Personal care sector applauds FDA safety approval of benzoyl peroxide amid benzene scare

12 Mar 2024 --- The US Food & Drug Administration (FDA) deems benzoyl peroxide a safe and effective anti-acne ingredient, addressing previous analysis by Valisure that suggested acne products containing benzoyl peroxide can produce high levels of benzene when exposed to hot temperatures.

“Personal care products companies do not add benzene to any over-the-counter [OTC] personal care product,” maintains the Personal Care Products Council.

“The findings in the most recent Valisure petition are based on unproven, questionable methods applying unrealistic conditions which are inconsistent with the way the product would be stored normally,” states the trade association.

“In a December 2022 letter, the FDA highlighted multiple deficiencies in Valisure’s analytical methods, stating that the lab should follow the same testing methods that drug manufacturers are required to use.”

Valisure previously detected levels of benzene across hand sanitizer, antipersperant and sunscreen products.Carcinogenic potential
Addressing various “substantial and alarming” concerns within the supply chain of consumer goods, testing company Valisure has filed several FDA Citizen Petitions over the years.

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene.

Benzene is a colorless or light-yellow liquid chemical at room temperature, classified as a human carcinogen. It has been used primarily as a solvent in the chemicals industry.

On March 24, 2021, Valisure announced its detection of benzene in multiple brands of hand sanitizer. 

“Benzene is known to cause cancer in humans, according to the US Centers for Disease Control and Prevention, the International Agency for Research on Cancer, the World Health Organization, and other regulatory agencies,” highlights the testing company.

“Of the 260 hand sanitizer products, 17% of batches contained benzene.”

Around this time, Valisure also submitted a petition to the FDA to take action on the contamination and update its guidance on benzene, resulting in the recalls of ArtNaturals products and Scentsational Soaps & Candles products.

Sunscreen, antiperspirants and shampoo
On May 25, 2021, Valisure flagged its detection of benzene in several brands of sunscreen.

Of the 294 sunscreen products tested, 27% of batches contained benzene. As a result, Valisure submitted a petition to the FDA, resulting in the recalls of Johnson & Johnson’s Neutrogena & Aveeno products and Coppertone’s products.

On November 4, 2021, Valisure issued an alert of benzene in several brands of antiperspirant body sprays. Of the 108 body spray products tested, 54% of batches contained benzene. Valisure submitted a petition to the FDA, resulting in the recalls of Procter & Gamble’s Old Spice, Secret, Aussie and Herbal Essences products.

On November 1, 2022, Valisure detected benzene in dry shampoos. Of the 148 dry shampoo products tested, 60% of the batches contained benzene.

Valisure’s most recent announcement on March 6, 2024, was the detection of benzene in benzoyl peroxide products. 

Unlike Valisure’s previous findings of benzene in sunscreens, hand sanitizers and other consumer products — where the benzene came from contaminated raw materials — the benzene in benzoyl peroxide products comes from the drug itself degrading into benzene, leading Valisure to conclude that the benzoyl peroxide market is “broadly affected.”

By Benjamin Ferrer