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Comprehensive Framework for Food Claims under FSSAI Conditional, Prohibited, and Approval Procedures

1. Conditional Claims under FSSAI Regulations

1.1 “Natural” Conditional Claims

Under Condition 9(1), a product that is inherently high, low, or free of a nutrient may use a claim only if the nutrient’s name is preceded by “natural” or “naturally”—for example:

“a naturally low sodium food” or “a naturally fiber‑free food.”

This ensures consumers understand that the nutrient profile is inherent, not due to processing or reformulation.

1.2 Use of Descriptive Adjectives

Regulation further restricts words like “natural,” “fresh,” “pure,” “authentic,” “real,” etc. to cases where the product genuinely fulfills the criteria listed in Schedule V.

  • If such words form a brand or trademark but mislead regarding nature of the product, a disclaimer must be placed (e.g. “This is only a brand name … does not represent its nature”).
  • Terms like “home-made,” “home‑cooked” are expressly prohibited because they mislead consumers about authenticity and origin.

These rules prevent misuse of aspirational or emotional descriptors.

2. Prohibited Claims

FSSAI Regulation 10 outlines strict limitations:

2.1 Disease‑Prevention or Treatment Claims

  • You cannot claim that a food prevents, alleviates, treats, or cures any disease or physiological condition—unless explicitly allowed under other rules.
  • Thus, marketing a food as “cures diabetes” or “treats anemia” is outright prohibited .

2.2 Medical or Professional Endorsements

  • Statements like “recommended by doctors/nutritionists” are not permitted unless such recommendations are explicitly allowed under other regulations FSSAI.

2.3 Misleading Added Nutrients

  • You cannot claim “added nutrients” if nutrients were added only to compensate for processing losses, rather than to add value.

2.4 Special Medical or Dietary Foods

  • Foods marketed for special dietary use or medical purposes must not carry claims unless specifically permitted under relevant FSSAI regulations.

2.5 Fear‑Based or Doubt‑Inducing Claims

  • Claims must not create fear or doubt about the safety of other foods or brands.

2.6 Risky Nutrient Levels

  • Foods containing nutrient levels that increase disease risk (like high trans fat or sodium) cannot make health claims.

2.7 Undermining Competitors

  • Marketing should not undermine products of other manufacturers to influence consumer behavior.

3. Approval of Claims: When Is Prior Approval Needed?

Regulation 11 states:

  • Prior approval from FSSAI is required for disease‑risk reduction claims that are not already defined under the Regulations or other applicable rules.
  • Defined claims in Schedule III (e.g., plant sterols reducing cholesterol) may be used legally without prior approval, if all conditions are met.

If your intended claim is not defined or standardized, you must apply to FSSAI before using it.

4. Procedure for Approval of Claims

Regulation 12 defines a structured approval process:

4.1 Required Application Contents

Any application must include the following materials, along with prescribed fees:

  1. Exact claim being proposed (maximum 3 claims per product).
  2. Name of ingredient/nutrient/substance the claim is based on.
  3. Validated analytical method for measuring the nutrient or substance.
  4. Scientific evidence supporting the claim (clinical data, literature).
  5. Explanation of how the claim is clear, meaningful, and consumer‑friendly.
  6. Human intervention studies under GCP and published results (for health/product‑level claims).
  7. Any additional supporting information, such as epidemiological data, meta‑analyses, formulation details.

4.2 Preliminary Scrutiny

FSSAI or an agency/panel appointed by it will conduct a preliminary review of the application.

4.3 Communication of Deficiencies

  • Within 90 days of application receipt, FSSAI must inform the applicant of any deficiencies.
  • The applicant has 30 days to respond; otherwise, the application is rejected outright.

4.4 Non‑Refundable Fees

  • Fees paid for claim approval are non-refundable, regardless of outcome.

4.5 Final Order and Amendments

  • Upon review, FSSAI issues a speaking order—either approving or rejecting the claim.
  • If amendments are suggested, you may resubmit the amended claim within 30 days for reconsideration.

4.6 Use Restriction After Rejection

  • If a claim is rejected, the FBO must not use that claim in any advertising, labeling, or promotion.

5. Redressal for Non‑Compliance

5.1 Penalty under Section 53

Any misleading or non-compliant claim triggers penalties up to ₹10 lakh under Section 53 of the FSSA, 2006

5.2 Non‑Compliance Procedure

  • Misleading claims can be brought to FSSAI’s attention through complaints or authority’s own motion.
  • FSSAI will analyze the claims (via agency/panel), request clarifications, and issue a final order within 90 days of receipt of information.
  • If correction is required, the FBO must respond within 45 days.

5.3 Corrective Advertising

If violations occur, FSSAI can order the FBO to issue a corrective advertisement within 30 days, through the same medium to neutralize the misleading effect.

6. Why These Rules Matter

6.1 Protecting Public Health

By restricting disease-related claims and requiring scientific substantiation, FSSAI prevents unjustified medical claims, protecting individuals from false assurances.

6.2 Ensuring Transparency

Conditional claims like “natural” must reflect objective product characteristics—not marketing rhetoric.

6.3 Credible Marketing

Approval procedures ensure that only well-substantiated claims reach the market—promoting consumer confidence.

6.4 Fair Competition

Prohibiting claims that undermine competitors ensures a level playing field and prevents unfair disparagement.

7. Compliance Best Practices for Food Businesses

To fully comply and benefit from these regulations:

7.1 Build a Claims Dossier

  • Compile scientific literature, clinical studies, analysis methods, and product nutritional profiles.
  • Document how a claim aids consumer comprehension (e.g., simplicity, clarity).

7.2 Audit Existing Labels

  • Review all current claims for terms like “natural,” “home-made,” or any disease risk statements.
  • Remove or revise claims that don’t meet Schedule V or fall under prohibited categories.

7.3 Engage Subject Matter Experts

  • Involve food scientists, clinicians, or nutritionists to validate claims.
  • Prepare expert affidavits to support your dossier.

7.4 Submit Thorough Applications

  • Stick to the three‑claims-per-product limit.
  • Ensure analytical methods are validated and peer-reviewed.

7.5 Monitor FSSAI Updates

  • Stay current with changes to Schedules, especially Schedules V (conditional adjectives), III (disease risk reduction), and IIA/IV (fortified foods and oils)

7.6 Prepare for Clarifications

  • Be ready to respond to deficiencies within 30 days.
  • Avoid delays or incomplete responses to prevent rejections.

7.7 Communicate Correctly If Claims Rejected

  • If required, draft corrective messaging.
  • Launch clarifications within 30 days of official instruction.

Conclusion

FSSAI’s regulatory framework on Conditional, Prohibited, and Approved Claims is comprehensive and rigorous. By enforcing:

  • Use of “natural/naturally” only when inherently applicable;
  • Blocking disease treatment or medical endorsements;
  • Demanding prior approval for unspecified disease-risk claims;
  • Providing a transparent submission and review process;
  • Enabling corrective actions and penalties for non-compliance—

The regulations strike a balance between protecting public health and enabling truthful, consumer-friendly marketing.

For food businesses, compliance isn’t a mere legal requirement—it’s a cornerstone of ethical branding, regulatory credibility, and sustainable consumer trust. Even as food science evolves, well-documented claims will stand firm in both courtrooms and kitchen counters.

Read more about this Regulation: Food Safety and Standards (Advertising and Claims) Regulations, 2018

Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article. 

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