Skin whitening products are used all over the world. Originally developed for the Asian market, western countries have seen them grow tremendously, often termed “skin lighteners” or “brighteners” to avoid regulatory scrutiny. While many of the ingredients used in these products are safe and well-established, consumers could put their health at risk if they are not aware of the dangers of improper application, or illegal formulations.
Whether used for cosmetic effects or to counter skin pigmentation issues, skin whiteners and lighteners carry risks and are often the target of regulatory actions and counterfeiting. Skin lightening products, both topical and injectable, frequently toe the grey zone between cosmetics and drugs, in the regulatory limbo we often call cosmeceuticals.
The US FDA has concerns over unsafe injection practices, harmful ingredients, and contaminants associated with skin whitening products. Improper injection techniques and poor hygienic practices can result in nerve or blood vessel damage, toxic systemic reactions, or infection. Mercury and hydroquinone are effective at whitening the skin but are banned in many markets for use as cosmetic whiteners due to health risks. However, these ingredients are known in counterfeit and black-market whitening products. Ingestible skin whitening formulations have also been developed in the form of candies, tablets, and beverages, many of which are exclusively available on the black market. With the global skin lightening market predicted to reach US $31.2 billion by 2024, the consumer demand for more effective, faster acting skin whiteners is unlikely to help staunch the flow of questionable products making their way into the hands of consumers.
The pervasiveness of the issue is highlighted by a recent U.S. Federal court ruling. Just this past September 2017, a manufacturer of skin whitening products was ordered by a Federal Judge on behalf of the FDA to cease sale and issue a recall of their products due to safety concerns. The company also has to undergo an expert review of their drug products and halt distribution until granted written permission from the FDA. The company’s products first came under fire in 2014 when stock was seized by U.S. Marshals.
This case illustrates the need for both manufacturers and consumers to understand the risks and regulations associated with skin whitening products. Consumers need to be aware of unproven treatments and deceptive marketing tactics and purchase products from trusted manufacturers. Meanwhile, manufacturers have the responsibility to ensure that their products are safe and comply with regulations.
If you have any questions, please feel free to contact Focal Point Research. We are industry leading Cosmetics and Drug Regulatory Consultants that you can trust to help guide your company in the right direction.