![]() “According to misinformation out there, hydroquinone is thought to be carcinogenic,” says Montclair, NJ dermatologist Jeanine Downie, MD. “This has repeatedly been proven not to be true.” There have also been studies done on rats that have proven the drug to be toxic, however those same studies have never been performed on humans. Personally, if used for no longer than, say, three consecutive months, hydroquinone 2% products are safe.” I suppose it can also result in allergic contact dermatitis, but that usually is an issue with higher percentage compounded hydroquinone products. “The concern is that this would lead to exogenous ochronosis, which is relatively rare but difficult to treat in darker skinned individuals. New York dermatologist Jacob Levitt, MD explains that the main concern about over-the-counter hydroquinone is unmonitored overuse. “Hydroquinone has been long banned in Europe because it is cyto-toxic, meaning it is toxic to the cells to prevent making of melanin pigments,” explains cosmetic chemist Ginger King. ![]() ban follows prior bans in other parts of the world like Japan, Australia and Europe. This change is the result of a loophole in the law that has implicated hydroquinone unnecessarily.” Part 330, hydroquinone and other non-prescription drugs that are not described in specified provisions are deemed new drugs, misbranded and must be subject to a new drug application. “In the CARES Act, hydroquinone found itself subject to elimination from over-the-counter access because it has not been found to be GRASE or generally regarded as safe,” adds Birmingham, AL dermatologist Corey Hartman, MD. The issue of halting sales of OTC hydroquinone has been on the table for many years, and the CARES Act was simply a convenient means to rule on OTC hydroquinone.” “A major piece of legislation presents an opportunity for Congress to vote on many other items. ![]() “As you probably know, a lot of major legislation includes many smaller pieces of legislation bundled in, and these never make the national news,” she explains. Why the CARES Act?Īccording to San Antonio, TX dermatologist Vivian Bucay, MD, the reason the ban was made as part of the CARES Act came down to convenience. It didn’t make any sense.” De La Cruz and her team had six months to quickly pull product from the shelves and halt production on their popular Lightening Serum. ![]() I thought, ‘did they mean hydroxychloroquine?’, which was in the news a lot at the time. “We were shocked,” says Glo Skin Beauty director of brand development Anna De La Cruz. “We had an OTC 2% hydroquinone formula, so the proposed ban is one of the things that we’ve heard about a lot about over the years, but when we found it was happening now as part of the Coronavirus Relief Act I thought it was a mistake. What does hydroquinone have to do with the coronavirus? It turns out, not much at all. While the decision by the FDA was made in September of 2020, not many industry experts or consumers really even knew it was happening. Surprisingly and with very little notice or fanfare, the over-the-counter version of the drug has been permanently pulled off shelves as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Since as far back as 2006, there has been a proposed ban on over-the-counter hydroquinone, a popular skin-lightening ingredient, but up until now the dark-spot fader had been available to purchase without a prescription in a 2% concentration. ![]()
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