Peran Badan Pengawas Obat dan Makanan terhadap Sanksi Pidana dalam Peredaran Produk Kosmetik yang Tidak Memiliki Izin di Kota Medan

Abstract

The development of the cosmetics industry has had both positive and negative impacts on consumers, particularly in Medan City. The high demand for cosmetics has driven irresponsible business actors to produce and distribute cosmetics without distribution permits from the National Agency of Drug and Food Control (BPOM). This study aims to analyze the role of BPOM in supervising illegal cosmetics, examine criminal sanction enforcement, and identify obstacles faced by PPNS investigators at BBPOM Medan. A qualitative empirical juridical approach with field research method was used, employing in-depth interviews, observation, and documentation. The primary informant is the Head of BBPOM Medan. Results show BPOM supervises through pre-market and post-market control, enforcement, and public education. Criminal sanctions under Article 435 of Law No. 17 of 2023 impose up to 12 years imprisonment or Rp5 billion fine. Key obstacles include limited investigator legal expertise, budget constraints, low public participation, fleeing suspects, and files returned by prosecutors. Strengthening investigator capacity, improving inter-agency coordination, and increasing public awareness are urgently needed.