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Deski Bertolens Tungga; Thelma S.M Kadja; Heryanto Amalo

Jurnal Hukum, Administrasi Publik, dan Ilmu Komunikasi 2024 Asosiasi Peneliti dan Pengajar Ilmu Hukum Indonesia

According to data obtained from the Food and Drug Supervisory Agency (BPOM), the total number of illegal cosmetics and/or containing prohibited/dangerous ingredients during the period from October 2021 to August 2022 was more than 1 million pieces with an economic value of IDR 34.4 billion. BPOM also followed up on findings based on reports from several drug and food supervisory authorities in other countries. Based on the report, as many as 46 (forty-six) cosmetics were withdrawn from circulation because they contained prohibited ingredients, microbial contamination, or were counterfeit cosmetics. During the same period, BPOM also carried out cyber patrols. This cyber patrol was carried out on website, social media, and e-commerce platforms to trace and prevent the circulation of illegal cosmetics and BPOM found and blocked (takedown) 83,700 links to the sale of illegal cosmetic products and containing prohibited/dangerous ingredients with a total product amount of 6.5 million pieces and an economic value of Rp 296.9 billion. This proves that there are still many illegal cosmetic products that contain harmful ingredients and do not have a distribution permit.  This research is a normative legal research supported by a statutory approach (statute approcach) which uses secondary data in the form of primary legal materials, secondary legal materials and tertiary legal materials that collect laws and regulations related to the legal issues at hand, case studies, collecting books, journals, dictionaries and other related literature. The legal materials that have been successfully collected are analyzed, namely description, interpretation, evaluation and systematic. The results of this study show that (1) Based on the form of consumer protection from the criminal aspect, there are five forms of consumer protection, namely: Protection against Unsafe Products; Fraud and Fraud Violation of Clear and Correct Information; Violations of Consumer Rights; Abuse of Power or Dominant Position, as well as unfair business practices. Criminal sanctions aim to provide a deterrent effect to business actors who harm consumers. (2) Based on the perspective of criminal law, the actions of DM business actors who have circulated illegal cosmetics without a distribution permit in decision number 572/Pid.Sus/2022/PN Smr, violate the provisions of Article 197 of Law Number 36 of 2009 concerning Health, which has affirmed that every person who deliberately produces and/or distributes pharmaceutical preparations and/or medical devices without having a distribution permit as mentioned in Article 106 paragraph (1) is criminally punished imprisonment for a maximum of (fifteen) years and a maximum fine of Rp.1,500,000,000,- (one billion five hundred million rupiah).

Diana Ndun; Orpa Ganefo Manuain; Rosalind Angel Fanggi

Jurnal Kajian Ilmu Sosial, Politik dan Hukum 2024 Asosiasi Peneliti dan Pengajar Ilmu Hukum Indonesia

This research is a normative research, so this data is carried out by conducting a literature study on the verdict. Data sources are obtained from primary legal materials, namely: laws and regulations and court decisions, secondary obtained from literature and literature studies, tertiary legal materials obtained from the internet, dictionaries, and encyclopedias. The results of the research obtained from analyzing the verdict show that (1). The basis for the judge's consideration in imposing criminal sanctions against distributors of pharmaceutical preparations without expertise and authority by looking at the Judge's Juridical Considerations and Non-Juridical Considerations of the judge is appropriate and uses an Article that meets the elements of the perpetrator's violation in accordance with the Health Law, but the imposition of criminal sanctions is very light and far from the provisions of the Article. (2). The suitability of the imposition of criminal sanctions in Decision Number 150/Pi.Sus/2021/PN Kupang with the Health Law given by the Judge to the defendant is so light that it cannot guarantee that the defendant will feel frustrated and will not repeat his actions again. This makes the sense of justice, usefulness and legal certainty not fulfilled properly. The author's suggestion that the criminal sanctions imposed by the Panel of Judges against the defendant should not only consider the behavior and actions of the defendant but also look at the consequences of the defendant's actions that can have a bad impact on the health of consumers/patients who take the hard drug.

Adrianty Charmelita Valentine Mali; Deddy. R. CH. Manafe; Rosalind Angel Fanggi

Jurnal Kajian Ilmu Sosial, Politik dan Hukum 2024 Asosiasi Peneliti dan Pengajar Ilmu Hukum Indonesia

Health is a state of health, both physically, mentally, spiritually and socially that allows everyone to live productively socially and economically. Health is based on legal provisions, including health law. The development of criminal acts in the field of health sciences One of the crimes in health law that is rampant is the crime in the field of pharmacy, one of which is circulating pharmaceutical preparations of drugs without a distribution permit. Drugs without a distribution permit cannot be freely traded to the public. This is not without reason, unlicensed drugs must be consumed in the right dosage so as not to endanger the health of the public or the people who consume the drug. This research is a normative juridical research using secondary data through literature studies, namely by using research on various sources of books, laws and regulations related to the crime of producing and distributing pharmaceutical preparations without a distribution permit. From the research conducted, it can be concluded that the application of criminal sanctions against criminal offenders who circulate pharmaceutical preparations without a distribution permit is contained in several laws and regulations, namely, Law No. 17 of 2023 concerning Health and Law No. 36 of 2009 concerning Health as a means of crime prevention. The implementation of this law is expected to ensnare the perpetrators of the crime of distributing pharmaceutical preparations without a distribution permit.

Sukma, Rakasyiwa Rewangga; Suliantoro, Adi

DINAMIKA HUKUM 2021 Universitas Stikubank

September 13, 2019, the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) issued a warning through the official FDA website, that contaminants were found that were thought to trigger cancer. It is known that the contamination is an impurity or nitrosamine compound or commonly called N-Nitrosodimethylamine (NDMA) which is included in chemical contamination originating from chemical elements or compounds that can endanger human health. Symptoms that appear are the skin and the whites of the eyes turning yellow, fatigue, darker urine, and abdominal pain. Based on this, there is a problem that needs to be analyzed, namely how the law protects consumers from consuming these materials, especially in the city of Semarang, are there any obstacles in the effort to protect consumers from consuming drugs containing NDMA. The methodology used in this research is juridical normative with secondary data, which is analyzed by analytical descriptive. The results of the analysis, it is known that the state through various provisions has protected consumers from consuming hazardous materials, including those in Article 8 "Regarding actions that are prohibited for business actors; Law Number 36 of 2009 concerning Health Articles 98, 99, 104 & 106 "Regarding the Security and Use of Pharmaceutical Preparations and Medical Devices" AND Regulation of the Minister of Health of the Republic of Indonesia 101 / MENKES / PER / XI / 2008 concerning Drug Registration. That in this protection effort, the government c.q BPOM is experiencing internal and external obstacles. Internal constraints, namely limited human resources and still low external business actors to meet the requirements for good production methods, with relatively low legal sanctions.   Keywords: Consumer Protection, NDMA Drugs, BPOM