Lab Wants Recall of Common Acne Meds

An independent lab is calling on the FDA to suspend sales of benzoyl peroxide after finding the acne medication degraded into a cancer-causing chemical in products from popular brands like ProActiv and Clearasil. Valisure analyzed 99 acne treatment products containing benzoyl peroxide (BPO). Before heating, the carcinogen benzene was detected in all but five of those products, often at levels above the FDA's safe limit of 2 parts per million, per Axios. After incubation at body temperature (98.6 degrees Fahrenheit), accepted pharmaceutical stability testing temperature (122 degrees), and the temperature of a hot car (158 degrees), benzene levels spiked, "sometimes at hundreds of times the conditional FDA limit," Valisure President David Light said Wednesday, per HealthDay.

The lab said the heat caused BPO to breakdown into benzene, which then leaked from packaging. Benzene was not only detected in a ProActiv product stored at 158 degrees for nearly 17 hours but in gas formed in the air around the product at levels 1,270 times the Environmental Protection Agency's limit for long-term inhalation exposure, Valisure said. The lab previously detected benzene in hand sanitizers, spray sunscreens, and dry shampoos, leading to some recalls, per Axios. But this discovery is "substantially different," said Light. While the benzene detected in other products "came from contaminated ingredients ... the benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself."

"The current evidence suggests that this problem applies broadly to BPO products currently on the market," said Valisure, which filed a citizen petition Tuesday calling on the FDA to "request recalls and a suspension of sales for [BPO] products." The FDA said Wednesday that it had received the petition and would respond in due course, per CNN. "Data must be verified as accurate and reproducible before it can be utilized to make regulatory decisions such as recommending product sale suspensions and recalls," it said. Clearasil parent company Reckitt Benckiser said the lab's findings "reflect unrealistic scenarios rather than real-world conditions," per CNN. It added it was "confident that all Clearasil products, when used and stored as directed on their labels as intended, are safe." (More FDA stories.)