The Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 was implemented on January 1, 2018. Recently, FSSAI, with the previous approval of the Central Government made the first amendment of the above regulations, i.e., Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) first Amendment Regulations, 2021.

These regulations cover eight (08) categories of Functional foods listed below:

• Health Supplements
• Nutraceuticals
• Food for Special Dietary Use
• Food for Special Medical Purpose
• Specialty Food Containing Plant or Botanicals
• Foods Containing Probiotics
• Foods Containing Prebiotics
• Novel Foods

All the Food Business Operators (FBOs) need to comply with these regulations’ provisions from April 01, 2022.

The major changes in the first amendment are as follows:

• The dosage formats such as tablets, capsules, syrups are included for the combination of vitamins and minerals, including the use of a single vitamin and mineral, at levels equal to a maximum of one (01) Recommended Dietary Allowances (RDA) or below shall be covered under these regulations.
• After the establishment of separate regulation on ‘Food for infant nutrition, 2020’, these regulations on ‘Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food’ do not apply to infants up to the age of 24 months. Under the Food Safety and Standards (Food for infant nutrition, 2020), foods applicable for infants up to the age of twenty-four (24) months are specified.
• Cereal grains, fruits, vegetables, legumes, and spices may be used as a supplement or nutraceutical as applicable, either as such or as processed ingredients, including extracts.  However, claiming specific health benefits on such food products would require prior approval from the Food Authority.
• Any “single purified chemical entity” listed in these regulations, except botanical extracts, is not permitted without prior approval of the Authority.
• Claims for the ingredients or products need approval.
• Disease risk reduction claims are omitted.
• Food for Special Dietary Use (FSDU) for sportsperson shall only be used under medical advice by a physician, certified dietician or nutritionist.
• Food for Special Dietary Use (FSDU) for sportsperson shall only be in the formats meant for oral consumption.
• Food for Special Dietary Use (FSDU) as a formula food for replacing all meals of the daily diet for slimming, weight management, and weight control purposes shall not be considered as Food for Special Dietary Use (FSDU) for a sportsperson.
• All the advertisements of Food for Special Dietary Use (FSDU) should specifically mention that the product is to be taken under medical advice, wherever applicable.
• Food business operators shall add the quantity of the nutrients at levels equal to a maximum of one (1) Recommended Dietary Allowances (RDA) or below. Prior approval of the Food Authority is required based on adequate scientific evidence of the food specially prepared for weight reduction and intended as a total replacement of complete diet with greater RDA in food format (except capsule, tablet, syrup).
• Food business operators shall notify in writing the Food Authority whenever they use esters, derivatives, and salts of vitamins, and salts and chelates of minerals. They are also required to submit additional safety data/information when requested by the Food Authority in such cases.
• Suitable esters, derivatives, isomers, and salts of amino acids may be used. The food business Authorities, the FBO’s shall notify them in writing whenever they use esters, salts, isomers, and derivatives, and also they should submit additional safety data or any other document in such cases.

Labeling

Food labeling is a vital communication tool. It's a legal requirement and helps the consumer make an informed decision while purchasing. The label should usually include information about constituents of the product, nutritional profile, manufacturing details, etc.  As per the revised set of nutraceutical regulations, the following are the key elements:

• Every package containing Food for Special Dietary Use (FSDU) must have a statement “FOR SPORTSPERSON ONLY" in close proximity to the name of the articles of food, “Recommended to be used under medical advice by a physician or a certified dietician or a nutritionist only” and the logo as specified below should be used for the article of food specially prepared for the sportsperson.
• Every package containing Food for Special Dietary Use (FSDU) shall carry the information - Provided that in case of the article of food specially prepared for the sportsperson, a statement that the product is not to be used by pregnant, nursing, and lactating women or by infants, children under five (5) years and elderly.
• Every package containing Food for Special Dietary Use (FSDU) shall carry the information, provided that a statement ‘for oral consumption only’ for the article of food specially prepared for the sportsperson.
• Every package containing Food for Special Dietary Use (FSDU) must have a statement ‘the food is not a sole source of nutrition and shall be consumed in conjunction with a nutritious diet’ for the article of food specially prepared for the sportsperson.
• Every package containing Food for Special Dietary Use (FSDU) must have a statement ‘the food shall be used in conjunction with an appropriate physical training or exercise regime’ for the article of food specially prepared for the sportsperson.

Probiotics & Prebiotics

Prebiotics are a type of fiber that the human body cannot digest, and they are also considered as food for probiotics. Probiotics are tiny living microorganisms, including bacteria and yeast. Both prebiotics and probiotics may promote helpful bacteria along with other organisms in the gut. The new amendment includes the following:

• The viable number of added probiotic organisms in food should be ≥10⁸ CFU in the recommended serving size per day.
• For adults, the maximum limit of prebiotic per day must not exceed 40g/2000 kcal.

Apart from these, amendments are observed in the schedule 1 and 4. Schedule 1 covers the list of newly added vitamins and minerals, and Schedule 4 includes the revised list of botanical ingredients.

Schedule -1 – Additions (List of vitamins and minerals and their components)

The new forms of vitamins and minerals included in the regulation are as below:

• Vitamin D: Vitamin D3 (cholecalciferol) – Sources from Lichen/Algae are permitted. However, the species of lichen/algae shall need prior approval from the Food Authority.
• Vitamin E: Tocotrienols
• Calcium:  from algae, including red seaweed
• Calcium: Natural forms of calcium obtained from corals, shells, pearls, conch, oysters, and milk
• Copper: Copper-oxide (copper (II) oxide, cupric oxide, and black copper oxide)
• Selenium: Selenious acid

Schedule – IV – Revisions (List of plant or botanical ingredients)

• FSSAI has amended Schedule – IV List of plant or botanical ingredients. The permitted range of usage for adults per day (given in terms of raw herb/material) is revised for a majority of the Botanicals.
• New Botanicals have been included in the list of Botanicals.
• Certain Botanicals have been removed from the list, e.g., Areca catechu L. (Supari: Seed); Carissa spinarum L. (Karawan: Fruit).

As we have already mentioned, all the Food Business Operators (FBOs) need to comply with these regulations' provisions from April 1, 2022. Therefore, all the FBOs need to assess their product formulations of botanicals and make the necessary changes to comply with the revised regulations.

Any food product/dietary supplement should be compliant with the specific markets for a smooth flow of the growth cycle. Understanding the Regulatory framework of a particular product is useful to make an informed decision right from the R&D stage. Get detailed information on the updated food regulation in India by consulting with Regulatory experts like Freyr.