Why Was OTC Hydroquinone Banned as Part of the CARES Act?

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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. 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. While the decision by the FDA was made in September of 2020, not many industry experts or consumers really even knew it was happening.  

What does hydroquinone have to do with the coronavirus? It turns out, not much at all. “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. I thought, ‘did they mean hydroxychloroquine?’, which was in the news a lot at the time. 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.

Why the CARES Act?

According to San Antonio, TX dermatologist Vivian Bucay, MD, the reason the ban was made as part of the CARES Act came down to convenience. “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. “A major piece of legislation presents an opportunity for Congress to vote on many other items. 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.”

“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. “Under 21 C.F. R. 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. This change is the result of a loophole in the law that has implicated hydroquinone unnecessarily.”

The recent U.S. ban follows prior bans in other parts of the world like Japan, Australia and Europe. “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. 

The Concern About Hydroquinone

New York dermatologist Jacob Levitt, MD explains that the main concern about over-the-counter hydroquinone is unmonitored overuse. “The concern is that this would lead to exogenous ochronosis, which is relatively rare but difficult to treat in darker skinned individuals. I suppose it can also result in allergic contact dermatitis, but that usually is an issue with higher percentage compounded hydroquinone products. I was surprised to see the FDA ban. Personally, if used for no longer than, say, three consecutive months, hydroquinone 2% products are safe.”

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. “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.”

“The CARES Act also included the OTC Drug Monogragh Reform Act, which included the old data on hydroquinone in rats,” adds Glenn Dale, MD dermatologist Valerie Callender, MD. “Currently, there is no reported cancer in humans with topical hydroquinone.”

What Happens Now

“This ban is, sadly, another example of rules and regulations that end up penalizing consumers for no good reason,” says Omaha, NB dermatologist Joel Schlessinger, MD. Dr. Schlessinger is also the founder of LovelySkin.com, an online skin-care retailer, and he says the journey to get these products back on the shelves is an uphill battle. “This will eventually lead to higher costs as it will be necessary for brands that want to include the ingredient to go through expensive clinical trials to put these products back on the market, if any company even decides to go through this process. I fear that no one will be willing to spend the millions of dollars it will take to reintroduce these useful forms of accessible hydroquinone.”

The Effect on BIPOC Consumers

According to many of the doctors we spoke to, the consumer for which the ban will have the greatest impact are those who depend on this drug the most. “I was surprised by this decision as were many of my colleagues, especially those of us who treat BIPOC patients,” notes Dr. Hartman. “People with darker skin tones are more likely to develop hyperpigmentation and rely on hydroquinone for treatment of various dyschromias. We organized immediately to try to maintain access of this important mediation for these populations that are disparately affected by disorders of pigmentation both medically and culturally.”

“It’s truly a shame,” adds Dr. Schlessinger. “These products are, in particular, essential for many skin-of-color patients, so this unfairly limits access to an already underserved population.” 

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