'Miracle shampoo' faces sale ban over toxic chemical claims

Moda Moda's "pro-change black" shampoo / Korea Times file

By Lee Hyo-jin

A shampoo introduced by a Korean cosmetics company which "miraculously" turns gray hair to black, is facing a major setback as the country's drug safety regulator seeks to ban the sale of the product citing the presence of toxic chemicals in its ingredients.

The "pro-change black" shampoo manufactured by Moda Moda was first launched in the U.S. market in June 2021 through a crowdfunding campaign on Kickstarter and hit the local market in August of that year.

According to the company, when used over a period of several months, the shampoo gradually turns gray hair to black. The product was developed jointly with Lee Hae-shin, a chemistry professor at the Korea Advanced Institute of Science and Technology (KAIST).

The developers took the idea from "browning reactions" of fruits such as apples and bananas when exposed to oxygen, caused by polyphenol (PPO). The company stressed that the shampoo is completely free of any materials that are toxic to the human body or allergy-inducing substances.

The "miracle shampoo" sold out fast among consumers who found this a great alternative to frequently dyeing their hair. Over 2 million bottles of "pro-change black" have been sold in Korea and overseas as of March, according to the company.

But Moda Moda ran into a major setback in December 2021, when the Ministry of Food and Drug Safety announced its plan to prohibit the use of 1,2,4-trihydroxybenzene (THB), the main substance of the shampoo, in cosmetics.

Lee Hae-sin, a professor of chemistry at Korea Advanced Institute of Science and Technology shows Moda Moda's shampoo during an interview with Hankook Ilbo, sister paper of The Korea Times at the newspaper's office, Oct.13, 2021. Korea Times photo by Han Ji-eun

The ministry took reference from a European Council (EC) decision made in December 2020 to add THB to its list of prohibited ingredients for cosmetics, based on an assessment by the Scientific Committee for Consumer Safety (SCCS).

In its report, the SCCS said it "does not consider 1,2,4-THB safe due to potential genotoxicity when used as an auto-oxidative hair dye component in permanent hair dye formulations."

"The systemic availability of 1,2,4-THB raises the risk of intracellular generation of hydrogen peroxide, as well as potential genotoxicity via DNA adduct formation by 1,2,4-THB and/or semi-quinones," it added.

On Jan. 26, the ministry concluded that it will revise relevant policies within the first half of the year. Once the process is completed, the revision will take effect after six months, following which the production of the shampoo will be banned.

Moda Moda is fiercely protesting, claiming that it is unfair to apply EC's standard to its product.

In a press conference held on Jan. 27, Professor Lee criticized the authorities for imposing excessive regulations on the innovative product.

"The SCCS report assessed the use of THB in dyeing products, not shampoos. These are two different hair products," said Lee.

"The mechanism used in our product is different from other coloring products," he said, urging the authorities to draw up new guidelines for newly-introduced products that do not fit the existing regulations.

The company also argued that the ministry is failing to provide clear reasons on its decision, and that the use of THB in cosmetics is not prohibited in many other countries such as the U.S. and Japan.

"We are conducting additional clinical trials to prove the safety of the shampoo, with the results expected to be announced in the first half of this year. We will submit the results to the government for further review," said a Moda Moda official, Thursday.

But the drug safety ministry stands firm on its stance.

"Our decision, which was made based on thorough discussion with experts, remains unchanged. We will proceed with necessary steps to revise the regulations, with public safety as our top priority," ministry spokesman Kang Baek-won told The Korea Times over the phone, the same day.

Ministry of Food and Drug Safety headquarters in Cheongju, North Chungcheong Province / Courtesy of Ministry of Food and Drug Safety

Regarding Moda Moda's criticism on the government's "excessive regulation" and that THB is not banned in other countries like the U.S. or Japan, Kang said, "We come up with necessary regulations depending on the situation of our country, not the policies adopted in other countries."

"It is hard to understand why the company is pushing to use the potentially harmful chemical in their product instead of using other verified hair-dyeing substances," he added.

The two sides are already engaged in legal disputes regarding Moda Moda's advertisements.

In September 2021, the ministry claimed that the cosmetics company has violated the law on safety standards on cosmetics and drugs by providing inaccurate information on its advertisement, describing the shampoo as a "functional" cosmetic product although it did not win necessary approval.

The ministry issued an administrative order banning the advertisement. But Moda Moda filed a lawsuit at the Seoul Administrative Court seeking to nullify the order.