Among imported cosmetic products sold in the domestic market, there are products contain banned substances. The United States and the UK banned imports of these products which were found to contain steroid substances. The cosmetic product in question is ‘BLUECAP’ that is manufactured by CATHARSIS ELSA, a Spanish-based company, is being sold as a product that treats skin disorders such as atopy, seborrheic dermatitis and psoriasis. 

 

This prompted the Korea Consumer Protection Board (KCPB) to inquire the National Institute of Scientific Investigation (NISI) to test hair spray, hair cream, shampoo and hair gel products that are currently available on the market. 

 

■ Hair spray & hair cream products using zinc pyrithione violated the standard of cosmetic ingredients 

 

In accordance with the ‘Regulation on Designation of Cosmetic Ingredients, and its Standard & Test Method’ promulgated by the Korea Food and Drug Administration (KFDA), zinc pyrithione can only be used in products that remove dandruff and cure itchiness. However, Bluecap hair sprays and hair creams were in violation of the Regulation for not including information it is a rinsing (cleaning) product and for using zinc pyrithione. 

 

Zinc pryithione causes eye and skin irritation and if it comes into eye contact, it can lead to serious complications. What is more serious is that even though the products labeled that its active ingredient was zinc pryithione, it passed customs inspections. 

 

■ Hair spray & shampoo products using zinc pyrithione showed positive steroid response 

 

Test results found that Bluecap hair spray and shampoo products showed a positive steroid response. 

Steroids are anti-inflammatory drugs used to cure skin diseases like atopy, psoriasis and seborrheic dermatitis. But it can lead to serious side effects if used without a doctor’s prescription, so it is banned for use in cosmetics. 

 

Although the specific name of the steroid has not been disclosed, the possibility is high that steroid substances are used in these products. Therefore, a more thorough and accurate inspection is required by relevant bodies. 

■ U.S. and UK have banned imports of steroid-containing products 

 

A few years ago, steroid substances were detected among Bluecap products following inspections by the U.S. and Canadian health authorities. In 2000, the U.S. Food and Drug Administration (FDA) confirmed that Bluecap hair spray and cream products contained betamethasone, a type of steroid. 

 

Bluecap products which were advertised as effectively treating chronic skin diseases such as psoriasis and eczema violated the U.S. federal regulation which state that zinc pyrithione cannot be used in generic drugs used to cure psoriasis. 

 

As a result, the U.S. has temporarily banned import of Bluecap products which are considered non-approved drugs and registered as DWPE (Detention Without Physical Examination) product until it is found compatible with FDA guidelines and standards. 

In November 2004, Health Canada also issued a warning to consumers to not use Bluecap shampoos that were found to contain betamethasone and hair sprays that may contain similar substances. 

 

Based on the above findings, KCPB carried out additional studies on the products in question and proposed to the KFDA ▲to verify the types of substances that showed positive steroid response ▲to recall and destroy import banned products sold in the domestic market and ▲to establish relevant policies.  

 

Source: Consumer Safety Center