Health Claims & Nutritional Claims – FSSAI Restrictions

In today’s fast-evolving food and wellness industry, consumers are more informed than ever. With rising health consciousness, people don’t just want to eat—they want to eat right. This shift has led to a surge in products making bold promises: “Boosts immunity,” “Low sugar,” “Rich in protein,” or “Supports heart health.” While such health claims & nutritional claims – FSSAI restrictions ensure these statements aren’t misleading, they also protect both consumers and responsible businesses.

For food manufacturers, startups, and nutraceutical brands, understanding the FSSAI guidelines for health claims is not just about legal compliance—it’s about building trust, avoiding penalties, and standing out in a crowded market. The Food Safety and Standards Authority of India (FSSAI) plays a critical role in regulating what can and cannot be claimed on food packaging and advertisements. Without proper adherence to the FSSAI nutrition and health claim regulations, even well-intentioned brands risk facing fines, product recalls, or reputational damage.

This comprehensive guide dives deep into the FSSAI restrictions on health and nutritional claims, offering clarity on labeling rules, scientific substantiation, common violations, and best practices for compliance. Whether you’re launching a new health drink, marketing a protein bar, or selling dietary supplements, this article will equip you with actionable insights to stay compliant and competitive.

We’ll explore:

What constitutes a health vs. nutritional claim
Why FSSAI regulates these claims
Detailed nutritional labeling FSSAI rules
Real-world examples of misleading claims
Penalties for non-compliance
Step-by-step compliance checklist

you’ll have a clear roadmap to ensure your product labels and marketing campaigns meet all FSSAI advertising guidelines and avoid costly mistakes.

1. Why Health & Nutritional Claims Matter

The Indian food and beverage market is booming. From ready-to-eat meals to functional foods and nutraceuticals, innovation is reshaping how we eat. But with innovation comes responsibility—especially when brands make claims about health benefits.

Consumers today are no longer passive buyers. They read labels, search for ingredients, and compare nutrition facts before purchasing. A 2023 survey by NielsenIQ found that over 78% of urban Indian consumers consider health claims while choosing packaged foods. Another report by FSSAI revealed that misleading advertisements are among the top consumer grievances in the food sector.

FSSAI nutrition and health claim regulations

Enter the FSSAI—India’s apex food regulator. Its mission? To ensure that every claim made on a food product is truthful, scientifically backed, and not deceptive.

When a cereal brand says “High in fiber,” or a beverage claims “Supports digestion,” these aren’t just marketing slogans—they are regulated statements governed by strict FSSAI nutrition and health claim regulations. These rules exist to:

Prevent false or exaggerated claims
Protect vulnerable populations (like diabetics or children)
Promote fair competition
Encourage transparency in food labeling

For example, during the peak of the COVID-19 pandemic, several brands claimed their products could “boost immunity” or “prevent viral infections.” Many of these were flagged by FSSAI as misleading because they lacked scientific evidence. Some companies faced penalties, product bans, or public warnings.

Similarly, a “sugar-free” product must meet specific criteria under FSSAI norms—simply removing table sugar isn’t enough if artificial sweeteners or hidden sugars are present.

As a food business owner, navigating these FSSAI guidelines for health claims might seem complex. But non-compliance carries serious risks:

Legal action under the Food Safety and Standards Act, 2006
Fines up to ₹10 lakh
License suspension or cancellation
Damage to brand reputation

On the flip side, compliance brings benefits:

Consumer trust
Easier e-commerce listings
Export opportunities
Competitive advantage

This guide will walk you through every aspect of health claims & nutritional claims – FSSAI restrictions, helping you craft accurate, compliant, and impactful messaging for your products.

Let’s begin by understanding exactly what health and nutritional claims mean under Indian law.

2. What Are Health & Nutritional Claims?

Understanding the difference between health claims and nutritional claims is the first step toward compliance with FSSAI nutrition and health claim regulations.

What Is a Nutritional Claim?

A nutritional claim refers to a statement about the nutrient content of a food product. These are often seen on packaging as:

“Low fat”
“Rich in calcium”
“Zero cholesterol”
“High in protein”
“Sugar-free”

These claims describe the amount or presence of specific nutrients like vitamins, minerals, fats, proteins, or energy (calories). They help consumers make informed choices based on their dietary needs.

Under FSSAI regulations, nutritional claims must meet defined thresholds. For example:

A product labeled “low fat” must contain no more than 3 g of fat per 100 g (for solids) or 1.5 g per 100 ml (for liquids).
“Sugar-free” means less than 0.5 g of sugar per 100 g or 100 ml.

Such precision ensures that consumers aren’t misled by vague or inflated statements.

What Is a Health Claim?

A health claim goes a step further. It describes a relationship between a food component and a health benefit. Examples include:

“Calcium helps build strong bones”
“Omega-3 fatty acids support heart health”
“Fiber aids digestion”

These claims suggest that consuming a particular nutrient or food may reduce the risk of disease or improve bodily functions.

However, not all health claims are allowed. FSSAI permits only those that are:

Scientifically proven
Listed in the official schedule
Accurately worded

For instance, saying “Vitamin C boosts immunity” is permitted only if it uses the exact phrasing approved by FSSAI and is supported by clinical studies.

Therapeutic Claims: A Strict No-Go Zone

There’s a third category—therapeutic claims—that FSSAI strictly prohibits on general food products. These include statements like:

“Cures diabetes”
“Treats arthritis”
“Prevents cancer”

Such claims imply medical treatment and fall under the purview of drugs, not food. Only licensed pharmaceuticals or Ayurvedic medicines (under specific regulations) can make such assertions.

Key Differences Between Claim Types

Feature	Nutritional Claim	Health Claim	Therapeutic Claim
Definition	Describes nutrient content	Links nutrient to health benefit	Suggests treatment/cure of disease
Example	“High in iron”	“Iron supports red blood cell formation”	“Cures anemia”
Regulated by	FSSAI Nutrient Criteria	FSSAI Approved List	Drug Controller of India
Allowed?	Yes, with conditions	Yes, if approved	No (on regular food)

Common Examples of Claims in the Market

Here are some real-life examples—and whether they comply with FSSAI guidelines for health claims:

“Zero trans fat”
✅ Permitted if trans fat ≤ 0.2 g per serving.
“Boosts immunity”
⚠️ Only allowed with approved wording and scientific backing. During COVID-19, many brands misused this claim.
“Natural flavor”
✅ Allowed if derived from natural sources, but must not mislead (e.g., calling synthetic vanillin “natural”).
“Lowers cholesterol”
⚠️ Requires proof and specific phrasing like “Plant sterols help reduce LDL cholesterol.”
“Detoxifies liver”
❌ Prohibited—this is a therapeutic claim.

Understanding these distinctions is crucial. Mislabeling a therapeutic claim as a health claim can lead to severe penalties.

In the next section, we’ll explore why FSSAI regulates these claims and how they protect both consumers and ethical businesses.

3. Why FSSAI Regulates Food Claims

You might wonder: Why does the government need to control what I say about my product? After all, isn’t marketing about highlighting benefits?

Yes—but only if those benefits are real, fair, and not misleading. That’s where FSSAI steps in.

Protecting Consumers from Misleading Claims

Imagine buying a “sugar-free” energy drink, only to find it contains high-fructose corn syrup. Or feeding your child a “digestive health” biscuit that actually causes bloating. These aren’t hypotheticals—they’ve happened.

FSSAI’s primary goal is consumer protection. In a country where millions suffer from lifestyle diseases like diabetes, obesity, and hypertension, false claims can have serious health consequences.

For example:

A diabetic person relying on a “sugar-free” product that still spikes blood glucose due to hidden carbs.
A parent giving a child an “immunity-boosting” juice during flu season, believing it prevents illness—when no food can guarantee that.

By enforcing FSSAI nutrition and health claim regulations, the authority ensures that:

Labels reflect actual nutritional content
Health benefits are backed by science
Marketing doesn’t exploit fear or misinformation

Ensuring Scientific Substantiation

FSSAI doesn’t allow claims based on opinions, traditions, or anecdotal evidence. Every health claim must be supported by:

Clinical trials
Peer-reviewed research
International standards (like EFSA, FDA, WHO)

For instance, to claim “Omega-3 fatty acids contribute to normal brain function,” a brand must provide studies showing this effect in humans, not just animals or test tubes.

Even nutritional claims require lab testing. You can’t claim “high in protein” unless your product meets the minimum threshold (e.g., ≥20% of RDA per 100g).

This scientific rigor prevents companies from using vague terms like “superfood” or “detox” without proof.

Maintaining Fair Competition

Without regulation, unethical brands could gain an unfair advantage by making exaggerated claims.

Example:

Brand A sells a protein bar with 10g protein and says “Rich in protein” (truthful).
Brand B sells a bar with 5g protein but claims “Powerful Protein Punch!” (misleading).

If unchecked, Brand B might outsell Brand A—not because its product is better, but because its marketing is louder.

FSSAI advertising guidelines level the playing field. All brands must play by the same rules, ensuring competition is based on quality, not deception.

Preventing Public Health Crises

During the pandemic, dozens of brands claimed their products could “boost immunity” or “fight viruses.” Some even implied protection against COVID-19.

FSSAI issued multiple advisories warning against such claims. In 2020, it banned over 30 products for making unverified immunity claims. One brand selling herbal drops was fined ₹5 lakh for claiming it could “prevent respiratory infections.”

Such actions weren’t about stifling innovation—they were about preventing panic, false hope, and potential harm.

Aligning with Global Standards

India’s FSSAI regulations on functional foods and health claims are inspired by global bodies like:

Codex Alimentarius (UN food standards)
European Food Safety Authority (EFSA)
US FDA

This alignment helps Indian products meet export requirements and builds international trust.

For example, a “heart-healthy” claim approved by FSSAI is more likely to be accepted in the UAE or Singapore, where similar standards apply.

Building Long-Term Consumer Trust

When consumers see consistent, truthful labeling, they develop confidence in the food system. This trust is essential for:

Adoption of fortified foods
Growth of the nutraceutical industry
Success of health-focused startups

In short, FSSAI regulations on health claims aren’t red tape—they’re a framework for ethical marketing, public safety, and sustainable growth.

Now, let’s dive into the specifics: FSSAI guidelines for nutritional claims.

4. FSSAI Guidelines on Nutritional Claims

Nutritional claims are among the most commonly used statements on food packaging. But not all “low fat” or “high fiber” labels are created equal.

Under FSSAI regulations, every nutrient content claim must meet strict scientific criteria. Let’s break down the rules.

General Principles for Nutritional Claims

Before making any claim, FSSAI requires that:

The claim must be clear, accurate, and not misleading.
It must comply with defined thresholds.
The product must not be nutritionally inadequate in other ways (e.g., low fat but high sugar).
Terms like “natural,” “fresh,” or “organic” must not mislead consumers.

Permitted Nutritional Claims & Their Criteria

Here’s a detailed table of common nutritional claims and their FSSAI-approved conditions:

Claim	Solid Foods (per 100g)	Liquid Foods (per 100ml)	Additional Conditions
Energy Free / Zero Calories	≤ 4 kcal	≤ 4 kcal	Must also be low in energy-dense ingredients
Low Energy	≤ 40 kcal	≤ 20 kcal	–
Reduced Energy	At least 30% less than reference product	At least 30% less than reference product	Reference product must be clearly defined
Fat Free	≤ 0.5 g fat	≤ 0.5 g fat	–
Low Fat	≤ 3 g fat	≤ 1.5 g fat	–
Reduced Fat	At least 30% less fat than reference	At least 30% less fat than reference	–
Saturated Fat Free	≤ 0.1 g sat fat	≤ 0.1 g sat fat	Total fat must also be low
Low Saturated Fat	≤ 1.5 g sat fat	≤ 0.75 g sat fat	–
Sugar Free	≤ 0.5 g sugar	≤ 0.5 g sugar	Includes all mono- and disaccharides
Low Sugar	≤ 5 g sugar	≤ 2.5 g sugar	–
Reduced Sugar	At least 30% less sugar than reference	At least 30% less sugar than reference	–
High in Protein	≥ 20% of RDA*	≥ 20% of RDA	Must contain essential amino acids
Source of Protein	≥ 12% of RDA	≥ 12% of RDA	–
High in Fiber	≥ 6 g fiber	≥ 3 g fiber	Must be from natural sources or approved additives
Source of Fiber	≥ 3 g fiber	≥ 1.5 g fiber	–

*RDA = Recommended Dietary Allowance (as per FSSAI)

✅ Example: A breakfast cereal with 7g of fiber per 100g can claim “High in fiber.” One with 4g can say “Source of fiber.”

Vitamin & Mineral Claims

Claims about vitamins and minerals must specify the nutrient and meet minimum thresholds:

Claim	Minimum Level Required
“Source of [Nutrient]”	≥ 15% of RDA per 100g or 100ml
“High in [Nutrient]”	≥ 30% of RDA per 100g or 100ml
“Rich in [Nutrient]”	Same as “High in”

❗ Note: You cannot claim a vitamin is “natural” unless it’s derived from natural sources (e.g., vitamin C from amla, not ascorbic acid).

Special Rules for “Natural,” “Fresh,” and “Organic”

These terms are often misused. FSSAI has clear definitions:

Natural: The ingredient is minimally processed and not synthetic. Cannot be used if artificial flavors, colors, or preservatives are added.
Fresh: Applies only to unprocessed foods (e.g., fruits, vegetables). Cannot be used for frozen, canned, or preserved items.
Organic: Must be certified under FSSAI’s Organic Regulations (Jaivik Bharat). Cannot be used without certification.

🚫 Common Mistake: Calling a juice “100% natural” when it contains preservatives like potassium sorbate.

Conditions for Comparative Claims (e.g., “Reduced Fat”)

If you say “reduced fat,” you must:

Compare with a similar product from the same brand (reference product)
Ensure the reference product is available in the market
State the percentage reduction (e.g., “30% less fat than our original recipe”)

Prohibited Nutritional Claims

FSSAI bans certain terms that are vague or misleading:

“Diet” (unless part of a registered brand name)
“Light” (unless referring to color or texture)
“Pure” (unless scientifically verifiable)
“Miracle” or “cure-all” language

Actionable Tips for Compliance

✔️ Conduct third-party lab tests to verify nutrient levels
✔️ Keep scientific dossiers ready for FSSAI audits
✔️ Use only approved phrasing from FSSAI’s list
✔️ Avoid comparative claims without data

In the next section, we’ll explore FSSAI guidelines on health claims, which are even more tightly regulated.

5. FSSAI Guidelines on Health Claims

While nutritional claims describe what’s in the food, health claims explain what the food does for the body. And these are far more sensitive.

FSSAI allows only specific, science-backed health claims—and even then, with strict wording and conditions.

Permitted Health Claims: The Approved List

FSSAI has published a Schedule of Permitted Health Claims under Regulation 2.4.4 of FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.

As of 2025, over 70 health claims are approved, grouped into categories:

1. General Function Claims

“Calcium is needed for the maintenance of normal bones”
“Iron contributes to normal cognitive development in children”
“Vitamin D helps in calcium absorption”

2. Reduction of Disease Risk Claims

“Plant sterols/stanols help reduce LDL cholesterol”
“Sodium reduction helps lower blood pressure”

⚠️ These require stronger scientific evidence and are only allowed on foods that meet specific nutrient profiles.

3. Children’s Development & Health

“DHA contributes to normal brain development in infants”
“Iodine is necessary for normal cognitive development in children”

4. Weight Management

“Consumption of foods high in fiber increases satiety” (allowed only if high in fiber)

❌ Not allowed: “Burns fat,” “Lose weight fast,” or “Blocks carbs.”

Scientific Substantiation: The Backbone of Health Claims

To use any health claim, you must provide:

Clinical studies (human trials preferred)
Meta-analyses or systematic reviews
Data from recognized institutions (ICMR, WHO, EFSA, etc.)

FSSAI may ask for this evidence during licensing or inspection.

📌 Case Example: A brand claimed “Ashwagandha reduces stress.” While traditional use exists, FSSAI required randomized controlled trials (RCTs) to approve the claim. Without them, the claim was disallowed.

Restrictions on Immunity-Boosting Claims

Post-pandemic, “immunity” became a marketing buzzword. But FSSAI cracked down.

Allowed:

“Vitamin C supports normal immune function”
“Zinc contributes to normal immune system”

Not allowed:

“Boosts immunity to fight viruses”
“Protects against infections”
“Enhances immunity by 50%”

🚫 During 2020–2021, FSSAI issued over 100 notices to brands misusing immunity claims.

Weight-Loss & Slimming Claims: A Red Zone

FSSAI prohibits direct weight-loss claims on food products.

❌ Banned:

“Lose 5 kg in 1 week”
“Burns belly fat”
“Blocks fat absorption”

✅ Permitted (with conditions):

“High in fiber, which may increase satiety”
“Low energy, suitable for calorie-controlled diets”

Even then, the product must not be high in sugar or fat.

Disease-Curing Claims: Strictly Prohibited

No food product can claim to cure, treat, or prevent diseases.

🚫 Absolutely banned:

“Cures diabetes”
“Prevents heart attacks”
“Treats arthritis”
“Eliminates acidity”

Such claims are reserved for drugs and medicines regulated by the Central Drugs Standard Control Organization (CDSCO).

⚖️ Legal Case: In 2022, a ghee brand claimed “Helps manage blood sugar in diabetics.” FSSAI ordered a recall and imposed a ₹7 lakh fine.

Functional Foods & Nutraceuticals: Extra Scrutiny

Products like energy bars, probiotic drinks, or fortified cereals fall under FSSAI regulations on functional foods. They must:

Declare functional ingredients clearly
Provide dosage information
Include a disclaimer: “This product is not intended to diagnose, treat, or cure any disease”

Labeling Requirements for Health Claims

When using a health claim, you must:

Use the exact wording from FSSAI’s approved list
Include a disclaimer if the claim is conditional
Ensure the font is legible and not misleadingly emphasized

✅ Correct: “Calcium contributes to normal bone health”
❌ Incorrect: “Builds unbreakable bones!”

Actionable Checklist for Health Claims

Before using a health claim, ask:

Is it on FSSAI’s approved list?
Do I have scientific evidence?
Is the product nutritionally balanced?
Am I using the exact phrasing?
Have I added required disclaimers?

Failure to follow these steps can result in penalties—discussed in detail later.

Next, we’ll cover nutritional labeling requirements, which are just as critical.

6. Nutritional Labelling Requirements

Even if your product makes no claims, nutritional labeling is mandatory for all pre-packaged foods under FSSAI.

Mandatory Information on Food Labels

Every packaged food must display:

Name of the product
List of ingredients (in descending order)
Nutrition information (per 100g/ml and per serving)
Date markings (Best Before, Use By)
Net quantity
FSSAI license number
Name & address of manufacturer
Veg/Non-Veg logo
Country of origin (for imported foods)
Instructions for use (if needed)

Nutrition Facts Table Format

FSSAI mandates a standardized format for the nutrition panel:

Nutrition Information
Per 100g        Per Serving (XXg)
Energy          XXX kcal       XXX kcal
Protein         Xg             Xg
Carbohydrates   Xg             Xg
Sugars          Xg             Xg
Fats            Xg             Xg
Saturated Fat   Xg             Xg
Trans Fat       Xg             Xg
Sodium          Xmg            Xmg

✅ Additional: Vitamins and minerals can be listed if a claim is made.

Allergen Declaration

FSSAI requires bold declaration of common allergens:

Cereals containing gluten
Milk and dairy
Eggs
Peanuts, tree nuts
Soy
Fish and shellfish

Example: “Contains milk and soy.”

Font Size, Placement & Language

Font size: Minimum 1.2 mm height for small packages (<80 cm²), 1.6 mm for larger ones.
Placement: On the principal display panel or immediately adjacent.
Language: Must be in English and Hindi (unless exported).

Serving Size Rules

Serving size must be:

Realistic (e.g., 30g for chips, 250ml for juice)
Based on standard consumption patterns
Clearly defined

❗ Don’t manipulate serving size to hide high sugar/fat content.

Front-of-Pack (FoP) Labeling: The New Wave

FSSAI is moving toward Mandatory FoP Labels (like traffic light systems) to warn about high sugar, salt, and fat. Though not yet enforced, brands should prepare.

7. Common Misleading Claims & FSSAI Action

Let’s look at real cases where brands crossed the line.

Case Study 1: Immunity Drops During COVID-19

A brand sold herbal drops claiming “Boosts immunity to fight viruses.”
✅ Reality: No clinical proof.
❌ Action: FSSAI banned the product, fined ₹6 lakh.

Case Study 2: “Sugar-Free” Chocolates with Hidden Sugars

A chocolate brand labeled “sugar-free” but used maltitol (a sugar alcohol).
✅ Allowed? Only if total sugar equivalents are <0.5g.
❌ Issue: Maltitol had high glycemic impact.
Action: Product recalled.

Case Study 3: “Cures Acidity” Health Drink

A digestive drink claimed “Eliminates gas and acidity.”
❌ Violation: Therapeutic claim on food.
Penalty: ₹4 lakh fine, license suspended.

Penalties Imposed (2020–2024)

Brand	Violation	Penalty
XYZ Nutri	False immunity claim	₹5.2 lakh
ABC Foods	Misleading “organic” label	₹3.8 lakh
PQR Beverages	Unapproved health claim	Product recall

These cases show FSSAI’s zero-tolerance policy.

8. Penalties for Misleading Food & Health Claims

Under FSS Act, 2006, penalties include:

Fine: Up to ₹10 lakh
Imprisonment: Up to 6 months
License Suspension/Cancellation
Product Seizure & Recall

Repeat offenders face harsher action.

9. How to Make Compliant Health & Nutrition Claims

Step-by-Step Compliance Guide

Test Your Product (lab analysis)
Review FSSAI’s Approved Claim List
Gather Scientific Evidence
Draft Claims Using Exact Wording
Add Disclaimers
Submit for Approval via FoSCoS Portal
Update Labels & Ads

Use FSSAI’s FoSCoS portal for licensing and approvals.

10. Benefits of Compliance

Builds consumer trust
Avoids legal trouble
Enables e-commerce & exports
Enhances brand value

11. Common Mistakes to Avoid

Using “natural” without proof
Copying US/EU claims without FSSAI approval
Omitting allergens
Exaggerating benefits

12. FAQs

Can I say “sugar-free” if product has <0.5g sugar per 100g?

✅ Yes, as per FSSAI nutritional labeling rules.

Can supplements claim to “cure diabetes”?

❌ No. That’s a therapeutic claim, prohibited under FSSAI regulations on functional foods.

Do I need prior approval before printing claims on labels?

Not always, but FSSAI can audit. Best to consult an expert.

Are celebrity endorsements regulated under FSSAI?

Yes. Celebrities can be penalized for promoting misleading claims.

13. Conclusion & Call-to-Action

Understanding health claims & nutritional claims – FSSAI restrictions is no longer optional. With stricter enforcement and informed consumers, compliance is key to survival and growth.

Don’t risk your brand on vague or false claims. Follow FSSAI guidelines for health claims, ensure accurate nutritional labeling FSSAI rules, and build a trustworthy, sustainable business.

👉 Need help with FSSAI compliance?
Contact our team of food labeling experts for audits, claim approvals, and FoSCoS registration support.

Internal Links: FSSAI Licensing Guide, Nutraceutical Compliance Checklist, Food Labeling Rules 2025

Meta Title: Health Claims & Nutritional Claims – FSSAI Restrictions
Meta Description: Learn FSSAI restrictions on health & nutrition claims in India. Complete guide on labeling rules, penalties, and compliance tips for food businesses.