Valisure Alleges presence of Benzene in Benzoyl Peroxide. Initiates a Citizen Petition

Valisure Alleges presence of Benzene in Benzoyl Peroxide. Initiates a Citizen Petition

On March 5, 2024, Valisure filed a Citizen Petition under Sections 301(21 U.S.C. § 331), 502 (21 U.S.C. § 352), 505 (21 U.S.C. § 355), 702 (21 U.S.C. § 372), 704 (21 U.S.C. § 374), and 705 (21 U.S.C. § 375) of the Federal Food, Drug and Cosmetic Act (the “FDCA”).[1] In accordance with 21 C.F.R. 10.20 and 10.30, the Petition alleges that several of benzoyl peroxide products were found to have high levels of benzene and that benzene concentrations are fluctuated to a higher point when the products are stored above normal room temperatures. These allegations have come after their extensive testing. Based on their testing, Valisure has requested the Commissioner of Food and Drugs to recall the products of benzoyl peroxide from the US market and suspend its further sales. In March 2021, Valisure filed FDA Citizen petition #4 alleging they have found Benzene in Hand Sanitizers.[2] As a result, Scentsational Soaps and Candles Inc. recalled their Hand sanitisers in April 2021 and again in May 2021. On May 24, 2021, Valisure filed FDA Citizen petition #5 alleging presence of Benzene in sunscreen products.[3] Johnson & Johnson had to recall their sunscreen products in July 2021. Subsequently, Beiersdorf and Bayer Lotrimin had to recall their products in September 2021 and October 2021 respectively.

Benzoyl Peroxide (BPO) is commonly found in acne regimens and skincare products. Its primary function is to keep pores clean and combat acne-causing bacteria. Benzoyl peroxide works to treat and prevent acne by killing bacteria underneath the skin, as well as helping the pores shed dead skin cells and excess sebum (oil). Valisure reported that some products contained up to ¹two times the allowed amount of benzene according to US Food and Drug Administration (FDA) guidelines, especially when tested at higher temperatures mimicking product breakdown over time. When BPO breaks down over time, it can form benzene, a known carcinogen. Valisure’s testing also looked at benzene in the air surrounding acne treatments. They found that even an unopened Proactiv product leaked high levels of benzene when kept at 104 degrees Fahrenheit, for approximately 17 hours.

People across the United States have expressed their opinions on the Citizen Petition filed by Valisure. Commenting on the topic, the Wall Street Journal called it a legal shakedown. In 2022, Unilever internally tested its dry shampoo voluntarily and found that some batches had excessive benzene than the approved limit. As a consequence of it the Company recalled those batches as abundance of caution. Yet Valisure, filed its Citizen Petition which led to filing of a class action suit against the company^.

Shook Hardy and Bacon L.L.P has alleged that Valisure has a record of working with Food and Drug Administration and filed Citizen Petitions to publicize their findings in the past with an intention to devising product liability litigation related to ranitidine, sunscreen and other products.

Independent laboratories such as Valisure, does play an important role in keeping the big manufacturing companies producing chemical based products in check with their regular testing and releasing their findings for the public. But at times, it also raises a doubt that whether such testing is done from a public benefit perspective or is it a way to devising product liability litigations and shakedowns. It also raises a question about the involvement of competitors/rivals in these testing taken up by the independent laboratories.

While, just because the findings of such laboratories are not supported by any medical expert does not make them unreliable, at the same time, the Legislature need to come up with laws to regulate their functioning and disclosure policies. Such organisations need to be held responsible for the losses Companies face due to their publications and petitions.

[1] See Petition at: https://assets-global.website-files.com/6215052733f8bb8fea016220/65e8560962ed23f744902a7b_Valisure%20Citizen%20Petition%20on%20Benzene%20in%20Benzoyl%20Peroxide%20Drug%20Products.pdf

[2] See Petition #4 at: https://assets-global.website-files.com/6215052733f8bb8fea016220/626fee4c78a2e4769ba2b7fe_FDA-2021-P-0338-0001_attachment_1.pdf

[3] See Petition #5 at: https://assets-global.website-files.com/6215052733f8bb8fea016220/62728f83d7f91acc8572e9ee_FDA-2021-P-0497-0001_attachment_1.pdf