The CDSCO has cancelled the registration of FatX due to misleading claims that the cosmetic product could dissolve fat cells, which the regulator deemed unauthorized drug claims violating the Drugs and Cosmetics Act and Cosmetics Rules.

CDSCO Cancels FatX Registration Over Claims

By Shalini Bhardwaj New Delhi [India], October 31 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of FatX over discrepancies between the approved product label and claims made by the company on its official website. According to the order, the company was marketing the product as a treatment for dissolving fat cells and reducing their size, which the regulator said amounted to drug claims and did not fall under the definition of cosmetics.

"On the official website of the importer (copy enclosed), 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 a treatment for dissolving the fat cells and reducing the size of fat cells, which are drug claims and do not fall under the definition of cosmetics," the order stated.

Regulatory Violations Cited

The CDSCO referred to clause (aaa) of Section 3 of the Drugs and Cosmetics Act, 1940, which defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearance. The order further cited Rule 36 of the Cosmetics Rules, 2020, which prohibits false or misleading claims by cosmetic products.

"As per the provisions of Rule 36 of the Cosmetics Rules, 2020, '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'," the order stated.

Show-Cause Notice and Cancellation

According to the order, a show-cause notice dated August 10, 2026, was issued to the firm for violation of clause (aaa) of Section 3 of the Drugs and Cosmetics Act, 1940, and Rule 36 of the Cosmetics Rules, 2020. The firm submitted its response on September 1, 2026, which the Licensing Authority found inconclusive and unsatisfactory. The company also requested that the voluntary surrender of its registration certificate be accepted.

"A show cause notice dated 10.08.2026 was issued by the Licensing Authority to the firm for violation of clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940 and Rule 36 of the Cosmetics Rules, 2020; the firm has submitted its response dated 01.09.2026, which is inconclusive and unsatisfactory. Further, the firm requested that the voluntary surrender of RC/COS-003300 be accepted," the order stated.

The Central Licensing Authority, exercising its powers under Rule 16 of the Cosmetics Rules, 2020, subsequently cancelled the registration certificate bearing number RC/COS-003300, dated July 15, 2022, which was valid until July 14, 2027.

"The undersigned, being the Central Licensing Authority empowered under Rule 16 of the Cosmetics Rules, 2020, keeping in view of the violation of clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940 and Rule 36 of the Cosmetics Rules, 2020, hereby cancels the Registration Certificate bearing no. RC/COS-003300 dated 15-Jul-2022 valid upto 14-Jul-2027 from the date of issue of this order," the notice read. (ANI)

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