Maharashtra FDA notice for Colgate brand, Sensodyne for ‘misleading consumers’

The notices were issued to Colgate-Palmolive (India) Limited, which produces Colgate, and GlaxoSmithKline Consumer Healthcare, which manufactures Sensodyne, on March 29.

The Maharashtra state Food and Drugs Administration (FDA) has sent notices to two manufacturers of popular toothpaste brands, Colgate Sensitive Toothpaste and Sensodyne, for selling “cosmetic products” as clinical ones. The authority said both brands have licences to manufacture and sell cosmetics only, and they are “misleading consumers by selling the products as medical remedies to dental problems”.

Maharashtra FDA has sent notice to GlaxoSmithKline Consumer Healthcare, which manufactures Sensodyne for selling cosmetic products as clinical ones. (Reuters File)

The notices were issued to Colgate-Palmolive (India) Limited, which produces Colgate, and GlaxoSmithKline Consumer Healthcare, which manufactures Sensodyne, on March 29 under section 17 C(c) and 18 A (ii) of the Drugs and Cosmetics Act, 1940, which prohibits brands from using misleading labels on cosmetics. FDA officials also seized stock worth ₹4.69 crore from warehouses of the two brands in Thane.

The manufacturers, however, said they are following branding rules and the claims on the labels were backed by research. Spokesperson of Colgate-Palmolive (India) Limited said the issue was only regarding certain variants, and not the whole brand. “We assure all our stakeholders that Colgate Sensitive Toothpaste complies with all the statutory FDA quality requirements set by the Bureau of Indian Standards (BIS). We have provided the FDA with details of our valid licence, claim support and other information,” the spokesperson said.

The official spokesperson of GlaxoSmithKline Consumer Healthcare said, “We are looking into the matter. Consumer safety is paramount for us and all our products are manufactured in strict compliance with national quality standards.”

However, Pallavi Darade, commissioner, FDA, Maharashtra, said both manufacturers have licences to make and sell these products as cosmetics, and not drugs. “Labels on certain variants of the products bear statements such as ‘repair and protect’, ‘clinically-proven relief’, and ‘daily protection for sensitive teeth’, which are not scientifically substantiated,” she said. “Thus, the brands are misleading consumers.”

Meanwhile, oral health experts and dentists said consumers cannot entirely rely on such products. Dr Sangeeta Ambhore, assistant professor, Government Dental College and Hospital, Colaba, said, “We do recommend certain variants of such toothpastes, but we do that only after diagnosing the problem. The variants are recommended to go along with our treatment.”