[News Space=Reporter seungwon lee] It has been revealed that THB, a substance banned by the Ministry of Food and Drug Safety, was detected in the product, The Gameuli shampoo. This is a case of regulatory backsliding after Korea completely banned the distribution of cosmetics containing THB, effective October 1, 2024, causing significant repercussions. Simultaneously, the promotion of a KAIST professor as a "technical advisor" and the controversy over exaggerated advertising of hair loss shampoo are increasing the overall credibility risk in the domestic functional shampoo market.

According to an article published by Maeil Business Newspaper on the 3rd based on analysis data from a testing agency, a sample of the The Gameuli shampoo extracted and analyzed with 90% methanol (MeOH) revealed an identical analysis pattern to the THB standard. Based on this, the testing agency concluded, "THB has been identified in The Gameuli shampoo."

THB, a previously banned ingredient, has reappeared 

In December 2023, the Korean Ministry of Food and Drug Safety designated 1,2,4-trihydroxybenzene (THB) as a "banned cosmetic ingredient" due to the difficulty in ruling out its genotoxic potential and revised the related notice. Under the revision, cosmetics containing THB were temporarily restricted to the sale of already manufactured stock until October 1, 2024, after which their domestic distribution was completely banned. The European Union's Scientific Committee on Consumer Safety (SCCS) also ruled THB unsuitable for use in cosmetics, stating that "the possibility of genotoxicity cannot be ruled out."

Nevertheless, the fact that the same retention time (approximately 1.5–1.75 minutes) and molecular weight transition (125.0→79.1 m/z) were observed and the same pattern was confirmed when the 90% methanol extract from the The Gameuli shampoo sample was analyzed in a laboratory analysis, as compared to the THB standard substance (0.5 ppm), makes it difficult to dismiss this as simple contamination or analytical error. The fact that a substance that the Ministry of Food and Drug Safety had declared "unsuitable as a cosmetic ingredient regardless of the amount used or environment of use" was detected again in a shampoo that was used repeatedly exposes a loophole in the management system.

KAIST Professor's "Technical Advisor" Promotion and Responsibility Debate

The controversy escalated when product distributor C&Vue featured Professor Lee Hae-shin of KAIST as a "technical advisor" on its homepage. Professor Lee's side insisted, "We have never signed a technical consulting contract with The Gameuli Shampoo, and the only product we were involved with was 'Bellarne Water Treatment.'" They also explained, "We requested from the beginning that they not use my name in promotional materials, but there was no improvement."

Legally, if this claim is true, C&V could be held responsible for misleading consumers into believing they have a technical advisory or quality assurance relationship. The Cosmetics Act stipulates suspension of manufacturing and sales operations, product recalls, and administrative actions for cosmetics made with prohibited raw materials. The Labeling and Advertising Act also prohibits advertising that misrepresents expertise or authority.

Considering that in cases where advertisements that could be mistaken for pharmaceuticals were subject to MFDS sanctions in the past, phrases such as “Professor of ○○ University” and “Recommended by the hospital director” were used as criteria for judgment, the use of the name of a KAIST professor is likely to become a key issue in regulatory authorities’ review.

Gravity Shampoo's explosive sales spark controversy over overhyped advertising

Polyphenol Factory, led by Professor Lee Hae-shin, has demonstrated unprecedented growth in the domestic functional shampoo market since its launch in 2024. The combination of a founder who was a KAIST Distinguished Professor, the advertising tagline "KAIST Patented Technology," and the storytelling behind patented ingredients like "LiftMax 308" led to a simultaneous CES exhibition, a home shopping sellout, and a top ranking on Olive Young and online shopping malls.

According to domestic and international public reports, Polyphenol Factory's Gravity Shampoo recorded cumulative sales of 1.65 million bottles and sales of approximately 30 billion won by the end of 2025 since its launch in April 2024. A case in which 1 billion won worth of the product was sold in 30 minutes was also featured on a Lotte Home Shopping broadcast in September 2024. Following its CES appearance, the company announced plans to enter the North American and European markets and launch on Amazon, emerging as a leading brand for "K-hair loss shampoo."

However, the aggressive figures presented in domestic clinical and marketing data, such as "19.22% increase in hair thickness after one use, 87.27% improvement in hair volume, and 73.23% hair loss reduction rate after two weeks of use," are being criticized as being too strong expressions that could lead general consumers to confuse medicine with functional cosmetics. In fact, the hashtag "# OOOO" in the advertising text related to Gravity Hair Lifting Shampoo is problematic, and a lawsuit is underway to suspend the execution of the Ministry of Food and Drug Safety's administrative disposition and to cancel it on the grounds of "false and exaggerated advertising that could be mistaken for a medicine." The first trial is awaiting a ruling.

Regulatory authorities are looking into whether this violates the Act on Labeling and Advertising and the Cosmetics Act, as a video has appeared that begins with the line, “Thin and weak hair, possible with KAIST technology,” and then shows hair that has gone bald, and then describes the transformation immediately after use as “even the remaining hair looks thicker.” The Ministry of Food and Drug Safety stated that “it sufficiently appears to be a violation of labeling and advertising,” and that the relevant local offices are sequentially investigating and taking action.

K-Shampoo Risks Seen Through International Regulations and Market Figures

The THB controversy isn't confined to Korea. Reflecting the SCCS's opinion, the European Union has been strengthening regulations on related whitening and functional ingredients, citing the potential for the production of safety-related substances, such as hydroquinone, during the decomposition process of derivatives. South Korea designated THB as a banned ingredient in 2023 and raised its regulatory standards to prohibit products produced after October 1, 2024, from containing even 1 ppm of THB.

However, the fact that THB was detected again in a similar concept shampoo four years after the browning shampoo incident (2020) suggests that structural flaws remain in companies' raw material and process management systems and internal compliance systems.

On the other hand, from a market perspective, the hair loss and scalp care market continues to grow rapidly despite regulatory risks. According to a global consulting firm and a domestic cosmetics and pharmaceutical industry report, the global hair loss treatment and care product market is projected to grow at an average annual rate of 8-10%, reaching hundreds of billions of dollars by 2030.

In Korea, the scalp and hair loss care market, including functional shampoos, anti-hair loss shampoos, and hair tonics, is also growing at around 10% annually, according to analysis, and is expected to reach a market value of over 1 trillion won by the mid-2020s. This incident highlights the precarious intertwining of regulation, marketing, science, and commerciality in this "high-growth market.

Remaining issues and future scenarios

The current issues can be broadly categorized into three. First, depending on whether the Ministry of Food and Drug Safety's official reanalysis reveals the presence, content, and route of THB in The Gameuli Shampoo, the severity of administrative measures, such as product recalls and business suspensions, as well as whether criminal liability is imposed, could vary.

Second, whether C&V's promotion of KAIST professors as "technical advisors" constitutes consumer deception under the Advertising and Labeling Act and the extent to which Professor Lee Hae-shin's claim of "unauthorized use" is proven are key issues in future civil and criminal liability disputes.

Third, following the lawsuit against Polyphenol Factory's Gravity Shampoo and the investigation into false advertising, regulatory guidelines governing advertising practices and clinical data disclosure across the domestic functional shampoo industry are likely to be strengthened.

An industry expert pointed out that, "This incident goes beyond a simple individual product issue and makes us look back on the governance of the Korean beauty and bio industry, as the ingredient that already caused a social stir once before due to the controversy over genotoxicity has resurfaced, and the structure in which the scientist's name and university brand are consumed as a 'technology guarantee check' is being repeated."

This is a point that simultaneously demands a final decision from the Ministry of Food and Drug Safety, a responsible explanation from companies, and a social consensus on how the names of universities and researchers should be used in commercial advertisements.