Efficacy Claim Rules: What Brands Can and Cannot Say

Regulatory scrutiny of cosmetics efficacy claims has grown more detailed in recent years, and many brands have found that the old logic of claiming whatever you sell no longer works. The core of the new rules can be put in one sentence: any efficacy you claim must be supported by corresponding evaluation evidence. This article breaks down the questions brands care about most, so you feel prepared when launching a new product, clearing copy review and publishing product pages.

Whether you are a newly started brand or a mature team with years of experience, any product listed in the domestic market has to deal with the new efficacy claim rules. The impact is not confined to one step — it runs through formula initiation, efficacy evaluation, label printing, product page copy and livestream scripts. Understanding it properly saves not only penalty risk but also the time and rework cost of repeated drafting.

What Efficacy Claim Management Actually Covers

Simply put, efficacy claim management means if you dare claim it, you must be able to prove it. Every efficacy description a brand writes on packaging, product pages or in advertising needs a corresponding summary and evaluation report uploaded to the designated national platform, so that claims and evidence match one to one. Many manufacturers and brands used to assume close enough is fine; that route is now effectively closed.

In practice, a few points brands most often overlook. First, the responsible party for efficacy claims is the registrant or filer — in ordinary terms, the brand, not a manufacturer taking the blame. Second, evaluation materials must be archived and available for inspection; what you upload to the platform is a summary, and the raw data has to be kept yourself. Third, claim wording must match the evaluation conclusion — overstating by even a little is not acceptable.

Note: Settle the Filing Entity Early

If your brand uses a contract manufacturing model, efficacy evaluation can be assisted by the factory, but the accountability and the account used to upload materials remain yours. Choosing a cosmetics ODM partner such as DEVA INTERNATIONAL saves a great deal of trouble around archiving materials and coordination.

Claim Categories and Their Evaluation Methods

The new rules divide evaluation methods into four categories. At project initiation, brands need to decide which method proves their selling point most economically and most safely.

Human Efficacy Evaluation Trials

The most rigorous and most frequently required category. Efficacy is proved through volunteer use, instrument measurement or expert assessment, covering moisturising, brightening, acne care and anti-wrinkle. Timelines are long and costs high, but the persuasive power is the strongest.

Laboratory Tests

Physicochemical or biological methods are used in a controlled environment. Soothing and repair claims, for example, can be supported through in vitro cell or barrier function testing, which suits efficacy points with a clear mechanism.

Literature or Research Data

Citing published scientific research, classical texts or existing data. This is the lowest-cost route for some claims, but you must ensure the literature is relevant to the product formula and usage, and cannot be applied mechanically.

Use Tests (Consumer Testing)

Feedback collected through consumer use questionnaires and subjective evaluation. Common for experience-led claims such as light and non-tacky or easy absorption, with relatively softer evidence strength.

Which Claims Require Efficacy Evaluation

Not every efficacy demands an elaborate human trial, but a few categories sit squarely in the high-risk zone under close regulatory watch, where evaluation materials are indispensable:

• Claims of spot fading and brightening, sun protection, anti-hair-loss, acne care, anti-wrinkle, firming, soothing, oil control or exfoliation normally require a corresponding efficacy evaluation report.
• Claims involving new raw materials or special cosmetics, such as sun protection or brightening special registration products, face stricter requirements, with special registration and efficacy evidence needed together.
• Claims involving disease treatment or medical wording already fall outside the scope of cosmetics. This is a red line and must never be touched.

Pitfall: some brands save on evaluation costs by swapping brightening for radiance or luminous white. Note that the judgement standard is actual meaning rather than wording — if consumers understand it as brightening, it must still be evaluated along the brightening route. If you want a special registration product, go directly through compliant brightening special registration manufacturing rather than gambling on wordplay.

Which Claims Can Be Exempt from Evaluation

The new rules also give brands some breathing room. The following categories are usually exempt from submitting efficacy evaluation materials, provided the description is truthful and makes no implication:

• Claims that work only through physical means and whose efficacy matches the physical mechanism, such as certain cleaning and makeup removal descriptions.
• Basic hydration and moisturising claims can follow a simplified route where reasonable explanation is provided, but quantified promises such as 24-hour long-lasting hydration still require evidence.
• Claims about the efficacy of the raw material itself rather than the finished product, where these are recognised objective facts, can be supported by literature or explanation.

Worth noting: exemption from evaluation does not mean anything can be said. Even on the simplified route, claim wording must match the actual product, and no exaggeration is permitted.

Compliant Expression in Labels and Advertising

Copy is where brands most often make mistakes. Labels and advertising fall under different regulatory regimes but share the same compliance logic: if you say it, you have to prove it.

On labels, efficacy names must match the uploaded evaluation summary, and promises absent from the evaluation report cannot appear. In advertising and product pages, watch out for absolute terms such as strongest or 100% effective, medical terms such as anti-inflammatory or treatment, and unquantifiable promises such as fine lines softened in three days without evidence. Livestream and short video scripts are also within regulatory scope, and an offhand remark from a host that it works after one use can become evidence of a violation.

Note: Move the Evidence Checklist Into the Planning Stage

Many teams write copy first and add evaluation later, and end up with claims outrunning the evidence. The steadier approach is to settle the claim points at initiation and schedule evaluation in parallel, so evidence and selling points are born together. In its OEM/ODM services, DEVA INTERNATIONAL incorporates efficacy evaluation coordination into the delivery schedule, reducing rework for brands later on.

A Pitfall Checklist for Brands

• Avoid unsupported claims: every efficacy point should trace back to an evaluation report or literature, rather than relying on the idea that everyone in the industry writes it that way.
• Avoid exaggerated scales: softening fine lines and smoothing wrinkles are very different levels of promise, and the latter demands far stronger evidence.
• Avoid borrowing medical language: cosmetics are not medicines, and any hint of treatment, anti-inflammatory or antibacterial action is a high-risk area.
• Avoid unsupported data claims: if you use figures such as 98% user satisfaction, you must be able to produce the test protocol and sample size.
• Avoid applying one category's claims to another: baby-and-child and sensitive-skin claims are more sensitive, so both evidence and wording need to be more restrained.

FAQ: Frequently Asked Questions from Brands

Q1: With a limited budget, can a small brand do only the cheapest literature evaluation?

Yes, but it must match the claim type. The literature route suits claims with clear scientific support; if your core selling point is a high-risk efficacy such as acne care or brightening, literature usually is not enough and human or laboratory evaluation is still required.

Q2: If the manufacturer does the evaluation, whose responsibility is it?

Evaluation can be commissioned to a third party or assisted by the factory, but the registrant or filer — the brand — is always the responsible party, and both uploading materials and compliance accountability sit with you.

Q3: Do older product page descriptions need rewriting?

A systematic self-check is advisable. Anything involving an efficacy promise without corresponding evidence should either gain evaluation support or be taken down, rather than waiting for a spot check or complaint.

Q4: How should claims be handled for special registration products such as sun protection and brightening?

Special registration is itself strong evidence, but claims must stay within the registered scope and cannot be extended to unregistered efficacy points. Choosing a factory with sun protection special registration manufacturing capability keeps formulation and claims aligned end to end.

About DEVA INTERNATIONAL

Guangzhou DEVA Biotechnology Co., Ltd. (DEVA INTERNATIONAL) has spent nearly 20 years on the R&D and manufacture of fresh-active efficacy cosmetics. It is a cosmetics ODM company integrating R&D, production and special registration manufacturing, holding special cosmetics registration qualifications for sun protection and brightening, along with ISO 22716 and GMPC system certifications, and able to support compliant manufacturing for domestic markets and Southeast Asian expansion (BPOM, HALAL).

Learn more about our products and manufacturing services at www.txodm.com.