JAKARTA - The Food and Drug Supervisory Agency (BPOM) revoked the distribution permit for 16 beauty cosmetic products that were used as injection drugs using needles and microneedles.

The Head of BPOM Taruna Ikrar said that this firm action was the result of intensive supervision of cosmetic circulation in the period September 2023-October 2024.

"The trend of using products registered as cosmetics but applied using needles that are widely circulated has been successfully disclosed by BPOM and needs to be brought under control," said Taruna in a written statement, Tuesday, November 12, which was confiscated by Antara.

In accordance with BPOM Regulation Number 21 of 2022 concerning Procedures for Application for Cosmetic Notifications, he said, cosmetic products are defined as ingredients or preparations intended to be used on the outside of the human body such as epidermis, hair, nails, lips and genital organs outside, or teeth and membranes of mouth mucose, especially for cleaning, fragrance, changing appearance and/or improving body odor or protecting or maintaining the body in good condition.

"Therefore, the products used with needles or microneedles or used by means of injection are not included in the cosmetic category," he said.

According to him, the products used by injection must be sterile and applied by medical personnel.

Cosmetics, he continued, are not sterile products and in general can be used by anyone without the help of medical personnel and are not intended to have an effect under the epidermis layer of skin.

Therefore, even though this product has been registered as cosmetics, it still violates regulations and endangers the health of its users.

"Injections carried out using products that are not appropriate and are applied by non-medical personnel are at risk of health, ranging from allergic reactions, infections, damage to skin tissues, to causing systemic side effects," he explained.

The cadet emphasized that the use of cosmetics by being injected is very dangerous for health. He assessed that products like this are categorized as drugs and must be registered as medicinal products.

The cosmetics they find are applied as drugs using needles or microneedles that can be recognized for their characteristics. He explained that products like this have a distribution permit as cosmetics and are usually fluid-shaped in ampoule, vials, or bottles accompanied by/without syringes. However, he said, the marking and/or promotion was stated to be applied by injection.

His party explicitly asked business actors to run their business in accordance with the provisions of the applicable laws and regulations. Business actors, he said, must register products in accordance with commodities regulated in statutory provisions.


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