FDA cracks down on Sensodyne, Colgate over ‘clinical’ claims

Two popular toothpaste brands have run into trouble with the State Food and Drug Administration (FDA) for allegedly misguiding people with claims made on their tubes and cartons. The FDA’s Thane division seized toothpaste tubes worth crores of rupees last week, and will now challenge the claims made by the two brands in court.

According to FDA officials, the branding of the two toothpastes — one belonging to Sensodyne and the other from Colgate — were using claims that contradicted the terms of the licence issued.

“Sensodyne Fluoride toothpaste, Fresh Gel and its variants made claims of repair and protection, clinically proven relief, and daily protection for sensitive teeth inscribed on the carton and the tube. Colgate Anticavity Toothpaste, Sensitive had 24/7 sensitivity protection and clinically proven relief inscribed,” Viraj Paunikar, Joint Commissioner, FDA, Konkan division, Thane, said.

However, these two toothpastes, officials said, only had the cosmetic licence. “All toothpastes get a cosmetic licence, but these are general toothpastes and medical toothpastes have to seek drug licence. These two toothpaste products only had a cosmetic licence, which means they fall under the general category and can not claim to be medical toothpastes,” Mr. Paunikar said.

As per rules, while all toothpastes get cosmetic licence, only certain toothpastes that are approved by clinicians get licensed as medicinal so that they can be recommended by dentists to their patients.

“We had studied the two products after which we had prohibited their sale and sent their samples to a laboratory. Only after we were sure, did we take the action. We have no objections to the brand or the quality. It is the claims that they made, which go against the definition of cosmetics as given by the Act,” he said.

While officials indicated that the two products were misguiding people with the claims meant for marketing and sales, the two products and their variants worth ₹4,69,30,768 were seized.

“We have also seized variants of the two toothpastes such as the different weights, flavours, and other variety that they offered. On March 29, we raided two godowns where these products were stored. While Sensodyne toothpaste product stock worth ₹4, 27,44,762 was seized, stock worth ₹41,86,006 of Colgate and its variants were seized,” Mr. Paunikar said.

FDA officials said they will soon go to court over the issue, and are also looking at other brands for such violations of licensing terms.

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Printable version | May 24, 2020 4:35:55 PM |

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