Cosmetic Claims Substantiation: What Evidence Do You Need Before Writing ‘Clinically Tested’ or ‘Anti-Wrinkle’?

What counts as a claim for a cosmetic product?

A claim is not just the headline on the pack. The EU common criteria for justifying cosmetic claims treat as a claim anything that conveys a product’s characteristics or functions, whether text, a brand name, a picture or a symbol, on the label or in advertising in any medium. ^[4]

This broad definition matters in practice. A “before and after” image on the shop page, a product name containing “retinol”, or a line spoken by an influencer in a short video all signal a promised effect to the consumer, and all need the same review as the label.

Which framework applies in Saudi Arabia and the Gulf?

In June 2025, the Saudi Food and Drug Authority announced its adoption of the updated technical regulations SFDA.CO/GSO 1943:2024 on safety requirements and SFDA.CO/GSO 2528:2024 on cosmetic and personal care product claims. It stated that failing to comply with the claims controls is a violation subject to the fine set out in the violations schedule of the Cosmetic Products Law. ^[1]

GSO 2528:2024 is a Gulf technical regulation in its second edition, approved in May 2024. It deals with the criteria for permitted claims, and its catalogue page notes that a product carrying unacceptable claims may fall outside the scope of cosmetic products. ^[2] Gulf-level adoption does not mean identical enforcement in every country: registration and market surveillance run through each national authority, so check the adopted version in the market of sale.

SFDA’s general rules for product claims add clear principles: a claim must be truthful, without exaggeration or ambiguity; it must rest on evidence from a reliable source relating to the ingredients or the finished product; the applicant must produce that evidence on request; and claims must be in Arabic and English. A cosmetic must not carry a medicinal claim or be presented as treating or preventing disease. ^[3]

What does “clinically tested” actually mean?

On its own, the phrase tells the reader nothing about the result. The test may have been a skin tolerance assessment on volunteers, which is useful for safety but proves nothing about the look of wrinkles or an even skin tone. So ask for a report that states:

• The formula tested and its version number, and whether it matches what will be sold.
• The panel, its size, the method of use and the duration.
• What was actually measured: instrumental readings, expert grading or users’ opinions.
• The result as reported, not as marketing would like to word it.

The EU criteria require studies to be relevant to the product and the claimed benefit, well designed and conducted, reproducible and ethical, with a level of evidence proportionate to the type of claim. ^[4] SFDA also warns against using data the public cannot verify or research that overstates a product’s value. ^[3]

How should you read an “anti-wrinkle” claim?

The first question is not “do we have evidence?” but “what exactly are we promising?”. In the US, a product intended to affect the structure or function of the body, such as removing wrinkles or increasing the skin’s collagen production, is treated as a drug, or sometimes a medical device, even if the effect shows in appearance, while moisturising and hiding signs of ageing with make-up remain cosmetic. ^[5]

The UK Advertising Standards Authority’s guidance says the name “anti-wrinkle” is hard to substantiate and may be acceptable if the context makes clear the effect is temporary or limited to the appearance of lines, and that physiological or cumulative claims need a much higher level of evidence. ^[6] These are non-Gulf references, but they help a review team weigh a phrase before putting it to the local authority.

When is an ingredient study not enough?

Many suppliers provide studies on the active ingredient alone. These are useful, but they do not transfer automatically to the finished product. The EU criteria forbid an ingredient claim from implying that the finished product has the same property when it does not, and require suitable evidence for extending the property, such as showing the ingredient is present at an effective concentration. ^[4]

Check three differences before relying on a supplier study: the concentration, the base in which the ingredient was tested compared with your formula, and the method and duration of use. If any of these differs materially, either obtain evidence on the product itself or settle for a narrower claim, such as stating that the ingredient is present without attributing its effect to the cream.

Which other phrases deserve a second look?

Not every non-compliant claim exaggerates efficacy. The EU criteria set several limits that marketing teams often overlook: ^[4]

• Implying official approval: a phrase suggesting that a regulator endorsed the product or its efficacy is not acceptable, and registration or notification is not a certificate of efficacy.
• Presenting the legal minimum as a benefit: highlighting that a product is “free from” a substance the law already bans suggests a benefit that does not exist.
• False uniqueness: a product must not be presented as unique in a property that similar products share.
• Denigrating competitors: a claim must not disparage a competitor’s product or a legally permitted ingredient.
• Opinions dressed as facts: users’ views must not be worded as a proven result unless they reflect verifiable evidence.

Percentage claims, such as “X% of users noticed an improvement”, need documented consumer use or perception testing on the product itself, and users’ opinions alone are not enough for a physiological claim, which requires a much higher level of evidence. ^{[4, 6]} Keep the exact question put to participants and their number, because the published phrase must match what they were actually asked.

Hypothetical example: a new cream for the Saudi market

Hypothetical example: a company is preparing to launch a night cream in Saudi Arabia. Marketing proposes two phrases: “clinically tested” and “removes wrinkles in two weeks”. The review shows that the only clinical test was a skin tolerance study, and that the wrinkle study was run by the supplier on the ingredient at a higher concentration than in the cream.

The team decides to:

1. Reword the first phrase to describe the test accurately, or drop it.
2. Delete “removes wrinkles”, because it implies a physiological effect and may be treated as a medicinal claim. ^{[3, 5]}
3. Commission a use study on the finished product before making any claim about the look of lines.
4. Review the Arabic and English text, the advert and the shop page together so the promise does not differ across channels.

How do you build the evidence file, and who signs off the phrase?

Give each claim a row in a single register linking: the final phrase in full, the evidence and its report number, the formula and pack version, the market of sale, and the approval date and approver. This register answers quickly when a regulator asks for evidence, and it exposes any claim that has lost its support after a product change.

Allocate responsibilities clearly: development judges how well the scientific evidence fits the formula, quality confirms the product version, compliance checks local classification and the wording in both languages, and marketing publishes nothing that has not gone through this path. The EU criteria also require any condition on which the effect depends, such as use with another product, to be stated clearly. ^[4]

Repeat the review whenever the formula, supplier, pack or directions for use change, and on entering a new Gulf market; a claim accepted in one country may need different wording in another.

Conclusion

Start from the phrase as the consumer will read it, then ask what evidence proves it for the product that will be sold, not for an ingredient or another formula. Record the link between phrase, evidence and product version, and check the adopted regulation in the market of sale before publishing.