Lok Sabha Question No. 98 (STARRED), answered on 2021-12-03
Subject: Nutraceutical Product
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Midhun Reddy, Sanjeev Kumar Singari

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

## LOK SABHA STARRED QUESTION NO.98 TO BE ANSWERED ON THE 3 RD  DECEMBER, 2021 NUTRACEUTICAL PRODUCT

## *98. SHRI P.V. MIDHUN REDDY: DR. SANJEEV KUMAR SINGARI:

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

- (a)  whether  the  Government  is  aware  that  a  number  of  food  product  companies  are developing  nutraceutical  products  which  claim  to  provide  relief  to  consumers  from health conditions like diabetes, obesity, chronic pains and anemia;
- (b) if so, the details thereof; and
- (c)  the  manner  in  which  the  Government/  Food  Safety  and  Standards  Authority  of India (FSSAI) ascertain authenticity/genuineness of such products and regulate them?

## THE MINISTER OF HEALTH AND FAMILY WELFARE

## ANSWER (DR. MANSUKH MANDAVIYA)

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

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 98* FOR 3 RD  DECEMBER, 2021

(a) & (b): As per information received from Food Safety and Standards Authority of India (FSSAI), the standards for nutraceuticals under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical  Purpose,  Functional  Food  and  Novel  Food)  Regulations,  2016  have  been notified  by  FSSAI.  The  regulations  list  out  ingredients  including  vitamins  and minerals, additives and specific labelling for products covered under these regulations. Further, the said regulations also have provisions regarding claims.

As per these regulations, the labelling, presentation and advertisement shall not claim that the nutraceutical product has the property of preventing, treating or curing a human disease, or refer to such properties. For health claims such as enhanced function claims, disease risk reduction claims, immunity claims etc., where scientific support does  not  exist,  or  if  a  novel  ingredient  is  to  be  introduced,  there  shall  be  a  prior approval of the Food Authority which shall be based on adequate scientific evidence. If the health claims are product led, the food business operator shall notify to the Food Authority  before  putting  the  same  in  the  market,  by  submitting  relevant  documents along with a copy of the label. FSSAI has constituted an Expert Committee on Claims for  scrutiny  of  the  Claims.  The  Food  Business  Operator  (FBO)  who  wants  to manufacture, import, market or sell these products shall comply with the aforementioned  regulations.  The  said  regulation  is  available  on  FSSAI  website www.fssai.gov.in

(c):  All  Food  Business  Operators  have  to  comply  with  the  aforesaid  regulations. Further,  to  ensure  compliance  of  these  standards  laid  down  under  Food  Safety  and Standards  (FSS)  Act,  2006  and  the  rules  and  regulations  made  thereunder,  regular surveillance, monitoring, inspection and sampling of food products are undertaken by the  officials  of  Food  Safety  Departments  of  the  respective  States/UTs  and  Central Enforcement  Authorities.  In  cases  where  the  food  samples  are  found  to  be  nonconforming,  penal  action  has  been  initiated  against  such  violating  Food  Business Operators as specified under Chapter IX of the FSS Act, 2006.

FSSAI has recognised and notified a total of 235 NABL accredited food testing laboratories (both primary and referral) across the country. Out of these,20 food testing laboratories are able to test nutraceuticals and such products.

Moreover,  in  order  to  keep  regular  watch  on  Food  and  Beverages  related advertisements appearing across various print and electronic media, FSSAI has signed Memorandum  of  Agreement(MoA)  with  Advertising  Standards  Council  of  India (ASCI),  a  self-regulatory voluntary organization of the advertising content for exclusive tracking, tracing and evaluation of all Food and Beverages advertisements appearing across various media which could be potentially violating the provisions of FSS Act, Rules and Regulations made thereunder.

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