The Food Safety and Standards Authority of India (FSSAI) has clarified that under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, there are no specific restrictions for combining ingredients.
In this regards, the FSSAI has issued FAQs to answer general queries vis-à-vis the said regulation.
FSSAI clarified that these products cannot be licensed under proprietary food as well, because Section 2.12 of FSS (Food Products Standards and Food Additives) Regulations, 2011, excludes Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food.
FSSAI has added that it is the responsibility of FBOs to keep in mind the potential synergistic or antagonistic interactions amongst a combination of ingredients leading to impact on stability, bioavailability, safety, and efficacy of the product.
“FBOs are required to provide data on the scientific rationale for formulating such combinations, based on the scientific literature in peer reviewed publications or data generated by FBOs/innovators or suppliers of such ingredients to the Authority as and when demanded,” the statement read.
Further, the labelling, presentation and advertisement of the products covered under these regulations shall not claim that the product has the property of preventing, treating or curing a human disease.
FSSAI explains, food or ingredient as specified in FSS (Food Products Standards and Food Additives) Regulations, 2011, and for which standards are provided, and the plants and botanicals listed in Schedule IV to these regulations offered in normal or naturally occurring food form shall not constitute a ‘Health Supplement’ or ‘Nutraceutical,’ or ‘Food for Special Dietary Use’ or ‘Food for Special Medical Purpose’.
Vegetables (e.g., bhindi, karela), cereals (e.g., ragi, jowar, millets), legumes (e.g., Rajmah), spices (pepper, jeera, turmeric), fruits (amla, jamun, grape), and other plants or botanicals, minimally processed (cleaned, de-weeded, sorted, dried or powdered), in either as juice or cooked form, shall not constitute ‘Health Supplement’ or ‘Nutraceutical’ or ‘Food for Special Dietary Use’ or ‘Food for Special Medical Purpose.’
And in case of the naturally occurring nutrient in a product, the FBO has to mention it in the claim that ‘this food is by its nature …X….’, where X refers to essential distinguishing characteristic as demonstrated by the generally accepted scientific data to make consumer aware.
FSSAI has said that mere combinations of vitamins and minerals formulated in tablet, capsule, syrup formats do not bring the product under these regulations.
On licensing, the FSSAI has clarified that licence for products complying with these regulations shall be granted in accordance with the FSS (Licensing and Registration of Food Businesses) Regulations, 2011, except for novel foods which need prior approval as per NSF regulations.
Product Approval
On the question, what will happen to products licensed earlier but not covered under these regulations? FSSAI has clarified that FBOs were required to ensure compliance of their existing and new products with all the provisions under these regulations by January 1, 2018. Any products/ingredients not covered under these regulations are not allowed from January 1, 2018, unless they are included in these regulations or approved by the Authority under Non Specified Food (NSF) regulations, as the case may be.
FSSAI has clarified that all those applications seeking product approval pending for decision as on August 19, 2015, became defunct and no product approval is required, if such products explicitly got covered under the draft nutraceutical regulations, 2015 made available to the public on September 11, 2015.
The draft regulations issued on Sept 11, 2015, were gazette notified on Dec 23, 2016, with certain changes. However, the products which got covered under the draft notification on Sept 11,2015, but not complying to the extant regulations gazette notified on Dec 23, 2016, would require approval under NSF regulations.
Also, product approval is not required in respect of the products for which applications seeking product approval were filed in the earlier regime but later on covered in the nutraceutical regulations gazette notified on Dec 23, 2016.
“However, the applications filed for product approval as per the earlier PA regime and are pending in light of directions of the court dated Aug 19, 2015, and which do not comply the extant regulations were given a chance to re-submit application along with necessary documents as per requirements of the NSF regulations without additional fees for further examination of their application. Since the given timeline was over, the applications where details were not received, have been closed,” clarifies FSSAI.