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FDA undecided on safety guidelines for hydroquinone use

Published on September 8, 2009 at 8:45 AM · No Comments

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.

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