Cosmetic Claims Substantiation: What Counts as Evidence Under Indian Rules

Walk down any Cosmetics aisle and you will see claims like “clinically proven,” “dermatologist tested,” or “reduces fine lines in two weeks.” These claims sell products — but under the Cosmetics Rules, 2020, they also come with legal responsibility. Under Rule 36 of the Cosmetics Rules, 2020, a Cosmetic must not purport or claim to convey an idea that is false or misleading to the intending user. This article looks at what the 2020 Rules say about claims, and what kind of evidence is expected to stand behind them.

The Basic Rule: No False or Misleading Claims

The starting point is simple and applies to every Cosmetic sold in India: a product may not claim, or give the impression, of anything that is false or misleading to the person using it. This is a broad principle, not a narrow technical rule, and it covers the overall impression a claim creates — not just its literal wording.

Rule 36 prohibits claims or representations that are false or misleading. For example, implying a result that only a small, unrepresentative group of users experienced, without saying so, can still create a false impression.

Extra Requirements for New Cosmetics

The 2020 Rules introduced the concept of a “New Cosmetic” — a product that contains a novel ingredient not previously used anywhere in the world or not recognized for Cosmetic use in any national or international literature.

If your product falls into this category, the bar for claims evidence is higher. Before such a product can be imported or manufactured, the company must apply to the Central Licensing Authority and submit data on both the safety and the effectiveness of the product. In other words, for genuinely novel formulations, evidence of efficacy is not just good practice — it is a precondition for approval.

For Cosmetics that use established, previously recognized ingredients, this specific pre-approval requirement does not apply in the same way, but the general prohibition on false or misleading claims still governs whatever is printed on the label or used in marketing.

Claims Beyond What Is Permitted Need Approval

Here is a point that often gets missed: even after a product is registered, a company cannot simply add new claims to the label or advertising without limit. Claims that go beyond what has been permitted for that product require prior approval from CDSCO before they are used.

This matters for marketing teams especially. A claim that seemed like a harmless addition — for instance, upgrading “moisturizes skin” to “clinically proven to repair skin barrier” — is a substantive change in claim type, and should be checked against what has actually been approved and supported with data, rather than treated as a copywriting decision.

Safety Testing Standards Behind the Claims

Claims substantiation is closely tied to safety testing. Where safety evaluation of a new Cosmetic is required, the testing methods must follow the standard published by the Bureau of Indian Standards — IS 4011:2018, “Methods of Test for Safety Evaluation of Cosmetics” — as amended from time to time. Using outdated test protocols, or protocols recognized in another country but not aligned with this Indian standard, creates a gap between what a company believes it has proven and what Indian regulators will accept as proof.

Common Ways Companies Get This Wrong

Based on patterns seen across the industry, a few recurring mistakes lead to claims problems:

• Reusing global claims language as-is. A claim substantiated for a US or EU market, using a different testing standard, is not automatically valid in India. The underlying data may need to be re-evaluated against Indian requirements.
• Treating marketing copy as separate from regulatory approval. Claims on packaging, on the company website, and in influencer content are all covered by the same “no false or misleading claims” principle — inconsistent claims across channels increase risk.
• Assuming “consumer perception” studies are enough. A perception study tells you how people feel about a claim, not whether the claim is scientifically true. Regulators are looking for effectiveness data, not marketing research.
• Missing the distinction between general Cosmetic benefit language and a specific new claim. “Nourishes skin” is a different regulatory question from “clinically proven to reduce wrinkles by 30% in four weeks.” The second requires a level of evidence the first does not.

Building a Defensible Claims File

A practical way to stay on the right side of this requirement is to maintain a claims substantiation file for each product — a single internal document that records, for every claim on the label or in marketing:

• The exact wording of the claim

• The study or data supporting it

• The testing standard used

• Where applicable, whether the claim formed part of the information/claims permitted for a new cosmetic under Form COS-3

This file should be created before a product launches, not reconstructed afterward when a question arises.

Conclusion

Claims are where marketing ambition and regulatory reality most often collide. The Cosmetics Rules, 2020 do not prohibit Cosmetic benefit or performance claims as such. However, under Rule 36, a Cosmetic must not purport or claim to convey any idea that is false or misleading to the intending user. For a new Cosmetic, Rule 32 requires the submission of prescribed safety and effectiveness data, and the conditions of Form COS-3 apply to claims permitted for such a product.