FDA undecided on safety guidelines for hydroquinone use

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the US market for physician-dispensed cosmeceutical pigment control products will experience considerable growth in sales over the next five years. MRG's US Markets for Physician-Dispensed Cosmeceuticals 2009 report finds, however, that product safety issues involving hydroquinone, the active ingredient in many pigment control products, have led the Food and Drug Administration (FDA) to second guess the use of the compound in such products.

Pigment control products are designed to reduce hyperpigmentation of the skin, including sun and age spots, scars, and acne discolorations, along with other skin conditions that cause uneven pigmentation. In 2006, the FDA proposed a ban on over-the-counter sales of hydroquinone products due to studies in rodents that indicated that hydroquinone may act as a carcinogen. Three years later, the FDA continues to review comments on the proposed ban but has yet to make a final ruling. Over-the-counter products containing 2% hydroquinone or less are still sold in the retail market, while products containing up to 4% hydroquinone are available by prescription only. The FDA plans to make a final ruling by the end of the year.

The uncertainty surrounding hydroquinone-based products has prompted some companies to explore the use of other skin lightening ingredients that are safer but yield similar aesthetic results. Additionally, some physicians have refrained from recommending hydroquinone products to their patients. Although the compound has been shown to be highly effective in skin lightening applications, concerns over product safety linger. If the FDA were to enforce a ban, all existing products in the market would require FDA approval before being sold and all products would be available by prescription only.

"If new pigment control products were able to generate fast, effective results without the use of hydroquinone, the pigment control market would experience tremendous growth," says Kevin Flewwelling, Manager of the Aesthetics division at MRG. "Although we don't think the FDA will ban the use of over-the-counter hydroquinone-based products, we expect that companies will continue to invest in the research and development of new, non-hydroquinone pigment control products because of the tremendous market opportunity."

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