Which category is your product?
Health supplement, nutraceutical, special dietary use, special medical purpose, probiotic or Ayurveda Aahara. Each has its own formats, limits and label lines.
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- Every ingredient checked against its schedule
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Pick one to see what it allows.
Health supplement
Concentrated nutrients or other listed substances, taken to add to the normal diet.
- Ingredients
- Vitamins, minerals, botanicals and other listed nutrients from Schedules I, II and IV. Not Schedule III.
- Limits
- Vitamins and minerals up to 1 RDA a day. A nutrient you claim must be at least 15% of the RDA (30% for “high”).
Formats
- TabletAllowed
- CapsuleAllowed
- PowderAllowed
- GummyAllowed
- LiquidAllowed
- DropsAllowed
- Bar or biscuitAllowed; label must set it apart from ordinary food
The label must carry
- “Health Supplement” with the name
- NOT FOR MEDICINAL USE
- Recommended daily usage, and a warning not to exceed it
- Who it is for (age group)
Nutraceutical
Products built around a naturally occurring bioactive ingredient with a physiological benefit.
- Ingredients
- At least one Schedule III ingredient, plus others from the schedules if you like.
- Limits
- Up to 1 RDA. Above that only with FSSAI’s prior approval, and never in a tablet, capsule or syrup.
Formats
- TabletAllowed
- CapsuleAllowed
- PowderAllowed
- GummyAllowed
- LiquidAllowed
- DropsAllowed
- Bar or biscuitAllowed; label must set it apart from ordinary food
The label must carry
- “Nutraceutical” with the name
- NOT FOR MEDICINAL USE
- Recommended daily usage, and a warning not to exceed it
- Who it is for (age group)
Special dietary use
Foods for people with a particular physical or physiological condition, including foods for sportspersons.
- Ingredients
- Ingredients from any schedule, suited to the stated condition.
- Limits
- Up to 1 RDA; above only with prior approval, in food formats.
Formats
- TabletAllowed
- CapsuleAllowed
- PowderAllowed
- GummyAllowed
- LiquidAllowed
- DropsAllowed
- Bar or biscuitAllowed
The label must carry
- The category name with the product name
- The medical-advice statement the rules set
- Sports foods: “FOR SPORTSPERSON ONLY”, and nothing on WADA’s prohibited list
Special medical purpose
Foods for the dietary management of patients, used under medical supervision.
- Ingredients
- Ingredients from any schedule, for the condition it manages.
- Limits
- Up to 1 RDA. Tablets, capsules, pills, drops, gummies, jellies, chewables and mouth-dissolving strips are not allowed.
Formats
- TabletNot allowed
- CapsuleNot allowed
- PowderAllowed
- GummyNot allowed
- LiquidAllowed
- DropsNot allowed
- Bar or biscuitAsk us
The label must carry
- The category name with the product name
- To be used under medical supervision
Prebiotic & probiotic
Foods with live beneficial microbes (probiotics), or fibres that feed them (prebiotics).
- Ingredients
- Listed strains and prebiotic fibres (Schedule IV).
- Limits
- Probiotic: at least 10⁸ live microbes (CFU) a day. Prebiotic: no more than 40 g a day.
Formats
- TabletNeeds approval
- CapsuleNeeds approval
- PowderAllowed
- GummyAsk us
- LiquidAllowed
- DropsNeeds approval
- Bar or biscuitAsk us
The label must carry
- The category name with the product name
- Strains and the live count
- Recommended daily usage
Ayurveda Aahara
Foods made to recipes in the classical Ayurvedic texts, sold as food, not as medicine.
- Ingredients
- As in the classical text. No added vitamins, minerals or amino acids.
- Limits
- A recipe on FSSAI’s list needs no prior approval. A new recipe, a new format, or a recipe aimed at a disease does.
Formats
- TabletAs in the classical text
- CapsuleAs in the classical text
- PowderAs in the classical text
- GummyAs in the classical text
- LiquidAs in the classical text
- DropsAs in the classical text
- Bar or biscuitAs in the classical text
The label must carry
- “AYURVEDA AAHARA” next to the name, with its logo
- ONLY FOR DIETARY USE
- Contraindications and drug interactions
- Oral use only; keep out of reach of children
AllowedNeeds FSSAI approvalNot allowedAllowed with conditionsAsk us
Rules for every category
Food, Ayurvedic food or medicine?
Three questions to find which rulebook your product sits in.
Question 1 of 3
Does the product claim to treat, cure, mitigate or prevent a disease?
Question 2 of 3
Is it a recipe from a classical Ayurvedic text, sold as food?
Question 3 of 3
Are all ingredients on FSSAI’s lists, at levels within the limits?
Products meant to treat or prevent disease are drugs under the Drugs and Cosmetics Act. That means CDSCO or the State drug controller, or the AYUSH route for Ayurvedic medicines. Remove the disease claim and the product may come back into food.
A food made to a classical Ayurvedic recipe. Listed recipes need no prior approval. No added vitamins or minerals, and no disease claims.
Pick the right category next. It decides the formats, limits and label lines that apply.
An ingredient or level outside the lists makes it a non-specified food. It needs FSSAI’s approval before sale, or a change of formula.
Guidance, not a ruling. Borderline products need a written opinion; ask us.
Category questions
How do I choose between health supplement and nutraceutical?
A nutraceutical must contain at least one Schedule III ingredient. A health supplement must not. The ingredients decide it, not the marketing name.
My product has ashwagandha extract. How much is allowed?
The schedule sets a range for the root. An extract is converted back to root using its ratio: 500 mg of a 10:1 extract is 5 g of root. The plant part must also match the schedule.
Is an Ayurvedic product a food or a medicine?
If it claims to treat a disease, it is a medicine under the AYUSH route. A classical recipe sold as food, with no disease claim, can be Ayurveda Aahara under FSSAI.
Not sure of your category?
Send us your ingredient list. A regulatory advisor calls you back within 2 working hours.
- Free 10-minute check
- Filed within 3 working days of getting your documents
- Licence in your own name
- Government fee paid by you directly to FSSAI
Thank you. We have your details.
We will call you within 2 working hours (Mon–Sat, 10 am–7 pm).
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