https://dinastires.
org/JLPH Vol.
No.
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DOI: https://doi.
org/10.
38035/jlph.
https://creativecommons.
org/licenses/by/4.
The Role of the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan-BPOM) in Skincare Overclaim Cases: Consumer Protection Perspective Due to Negligence in Monitoring Inconsistencies in Product Content and Labeling Prashandya Natasya Putri Aprilianti1.
Aris Toteles2.
Evi3.
Universitas Palangka Raya.
Palangkaraya.
Indonesia, natasyaaprilianti13@gmail.
Universitas Palangka Raya.
Palangkaraya.
Indonesia, aristoteles@law.
Universitas Palangka Raya.
Palangkaraya.
Indonesia, evi@law.
Corresponding Author: natasyaaprilianti13@gmail.
Abstract: The skincare industry in Indonesia is experiencing rapid growth but is accompanied by an increase in cases of overclaim, namely excessive or inconsistent claims between the content and product labels circulating on the market.
This practice not only misleads consumers but also has the potential to pose serious health risks.
This study aims to analyze the role of the Indonesian Indonesian Food and Drug Authority in cases of skincare overclaim from a consumer protection perspective, especially due to negligence in supervising the inconsistency of product content and labels.
The research method used is normative juridical with a statutory approach, reviewing laws and regulations such as Law Number 8 of 1999 concerning Consumer Protection.
Law Number 17 of 2023 concerning Health, and the Regulation of the Indonesian Food and Drug Authority.
The results of the study show that BPOM has a role in pre-market and post-market supervision of skincare products.
However, there are still gaps in the supervision system that cause products with inconsistency in claims to continue to circulate and harm consumers.
This study recommends strengthening the supervision and law enforcement mechanisms for business actors and the Indonesian Food and Drug Authority in order to ensure more effective consumer protection and prevent similar cases from recurring in the future.
Keyword: Overclaim Skincare.
National Authority of Drug and Food Control.
Consumer Protection.
Supervisory Negligence.
INTRODUCTION
In recent years, the skincare industry in Indonesia has experienced significant growth, driven by increasing public awareness of the importance of skincare and the development of beauty trends.
However, amidst the proliferation of skincare products on the market, various issues have emerged related to product safety and reliability, especially in terms of the conformity between product content and the label listed.
One of the issues that has emerged is the case of overclaims on skincare products, where manufacturers claim product benefits excessively or do not match the actual content (Pada et al.
, 2.
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This not only misleads consumers but also has the potential to pose serious health risks.
Indonesian Food and Drug Authority (BPOM), as the institution responsible for supervising and regulating skincare products in Indonesia, has a crucial role in ensuring that products on the market are safe and in accordance with applicable regulations and in accordance with the claims listed on the label.
However, in several cases, discrepancies were found between product content and claims listed on the label, indicating negligence in the supervision process.
In several recent cases, there has been negligence in BPOM supervision, resulting in skincare products with inappropriate claims still circulating on the market.
For example, in the case of overclaim skincare with the brand initials 'DS' that occurred some time ago, which made excessive claims regarding the content of their active ingredients, especially in their HB dusting product, laboratory test results found that the active ingredient content in the form of niacinamide in the product, which is often promoted as a skin lightener, was not detected in significant amounts.
In fact, the results show that the content may be so small that it does not provide the impact expected by consumers (Oliveira et al.
, 2.
This condition raises serious questions regarding BPOM's legal responsibility in protecting consumers from harmful practices.
(Awalin et al.
, 2.
From a consumer protection perspective, the discrepancy between the content and label of a skincare product is a violation of consumers' rights to obtain accurate information and product safety guarantees.
Consumers who are victims of overclaims or excessive claims not only experience material losses but also have the potential to experience serious health impacts.
Therefore, it is important to examine the extent to which BPOM can be held legally responsible for negligence in supervision, as well as how existing legal mechanisms can be strengthened to ensure more effective consumer protection.
(Marlina et al.
, n.
Consumer protection is an important aspect of consumer law, as regulated in Law Number 8 of 1999 concerning Consumer Protection.
Consumers have the right to obtain correct, clear, and honest information about the products they purchase.
However, when violations such as overclaims and product content discrepancies occur, consumers are often the most disadvantaged parties.
Therefore, it is important to know the role of BPOM in accordance with the regulations in this context, as well as to find legal solutions that can ensure better consumer protection (Dadhan Marganti Ritonga, 2.
The cases of skincare overclaims that have been rampant in Indonesia in recent times are evidence that the existing supervision system still has gaps that need to be fixed.
Without clear and firm accountability or follow-up, consumers will continue to be vulnerable to detrimental practices.
Therefore, this study aims to analyze the role of the Indonesian Food and Drug Authority (BPOM) in cases of skincare overclaims, especially from a consumer protection perspective, by reviewing applicable regulations, cases that have occurred, and existing supervision mechanisms.
It is hoped that it can provide recommendations to strengthen the supervision and consumer protection system in Indonesia.
Cases like these raise serious questions about the role of BPOM in protecting consumers from products that do not meet safety and legality standards.
What are the legal regulations related to BPOM's role in cases of skincare overclaims related to inconsistencies in product content and labels from a consumer protection perspective? What is BPOM's role in cases of skincare overclaims related to inconsistencies in product content and labels that harm consumers? The main objective of this study is to identify the truth of the consistent relationship between behavior and legal rules.
This study also aims to evaluate the consistency of positive law, identify weaknesses in the law, and provide recommendations for legal reform.
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METHOD
The type of research used by the author in this study is a normative legal research method, or legal research that is library research .
ibrary stud.
that focuses on the analysis of laws and written legal norms that are relevant to the research topic.
Normative legal methods include the use of data from library materials such as laws and legal literature.
are dogmatic, namely accepting the law as a truth that must be followed.
use deductive logic, namely from general norms to specific applications.
are descriptive and prescriptive, namely explaining legal rules and providing solutions.
do not require field observations.
and use a statutory, conceptual, and case approach.
This approach is used to understand, interpret, and evaluate a legal norm based on written texts in related laws and regulations.
In essence, the statutory approach is a core method in normative legal research that relies on analysis of regulatory texts to understand, criticize, or recommend changes to the law.
The reason the author chose this method and approach is because it is more systematic because it focuses on clear and efficient legal texts as a system of norms and examines the internal aspects of positive law without conducting direct field research and is relevant for policymaking in revising or creating new laws.
So in writing this article, the author uses the legal basis of statutory regulations, namely Law Number 8 of 1999 concerning Consumer Protection and Law Number 17 of 2023 concerning Health, as well as regulations related to the topic raised, namely the Regulation of the Indonesian Food and Drug Authority (BPOM).
RESULTS AND DISCUSSION
The Indonesian Food and Drug Authority (BPOMRI) was actually formed during the Dutch era under the name De Dient van De Valks Gezonheid (DVG) under the auspices of a Dutch pharmaceutical company.
DVG itself acted as an institution tasked with producing chemical drugs as well as a pharmaceutical research center at that time.
In 1964.
DVG, which was the forerunner to the formation of BPOM, officially became the property of the Indonesian government and changed its name to the Pharmaceutical Inspectorate.
After three years, the Pharmaceutical Inspectorate changed its name again to the Pharmaceutical Affairs Inspectorate.
(Maros & Juniar, 2.
In 1976, the Pharmaceutical Affairs Inspectorate again underwent a complete internal overhaul with the new name of the Directorate General of Pharmacy.
This is where the history and work system of BPOM began.
The Directorate General of Pharmacy itself finally became the only special institution tasked with supervising and researching the distribution of drugs and food in Indonesia by collaborating with a number of related institutions such as the Ministry of Health, the National Pharmaceutical Institute, and the State Pharmaceutical Industry (Awalin et al.
, 2.
Regulation in the pharmaceutical sector began with the establishment of DC.
(DeDients van De Valks Gezonhei.
, which in the organization was handled by the Pharmacy Inspectorate Continued by the Pharmacy Affairs Inspectorate until 1967 and by the Directorate General of Pharmacy until 1976, with the main task of meeting the people's needs for pharmaceutical supplies.
(Maros & Juniar, 2.
In 1975, the government changed the Directorate General of Pharmacy to the Directorate General of Drug and Food Supervision, with the main task of implementing the regulation and supervision of drugs, food, cosmetics, and medical devices, traditional medicines, narcotics, and hazardous materials.
To carry out these tasks, a technical implementing unit was formed in this directorate, namely the Drug and Food Inspection Center at the center and the Drug and Food Supervisory Center in all provinces.
To optimize supervision of drugs and food, the government has taken a policy by making changes to the Directorate General of Drug and Food Control, which previously was responsible to the Ministry of Health, but now, after the changes, the Food and Drug Authority is responsible to the President.
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The Food and Drug Authority is now a non-departmental government institution based on Presidential Decree No.
103 of 2000 and has undergone changes through Presidential Decree No.
166 of 2003.
In essence, we currently know the Food and Drug Authority (BPOM) as a non-ministerial government institution in Indonesia that is responsible for supervising the distribution of drugs, food, cosmetics, health supplements, traditional medicines, and other therapeutic products.
The Food and Drug Authority (BPOM) operates under the direct coordination of the President of the Republic of Indonesia and has a crucial role in protecting the public from dangerous, fake, or substandard products.
So, in the context of overclaimed skincare, the Food and Drug Authority (BPOM) acts as the main regulator that ensures products meet safety standards, honesty of claims, and do not mislead consumers.
However, recently the figure of the Detective Doctor has been buzzing on social media after sharing the results of laboratory tests on a number of well-known skincare brands.
The Detective Doctor exposed a number of skincare brands that were said to overclaim or exaggerate the efficacy of the product.
Skincare brands were found to exaggerate the efficacy of products whose contents turned out not to match those listed on the packaging.
For example, a skincare product contains an active ingredient that is said to be able to fight various skin problems and brighten the skin in just a few days of use.
Another example is a skincare product that sells niacinamide serum with a content of 10% .
en percen.
However, the results of the laboratory test showed that the percentage was only 3% .
hree percen.
Regarding the recent skincare overclaim cases in Indonesia, according to the results of laboratory tests conducted by Dokter Detektif, there are several local skincare brands that are well-known among the public that have been proven based on laboratory test results to have made overclaims.
These products include Products with the brand initials 'AZ' Skincare products with the brand initials 'AZ' are suspected of overclaiming, after their product AZ Niacinamide 10% Dipotassium Glycyrrhizate Glorious Serum only contained 45% niacinamide based on laboratory test results.
In addition.
Dokter Detektif also revealed the product AZ Retinol Smooth Glowing Serum.
The retinol content in this product is 1% ceramide and resveratrol.
However.
Dokter Detektif revealed that the content of the 1% product is apparently only 0.
00096% retinol.
However, 'AZ' then spoke up.
They apologized for the differences in laboratory test results that may have occurred internally or externally.
Products with the brand initials 'DS' The 'DS' product is included in the ranks of overclaimed skincare brands.
DS Sleeping Mask Retinol Booster contains 2% Actosome Retinol.
However, from the results of laboratory tests, it turns out that the content is not appropriate because DS Sleeping Mask Retinol Booster only contains 0.
03% pure retinol, or the equivalent of 1% Actosome Retinol.
Products with the brand initials 'SSK' The product.
SSK Retinol Serum, which is claimed to contain 1% retinol, is actually not in accordance with the results of laboratory tests, because the content is only 0.
0054% of the stated claim.
Products with the brand initials 'MY' The MY Beauty Glow Up Cream product is claimed to contain 10% niacinamide.
However, from the results of laboratory tests, the claim is not appropriate.
The niacinamide content is only 5.
Products with the brand initials 'TO' The famous local brand, 'TO,' is included in the next list of overclaimed skincare.
Its product, namely Gluta Bright B3 Serum, which is claimed to contain 10% niacinamide, was proven to contain only 4.
97% niacinamide.
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The Food and Drug Authority (BPOM) is considered slow to respond and follow up on this case, because these products have been circulating for a long time and are still circulating There are many consequences in this case, and the ones who feel the most impact are Consumers are financially disadvantaged and are at risk of experiencing irritation/failure of results.
In addition, this also damages consumer trust in the local skincare Currently, the Food and Drug Authority (BPOM) has threatened to revoke distribution permits for products proven to overclaim, but the implementation of these sanctions must be carried out consistently and transparently in order to provide a deterrent effect for business Until now, some cases of skincare overclaims in Indonesia are still under investigation by BPOM and administrative law enforcement.
Legal Regulations Related to the Role of the Food and Drug Authoritynin Cases of Skincare Overclaims Related to Inconsistencies in Content and Product Labels from a Consumer Protection Perspective BPOM has set clear regulations regarding advertisements and claims that can be used by business actors.
This aims to protect consumers from incorrect information and ensure transparency in product marketing.
(Maros & Juniar, 2.
From a consumer protection perspective in Indonesia, the Food and Drug Authority (BPOM) plays an important role in supervising skincare products and ensuring that products circulating on the market are safe, of high quality, and in accordance with the claims stated on the label.
Legal regulations related to the role of BPOM in cases of skincare overclaims and inconsistencies in content with product labels are regulated in several laws and regulations (Utomo & Alfredo, 2.
, including:
Legislation .
Law Number 8 of 1999 concerning Consumer Protection (UUPK) The Consumer Protection Law (UUPK) regulates the rights and obligations of consumers and business actors.
Law Number 8 of 1999 concerning Consumer Protection (UUPK) regulates consumer protection efforts, consumer rights, and sanctions against business actors who violate The consumer protection efforts in question are to guarantee legal certainty, increase consumer awareness, ability, and independence, foster a sense of responsibility for business actors, guarantee the continuity of the production of goods and/or services, and guarantee the health, comfort, security, and safety of consumers.
This law also regulates consumer rights, including the right to comfort, security, and safety.
the right to choose and obtain goods or and the right to correct, clear, and honest information.
In this case.
BPOM acts as an institution that supervises business actors to fulfill their obligations to provide correct, clear, and honest information about the products sold.
Article 4, letter c, of the Consumer Protection Law (UUPK) states the consumer's right to obtain correct, clear, and honest information about the condition and guarantee of goods/services.
Article 8, paragraph .
, of the Consumer Protection Law (UUPK) states that business actors are prohibited from producing or trading goods that do not comply with the information provided on the label (Mariette et al.
, 2.
In the context of overclaimed skincare, business actors .
anufacturers or distributor.
can be considered to have violated the provisions if the product does not match the claims made or if there is a discrepancy between the content and the product label.
(Kuncoro & Syamsudin, 2.
( Article 19, paragraphs .
, of the Consumer Protection Law (UUPK) regulates sanctions for business actors who violate these provisions, including compensation, fines, or revocation of business licenses.
If a violation occurs.
BPOM can take administrative action against business actors, and consumers have the right to file a lawsuit to claim compensation(Faizin Mohammad, 2.
Relevance to BPOM, namely.
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for pre-market supervision .
irculation permit.
and post-market supervision of products in BPOM is responsible for supervising the circulation of cosmetic products to comply with the provisions of the UUPK.
(Suyudi, 2.
Law Number 17 of 2023 concerning Health Law Number 17 of 2023 concerning Health (UU Healt.
is a revision of Law Number 36 The Health Law aims to guarantee the rights of every citizen to health and quality health services.
The Food and Drug Authority (BPOM) has an important role in implementing the Health Law.
BPOM is tasked with protecting the public from the risks of drug, food, and cosmetic products that do not meet safety and quality standards.
Thus, the Health Law and BPOM complement each other in efforts to improve public health through strict regulations on health products, such as drugs, food, cosmetics, and skincare products.
BPOM Regulation .
BPOM Regulation Number 17 of 2022 concerning Amendments to BPOM Regulation Number 23 of 2019 concerning Technical Requirements for Cosmetic Ingredients BPOM Regulation Number 17 of 2022 is a regulation that amends BPOM Regulation Number 23 of 2019.
This regulation plays an important role in addressing cases of skincare overclaims in Indonesia.
This regulation strictly classifies cosmetic ingredients into three categories, namely permitted ingredients .
ith maximum usage limit.
, prohibited ingredients .
, mercury, hydroquinone more than 1% .
ne percen.
, and steroid.
, and ingredients that must be supported by scientific evidence if claimed to have certain effects .
, niacinamide for "brightening" and retinol for "anti-aging").
Many skincare products claim "instant" effects by using hazardous ingredients or doses exceeding the provisions.
BPOM Regulation Number 17 of 2022 is the legal basis for banning such products and withdrawing them from the market.
This regulation is the main weapon against the possibility of skincare overclaims because this regulation limits risky ingredients that are often used for false claims and forces manufacturers to be responsible for their claims with scientific evidence.
The core of BPOM Regulation Number 17 of 2022 concerning Technical Requirements for Cosmetic Ingredients regulates List of ingredients that are prohibited, restricted, or permitted in cosmetic products.
Safety and stability of the ingredients used.
Product claims must be in accordance with the function of the ingredients contained in it.
For example, if a skincare product contains retinol for "anti-aging," then the retinol content must meet the permitted safe limit.
Overclaims can occur when product claims are not supported by the function of the ingredients contained.
for example, a product may claim to brighten skin in five days when, in fact, the product does not contain niacinamide according to the established standards and is almost undetectable to contain the ingredient.
BPOM's negligence in violating this regulation, namely not verifying the conformity of the ingredients with the claim before issuing a permit, permitting products with certain ingredients without carrying out strict supervision, and being slow to withdraw products after violations are found.
In this context, if BPOM grants permission to a product with ingredients that do not meet the requirements, then the product is at risk of danger and misleading claims.
If BPOM does not take strict action against post-permit violations, overclaims will continue to (M.
Ferdiansyah, 2.
Article 3, paragraph .
, of BPOM Regulation Number 3 of 2022 concerning Technical Requirements for Cosmetic Claims This regulation regulates the use of overclaim sentences used in advertising skincare products that result in conflict with applicable regulations, such as consumer rights and business actors' obligations.
The contents of Article 3, paragraph .
, of BPOM Regulation Number 3 of 2022 stipulate that "cosmetic claims must be supported by valid and accountable scientific evidence.
" This means that every claim listed in a skincare product .
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must have a scientific basis, such as clinical trials, recognized literature studies, and supporting data from trusted research.
If there is an overclaim of skincare .
xcessive claims without evidenc.
, then BPOM is considered negligent if it does not verify scientific evidence before issuing a distribution permit and fails to take action on the product after the overclaim is proven.
In addition, the form of BPOM's negligence that violates this article is granting a permit without first checking the data related to the product that will be granted a distribution permit, so that BPOM ignores the obligation to verify claims.
Then, it is slow to give instructions to business actors to withdraw products after public reports, so that BPOM fails to carry out post-permit supervision.
And the form of BPOM's negligence that violates this article is not taking firm action against producers who violate, so that BPOM is considered not serious about enforcing its own rules.
BPOM Regulation Number 22 of 2022 concerning Criteria and Procedures for Cosmetic Registration Regulations related to cosmetic or skincare claims are regulated in BPOM Regulation Number 22 of 2022.
The regulation states that all product claims must be supported by scientific data and clinical trials that show the conformity between product claims and lab results before obtaining a distribution permit.
This regulation requires business actors to include accurate and non-misleading information on product labels, including a list of ingredients used and claims of product benefits.
The core of BPOM Regulation Number 22 of 2022 concerning Criteria and Procedures for Cosmetic Registration, namely regulating cosmetic registration procedures in Indonesia, includes document requirements such as safety tests, claims, and composition.
mechanisms by BPOM.
and post-registration obligations such as reporting changes and This regulation aims to ensure that only products that meet safety, efficacy, and honesty standards for claims are circulated on the market.
During the registration process.
BPOM is required to verify the truth of the claim.
Claims must be supported by clinical trial data or scientific literature.
If BPOM is not strict in verification, products with excessive claims .
can pass the registration stage.
During post-registration.
BPOM must monitor the conformity of advertisements with registered claims.
Many cases of overclaims also occur because manufacturers change/expose claims after obtaining permission.
In addition.
BPOM is also not proactive in monitoring changes in claims on the market.
The form of BPOM's negligence that violates this regulation is negligence in the initial evaluation, where BPOM allows registration without adequately checking the claim evidence.
BPOM is also negligent in post-registration supervision, where BPOM does not take action on illegal claim changes in marketing and is slow to provide instructions to withdraw products that are proven to be overclaimed.
In addition, low transparency means that BPOM does not publish the basis for making registration decisions, making it difficult for the public to track the validity of product claims.
In conclusion.
BPOM Regulation Number 22 of 2022 concerning Criteria and Procedures for Cosmetic Registration is the first line of defense to prevent overclaims, namely through strict verification during registration and ongoing supervision after permission.
BPOM's negligence in its implementation causes overclaimed products to easily pass registration, and misleading claims continue to circulate without action.
If there is a discrepancy between the content and the label, or if there is an excessive claim .
BPOM can issue instructions to withdraw the product from circulation, impose administrative sanctions, or even file legal action.
Overall.
BPOM has the responsibility to ensure that skincare products in circulation meet safety and quality standards and provide accurate information to consumers.
If a violation occurs.
BPOM has the authority to take legal and administrative action to protect consumers.
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The Role of the Food and Drug Authority in Skincare Overclaim Cases Related to Inconsistencies in Content and Product Labels that Harm Consumers The Food and Drug Authority (BPOM) is a non-ministerial government in Indonesia that is responsible for supervising the distribution of drugs, food, cosmetics, health supplements, and other related products.
Based on Presidential Regulation Number 80 of 2017 concerning the Food and Drug Authority.
BPOM has important duties, functions, and authorities in supervising a product that will be circulated on the market (Njatrijani.
, & Madjan, 2.
Based on Presidential Regulation Number 80 of 2017.
BPOM has the following main duties:
Supervising drugs, food, cosmetics, health supplements, traditional medicines, biological products, and other therapeutic products.
Ensuring that products in circulation are safe, efficacious/beneficial, and meet quality Protecting the public from dangerous, counterfeit, or legally unsatisfactory products.
Based on Article 3 of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Authority, in carrying out the task of supervising drugs and food.
BPOM carries out the following functions: (Kairupan, 2.
Implementation of national policies in the field of drug and food supervision.
Preparation and determination of norms, standards, procedures, and criteria in the field of supervision before distribution and supervision during distribution.
Implementation of supervision before distribution and supervision during distribution.
Coordination of the implementation of drug and food supervision with central and regional government agencies.
Provision of technical guidance and supervision in the field of drug and food supervision.
Implementation of action against violations of provisions of laws and regulations in the field of drug and food supervision.
Coordination of the implementation of tasks, guidance, and provision of administrative support to all elements of the organization within BPOM.
Management of state property/assets that are the responsibility of BPOM.
Supervision of the implementation of tasks within BPOM, and Implementation of substantive support to all organizational elements within the BPOM Supervision before distribution, as referred to in paragraph .
, is supervision of drugs and food before distribution as a preventive measure to ensure that drugs and food in circulation meet the standards and requirements for safety, efficacy/benefits, and product quality that have been set.
Supervision during distribution, as referred to in paragraph .
, is supervision of drugs and food during distribution to ensure that drugs and food in circulation meet the standards and requirements for safety, efficacy/benefits, and product quality that have been set, as well as law enforcement actions.
In addition.
BPOM also has the authority to:
Issue/revoke distribution permits for drugs, food, cosmetics, and other products.
Conduct inspections of production and distribution facilities, such as factories, pharmacies, shops, and others.
Take product samples for laboratory testing.
Order a product recall from the market if it has the potential to be dangerous.
Take action against violators, starting from warnings and fines to criminal recommendations.
Destroy products that violate the provisions.
Cooperate with international authorities, such as the World Health Organization (WHO) and the US Food and Drug Administration (FDA), in supervising import/export products.
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inconsistencies in content with labels that are detrimental to consumers.
BPOM is tasked with supervising the circulation of skincare products based on Law Number 8 of 1999 concerning Consumer Protection (UUPK), which in Article 8 prohibits business actors from making misleading claims(Andra Tri Setiyani & Indriasari, 2.
Based on the results of my research, the Food and Drug Authority (BPOM) functions as a supervisory responsible for ensuring the safety and effectiveness of products circulating in the market.
In the case of skincare overclaims, the Food and Drug Authority (BPOM) cannot be sued directly by consumers regarding overclaimed products because they function as a However, if there is a loss caused by overclaims, consumers can file a lawsuit against the manufacturer of the product.
BPOM is not directly responsible for claims made by the manufacturer.
Consumers who feel disadvantaged by claims that do not correspond to the actual content of a product can file a lawsuit against the product manufacturer.
(Supu, 2.
The Food and Drug Authority (BPOM) can be sued legally, especially through the State Administrative Court (PTUN), if it is considered to have committed an unlawful act related to drug supervision and licensing, including cases of overclaims or conveying misleading information, in which BPOM is considered to have lied to the public, and negligence in testing and supervising drugs, food, and cosmetics containing dangerous contaminants, which have the potential to harm consumers.
The lawsuit in this case demands that BPOM retest all food, drug, and cosmetic products that have been given distribution permits and asks BPOM to be responsible for negligence in supervision that causes losses to consumers.
In this context, overclaims that are detrimental to consumers and are not handled properly by BPOM can be the basis for a lawsuit for unlawful acts against BPOM.
However, this legal process is usually related to administrative and state administration aspects, namely disputes over BPOM's decisions that issue distribution permits for food, drug, and cosmetic products.
Court decisions can order BPOM to revoke the distribution permit of a particular product if it is proven to be dangerous or not in accordance with the provisions.
In the case of skincare overclaims raised in this writing.
BPOM, as the supervisor, has an important role in supervising skincare product claims so that they are not excessive .
and misleading to consumers.
However, in the case of skincare overclaims that are rampant in Indonesia, the main responsibility for consumer losses remains with the business actors or producers of the products.
This is because the skincare overclaim case studied by the author is a case of mild overclaims that do not endanger the health of consumers, but consumers are still harmed in this So that consumers have the right to demand accountability from both business actors or product producers and BPOM as the supervisor who grants a distribution permit for a product.
The author can conclude that the role of the Food and Drug Authority in the case of skincare overclaims is to ensure that the product packaging label does not contain misleading claims and is in accordance with scientific data and valid clinical trials before the product receives a distribution permit.
BPOM also has the authority to impose administrative sanctions on business actors who are proven to have made overclaims, such as revoking distribution permits and imposing fines.
Then, the most important thing is that BPOM must also tighten supervision of skincare products so that the claims listed are in accordance with the facts and do not harm consumers.
Although the Food and Drug Authority (BPOM) cannot be sued, they have the authority to take action against producers who violate regulations, including issuing instructions to revoke distribution permits and sanctions in the form of demands to pay compensation to This shows that BPOM plays a role in protecting consumers even though it cannot face threats directly.
Public pressure and lawsuits are needed to ensure that BPOM is more transparent and proactive.
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CONCLUSION
Indonesian Food and Drug Authority(BPOM) has a very important role and responsibility in supervising and ensuring the safety, quality, and honesty of skincare product information circulating in Indonesia.
However, in practice, there are still gaps in the supervision system, both at the pre-distribution and post-distribution stages, which cause products with excessive claims .
to continue to circulate, thereby misleading and harming consumers and violating consumers' rights to obtain correct, clear, and honest information as regulated in the Consumer Protection Law.
Although BPOM cannot be sued directly by consumers, this institution can still be held accountable through legal channels if it is proven to be negligent in carrying out its duties, which results in losses that endanger consumers.
In this context, producers or business actors remain the main parties responsible for false claims, but BPOM is also required to tighten verification and supervision so that products that are permitted to circulate truly meet the standards of safety and honesty of claims.
Reform in the supervision system and enforcement of sanctions by the Food and Drug Authority (BPOM) is very necessary to ensure optimal consumer protection.
BPOM is legally responsible for pre-market supervision .
arketing permi.
and post-market supervision .
upervision of products in circulatio.
If negligence occurs that causes consumers to feel disadvantaged due to overclaim.
BPOM can be held accountable through mechanisms in accordance with applicable provisions, namely, revoking the product's distribution permit, issuing instructions to withdraw the product from the market, and taking legal action against business actors or producers of problematic If BPOM is negligent in carrying out its functions so that overclaims occur that are detrimental to and endanger consumers, then there is potential for legal liability both administratively and civilly, including the possibility of lawsuits from consumers who are This journal emphasizes the need to strengthen BPOM's supervisory mechanism and legal reform so that consumer protection can run more effectively.
The recommendations submitted include increasing transparency, enforcing strict sanctions against business actors who violate, and optimizing the role of the Food and Drug Authority in educating and supervising skincare products in Indonesia.
Thus, it is hoped that consumers can be protected from overclaim practices and obtain guarantees for the safety and reliability of the skincare products they use.
REFERENCE