CDSCO cancels FatX Solution registration over 'fat-dissolving' claims
India's drug regulator has cancelled the registration of a slimming product after finding that it was being marketed with claims that are not permitted for cosmetics. The Central Drugs Standard Control Organisation (CDSCO) acted against FatX Solution, promoted by the Delhi-based importer Tekno Midas Aesthetics, in an order dated October 28.
The regulator said the company's website described the product as one that could dissolve fat cells and reduce their size. In CDSCO's view, these are drug-related claims and fall outside the definition of a cosmetic under the Drugs and Cosmetics Act, 1940.
The action followed a scrutiny of the company's application and its website. During this review, the regulator found differences between the claims being made online and those mentioned on the approved product label.
Under the Cosmetics Rules, 2020, cosmetic products cannot make false or misleading claims. The rules define a cosmetic as a product meant for cleansing, beautifying, promoting attractiveness or altering appearance. Claims that a product dissolves fat cells go beyond this definition, the regulator said.
CDSCO had issued a show-cause notice to the company on August 10, citing violations of the Drugs and Cosmetics Act and the Cosmetics Rules. The company submitted its response on September 1, but the regulator found it inconclusive and unsatisfactory. The firm also requested that its registration certificate be voluntarily surrendered.
Rajan Bhatnagar of Tekno Midas Aesthetics told this publication that the product had been registered as a cosmetic more than four years ago. "At that time, the licence was granted because the product was registered as a cosmetic. The authorities have now changed their interpretation of the category under which the product falls. Earlier, it was considered a cosmetic, but now they say it falls under another category," he said.
He added that the company had decided not to contest the matter after receiving the notice. "We did not want to get into any dispute or challenge the notification. We voluntarily requested the surrender of the licence, and the authorities cancelled it," he said.
The Central Licensing Authority subsequently cancelled the registration certificate, RC/COS-003300, which was issued in July 2022 and was valid until July 14, 2027. The cancellation took effect from October 28.
The case turns on a distinction that matters for both consumers and manufacturers. Cosmetics and drugs are regulated differently in India. A product cleared as a cosmetic is not required to establish therapeutic benefit, and its permitted claims are limited to appearance and grooming. A product that claims to act on the body in a medicinal or physiological way is treated as a drug and needs a drug licence, along with evidence to support its claims.
Regulators across markets have increasingly scrutinised slimming and beauty products for claims that blur this line. Advertising that suggests a cosmetic can remove fat or change body composition can mislead buyers into expecting outcomes that the product has not been cleared to deliver.
The cancellation means FatX Solution can no longer be marketed under the cosmetic registration it held. It does not, by itself, bar the company from applying afresh under a different category, should it choose to do so with the supporting data that such an approval would require.
