Benzene Contamination Prompts FDA to Implement Stronger Standards for Sunscreen Products

The U.S. Food and Drug Administration (FDA) has announced plans to improve the safety and efficacy of over-the-counter sunscreen products in light of the recent sunscreen recall stemming from potentially harmful benzene contamination. A known carcinogen, benzene has been linked to a potential risk of leukemia and other cancers of the blood cells, according to the American Cancer Society. If you or someone you love has been diagnosed with cancer allegedly caused by benzene exposure in sunscreen, contact Consumer Safety Watch today. We can help you determine whether you are eligible to file a sunscreen cancer lawsuit against the product manufacturing company.

Sunscreen Products Recalled Due to Benzene Contamination

A massive sunscreen recall was issued over the summer after testing revealed dangerously high levels of benzene, an industrial chemical linked to a variety of cancers and blood disorders, including acute myeloid leukemia, non-Hodgkin’s lymphoma, multiple myeloma, hairy cell leukemia, chronic lymphocytic leukemia, and others. The potential risk of benzene exposure from certain aerosol sunscreens garnered public attention in July, when Johnson & Johnson was forced to recall all lots of five Neutrogena and Aveeno aerosol sunscreen products, including Neutrogena brand Beach Defense, Cool Dry Sport, Invisible Daily and Ultra Sheer sunscreens, and Aveeno brand Protect + Refresh sunscreen due to benzene contamination.

“While benzene is not an ingredient in any of our sunscreen products, it was detected in some samples of the impacted aerosol sunscreen finished products,” said Johnson & Johnson in a July 14 press release announcing the recall. “We are investigating the cause of this issue, which is limited to certain aerosol sunscreen products.” The Neutrogena and Aveeno sunscreen recall is particularly troubling given the array of pharmaceutical drugs that have been recalled over the past several years due to contamination with other cancer-causing chemicals called nitrosamines. One of the most recent drug recalls was issued for Chantix, a smoking cessation medication made by Pfizer that was found to contain unacceptable levels of the carcinogen N-nitroso-varenicline, which can increase the risk of certain cancers in users.

FDA Announces Proposed Order for OTC Sunscreen Safety

Following the high-profile sunscreen recall, the FDA began looking for ways to strengthen the standards for sunscreen products sold in the U.S. On September 24, 2021, the FDA issued a press release announcing steps the agency plans to take to improve the “quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.” A key component of this plan is a proposed order issued by the FDA to amend and revise a Final Administrative Order issued in 2020, concerning nonprescription sunscreen drug products. If approved, the proposed order would implement new conditions sunscreen products sold in the U.S. would have to meet in order to be considered safe and effective by the FDA, including conditions related to sunscreen ingredients, labeling, and testing.

“Today’s activities represent a key milestone in our implementation of transformative new authorities related to OTC drugs that will allow us to continue ensuring that sunscreens are safe and effective for frequent, life-long use and provide consumers with the protection they expect from these products,” stated Acting FDA Commissioner Janet Woodcock, M.D. in the press release. “We are committed to using our new authorities to help meaningfully advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.”

Valisure Detects Benzene in Sunscreen Products

Making sunscreen products safer and ensuring that they provide users with the protection they expect and need is critical, considering the fact that nearly 80 sunscreen products tested by an independent online pharmacy earlier this year were found to contain benzene, including brand name sunscreens like Neutrogena, Aveeno, and Banana Boat, and generic sunscreen products like CVS Health sunscreen. According to a press release issued by Valisure in May, 27% of the sunscreen samples tested by the pharmacy contained detectable levels of benzene and some batches contained benzene at levels three times the concentration limit set by the FDA. Based on its findings, Valisure called for the FDA to recall the contaminated batches of sunscreen and requested that the agency “better define limits for benzene contamination in drug and cosmetic products.”

J&J Faces Wave of Sunscreen Cancer Lawsuits

Valisure’s findings ultimately led to the Neutrogena and Aveeno sunscreen recall issued in July, and Johnson & Johnson now faces a wave of lawsuits filed by consumers who allege that the company put their health and well-being at risk by failing to warn about the presence of benzene in its sunscreen products. If you believe you have been adversely affected by benzene-contaminated sunscreen, do not hesitate to speak to a product liability lawyer about your legal options. An experienced attorney can evaluate your claim, explain your rights, and help you pursue the compensation you deserve for your injuries.