CDSCO cancels import licence of Korean cosmetic FatX over misleading ‘fat-dissolving’ claim
New Delhi: India’s apex drug regulator has cancelled the import registration certificate of a South Korean cosmetic product FatX solution, marketed by Delhi-based Tekno Midas Aesthetics, for making misleading therapeutic claims about dissolving fat cells, according to the two officials and a regulatory document reviewed by Mint.
The Central Drugs Standard Control Organisation (CDSCO) found that the firm marketed the product on its website as a treatment to “dissolve fat cells and reduce their size”. It ruled that such claims fall under the definition of a drug and do not qualify as a cosmetic under the Drugs and Cosmetics Act, 1940.
Under the Drugs and Cosmetics Act, 1940, cosmetics are defined as products applied by rubbing, pouring, sprinkling, or spraying solely to cleanse, beautify, boost attractiveness, or alter visual appearance.
Emphasizing that dissolving fat cells alters cellular and physiological structures, the CDSCO ruled that therapeutic claims fall strictly under drug regulations. Marketing the product with such claims violates the Cosmetics Rules, 2020, which bar companies from misleading consumers.
“Prohibition against false or misleading claims. No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user,” read the document, citing the rule.
‘Discrepancies in claims’
The regulator said it conducted a detailed scrutiny of the registration documents alongside the importer’s official website, which uncovered huge mismatches between what had been legally cleared and what was actively marketed to the public. “Discrepancies/mismatches have been observed with respect to the availability of claims on the marketed product labels against the approved product label. On the website, the product is being marketed as treatment for dissolving the fat cells and reduces the size of fat cells which are drug claims and does not attract the definition of cosmetics,” the document read.
After these violations were detected, the licensing authority served a show-cause notice to the firm on 10 August 2026. However, when the company submitted its response on 1 September 2026, it failed to provide a valid defense and instead requested the regulator to accept a voluntary surrender of its licence, the regulator said.
“The firm has submitted its response… which is inconclusive and unsatisfactory. Further, the firm requested that the voluntary surrender of [its licence] be accepted,” said the document.
Drugs controller general of India (DCGI) Rajeev Singh Raghuvanshi rejected the company’s response as inconclusive and unsatisfactory. Rejecting the plea for voluntary surrender, the Central Licensing Authority invoked Rule 16 of the Cosmetics Rules, 2020, to formally cancel the company’s registration certificate with immediate effect. The permit was granted in July 2022 and would have been valid until July 2027.
“The decisive regulatory action underscores heightened surveillance by the CDSCO over imported aesthetic solutions, injectables, and cosmetic formulations being sold in the domestic market without appropriate statutory clearances,” said one of the officials cited above.
Cracking down on violations
India is turning the screws on cosmetics firms making fake claims. In September the drug regulator cancelled all three import registrations of Skintl Enterprises, a major Korean beauty products importer, over labelling violations and misbranding, and unauthorized warehouse and storage.
Dr. Saurabh Arora, managing director of cosmetics brand Auriga Research, said, “It is a common practice to exploit the relatively simpler regulatory pathway for cosmetics to market products making therapeutic claims. Cosmetics are meant to enhance appearance and act on the surface, whereas claims such as dissolving or destroying fat cells bring a product under the definition of a drug, which requires a much stricter approval process. CDSCO’s action reinforces the correct interpretation of existing laws and is important for preventing potentially unsafe products from reaching consumers under the guise of cosmetics.”
Queries emailed to spokespersons for the health ministry and the DGCI office on Saturday remained unanswered at the time of publishing. Tekno Midas Aesthetics could not be contacted via email and a telephone call to the company was not answered.
