The majority of India’s health-conscious population now uses nutraceuticals as their main dietary supplement. Nutraceuticals, often known as nutritional supplements, are widely used in the healthcare industry and available in a variety of forms, such as pills, syrups, gum, and capsules. The market for nutritional supplements is anticipated to expand by 50% (CAGR), from $4 billion in 2017 to 18 billion in 2025. This article seeks to provide a succinct review of FSSAI regulations for dietary supplements. So, if you want to start a nutraceutical business, you must Apply for FSSAI online registration, which fssaifoodlicense will assist you with.

What do the FSSAI regulations for nutritional supplements say?

The Food Safety and Standards Authority of India (FSSAI) has established guidelines for the licensing and fssai registration of businesses engaged in the food industry within this scope. Regarding the clearance of nutraceuticals in the Indian market, the FSSAI has supported a few regulatory standards. The Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Innovative Food) First Amendment Rules, 2021, was created by the FSSAI with the prior consent of the Central Government.

The FSSAI has made it clear that a combination of minerals and vitamins in the form of capsules, tablets, or syrups shall not fall within any of the expected categories of such rules when minerals and vitamins are added. So, if you want to prove your validity, you must apply for an FSSAI registration license.

Following eight functional food categories are covered under the FSSAI Rules for Nutraceuticals

  • Supplements for health.
  • Dietary supplements for obtaining a food license.
  • Special medical purpose food.
  • Specialty Food Using Plant or Botanical Ingredients.
  • Probiotic-containing foods.
  • Prebiotic-containing foods.
  • Unique Foods.

Significant modification to the first amendment

  • If you want to apply for a food license, the dosage formats such as tablets, capsules, and syrups are included for the combination of vitamins and minerals, including the use of a single vitamin and mineral, at levels equivalent to a maximum of one Recommended Dietary Allowances or below.
  • The Fssai Nutraceuticals laws on “Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food which shall not apply for 24 months’ infants age” are included in the Regulation Act of Food for Infant Feeding, 2020.
  • Foods applicable for infants up to the age of twenty-four months are described in the Food Safety and Standards (Food for Infant Nutrition, 2020) and are used to apply for fssai registration online.
  • Depending on the situation, cereal grains, fruits, vegetables, legumes, spices, and extracts may be employed as dietary supplements or nutraceuticals. However, in order to make particular health claims on such food products, previous Food Authority clearance for a fssai registration license is required.
  • Except for botanical extracts, none of the “single pure chemical entities” stated in these regulations are allowed without the Authority’s previous consent.
  • Illness risk reduction statements are excluded, and claims regarding products’ contents require permission.
  • Food for Special Dietary Use (FSDU) for athletes should only be consumed when prescribed by a doctor, registered dietitian, or nutritionist.
  • Sportsperson’s food for special dietary use (FSDU) shall only be in oral consumption-oriented formats.
  • Food for Special Dietary Use (FSDU) for a sportsperson shall not include formula foods used to replace all meals in the daily diet for purposes of weight loss, weight management, or weight control.
  • To apply for a food license, all Food for Special Dietary Use (FSDU) advertisements must explicitly state that the product should only be used in accordance with a doctor’s advice.
  • The Food Authority’s approval is necessary based on sufficient scientific evidence for the food that is specifically prepared for weight loss and intended to completely replace a complete meal with a higher RDA in food format, excluding capsule, pill, and syrup. If you intend to apply for the Fssai registration online.
  • Operators of food businesses must notify the Food Authority in writing anytime they employ vitamin esters, derivatives, and salts, as well as mineral salts and chelates. Additionally, they must provide more safety data or information upon request from the Food Authority in such circumstances.
  • You can employ the appropriate esters, derivatives, isomers, and salts of amino acids. Every time they utilize esters, salts, isomers, or derivatives, the food business authorities, or FBOs, must get written notice from them. In addition, in these circumstances, they must also present any supplementary safety data or other documents.

Nutraceuticals Labeling and packaging

  • Food labelling is an essential tool for communication. It is a requirement under law and aids customers in selecting products with knowledge. Typically, the label should provide details on the product’s components, nutritional profile, production process, etc. The following criteria must be met in order to obtain an FSSAI registration license, according to the updated set of nutraceutical laws.
  • Food for Special Dietary Use (FSDU) products must be packaged with the words “FOR SPORTSPERSON ONLY” next to the name of the food items, the words “Recommended to be used under medical advice by a physician, a certified dietician, or a nutritionist only,” and the logo shown below for the food item specifically made for the sportsperson.
  • Every package of food labelled “Food for Special Dietary Use” (FSDU) must include the following information: “Product not intended for use by pregnant, nursing, or lactating women, infants, children under the age of five, or the elderly.” This statement does not apply to food prepared specifically for athletes. The fssai license renewal will follow the same rules.
  • Every packaging containing Food for Special Dietary Use (FSDU) must include the following information: “for oral consumption only” for any food item specifically made for athletes.
  • In order to get a food license, food for special dietary use (FSDU) goods must have the statement “the food is not a single source of nourishment” labelled on every packaging.
  • The phrase “the food shall be used in conjunction with an appropriate physical training or exercise regime” must appear on every package of food for special dietary use (FSDU). The same procedure must be followed if you want to apply for a food license renewal after your current one expires.

Probiotics & Prebiotics

Prebiotics are a form of fibre that the body cannot digest but which probiotics are thought to eat. Probiotics are microscopic, living organisms like yeast and bacteria. Both prebiotics and probiotics may support beneficial bacteria in the gut in addition to other organisms. The new amendment stipulates that 108 CFU of viable probiotic organisms added to food must be consumed daily in accordance with suggested serving sizes in order to get a fssai registration license, for example. Prebiotic intake for adults is restricted to no more than 40g/2000 kcal per day.

Amendments are noted in Schedules 1 and 4

List of vitamins, minerals, and their components in Schedule 1.
  • Vitamin D3 (cholecalciferol) is allowed from sources such as lichen and algae. However, the Food Authority must first approve the lichen/algae species.
  • Tocotrienols from vitamin E to obtain a food license.
  • Algae, notably red seaweed, provide calcium.
  • Calcium can be found in its natural forms in coral, shells, pearls, conch, oysters, and milk.
  • Black copper oxide, cupric oxide, and copper oxide (copper (II) oxide) and Selenious acid.
List of plant or botanical compounds under Schedule IV
  • For the bulk of the botanicals, the adult daily consumption range (expressed in terms of raw herb/material) has been changed.
  • The list of botanicals now includes new additions.
  • Several botanicals, such as Carissa spinarum L. and Areca catechu L. (Supari: Seed), have been taken from the list (Karawan: Fruit).

As we’ve already stated, in order to obtain a fssai license, all Food Business Operators (FBOs) must abide by the laws’ requirements, and the same procedure is followed to request a food license renewal of an existing license. As a result, all FBOs must evaluate the botanical product compositions they use and make the required adjustments to comply with the updated requirements.


In India, nutritional supplements are in high demand due to their effectiveness in the treatment and prevention of disease. Thus, FSSAI is required to reduce adverse effects, abuse, adulteration, toxicity, and overdose when food is consumed by humans. The supply of subpar products is being restricted by regulatory authorities in India due to the rising demand for dietary supplements.

For the growth cycle to proceed smoothly, every food product or dietary supplement should be in compliance with the relevant markets. Making an informed decision from the R&D stage forward depends on having a thorough understanding of the regulatory framework for a given product.

Obtain comprehensive details on India’s most recent food regulations from the best food license consultants at fssaifoodlicense. Let us know if you have any questions about the FSSAI laws for nutraceuticals in India or if you want assistance obtaining an FSSAI registration license.