Food and Drug Monitoring Agency (BPOM) in Protection Consumer To Product Maintenance Skin

Abstract

This study aims to determine and analyze the role of the BPOM (Indonesian National Agency of Drug and Food Control) in protecting consumers from skincare products containing mercury. It also aims to identify and analyze the legal actions taken by BPOM Makassar City against skincare products that do not meet quality standards. This research uses an empirical legal research method, which involves field data as the primary source, such as interviews and observations. The results of the study indicate: (1) The role of BPOM in providing consumer protection against the circulation of skincare products containing mercury by monitoring and supervising the circulation of skincare products in the market to ensure they do not contain harmful substances, implementing pre-market surveillance, conducting post-market surveillance, and inspecting skincare products circulating in the market. (2) The legal actions taken by BPOM against skincare products that do not meet quality standards include administrative sanctions and criminal sanctions. As recommendations: (1) The government needs to implement stricter supervision to better protect consumers from the use of cosmetics that do not have BPOM circulation permits. (2) There must be good cooperation between the government, BPOM, and law enforcement authorities in efforts to protect consumers from the circulation of cosmetics that do not meet the standards, through regular supervision of producers and business actors, as well as providing outreach to the public to raise awareness.

INTRODUCTION

Health is very valuable factor in life , health is grace the god who deserves guarded by every Humans . Health plays a very important role important in activity everyday , good aspect physique both physical and non- physical . Also in Islam recommended For guard health Because guard health is obligation for human . [1]

In Article 1 paragraph (1) of the Republic of Indonesia Law Number 17 of 2023 concerning Health , health is defined as condition Healthy someone , good in a way physical , mental , and social and not just free from disease For make it possible life productive . Article 1 paragraph (12) of the Republic of Indonesia Law Number 17 of 2023 concerning Health states: Pharmaceutical preparations are drugs, drug ingredients, natural drug ingredients , including Natural Medicine Ingredients , Cosmetics , Supplements health and medicine quasi .

In the era of trade free moment this , various brand cosmetics with diverse function can found in the market. Products cosmetics that appear blessing progress industry pharmacy has become need public along with change style live . Many companies compete​ For produce product new and exciting beauty​ For fulfil diverse need consumers . Some entrepreneurs who don't responsible answer utilise people's desire to always seen attractive and perfect with produce or sell cosmetics that are not in accordance standard . [2]

Marketing This especially leading to women who want get results fast and effective . They usually interested buy cosmetics with price low while hope get results instant . Situation This often create injustice for consumers , especially when they is at in position vulnerable , because they become target For to achieve profit maximum without notice rights they , like lack of clear information​ about product .

Based on Regulation Head of BPOM of the Republic of Indonesia Number 2 of 2014, which is change second from regulation previously , there was a number of prohibited materials​ For used in making cosmetics Because including in the list of substances dangerous . Some product cosmetics contain material dangerous , This includes Chemical Drugs (BKO) which can endanger health . Examples of BKO include dye red K3, dye red K10, acid retinoate , mercury , various type antibiotics , dexamethasone , and hydroquinone . [3]

Hydroquinone used in product beauty as material For whitening and brightening skin . However , the use of material This Can cause irritation , redness , and stinging sensation burns on the skin . Therefore that , the Law Number 8 of 1999 concerning Protection Consumers , who are used to called UUPK, and the law other made For protect consumer in aspects of Civil Law and Public Law. UUPK stipulates standard For give certainty law . In addition , UUPK also regulates interaction between consumers and actors business in Indonesia " everything effort For ensure certainty " law " in Article 1 Number 1 of the UUPK aims to give protection law to consumer from action that is not fair that can harm them and the perpetrators effort . [4]

As a result , manufacturers beauty that runs business without permission from the Food and Drug Monitoring Agency (BPOM) is trying For to achieve more benefits​ high . Consumers , especially teenagers , often use product cosmetics that are not registered Because lack of understanding about possible risks​ arise . In the era of trade free , various product cosmetics with different names , prices and benefits can found in the market. With existence freedom in selling , lots entrepreneurs who don't responsible answer try to achieve profit with produce or sell cosmetics that are not fulfil standard security . [3]

Purpose of Protection Consumer aiming For guard rights consumer in a way law and encourage practice fair trade​ as well as activity good effort . In addition , the goal is provide accurate and reliable information​ trusted to public . For example , in use product like cosmetics and goods beauty , government obligatory perpetrator business For give information complete about product these , especially those related with safety and health public . With the more the development of the cosmetics market , entrepreneurs must sensitive to need consumers . [5]

Protection consumers in the sector cosmetics are very important , especially Because Lots products sold on the market No fulfil standard safety and health . Many women affected advertisements that offer results fast with price affordable , without realize possible risks​ appear consequence use product said . Hazardous materials in cosmetics can cause various problem health , start from irritation skin until effect term longer length​ serious . In addition , the lack of clear information​ about composition product , no existence number permission distribution from BPOM and No listed date expired show that product the No can reliable .

Government play a very important role in protect consumer with become connector between perpetrator business and consumers . The goal is for transactions sell buy in progress in accordance with which regulations apply and which do not harm one​ parties . In addition , the government also has not quite enough answer For do guidance and conduct supervision in effort protection consumers . [6]

Interests and abilities financial public to product cosmetics are very high , but often not​ balanced with sufficient knowledge​ about safe product​ For used . As a result , society often difficulty differentiate between safe and dangerous products . While​ that , constant advertising and promotion​ done by the perpetrator business about product promising cosmetics​ results fast and easy push consumer For try it . Situation This utilized by several party For sell cosmetics that are not in accordance with standard and not own permission ( illegal ) distribution , which ultimately can endanger health consumers . [7]

Desire woman For always seen interesting often used by parties​ the party that does not responsible answer , which makes or sell cosmetics that are not in accordance with standard or regulations in force . Because many consumer No know materials used , methods​ manufacturing , and marketing strategies product said , then important For own rule law that can guard interest consumers . At the time this , many woman interested buy cosmetics offer cheap price and fast results​​ visible . [6]

BPOM's duties are regulated in the Decree of the Head of BPOM Number 02001/SK/KBPOM dated 26 February 2001 concerning BPOM's Organization and Work Procedures regulate about duties and functions of the POM Agency. Namely carry out task government in the field of supervision medicine and food , carry out policy certain in the field supervision medicine and food , coordination activity functional in implementation BPOM's duties include monitoring and providing guidance and conduct coaching to activity agency government in the field supervision and food . Function supervision this plays a very important role in frame protection consumer . Function government supervision​ started at the time a business entity will start production its products . For example in matter making product cosmetics , before make product cosmetics , manufacturers must Already own permission business industry . [8]

In the field skincare products , protection law is very important Because There is risks that can occur appear from use products that are not fulfil standard Security . Consumer need protected from effect side or damage that can happen consequence negligence in the production process , including use material dangerous . In general , purpose protection law for consumer is For create a safe and fair environment , and give guarantee that the products they use has through a correct and safe process . [9]

Head of BPOM of the Republic of Indonesia, Taruna Ikrar , stated that Makassar has appointed as one of the supervised area​ in a way strict by BPOM related Dangerous skincare products . He explain that in 2023 , there will be six case illegal skincare products in the region , totaling Rp 1.7 billion . "In 2023 , there will be six cases , five of which currently in the legal process , with a total of Rp. 1.7 billion ," he said . For In 2024, BPOM noted existence increase , with 10 cases illegal skincare products , three of which are Already enter stage law and its total value almost Rp 3.4 billion . " Year This Still ongoing , already there are 10 cases and three of them currently in legal process with a total value of IDR 3.4 billion ," he explained .

Head of the Makassar City BPOM, Hariani , revealed that from examination of 66 samples , found six skincare products that contain material dangerous . Some from product the No own permission For for sale . FF Day Cream Glowing product detected contain mercury , FF Night Cream also contains mercury , but Already registered and have permission . On the other hand , Raja Glow My Body Slim is drug traditional containing​ material chemistry forbidden . Hariani explain that Raja Glow products contain bisacodyl , namely material the usual active used For reduce weight . Mira Hayati Lighting Skin products are found contain mercury , while night cream from Mira Hayati yet get permission distribution from BPOM and detected positive contain mercury . Hariani suspect existence the party that does not responsible answer that adds mercury in skincare products during the production process , even though sample has checked and get permission before for sale . Recently this , police has set three owner skincare products that contain mercury .

METHOD

Type study This is study law empirical namely research conducted​ through studies field . In research This collected data from a number of respondents who then processed in accordance with technique the analysis used , then poured out in form descriptive use to obtain description condition Actually from law as fact social . In the research field research​ library needed at the time compile framework research (research design ) or proposal for use to obtain information beginning from study previous less​ more similar For deepen knowledge researcher about the method that will be used . [10]

DISCUSSION

The Role of BPOM Makassar City in Providing Protection Consumer To Circulation Skincare Products That Contain Mercury

Protection law needed consumers , because is the state's obligation to protect its people , including For user cosmetics fake . In an effort give protection consumer specifically user cosmetics said , then required role is BPOM, because BPOM is an institution the government that organizes affairs supervision medicine and food . [11] Supervision process to cosmetics set up in Constitution Protection Consumer about coaching and supervision to organization protection consumer with objective For protect interest consumer from all consequence bad caused​ circulation a goods and services . [12]

As for the basis The establishment of the Food and Drug Monitoring Agency (BPOM) is Presidential Decree ( Keppres ) Number 166 of 2000 concerning Position , Duties , Functions , Authority , Composition Organization , and Work Procedures of Non- Departmental Government Institutions . Currently , regulations the establishment of BPOM is listed in Regulation President Number 80 of 2017 concerning the Food and Drug Supervisory Agency . BPOM is institution independent responsible​ answer direct to President and coordinated with the Minister of Health. BPOM is tasked with supervise : Drugs, Drug ingredients , Narcotics , Psychotropics , Precursors , Substances Addictive , Traditional Medicine , Supplements health , Cosmetics , Processed food . BPOM carries out supervision For protect public from circulation medicines and foods that are not fulfil standard safety , efficacy , benefits , and quality , as well as nutrition .

Based on results interview with Ahmad Lalo saying in monitor and supervise circulation skincare products on the market so that it doesn't contain material dangerous like mercury with method Carry out premarket surveillance , namely supervision product before circulating such as the certification process method making good cosmetics​ For ensure that means production , equipment , materials to be used , the product to be produced , people who work fulfil requirements that have been set . And Implement post market supervision , namely supervision product during circulating , such as supervision means production , supervision means distribution , sampling and testing product For ensure that products produced and distributed​ Still in accordance with requirements and in accordance with the registered one .

BPOM also often do inspection to skincare products on the market , and the testing process For ensure security material the ingredients with method For implementation inspection consists of on Implementation inspection implemented regularly and throughout year , Implementation inspection in frame Cases and Inspections special in frame eradication product illegal cosmetics and contain material dangerous . While For ensure security products in circulation that is Sampling implementation ( purchase) products in circulation ) and testing in the laboratory regularly throughout​ year and implementation innovation Molkika ( Laboratory Car) Around Safe Cosmetics ) namely testing product cosmetic in a way fast and on the spot For know There is whether or not content material dangerous to cosmetics used by the public . For prevent skincare products that contain mercury circulating in the market BPOM has system supervision namely : [13]

Do supervision before (pre market) and during product Pharmaceutical Preparations and Processed Foods circulating (post market) for ensure safety , efficacy / benefits and quality Pharmaceutical Preparations and Processed Foods .

Ensure product Pharmaceutical Preparations and Processed Foods produced safe , efficacious / useful up to hand consumers .

Become consumer smart and empowered in choose and consume product Safe and responsive pharmaceutical and processed food preparations with wise information circulating .​

Based on results interview with Mutmainna as consumer Skincare users containing it mercury say with existence cooperation with a number of parties greatly influence awareness consumer will use of mercury skincare and reduce use skincare that contains it mercury as well as with existence submission online community​ can feel protected with the existence of a program that is owned The Makassar City BPOM and the public are aware where we will be report related the losses we experienced during use skincare products that contain mercury .

Legal Actions Taken by the Makassar City BPOM Against Skincare Products That Do Not Meet Quality Standards

Based on the Decree of BPOM RI Number HK.00.05.4.1745 of 2003 concerning Cosmetics , requirements quality cosmetics circulating in Indonesia must in accordance with Codex Indonesian Cosmetics and some other standards recognized by regulations legislation . Cosmetics it is said No fulfil condition if contain materials that are not allowed in cosmetics or contain permitted materials , however​ in amount that exceeds the limit. [13]

Based on results interview with Ahmad Lalo According to with Law of the Republic of Indonesia Number 17 of 2023 concerning Health , namely Every person who produces or to circulate Pharmaceutical preparations and/ or medical devices that are not fulfil standards and/ or condition safety , efficacy / benefit , and quality as meant in Article 138 paragraph (2) and paragraph (3) shall be punished with criminal maximum imprisonment of 12 ( twelve ) years or criminal a maximum fine of IDR 5,000,000,000 (five billion rupiah).

Based on Article 39 of the Decree of the Head of the Food and Drug Supervisory Agency of the Republic of Indonesia Number HK.00.05.4.1745 of 2003 concerning Cosmetics sanctions that can be given to perpetrator efforts , namely : [14]

Sanctions administrative , in the form of :

Warning written

Withdrawal products and withdrawals advertisement product the

Destruction product .

Termination temporary activity production , import distribution , storage , transportation and delivery product .

Revocation certificates and permits circulate .

Sanctions criminal in accordance provision Applicable legislation​

Perpetrator proven efforts​ do forgery about materials used​ in product cosmetics (which are not in accordance with registered composition​ or attached to the label) will prosecuted continue processed by BPOM. All cosmetics that will circulated must be notified moreover formerly as one of the form supervision , if there is perpetrator business that does fraud so can sentenced punishment criminal . BPOM does not can to drop punishment criminal penalties for perpetrators business that does cheating , but the POM will do coordination with parties related Perpetrator business that does violation in produce , sell , and or to circulate product cosmetics can worn sanctions criminal as has regulated by regulations legislation , basis the law that is Constitution Number 36 of 2009 concerning Health , namely : [15]

For perpetrator business that does cheating and not fulfil condition about product cosmetics ( contains material dangerous ) which has set up as should be able to subject to Article 196 with threat criminal imprisonment for a maximum of 10 ( ten ) years and a maximum fine of Rp. 1,000,000,000.00 ( one billion rupiah).

For perpetrator effort that does not own permission distribution on a product cosmetics that are produced , sold , or circulated can subject to Article 197 with threat maximum imprisonment of 15 ( fifteen ) years and a maximum fine of Rp. 1,500,000,000.00 ( one billion five hundred million rupiah).

CONCLUSION

The role of BPOM Makassar City in give protection consumer with methods : (1) Monitor and supervise circulation skincare products on the market so you don't contain material dangerous ; (2) Carrying out premarket surveillance , namely supervision product before circulating such as the certification process method making good cosmetics​ For ensure that means production , equipment , materials to be used , the product to be produced , people who work fulfil requirements that have been determined ; (3) Implementing post market supervision , namely supervision product during circulating ; (4) Doing inspection to skincare products on the market . And legal action taken by the Makassar City BPOM against skincare products that are not fulfil standard quality is sanctions administrative warning written , withdrawal product , destruction product , discontinuation temporary activity production and withdrawal certificate as well as permission circulation . Sanctions criminal in accordance with Law of the Republic of Indonesia Number 17 of 2023 concerning Health , namely Every person who produces or to circulate Pharmaceutical preparations and/ or medical devices that are not fulfil standards and/ or condition safety , efficacy / benefit , and quality as meant in Article 138 paragraph (2) and paragraph (3) shall be punished with criminal maximum imprisonment of 12 ( twelve ) years or criminal a maximum fine of Rp. 5,000,000,000 (five billion rupiah). The government need do more supervision​ strict so that public as consumer Can more protected from consequence use cosmetics that are not have permission distribution from BPOM. Consumers must more be careful and behave critical in buy product cosmetics with notice information contained​ in packaging product cosmetics , is it goods the Already own permission distribution or is illegal goods . And there must be good cooperation​ between Government , BPOM, and apparatus enforcer law in effort protect consumer to circulation cosmetics that are not fulfil standard . This cooperation can done with increase supervision regularly to​ producers and actors business as well as the holding of counseling to society so that society aware will importance security in use product cosmetics and society avoid from existence danger .

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