Hydroquinone, known as the gold standard and most effective skin lightening agent, is now disappearing from shelves & online stores all across the United States. Why you may ask? As part of the 2020 CARES Act, new regulations were passed limiting the availability of hydroquinone sold as an OTC product.
Hydroquinone in the 2020 CARES Act
Though the CARES Act of 2020 was mainly passed to provide financial relief to those affected by the Covid-19 pandemic, OTC regulation was tied into the CARES Act as minor legislation.
This is because Hydroquinone is listed with some other OTC medications that have not been officially found to be GRASE (generally regarded as safe and effective) by the FDA. After all, it was pending a final monograph (rule book covering conditions for active ingredients) from the FDA.
Though it's been safely included in many skin lightening products for years, its exclusion as
a GRASE drug requires the FDA to go back and conduct more well-controlled clinical investigations to confirm the product’s safety & effectiveness.
One rare condition, however, is linked to hydroquinone use: Exogenous Ochronosis. This disorder results in blue-black or gray-blue pigmentation around the applied area. Studies have shown that overuse of skin-lightening agents containing hydroquinone has been found to closely relate to the heightened disposition of EO.
Its diagnosis is quite difficult, usually mistaken as melasma, and thus, when more hydroquinone is used to treat it, exacerbates the problem. Keep in mind, however, that this condition is rare and usually occurs when hydroquinone is used more than recommended.
Future of Dark Spot Treatment
We certainly hope to see hydroquinone once again on the market for OTC use once it is determined to be GRASE by the FDA. While before this, we are working diligently to come up with a new formula with alternative effective ingredients for our skin lightening serum & cream and will have that available for sale shortly. Please stay tuned.