Evaluating the Efficacy of Cosmetic Product Safety Regulations in Malaysia: The Role of the National Pharmaceutical Regulatory Agency (NPRA) and Industry Compliance

Abstract

Various legislative measures, such as the Sale of Drugs Act 1952, Control of Drugs and Cosmetics Regulations 1984, Poison Act 1952, Guidelines for Control of Cosmetic Products 2022, and other directives introduced by the NPRA in Malaysia, are intended to control the safety of cosmetic products. Despite these existing laws and directives, cosmetic products containing hazardous ingredients persist in the Malaysian market. NPRA reportedly received 1,041 complaints about cosmetic products in 2022, while its website also displays an annual increase in cases involving cosmetic products that contain hazardous ingredients. The persistent presence of harmful cosmetic products in the market highlights significant gaps in efforts to control hazardous cosmetic products. This study examined the efficacy of cosmetic product safety regulations in Malaysia, focusing on the role of the National Pharmaceutical Regulatory Agency (NPRA) and industry compliance. This qualitative study gathered data from library databases and conducted semi-structured interviews with NPRA officers, cosmetic manufacturers, and cosmetic industry experts. Findings suggest that despite the extensive nature of the regulatory framework, its implementation, which heavily relies on self-regulation and post-market surveillance, requires serious improvement. While some cosmetic producers adhere to Good Manufacturing Practice (GMP) standards, there are still persistent issues related to product notification, misuse of self-regulation, and inadequate penalties for non-compliance. Therefore, an intensive awareness campaign aimed at cosmetic manufacturers is necessary to ensure the production of safe cosmetic products. Consumers must play their role in helping the NPRA control the sale of hazardous cosmetic products by performing safety checks before purchasing them.