The FDA in April this year issued a ban on the sale of over-the-counter hydroquinone products. Their concern was regarding the safety of these products and their potential misuse. Numerous OTC skin lightening products were being sold from sources that were often less than reputable including on social media. Currently the only product that is FDA approved that includes hydroquinone is Tri-Luma. All other formulations have been removed from the market or are being sold illegally. The exception to this is compounded topicals – a compounding pharmacy can still make hydroquinone creams with a prescription.
Prescription Requirement
There is an important difference between a product sold over-the-counter and a product sold with a prescription. The OTC product can be purchased and used without any input from a doctor or a pharmacist. There is no management of the treatment, monitoring of side effects, or dosage adjustment by a trained professional. When you have a lightening product prescribed, the doctor has reviewed your medical history and your skin condition. You get specific instructions for use from your doctor and pharmacist. In addition, you know that the compounding pharmacy is monitored by regulatory authorities and required to meet certain quality standards for their product.
Tri-Luma is a prescription product indicated for treating melasma that includes fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%. This formulation can help many patients however there is no adjustment of dose that is possible. There is no available formulation with just hydroquinone, or with a different dosage of hydroquinone. A compounding pharmacy is able to compound hydroquinone in any strength and in combination with other ingredients.
Reasons for Skin Lightening
Skin lightening products are not used just for changing the skin’s tone overall. Numerous skin conditions affect the pigment of the skin. Photoaging, acne, melasma, and more can all change the appearance of the skin. The main concern with these conditions is unevenness in the skin tone and noticeable discoloration. Photoaging is the changing of the appearance of the skin due to prolonged exposure to UV radiation. These changes can include wrinkles, sun spots, and other discolorations. After the skin heals from an acne flare-up, there can often be unsightly acne scars and hyperpigmentation. Melasma involves symmetrical patches of discoloration usually on the face that are triggered by sun exposure and hormonal changes.
These skin conditions are not just cosmetic concerns – they can significantly impact the patient’s quality of life. The narrative around skin lightening is that it is simply for people wanting to change their overall skin tone. However, most doctors prescribe these lightening products to help patients suffering from chronic conditions for which there are few treatment options. Often these conditions do not heal on independently and may become more severe without treatment. This is just to say that not all uses of skin lightening products are related to colorism and may actually be connected to diagnosed skin conditions.
Social Media
A recent CNN piece on the prevalence of skin lightening products on social media considered the possibility that influencers were pushing treatments that are potentially harmful. Some products are sold claim to not contain steroids, for example, but then after using them start giving customers stretch marks – a hallmark of topical steroid use. The nature of these platforms allows for the actual people behind an account to be obscured. When contacted about an issue with their product they often do not respond.
The analysis by CNN involved studying hash tags such as #skinwhitening, #skinlightening, #skinwhiteningtreatment, and #whiteningcream. The insights tool they used is only able to analyze public content – so it actually leaves out any groups that may be closed or profiles that are personal. When CNN reached out to sellers of OTC lightening products almost none replied. The environment is one of smoke and mirrors, with little oversight ensuring that products meet any quality standard.
Ingredients like steroids, hydroquinone, and mercury may be found in skin lightening products that can be purchased online without a prescription even though they have been banned by the FDA. As there are a significant number of accounts like this it has been difficult to regulate – at least that is what has been said by some social media companies. There is ad monitoring in place to help restrict advertising of these skin lightening products but they are not always 100% effective as illustrated in the CNN piece.
Sirona Biochem TFC-1067
A novel molecule referred to as TFC-1067 has been developed by Sirona Biochem as an alternative to hydroquinone. In studies it has been shown to be as effective as hydroquinone but is more selective about the areas of skin it lightens. One potential side effect of hydroquinone is lightening of the skin outside of the treatment area. If TFC-1067 continues to perform as well as hydroquinone but act more selectively it would be a great benefit to many patients suffering from acne, melasma, and other chronic skin conditions. Sirona Biochem has initiated a non-exclusive licensing agreement with Rodan + Fields to market the product. Because this is an entirely new chemical, it is possible this is an effective way to continue selling a high-strength lightening product without a prescription while also avoiding FDA oversight, which seems to be focused on hydroquinone at this time.
Compounded Hydroquinone
Hydroquinone can be made by a compounding pharmacy in the form of a cream in strengths that range from 4% to up to 10%. Usually 4-8% is the preferred strength by dermatologists who prescribe compounded creams. It is important to note that hydroquinone does have side effects, so it should always be used with supervision by a trained dermatologist. Check-ins with the dermatologist will help them monitor side effects and adjust your dosage or discontinue treatment if that is required.
Articles
U.S. FDA issues warning to companies selling unapproved skin lightening products – Reuters.com
Sirona Biochem Signs Definitive License & Supply Agreement with Skincare Industry Leader Rodan + Fields – Sirona Biochem
FDA Flags 12 Companies for Illicit Hydroquinone-containing Skin Brighteners – Cosmetics & Toiletries
An effective hydroquinone alternative for topical skin lightening – Journal of Cosmetic Dermatology
Social media is rife with skin-whitening products. But little is being done to regulate the market – CNN.com