In 1972, an over-the-counter drug review process was established by the Food and Drug Administration to regulate the safety and efficacy of over-the-counter (OTC) drugs. This created a book or “monograph” for each medication category that describes the active ingredients, indications, doses, route of administration, testing, and labeling. If a drug meets the criteria in its therapeutic category, it does not have to undergo an FDA review before being marketed to consumers.

As part of this process, drugs are classified into one of three categories: category I: generally recognized as safe and effective (GRASE) and not misbranded; category II: not GRASE; category III: lacking sufficient data on safety and efficacy to permit classification. This methodology was outdated and made it difficult under the old guidelines to make changes to medications in the evolving world of drug development. Some categories of OTC drugs, including hand sanitizers, hydroquinone, and sunscreens, have been marketed for years without a final monograph.

The signing of the “Coronavirus Aid, Relief, and Economic Security” (CARES) Act in March 2020 included reforms in the FDA monograph process for OTC medications. Under this proceeding, a final monograph determination was made for all OTC categories. While drugs in category I and some in category III may remain on the market, if certain specifications are met, category II drugs had to be removed within 180 days of the enactment of the CARES Act.

Hydroquinone was one of those that fell victim to the ban. Hydroquinone 2% cream, which was marketed for years as an OTC skin-lightening agent was classified by the FDA as category II and has now been removed from shelves. This ban is similar to hydroquinone bans in other places, including Europe. However, for manufacturers, this issue was under the radar and packaged in a seemingly irrelevant piece of legislation.

Among dermatologists, there is no consensus as to whether 2% hydroquinone is safe or not. However, the unmonitored use and overuse that is common for this type of medication has led to heightened safety concerns. Common side effects of hydroquinone include irritant and allergic contact dermatitis; the most difficult to treat side effect with long-term use is ochronosis. But there are no reported cancer data in humans with the use of topical hydroquinone as previously thought. Hydroquinone used short term is a very safe and effective treatment for hard to treat hyperpigmentation and is often necessary when other topicals are ineffective, particularly in our patients with skin of color.

The bigger problem however is the legislative process involved, as exemplified by this ban, which only came to light because of the CARES act.


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