More Sunscreen Recalls, Lawsuits Likely in Wake of Benzene Findings

child applying sunscreen at the beach

In July, Johnson & Johnson (J&J) announced a voluntary recall of five sunscreen products sold under its Neutrogena and Aveeno brands after internal testing confirmed the presence of benzene, a carcinogen. The next day, CVS Health announced it was pausing sales of two store-brand after-sun care products over benzene concerns.

These actions, which came in the wake of a report released in May by independent laboratory Valisure, may be just the tip of a Titanic-sized iceberg. Valisure tested 294 samples of 69 sunscreen and after-sun care products from various companies and found detectable levels of benzene in 78 samples, or about 27 percent, and many of the affected products are still available for sale. Further, the fact that the 69 products tested are only a fraction of the 11,000 registered sun care products on the market begs the question of what would be uncovered if more widespread testing were to be conducted.

What Is Benzene?

Benzene is a chemical that forms from both natural processes and human activities. Sources of benzene include industrial emissions, gasoline, volcanoes, forest fires, emissions from motor vehicles, cigarette smoke, and the burning of crude oil. Widely used by manufacturers in the United States, benzene is an ingredient in some lubricants, rubbers, dyes, detergents, drugs, and pesticides as well as in chemicals that are used to make plastics, resins, nylon, and synthetic fibers.

Harmful Effects of Benzene Exposure

Benzene is classified as a human carcinogen by the National Toxicology Progam (NTP) within the Department of Health and Human Services, which states that long-term exposure to high levels of benzene in the air can cause leukemia. It is also recognized as a Group I carcinogen by the International Agency for Research on Cancer (IARC), which has identified associations between benzene and several types of leukemia, multiple myeloma, and non-Hodkin’s lymphoma.

Most exposures to the chemical come from cigarette smoke or working in an industry that produces or uses benzene, according to the National Cancer Institute. The Occupational Safety and Health Administration limits exposure to benzene in the air of most workplaces to an average of 1 part per million (ppm) over an eight-hour workday or 5 ppm over any 15-minute period. The National Institue for Occupational Health and Safety (NIOSH) recommends even stricter controls in the workplace: an 8 hour time-weighted average (TWA) exposure of less than 0.1 ppm and a short-term limit of 1 ppm.

The Food and Drug Administration (FDA) classifies benzene as a Class 1 solvent that should not be used in any drug products unless its use is “unavoidable in order to produce a drug product with significant therapeutic advance,” in which case the concentration should be limited to 2 ppm.

During the pandemic, the FDA temporarily allowed alcohol-based hand sanitizers to contain up to 2 ppm of benzene.

Benzene in Sunscreen

Benzene is not necessary for the production of sunscreen or after-sun care products, and therefore no amount is acceptable, according to Valisure, which issued a citizen petition in May requesting that the FDA conduct investigations, order recalls of the contaminated product batches, and better define limits for benzene contamination in drug and cosmetic products.

“There is not a safe level of benzene that can exist in sunscreen products,” Dr. Christopher Bunick, Associate Professor of Dermatology at Yale University, said in a statement announcing the petition. “Even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”

Of the 78 product batches with detectable levels, 26 contained benzene in concentrations between 0.1 ppm and 2.0 ppm and 14 contained more than 2 ppm.

Product Recalls

J&J voluntarily recalled Aveeno Protect + Refresh aerosol sunscreen and four Neutrogena aerosol sunscreens: Beach Defense, Cool Dry Sport, Invisible Daily Defense, and Ultra Sheer.

“Based on exposure modeling and the Environmental Protection Agency’s framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences,” J&J said in a statement. “Out of an abundance of caution, we are recalling all lots of these specific aerosol sunscreen products.”

CVS Health paused sales of its After Sun Aloe Vera and After Sun Aloe Vera Spray “out of an abundance of caution,” according to a statement, which added that the retail giant was “working with our supplier to take appropriate additional steps.”

As benzene is not an ingredient in any of the impacted sunscreen products, experts say the contamination likely happened during the manufacturing process.

“Benzene could be a byproduct of the process of making the chemicals that companies sell to the formulators of personal care products and sunscreens,” Scott Faber, Senior Vice President of Government Affairs for Environmental Working Group, a consumer advocacy nonprofit, told CNN. “Or it could be that some of those chemicals break down into benzene, although that seems less likely.”

Either way, Faber said the discovery is “alarming,” especially in light of the fact that “the FDA does not require companies to test ingredients for contaminants, nor does it require testing for such chemicals at a finished product stage.”

Looking Ahead

Shortly after the Valisure announcement, attorneys began filing class action lawsuits against J&J and other sunscreen manufacturers alleging consumer fraud, unjust enrichment, and other charges. More lawsuits are likely to follow, as are recalls. A 2019 citizen petition to the FDA by Valisure about the presence of the carcinogen NDMA in ranitidine, sold under the brand name Zantac, led to the removal of all products containing ranitidine.

That is not to say that all sun care products will go away; in fact, 73 percent of the samples in Valisure’s study did not contain detectable levels of benzene, and experts have been quick to caution that sunscreen use is important in preventing skin cancer. “It is NOT a reason to stop using sun protection… to do so would be like hearing a particular car model was recalled and then committing to never drive again,” Dr. Ranella Hirsch, a past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, posted on Instagram.

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