US FDA probing allegations of benzene in sun-care products

Aug 6, 2021

Industry reacts to contamination claims, could be subject to further lawsuits

The US FDA has said it is inspecting certain sun-care products for benzene after a citizen petition claimed dozens of items were tainted with the cancer-causing substance — an inquiry that could prompt producers to address any safety issues.

The agency confirmed the examination to Chemical Watch following independent laboratory

Valisure’s revelation that it had detected benzene in nearly 80 sunscreen and after-sun articles. It petitioned the agency in May to scrutinize them and better regulate the carcinogen’s presence.

A couple of corporations have since pulled several items from retail shelves, while others have responded more slowly, even as legal challenges over benzene contamination mount.

Following its own research, Johnson & Johnson stopped supplying ve product lines in July, spanning all but two of its 26 offerings deemed tainted in Valisure’s request. Still, the multinational was hit with a class action seeking to bar it from selling benzene-containing sunscreens and compensate people for related harms.

The FDA said it is now “securing product samples and performing independent evaluation of collected samples to assess the data presented in the [Valisure] petition”, adding that it will collaborate with producers to handle any risks identified.

These entities must make sure their goods are nontoxic, the agency said. “We will continue to monitor the sunscreen marketplace to help ensure the availability of safe sunscreens for US consumers,” it said.

Industry Reaction

Since Johnson & Johnson’s sunscreen withdrawal, some of the other 20-plus brands Valisure called out have taken steps to deal with potential contamination, although others argue the threat is minimal.

CVS Health said it removed two after-sun sprays from stores “out of an abundance of caution” the day after Johnson & Johnson announced its recall. CVS Health said it is engaging with its supplier “to take appropriate additional steps”.

Quest Products, whose Sunburnt after-sun gel was flagged as containing roughly 1 part per million (ppm) of benzene, said it is looking into the matter with its manufacturer and other upstream entities. The manufacturer does not utilize the solvent in sun-care formulations or cleaning articles, Quest Products told Chemical Watch.

L’Oréal said it is studying Valisure’s results, adding that the concentrations below 0.1ppm discovered in its La Roche-Posay aerosol sunscreen are non-hazardous. According to Valisure, contamination under this threshold “warrants further investigation but is likely of less concern” than larger amounts needing FDA-initiated withdrawals.

Coppertone-owner Beiersdorf and pharmacy chain Walgreens did not specify what measures they are pursuing in response to Valisure listing benzene levels lower than 0.1ppm in their sun-care articles. Beiersdorf said its sunscreens “are rigorously evaluated for safety” via “comprehensive scientific testing”.

Banana Boat – which faces at least two class actions alleging benzene contamination – said its offerings “meet applicable FDA regulations for sunscreens, which are some of the strictest in the world”. However, the brand declined to comment on the lawsuits or its plans to revisit nine items Valisure said contained benzene at under 0.5ppm.

‘Not the last domino to fall’

Jason Richards, a partner with Aylstock, Witkin, Kreis & Overholtz, one law rm involved in litigation against Banana Boat, said he thinks businesses have been analyzing their sun-care goods for benzene since Valisure published its findings.

“As additional companies confirm benzene contamination, they will be forced to recall those affected products,” he told Chemical Watch. “This is an industry-wide problem that impacts many different sunscreen brands and manufacturers”, said Mr. Richards, whose rm also brought a similar class action against Neutrogena. “Johnson & Johnson’s recall is not the last domino to fall,” he said.

Mr. Richards said that corporation’s sunscreen withdrawal foreshadows more “company-led testing and company-led action” from others. “I would expect the manufacturers whose products were shown by Valisure to have the highest benzene content would and should act relatively quickly,” he said.

In preparing for litigation, “we have tested our own clients’ Banana Boat sunscreen products and found them to be contaminated,” he said.

Future Litigation

While they gradually consider and implement next steps, businesses could see further litigation.

David Byrne, a principal at Beasley Allen, one law rm behind the Johnson & Johnson suit, said it is “carefully reviewing the sunscreen benzene contamination issues associated with other sun-care product manufacturers”, but has not “made a final decision concerning additional legal action that may be necessary”.

According to Mr. Richards, “when product contamination cases are alleged and then verified by the company itself, resulting in the company voluntarily pulling the product from the market, that naturally drives more litigation.”

He predicts more class actions and personal injury claims from long-term sunscreen users suffering from blood cancer.

“Class action lawsuits are being led almost weekly around the country against various sunscreen manufacturers,” he said.

Article Written By: ALM Law