On Monday, Indian food safety watchdog FSSAI announced that health supplements cannot be sold as ‘medicines’ any more. New standards have been issued for manufacturers of health products to check mis-labelling.
The Food Safety and Standards Authority of India (FSSAI) has operationalised with immediate effect new standards for eight categories of products, including health supplements and nutraceuticals.
FSSAI will now start granting licences and approve products manufactured based on the new standards, CEO Pawan Aggarwal said.
“Last year, we had issued draft standards on health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food. We have finalised this and operationalised with immediate effect,” Aggarwal was quoted by news agency PTI as saying.
The approval for products was stopped in view of Supreme Court direction to this effect last year. FSSAI will now start giving licences to companies and approve products that comply with new standards, he said, adding about 600 applications were pending with the regulator.
However, these regulations will be enforced from January 2018.
“Considering that the regulation is final, FSSAI has made the regulations operational with immediate effect in order to facilitate food business,” the regulator said in a statement.
Under the new guidelines, FSSAI has specified that health supplements should not be sold as medicines and also fixed the permissible limits of various ingredients used in the products.
Every package of health supplement should carry the words ‘health supplement’ as well as an advisory warning ‘not for medicinal use’ prominently written, it said.
“The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, standards laid down by the international food standards body namely Codex Alimentarius Commission shall apply,” it added.
FSSAI further said health supplements may be used to supplement the normal diet of anyone above the age of five years.
Similar labelling and packaging norms have been prescribed for nutraceuticals, food for special dietary use, food for special medical purpose, functional and novel food.
Confederation of Indian Industry (CII) said the operationalisation of this regulation will help greatly in resolving the issues confronting this sector and creating a conducive regulatory environment for the industry to operate.
“A period of a year has been provided to FBOs (food business operators) to comply with the provisions of the regulation. In the interim period, the industry will need to work closely with the Food Authority to ensure a smooth transition to the new regime,” it said.