• CAA conducted about 100 raids related to cosmetics industry so far this year
• Whitening cream not registered as cosmetic products; NMRA looking temporarily

The lack of regulations specifically for the cosmetics industry is creating a dangerous environment for the public, who are increasingly on the lookout for ‘whitening’ creams that promise them lighter skin colour. 

An official at the Consumer Affairs Authority (CAA) told The Sunday Morning that they had conducted about 1,000 raids thus far this year related to the cosmetics industry. 

Dermatologists have termed a cosmetics act as the “need of the hour” as the increasing usage of skin whitening creams and substandard skincare products are posing serious health consequences for many across the country. 

‘Sorry state of things’ 

National Hospital of Sri Lanka (NHSL) Consultant Dermatologist and Sri Lanka College of Dermatology and Aesthetic Medicine Past President Dr. Indira Kahawita said that from 60 patients she had seen on a single day, six had whitening cream-related issues. 

“Every week, I see at least one person with stretch marks following the use of whitening creams. While fungal infections, stretch marks, and acne are the commonly-observed side effects of whitening creams, we are now seeing more unusual side effects like orange and brown pigmentation under the nails and unusual pigmentation of palms and soles. This is unexplained and we don’t know what is happening. That is the sorry state of things at the moment,” said Dr. Kahawita. 

She said that according to existing regulations, whitening creams could not be registered as cosmetic products: “This is because they are not safe. However, if somebody wants to improve their colour, there are certain skin lightening molecules that can be used. Yet, those products don’t give immediate whiteness, glass-like skin whiteness, or white skin in seven days – such results cannot be achieved with safe products.” 

She cautioned that not everybody faced side effects from whitening creams, pointing to one recent example where she had seen a patient with whitening cream-related side effects, whose sister had not experienced any side effects. 

“She asked me why I was asking her to stop using the product when her sister was fine.” 

Dr. Kahawita explained that whitening creams used three harmful substances: bleach, heavy metals, or steroids. 

“It is illegal to use standard skin bleaching products in cosmetics. They can only be used up to 4% in medicinal products. If anyone includes them in their cosmetic products, it is illegal. It is also not cheap,” she said. 

Therefore, she presumes that the more commonly-used substances are heavy metals, specifically mercury. 

“Some raids have discovered that some cosmetics have extremely high levels of mercury. The present regulation caps it at one part per million as high levels can cause kidney damage. Since people are now using creams all over the body, what about higher rates of absorption into the bloodstream and possible damage to the kidney later?” she questioned. 

She went on to say that it was also illegal to use steroids in cosmetics but that they were “fairly sure” most of them did so, since a majority of the side effects observed were due to steroids. 

Lack of regulation for cosmetics

According to Dr. Kahawita, since cosmetics are not regulated under the National Medicines Regulatory Authority (NMRA) Act, the NMRA lacks any mandate to instruct an entity not to manufacture a whitening cream. 

“Medicines and borderline products are regulated under the NMRA Act but cosmetics aren’t. If a cosmetics act existed, it could regulate the cosmetics industry, starting from the point of manufacture to sales,” she said, noting that the act had been in the draft stages for years.  

Therefore, she said that with the existing legal background, the only recourse was to obtain a court order against a manufacturer whose products had caused harm. 

“Other than that, if we are unable to prove there is a significant issue, the NMRA cannot put a stop to it.”

Despite the non-existing legal regulations, Dr. Kahawita emphasised: “Ethically speaking, no one can manufacture anything without registering their plant with the NMRA.” In addition to registering with the NMRA, Dr. Kahawita said that plants should follow Good Manufacturing Practices (GMPs). 

“This is a prerequisite and non-optional; it is necessary. The NMRA uses World Health Organization (WHO)-specified GMP standards. If a company gets its GMP certification from the NMRA, that means it conforms to WHO standards and that the production process happens according to internationally-accepted levels.”

She further criticised companies which were advertising the fact that they had the GMP certification: “It is not a trophy.”

However, she said that the current situation in Sri Lanka pointed to a disturbing trend where “anybody thinks they can manufacture creams”. 

“Salons are manufacturing their own products. If someone makes a cream and sells it to a client and the client develops an allergic reaction, the NMRA can’t do anything about it. Legal action is possible if the affected client makes a complaint to the CAA.” 

Safety, efficacy, and post-market surveillance 

Dr. Kahawita pointed to other wider issues that would arise even if a company were to register with the NMRA. 

“During registration, only the safety of the product is checked, not the efficacy. For medicines, we look at safety and efficacy both, but for cosmetics we only check safety.” 

She further pointed to another drawback – the non-availability of facilities in Sri Lanka to check for steroids. 

“Another issue about regulation is even if you give proper documents and get registration, there are certain people who will lower the quality during the manufacturing process. Post-market surveillance is not taking place in Sri Lanka, so companies may adulterate their products after they get the registration.”

Consumer responsibility 

Dr. Kahawita also said that consumer responsibility played a role in ensuring harmful products did not reach them. 

“One aspect of consumer responsibility is to report issues. The other is to ensure products are reliable. 

“These days, there are many products being advertised on Facebook to treat underarm darkness, with the claim that they are certified by the Ayurveda Department and the NMRA. The comments on these posts advertising such products only have a few questions, such as ‘price please,’ or ‘how quickly will I get white?’. But nobody asks what the ingredients are, whether there are steroids, and whether they could cause side effects.” 

Act still being drafted: NMRA

NMRA Chairman Dr. Ananda Wijewickrama told The Sunday Morning that when the NMRA Act was being drafted, it had been done so with the idea that a separate act for cosmetics would eventually be drafted as well. 

“That is why cosmetics are not included in the NMRA Act. However, the other act hasn’t been drafted yet although the Minister is pushing for it. Until then, it [the task of regulating cosmetics] has been temporarily given to the NMRA. This is a ‘plaster job’. We are doing it to a certain extent.”

Therefore, he said that since the act was yet to be drafted, there was no law for the NMRA to require cosmetic companies to register with the authority. “Ethically, they have to register. If they haven’t registered, we cannot take action as there is no law there.”

He added: “The cosmetics act has mostly been drafted now.”