	Required for functional cosmetics approval from the MFDS is mandatory before manufacturing or importing can begin
Safety Assessment	Requires a safety assessment especially for new or innovative ingredients. Imported products must meet Indian safety standards	Manufacturers are legally responsible for ensuring product safety. MOCRA requires that a responsible person must have adequate safety substantiation for cosmetic products	Mandatory cosmetic safety assessments are now required for all products before distribution and documentation must be retained and made available to the MFDS upon request
Testing	Compliance with Bureau of Indian Standards [BIS] specification is required India has also banned animal testing for cosmetics	Specific testing is not mandated by FDA but manufacturers must ensure safety through adequate substantiation. Animal testing is not a requirement	Animal testing for cosmetics is banned with limited exceptions. Extensive efficacy and safety data are required for functional cosmetic approval

HARMONIZATION CHALLENGES AND POLICY GAPS

Classification Ambiguities

In a number of jurisdictions, the term "cosmeceutical" has no legal definition. For instance, the Food and Drug Administration (FDA) in the United States does not recognize the term "cosmeceutical" as a distinct category; instead, goods must be classified as either medications or cosmetics based on their components and claims .The Drugs & Cosmetics Act, 1940, defines "drug" and "cosmetic," but excludes the term "cosmeceutical," according to the review "Cosmeceuticals: a transit state."  A new category known as "cosmeceuticals" was created in South Korea on July 1, 2000, under the Korean Cosmetic Products Act (KCPA). However, the regulations "do not clearly establish criteria to determine when a cosmetic product becomes a cosmeceutical" or standards to verify efficacy [18].

Efficacy and Safety Testing Gaps

Standards for pre-market testing and post-market surveillance of items that fall between the medicinal and cosmetics domains vary due to classification .Since the term "cosmeceutical" is not recognized, many goods advertised as such in the USA are not subject to FDA approval if they are classified as cosmetics, as stated in "Comprehensive review on cosmeceuticals." As a result, the requirements for effectiveness evidence are inadequate[18]. There is a lack of consistent guidance on functional/efficacy testing for therapeutic claims, but in India, the regulatory catch-all for "cosmeceuticals" means that even though they may be considered cosmetics, they still need to meet safety and labeling standards (such as heavy-metal limits and skin-irritation tests).[19]. While functional cosmetics are subject to more stringent regulations in Korea (such as the Ministry of Food and Drug Safety, or MFDS, overseeing the whitening and anti-wrinkle categories), the KCPA's previous cosmeceutical category was unclear about the necessary level of evidence for efficacy[20].

Claim Regulation and Consumer Transparency

Claim regulation is influenced by classification and testing inconsistencies; what a product can say, how evidence must back it, and how plain the labelling should be all differ. According to the article "Cosmetic-Cosmeceutical Products: Navigating the Regulatory Gray Zone," for instance, the U.S. FDA does not recognize the term "cosmeceutical," therefore a product that makes therapeutic claims may be regulated as a drug; for cosmetics, the label must be true and not deceptive. According to surveys conducted in India, "the lack of guidelines on product claim interpretation as well as an illustrative list of cosmetics  causes difference in interpretation between licensing authorities" across states[18]. In Korea, companies must manage both functional cosmetic regulation and potential drug-classification thresholds. While functional cosmetics have established approved claims (such as brightening and anti-wrinkle), the larger category of cosmeceuticals still has ambiguity surrounding legal claims.

Because of regulatory gaps, consumers may assume that "cosmeceutical" denotes drug-like regulation or rigor, however this may not be the case in many places.[18].

Cross-border Trade and Compliance Barriers

Compliance hurdles hamper the cross-border sale of cosmeceuticals and functional cosmetics because classification, testing, and claims vary by nation .In India, for instance, importation of goods with active chemicals or claims of therapeutic advantages may be subject to drug-license requirements under Chapter III of the Drugs & Cosmetics Act, according to the article "Cosmeceutical Formulation & Regulatory Insights in India"[19]. According to the NTE report on the Republic of Korea by the U.S. Trade Representative, "The KCPA laws relating to cosmeceuticals … don't specify requirements clearly... Efficacy must be demonstrated by meeting a standard. Approvers must check for efficacy and safety. The FDA regulates the import of cosmetics in the United States, but for items having therapeutic intent or drug-like claims, the categorization may change to drug/OTC regulation, increasing the burden of compliance.

Intellectual Property and Innovation Roadblocks

Uncertain regulatory classification and inconsistent IP/enforcement regimes pose challenges to the cosmeceutical industry's innovation environment.

For example, the study "Innovating Beauty: Unveiling the Role of Patents in the Cosmetic Industry" demonstrates how the cosmeceutical/cosmetic industry's high entry barriers and competitive innovation environment are reflected in the concentration of patent filings among significant firms[21].

ROLE OF INTERNATIONAL REGULATORY BODIES

World Health Organization (WHO)

The WHO publishes guidelines and normative standards that can, in turn, influence regulatory frameworks for cosmetics and items that are somewhat "cosmeceutical," despite its primary concentration on medications, vaccines, diagnostics, and blood products. Its "Good Regulatory Practices" guideline, for instance, lists nine fundamental principles for regulatory systems, including legality, consistency, impartiality, proportionality, clarity, efficiency, and transparency. While the World Health Organization does not publish a specific worldwide standard for cosmetics or cosmeceuticals in general, its normative work on the classification, reliance, and regulation of health goods offers helpful guidance for hybrid products [22].

International Organization for Standardization (ISO)

Although they are not legally binding, the international technical standards created by ISO give authorities and industry a single point of reference. In the field of cosmetics. Harmonized guidelines for good manufacturing procedures, packaging, labeling, and testing across jurisdictions are provided by ISO 22715 (Packaging & Labelling for Cosmetics) and other standards. Even in cases where regulatory classification is still inconsistent, these ISO standards aid in bridging technical harmonisation gaps (such as method validation, labelling, and packaging).Even though the regulatory (legal) classification of cosmeceuticals continues to differ, ISO standards promote the "technical" aspect of harmonisation (testing procedures, labelling consistency) [23].

Association of Southeast Asian Nations (ASEAN) Cosmetic Harmonisation

For cosmeceutical-type products and cross-border trade, ASEAN has served as a model for regional cosmetics regulatory harmonization. Important characteristics In order to standardize cosmetic product registration, mutual recognition, and technical standards among ASEAN Member States, the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) was signed on September 2, 2003 [24]

International Cooperation on Cosmetics Regulation (ICCR)

ICCR, a voluntary network of major regulators (Brazil, Canada, EU, Israel, Japan, Republic of Korea, and US) established to promote convergence of cosmetic regulatory procedures, is noteworthy even if it was not on your initial list. Working groups on ingredient safety evaluation, non-animal testing techniques, and sharing best practices .A forum for regulators to agree on proof standards and talk about concerns related to borderline classification .This forum is an example of a new worldwide regulatory cooperation structure that is pertinent to the regulation of cosmetics.[25]

EMERGING FRAMEWORKS FOR COSMETIC-DRUG HYBRID REGULATION

The growth of so-called "cosmeceuticals" or "functional cosmetics" has sparked discussion about hybrid regulatory approaches, even though the majority of jurisdictions treat items as either "cosmetics" or "drugs." Important points: Some countries (like South Korea) have already started using a hybrid tier-approach by classifying "functional cosmetics" (such anti-wrinkle and whitening products) differently from regular cosmetics.

Technically, if not yet legally, bridging the cosmetic-drug gap is supported by the drive for standardized analytical methods (via ISO) and standardized testing guidelines (through WHO/ISO).

For cosmetics, the ASEAN scheme (AHCRS) switches from pre-market clearance to mostly post-market surveillance, which is more indicative of a "lighter" regulatory regime and creates the possibility of hybrid regulation.[24].

ETHICAL, SAFETY, AND CONSUMER-AWARENESS PERSPECTIVES

Ethical Marketing Practices and Misinformation Control

Ethical marketing is becoming a major regulatory and consumer protection concern in the growing cosmeceutical industry. Misinformation is a major concern since products that fall between cosmetics and medicines are prone to making ambiguous or overstated promises.

India

Since there is no specific category for cosmeceuticals in India's regulatory framework for cosmetics (under the Central Drugs Standard Control Organization (CDSCO) and the Bureau of Indian Standards (BIS)), many products marketed with therapeutic-style claims may be classified as cosmetics instead, possibly avoiding more thorough scrutiny [26]. One regulatory gap that has been identified is the lack of explicit requirements regarding product claims. The Indian Vital Vigilance article notes that misleading labeling, counterfeit items, and products with high heavy-metal concentration are still problems. The phenomenon of "misbranded" and "spurious" cosmetics is well-documented [27].

USA

The Food and Drug Administration (FDA) in the United States does not recognize "cosmeceuticals" as a legal category; instead, it maintains the binary classification of "cosmetics" against "drugs." As a result, a crucial ethical and regulatory crossing may occur where items making structural or therapeutic claims are regulated as drugs rather than cosmetics[28].

South Korea

The Ministry of Food and Drug Safety (MFDS) in South Korea has created a category for "functional cosmetics" that requires premarket review for specific claims (such as whitening, wrinkle improvement, and UV protection) and forbids advertising that misleads consumers into believing a cosmetic is a medication [29].

Comparative Ethical Insights & Challenges

Each jurisdiction's ethical marketing requirements must cover claim substantiation, ingredient transparency, avoiding deceptive language, and distinct classification (cosmetic vs. functional/therapeutic).There is a particularly high risk of overpromising (therapeutic efficacy) while taking advantage of cosmetic regulatory laxity because cosmeceutical goods frequently place themselves above "mere cosmetics." E-commerce platforms, social media buzz, and influencer marketing make monitoring even more difficult; authorities must have proactive frameworks in place to keep an eye on digital marketing. It would be beneficial to harmonize claim frameworks, such as by establishing a uniform vocabulary for terms like "functional cosmetic," "advanced skincare," and "therapeutic cosmetic," with specific restrictions on words like "treat," "repair," and "restore."

RESEARCH GAPS AND FUTURE OUTLOOK

Lack of Unified Regulatory Lexicon:

Research Gaps

Scholarly research comparing the definitions, interpretations, and applications of "cosmeceutical," "functional cosmetic," "quasi-drug," and other such borderline categories in India, the United States, and South Korea is few. Empirical research on how manufacturers make classification decisions in various markets—such as whether to register a cosmetic product or a medication, how to phrase claims, and how to place active ingredients—and the resulting regulatory or economic results is few. There is a dearth of legal-analysis research that offers model taxonomy frameworks or regulatory definitions for the cosmeceutical industry that take claim, mechanism, ingredient, risk, and proof into consideration [30] .

Future Outlook

Regulatory organizations, business associations, and academic institutions might create a standardized taxonomy that distinguishes between groups according to factors like risk profile, active mechanism of action, evidence requirements, intended use/claims, and regulatory procedure. Taxonomy like this would give industry, consumers, and regulators clarity.
Stakeholder forums could attempt to create a common language (or at least map equivalencies) for product classification, involving regulators from South Korea, the United States, India, and international organizations such as the International Cooperation on Cosmetics Regulation (ICCR).[30]

Need for standardized testing protocols

Research Gaps

The testing and clinical evidence standards for borderline products in the three jurisdictions—what is necessary for safety, effectiveness, stability, claim substantiation, and manufacturing quality—are not well benchmarked. Few studies have examined the effects of protocol variations on product outcomes, market rejections, and recalls across jurisdictions (e.g., clinical trial design for anti-wrinkle claims, skin penetration tests, and long-term safety).The effectiveness of existing cosmetic testing techniques, which frequently concentrate on consumer safety and physical appearance, for cosmeceutical claims—which may imply biological mechanism or deeper effect—has not been sufficiently examined[30].

Future Outlook

There should be suggestions for globally recognized minimal data packages, such as specified trial size, duration, endpoint measures, inert vs. active control, and safety monitoring for a "wrinkle-reduction" cosmetic claim. Establishing consensus standards for cosmeceutical testing (safety and efficacy) through the ISO, OECD, and ICCR would make it easier for test reports to be recognized by one another and cut down on duplication .International post-market surveillance regulations, ingredient sourcing/traceability standards, and standardized Good Manufacturing Practice (GMP) for cosmeceuticals all require more study. Research could quantify the incremental cost/time trade-offs. Regulators may think about releasing guidelines on what incremental evidence burden applies and when a product transitions from cosmetic to cosmeceutical to medicine. [30]

OPPORTUNITIES FOR AI-DRIVEN REGULATORY HARMONIZATION AND BLOCKCHAIN TRACEABILITY

Research Gaps

While the use of AI and machine learning in cosmetic formulation is growing (for safety and efficacy, see predictive modeling),[30] The capacity of blockchain (or distributed ledger technologies) to enable end-to-end traceability of ingredients, sources, and manufacture in cosmetic and cosmeceutical supply chains, as well as the ability of those systems to connect with various regulatory regimes, has received little scholarly attention. For example, industry criticism has addressed traceability in cosmetics. [31]

Future Outlook

In order to promote harmonization, AI-driven technologies can help business and regulators map claims across countries and categorize items (drugs, cosmetics, and cosmeceuticals) according to language, ingredients, and mechanism. Tools such as "Cosmex AI," for instance, check formulas against a number of regulatory norms. Immutable traceability of ingredients (origin, batch, processing), manufacturing records, packaging, and transparent audit trails across markets can be made possible by blockchain or distributed ledger systems. This promotes regulatory trust, cross-border acceptance, and less supply-chain verification duplication. Combining blockchain and artificial intelligence (AI): for instance, a blockchain record can reveal the provenance of ingredients or production, while an AI system can identify regulatory non-compliance based on claims or ingredients. Prototyping such integrated systems for cosmeceuticals requires further research. For cosmeceutical products, regulatory agencies (in South Korea, the United States, and India) may test digital regulatory sandboxes where AI-based claim screening, blockchain traceability, and smart labeling (QR codes, digital product passports) are tested. Cost/benefit analysis, regulatory acceptability, and adoption hurdles (cost, data governance, and small-brand equity) should all be evaluated in research.[32]

CONCLUSION:

Summary of Comparative Insights At the nexus of pharmaceuticals and cosmetics, the cosmeceutical sector is characterized by fragmented regulation and rapid expansion. A comparison of South Korea, the United States, and India shows stark disparities in the way these nations see and handle "borderline" goods. The absence of a legally recognized "cosmeceutical" category under the Drugs and Cosmetics Act, 1940, creates ambiguity in India, where classification is primarily based on constituent composition and product claims. Compliance, enforcement, and consumer protection are made more difficult by the lack of a clear regulatory framework The Federal Food, Drug, and Cosmetic Act (FD&C Act) in the United States expressly does not recognize "cosmeceuticals" as a separate class. Depending on their claims and intended usage, products can be classified as either medications or cosmetics. The hybrid nature of cosmeceuticals was not addressed by the Modernization of Cosmetics Regulation Act (MoCRA, 2022), despite the fact that it improved monitoring by requiring facility registration and adverse event reporting With "functional cosmetics" (such as whitening, anti-wrinkle, and sunscreen) approved by the Cosmetics Act and undergoing pre-market evaluation by the MFDS, South Korea offers a more structured methodology. The distinctions between functional cosmetics and quasi-pharmaceutical items are not entirely clear, nevertheless, even with this approach.

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