Toxic Benzene Detected in Acne Products; FDA Urged to Recall Items

Excessive ranges of the cancer-causing chemical benzene have been present in varied benzoyl peroxide (BPO) pimples merchandise from main manufacturers, together with Proactiv, Clinique, Clearasil, and extra.

Valisure LLC, an unbiased testing laboratory, filed a petition with the US Meals and Drug Administration (FDA) on Tuesday, requesting a recall of therapies affected by elevated ranges of the carcinogen with a view to enable regulators to research.

Valisure examined 66 BPO merchandise, together with lotions, lotions, gels, and washes which might be obtainable over-the-counter from important retailers or in prescription kind. Presently, FDA tips enable as much as 2 components per million of benzene, and Valisure discovered pimples merchandise that include as much as 12 occasions the allowed quantity. Moreover, the components per million of benzene considerably elevated when the pimples merchandise have been examined at increased temperatures that have been designed to duplicate how the merchandise can break down over time.

Affected Merchandise:

Proactiv 2.5% BPO cream
Up & Up 2.5% BPO cream
Walgreens 10% BPO bar
Harris 10% BPO wash
Clinique 2.5% BPO cream
Clearasil 10% BPO cream
La Roche-Posay 5.5% BPO cream
PanOxyl 10% BPO cream
Sandra Lee MD 2.5% BPO lotion
Oxy 10% BPO cream
Galderma 5% BPO cream
Equate 10% BPO cream
Differin 5% BPO cream
CeraVe 4% BPO cream
Sandoz 5% BPO gel
TARO 2.5% BPO gel
Neutrogena 10% BPO gel
and extra

From its testing, Valisure discovered that Proactiv’s 2.5% BPO cream, manufactured by Taro Prescription drugs, contained 1761 components per million of benzene. Goal’s Up & Up 2.5% BPO cream had 1598 components per million; Estee Lauder’s Clinique 2.5% BPO cream had 401 components per million; Reckitt Benckiser Group’s Clearasil 10% BPO cream had 308 components per million, and Walgreens 10% BPO cream had 114 components per million, as a few of the merchandise with the best components per million.

From the Citizen’s Petition despatched to the FDA, Valisure additionally discovered detectable ranges of benzene in La Roche-Posay’s BPO cream, PanOxyl BPO cream, Sandra Lee MD BPO lotion, Oxy’s BPO cream, Galderma’s BPO cream, Equate’s BPO cream, and lots of extra.

As pimples is likely one of the most typical pores and skin situations within the US, particularly amongst youngsters and younger adults, will probably be essential for dermatologists to debate the latest findings with their sufferers.

“Right here, it isn’t contamination, somewhat benzoyl peroxide breaks down into benzene, stimulated to take action by the formulation of the merchandise themselves. What’s regarding is that almost all benzoyl peroxide-containing merchandise examined fashioned benzene (even the brand new triple mixture topical), typically at ranges 2 to 1000X increased than the emergency/conditional FDA restrict of two ppm,” he stated. “To make issues worse, benzoyl peroxide breakdown into benzene was accelerated by publicity to elevated temperatures equal to a scorching toilet or automobile, that means that sufferers and customers should be aware of find out how to retailer their benzoyl peroxide-containing product (not in a automobile!). Much more regarding, as benzoyl peroxide breaks down into benzene, the gaseous type of benzene was discovered to penetrate by sealed packaging at ranges practically 1000X increased than EPA lifetime publicity restrict (0.4 ppb) for the elevated threat of 1 most cancers per 100,000 individuals. Thus, benzoyl peroxide-containing pimples merchandise unsuspectedly are additionally an inhalation threat.”

Bunick shall be addressing the subject of BPO and benzene in a lecture on the American Academy of Dermatology Annual Assembly this week in San Diego, California, as a part of an pimples and rosacea session on Monday, March 11 at 10:40 AM PST.

He added, “Benzoyl peroxide (BPO) containing merchandise are extensively used topically for pimples vulgaris, folliculitis, hidradenitis suppurativa, and to a lesser extent for rosacea. Most stand-alone BPO formulations used immediately are obtained over-the-counter, whereas BPO-containing prescription merchandise usually mix BPO with one other lively medication, similar to a retinoid or antibiotic.”

In recent times, benzene has been detected in varied consumer-facing merchandise, together with sunscreens, over-the-counter antifungal merchandise, antiperspirants, and aerosol dry shampoo.

Valisure’s testing additionally checked out benzene within the air surrounding pimples therapies and located that even an unopened Proactiv product leaked excessive ranges of benzene when stored at 104 levels Fahrenheit, which is the temperature of a scorching bathe, for about 17 hours.

Delayed most cancers threat is an actual concern, in accordance with Bunick. In a latest publication popping out of the UK, researchers linked low-level continual benzene publicity to a rise in mortality. Publicity was low, as few as lower than 1 ppm.

“Hundreds of thousands of sufferers use over-the-counter or prescription pimples merchandise with benzoyl peroxide,” Bunick stated. “Dermatologists might want to have critical discussions with their sufferers concerning the long-term security dangers of utilizing these merchandise having benzene.”

References:

Edney A. Chemical linked to most cancers present in pimples lotions together with Proactiv, Clearasil. Bloomberg. March 6, 2024. https://www.bloomberg.com/information/articles/2024-03-06/cancer-causing-chemical-found-in-acne-creams-including-proactiv-clearasil
Valisure detects benzene in benzoyl peroxide. Information launch. Valisure. March 6, 2024. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-benzoyl-peroxide
Valisure citizen petition on benzene in benzoyl peroxide drug merchandise. Valisure. March 5, 2024. https://assets-global.website-files.com/6215052733f8bb8fea016220/65e8560962ed23f744902a7b_Valisurepercent20Citizenpercent20Petitionpercent20onpercent20Benzenepercent20inpercent20Benzoylpercent20Peroxidepercent20Drugpercent20Products.pdf
Bunick C. Carcinogen benzene in pimples merchandise containing benzoyl peroxide. Media assertion. March 5, 2024. Accessed March 6, 2024.
Valisure detects benzene in sunscreen. Valisure. Revealed Could 20, 2021.
Bayer points voluntary recall of particular Lotrimin and Tinactin spray merchandise as a result of presence of benzene. U.S. Meals and Drug Administration. Press launch. Revealed October 1, 2021.
P&G points voluntary recall of particular outdated spice and secret aerosol spray antiperspirants and outdated spice under deck aerosol spray merchandise attributable to detection of benzene. U.S. Meals and Drug Administration. Press launch. Revealed November 24, 2021.
Affairs O of R. Unilever points voluntary U.S. Recall of choose dry shampoos attributable to potential presence of benzene. U.S. Meals and Drug Administration.
Villeneuve PJ. Lengthy Time period Publicity to Ambient Benzene and Mortality. Am J Respir Crit Care Med. 2024 Feb 1.