Lok Sabha Question No. 58 (STARRED), answered on 2018-07-20
Subject: High Fluoride Content in Toothpaste
Ministry: HEALTH AND FAMILY WELFARE
Asked by: S. RAJENDRAN, BIDYUT BARAN MAHATO

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO.5 8 TO BE ANSWERED ON THE 20 TH JULY, 2018 HIGH FLUORIDE CONTEN T IN TOOTHPASTE

## *58. SHRI S. RAJENDRAN:

## SHRI BIDYUT BARAN MAHATO:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a)  whether  the  companies  manufacturing  toothpaste  are  using  high  fluo content in toothpaste and if so, the details thereof;
- (b) whether high fluoride co ntent in toothpaste is harmful and involves health ris and if so, the details thereof;
- (c) whether the Drugs Technical Advisory Board (DTAB) has decided to restr the use of fluoride content in toothpaste;
- (d)  if so, the details thereof along with the time by  which such restrictio likely to be implemented; and
- (e)  the  other  corrective  measures  taken/being  taken  by  the  Government  in regard?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF  HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

- (a)to ( e) : A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 58* FOR 20 TH JULY, 2018

(a)Manufacture, sale  and  distribution  of  cosmetics  in  the  country  are  reg under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereund Licenses to manufacture cosmetics for sale or for distribution are granted State  Licensing  A uthorities  (SLAs)  appointed  by  respective  State  Governments The  SLAs  are  legally  empowered  to  take  action  against  any  violation  of conditions of license.

Central Drugs Standard Control Organization (CDSCO) ,under the Ministry of Health & Family Welfare ,has not received any such report that the companies manufacturing toothpaste are using high fluoride content in toothpaste.

(b)      High  Fluoride  content  in  toothpaste  is  harmful  and  involves  healt Excess of fluoride ingestion can cau se dental fluorosis.

(c) & (d) Fluoride content in toothpaste is already restricted under Rule the Drugs and Cosmetics Rule 1945. As per the said rule, Fluoride content not be more than 1000 ppm in toothpaste and the content of fluoride in te rms of ppm shall be mentioned on the label and carton.

Drugs Technical Advisory Board (DTAB) deliberated the matter in its 79 th meeting held on 16/05/2018 and agreed to recommend amendment to Rule 149A to incorporate the labelling requirements for toothpaste containing fluorides for u of children.

(e) To manage the problem of Fluorosis, a National Programme for Prevention Control  of  Fluorosis  (NPPCF)  has  been  implemented  since  11 th Five  year  plan (2008- 09)  which  has  been  pro gressively  expanded  to  cover  148  districts  of  19 States.

The important components of the Programme are: - Surveillance of Fluorosis in the community; capacity building (Human Resource) in the form of training manpower  support;  establishment  of  diagnos tic  facilities  in  the  districts;  heal education for prevention and control of Fluorosis; management of Fluorosis including supplementation with Vitamins and minerals, surgery and rehabilitat

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