Miracle shampoo is toxic, regulator says as company protests
A miracle shampoo that can wash away the gray may be toxic, according to regulators.
Moda Moda, a cosmetics company founded in May 2021, hit the market in August last year with Pro-Change Black.
According to the company, washing hair with the shampoo reduces the gray gradually over a period of a few months.
Pro-Change Black shampoo was jointly developed by Moda Moda and KAIST chemistry professor Lee Hae-shin.
Marketed at 34,000 won ($28) for a 300-milliliter bottle, a price point inhabited by premium shampoos, Pro-Change Black sold out in its first day on Amazon and was a big hit, according to local press reports.
Sales of the Pro-Change Black shampoo have so far exceeded 50 billion won.
The Ministry of Food and Drug Safety (MFDS) is set to prohibit the sale and production of the shampoo citing the presence of toxic chemicals.
It announced on Dec. 27 that 1,2,4-trihydroxybenzene (THB), a substance included in Moda Moda's Pro-Change Black shampoo, has potential toxicity that can damage genetic information in cells.
After three weeks of discussion with Moda Moda, the agency concluded on Jan. 26 to impose the ban on the manufacturing and sale of cosmetics products containing 1,2,4-THB.
The ministry is currently revising the relevant regulations so that the substance is no longer allowed in shampoos. Once that is complete, the rule will take effect in six months.
Cosmetics are covered by the MFDS, and the ministry argues that the shampoo is a cosmetic product.
Moda Moda protested, arguing that the MFDS did not provide enough evidence to prove that 1,2,4-THB causes damage to the human body when used in shampoo.
The ministry's announcement came as a shock to many consumers, especially because the Pro-Change Shampoo was believed to be less harmful than regular hair coloring products.
Pro-Change Black was described by Moda Moda as the world's first hair dyeing shampoo using the "browning reaction" caused by polyphenol, and completely free of harmful and allergy-inducing coloring agents such as p-phenylenediamine (PPD) or 2,5-diaminetoluene.
"We found a solution in nature's antioxidation principles, which can be seen in the browning of fruits and vegetables," according to Moda Moda's website.
Moda Moda claims Pro-Change Black shampoo is a healthier and safer alternative to existing hair dyeing products.
The company needs to halt the production of Pro-Change Black shampoo this year, and sales will be prohibited from 2024 at the earliest.
The ban is in line with a 2019 report by the Scientific Committee on Consumer Safety (SCCS) under the European Commission.
The SCCS wrote that it "does not consider 1,2,4-trihydroxybenzene safe due to potential genotoxicity when used as an auto-oxidative hair dye component in permanent hair dye formulations," and prohibited utilizing 1,2,4-THB in hair and eyelash products in the EU from September 2021.
A substance with genotoxicity damages genetic information in cells, causing mutation and disease.
The MFDS said that 1,2,4-THB might cause skin sensitization as well, which makes skin more sensitive to external stimuli and induces an immune reaction.
Moda Moda immediately voiced its opposition and criticized the MFDS for over-regulation.
The company issued a statement on its website on Dec. 29, two days after the MFDS announcement, emphasizing that the restrictions in the EU were imposed on the premise that the THB could be harmful when used in hair coloring products.
Moda Moda argues that the case is different for its Pro-Change Black shampoo as the regular hair coloring products are applied to hair for a relatively long time and contain PPD, another potentially toxic substance, in addition to the THB.
"Moda Moda's shampoo is used only in a small amount for a short period of time, about 2 to 3 minutes, and designed to be washed away completely as any other shampoo product," wrote Moda Moda.
Lee Hae-shin, co-developer of Pro-Change shampoo, said that the MFDS guidelines on chemical use cannot be applied without adjustments in Moda Moda's case.
"From a scientific perspective, Moda Moda's hair dyeing mechanism is completely different from the existing coloring products," Lee said during an online press conference held on Jan. 12, arguing that different rules and safety measures should be applied for different products.
Lee and Moda Moda emphasized that the regulator should not impede innovation just because a newly developed product does not fit in the traditional product classification, and requested a new category be created and safety regulations be devised for products like the Pro-Change Black.
"The Ames Test cannot provide solid evidence for complete prohibition of substance usage, since it lacks accuracy in evaluating actual toxicity and impact a substance has on the human body," said Lee Gyu-ree, a chemistry professor at Gyeongsang National University, referencing the process that was used for examining the toxicity of the THB in the SCCS report.
Lee criticized the regulator for not conducting a safety test on its own before introducing the ban.
"The MFDS should provide its own scientific evidence." he said.
Lee pointed out that the sensitivity and structure of the scalp are different from that of regular skin, though he added that further examination is needed.
"It is true that the risk would go down if a person is exposed to the 1,2,4-THB for a comparatively shorter amount of time," said Kim Kyu-bong, a pharmacology professor at Dankuk University specializing in toxicology, but he warned that daily use with water, which often facilitates chemical absorption, should be taken into account as well.
Consumers are growing anxious, unsure whether to use the shampoo or not.
"I bought the shampoo in a bundle, though it was much more expensive than a regular shampoo," fumed an office worker in his fifties. "Should I quit using it? I don't know who to believe."
"I was so shocked to hear the news today," one person wrote on the Moda Moda website, "since I'm pregnant, I need a refund right now."
Others are less cautious.
"Moda Moda shampoo was like a miracle to me since I was severely allergic to the regular hair-dyeing products,"a woman wrote online, "so I'm going to buy some more shampoos now!"
"It goes without saying that the MFDS should look closely into the safety of products and protect the consumers, though I'm not sure if that's what they are doing now," another person wrote on Jan. 12 on Moda Moda's YouTube channel.
Since the shampoo "is not like any other products before, the MFDS should come up with a new set of rules in line with the innovation, so that more innovative technologies would emerge in the future."
Moda Moda issued a statement on Jan. 26 in response to the ministry's final decision, saying that it will run an additional safety test with KAIST by June and try to communicate with the MFDS once again.
"The ministry did not give us a clear answer with enough scientific evidence, even though we submitted a number of safety test results conducted by professional institutes and requested reconsideration," Moda Moda said in a statement.
This is not the first time that the MFDS clashed with Moda Moda.
On Sept. 30, the regulator noted that Moda Moda violated the regulation on safety standards of cosmetics products by inaccurately advertising the shampoo as a functional cosmetic product with a hair dyeing effect, though it did not go through the approval process for hair coloring cosmetics.
The agency issued an administrative order to prohibit Moda Moda from advertising for four months in November, but Moda Moda filed a lawsuit in the Seoul Administrative Court against the MFDS.
The Court found the regulation unfair, lifting the restriction on the company in December.
BY SHIN HA-NEE [firstname.lastname@example.org]