A Tiny Lab Found Benzene in Sunscreen and Hand Sanitizer. Why Did the FDA Go After It?
The agency inspected Valisure after its damning findings led to major recalls. Now, consumer claims of harm against implicated companies could be derailed.
Over the past few years, a tiny Connecticut-based laboratory has had a string of successes uncovering serious safety problems in common consumer products and medications.
The first came in 2019 when the lab, Valisure, found a cancer-causing substance in the blood pressure drug valsartan. Later that year, it detected a different carcinogen in the heartburn drug ranitidine and its brand name version, Zantac. Then last year, the company found benzene, also carcinogenic, first in hand sanitizers and then in several spray sunscreens, as well as in other aerosol skin care products.
The Food and Drug Administration and manufacturers seem to have found Valisure’s testing credible: Prompted by those results, companies have now recalled more than 25 million products from the market, including Aveeno and Neutrogena aerosol sunscreens and Old Spice spray deodorant.
Valisure’s work has raised the alarm on both the quality and safety of drugs and personal care products for millions of consumers and their families. Instead of this ongoing hostility, FDA should embrace their efforts in the pursuit of safeguarding the public’s health.
The stakes are also significant for consumers’ public health and safety. Manufacturers of some of the affected products have seized on the FDA’s report, using it to try to undermine lawsuits brought by consumers who purchased brands implicated in Valisure’s testing. That includes cases filed over benzene contamination in sunscreen and the problems identified in Zantac. (Attorneys for the companies didn’t respond to requests for comment.)
The FDA declined to respond to a detailed list of questions from CR on the matter. “As a general policy, the FDA cannot discuss any potential or ongoing investigations,” an agency spokesperson says.
The agency has not discussed the matter directly with Valisure since the inspection ended several months ago. U.S. Rep. Rosa DeLauro, D-Conn., whose district includes where Valisure is based, has tried to get answers from the FDA in the meantime, but to no avail.
“I fear, whether deliberate or not, FDA is in the act of shooting the messenger,” DeLauro says in a statement to CR.
“Over the last several years, Valisure’s work has raised the alarm on both the quality and safety of drugs and personal care products for millions of consumers and their families,” she says. “Instead of this ongoing hostility, FDA should embrace their efforts in the pursuit of safeguarding the public’s health. That is why I am confused by this investigation and FDA’s stunning misunderstanding of what Valisure does and does not do.”
The timing of the inspection alone seems odd, says Dave Andrews, senior scientist at the Environmental Working Group, an advocacy organization. During the COVID-19 pandemic, the FDA had limited in-person inspections only to facilities that were deemed high priority and “mission-critical.”
Nevertheless, it wasn’t until late December—about half a year after the FDA’s inspection of Valisure ended and after CR highlighted how the agency had misled consumers on the dangers of benzene—that the FDA decided to advise companies on what to do if they find the carcinogen.
Says Andrews: “From these documents, it sure looks like the FDA dedicated a significant amount of time and effort inspecting Valisure, when their time and effort could have been better served investigating the source of benzene in consumer products.”
Importance of Independent Testing
Valisure was founded as an independent laboratory by Light and his friend, Adam Clark-Joseph, PhD, in 2015. By 2018, the pair had started a pharmacy that they attached to the lab and bought products wholesale like any pharmacy would, Light says. But they took things one step further and began testing each product to confirm everything they sold contained what they claimed, and didn’t have potentially harmful ingredients.
The company has since sold its pharmacy operation to concentrate only on quality and safety testing. It continues to test products for the pharmacy’s new owner, Medly, along with other business clients looking to certify for their customers that what they’re buying is legitimate.
Light says Valisure finds safety issues or other product defects with about 10 percent of the products it tests. And since 2019, the company has filed a half-dozen citizen petitions to the FDA based on its work, primarily related to benzene and NDMA, a carcinogenic chemical that Valisure found in drugs such as ranitidine, the generic form of Zantac. Companies have generally acted fast to remove implicated products from the market.
“Independent testing like Valisure’s provides another avenue for protecting consumers from unsafe products,” Brian Ronholm, CR’s director of food policy, says, “so it doesn’t make sense that the FDA would seemingly try to undermine it.”
Consumer Complaints Derailed?
Caught in the lurch are consumers who allege they have been harmed by the products but find that manufacturers are using the FDA’s investigation to undermine lawsuits they’ve brought against the companies.
For example, Philadelphia resident Lisa Zayas says she used Banana Boat sunscreens for years before Valisure’s findings were released, according to a complaint filed in February. She purchased the product to prevent cancer, the suit says, “with the assumption that it was free of benzene, a carcinogen."
Zayas’ potential class-action lawsuit aims to provide relief to consumers who say they wouldn’t have bought the product had they known it was contaminated with benzene.
But lawyers for Edgewell Personal Care, the maker of Banana Boat sunscreens, have asked courts to dismiss the lawsuit in part because they say Zayas’ case is “undermined by the FDA’s report on its inspection of Valisure.”
Courts have yet to rule on Edgewell’s motions.
Kevin Laukaitis, co-attorney for Zayas, declined to comment specifically on the lawsuit because it remains ongoing. But he says it’s not unusual for companies facing such allegations to attack the testing behind it.
“I’m not surprised to see what Banana Boat is raising,” he says, “but we stand by the allegations in our complaint, and we’ll brief the issue and litigate the case.”
Light, at Valisure, says using the FDA’s investigation to discredit his company’s test results is spurious.
For one thing, he says the FDA has not addressed the confusion about the kind of work the company does, despite repeated requests from the company to resolve the issue (PDF).
CR’s review of the FDA’s 56-page inspection report and other records found no evidence to support the agency’s contention that Valisure is doing preapproval testing for manufacturers. The FDA’s position was based on language that the agency says it had found on Valisure’s website, records show (PDF), and an agency inspector was ordered to determine whether the lab was indeed conducting preapproval testing. But when asked during the inspection, Light says the agency’s employee couldn’t point to the specific statements.
In the report, Light says the agency’s rules for labs conducting regulatory testing do not apply to Valisure, because it does not do such work. Nonetheless, the FDA cited Valisure for allegedly violating those regulations, though the report is silent on why, or how, the inspector concluded the rules applied to the lab.
Light says the FDA has not spoken with him about the matter since its “high priority inspection” ended seven months ago. A lengthy response Light sent (PDF) last July, which detailed why he believed the FDA misunderstood the situation, has gone without a reply, he says.
In any case, the companies themselves recalled many of the products after Valisure’s tests.
And Light maintains that Valisure’s accreditation to the International Organization for Standardization, a widely respected standard-setting company for businesses, should be more than enough to dissuade any critics.
“It is unfortunate and, I think, misleading for anyone—defendants in litigation or otherwise—to be using that kind of misunderstanding as a reason for why science isn’t being done right,” Light says.
If the FDA possesses additional evidence or information that would shine a clearer light on this situation, it would seem it is long past the time for them to reveal it.
Lack of Communication
It’s unclear how manufacturers cited in the lawsuits even found out about the FDA’s inspection of Valisure. The inspection is not included in an FDA database published online, though the FDA says some might not be included until a final enforcement action is taken. CR only learned about the matter after reviewing a Freedom of Information Act request made by a law firm representing Banana Boat published in an online log by the FDA. (A lawyer representing the firm didn’t respond to a request for comment.)
The agency’s communication about the situation has been complicated, as well.
In response to CR’s FOIA requests, the FDA released a copy of the inspection report of Valisure. When FDA releases such records, that indicates the agency’s investigation of the matter has been closed, according to FDA policy (PDF).
After that happens, FDA policy advises staff to tell a company that its investigation is complete and if any corrective actions are still needed.
Light says he hadn’t even seen the agency’s lengthy inspection report until CR provided a copy for him to review.
“We’re getting a lot more information about this from you than the FDA,” he says.
That’s likely because the investigation is still ongoing. In March, after the FDA sent CR a one-line statement in response to questions for this article, the agency’s FOIA office contacted us and said that it had inadvertently released the Valisure inspection report. The agency asked us to destroy a copy of the record. We declined.
After an inspection, the FDA advises its staff to complete a recommendation on whether it should escalate regulatory enforcement action and issue a warning letter—a public notice to companies of regulatory issues that need to be corrected. That recommendation should be issued “within 15 working days after completion of the inspection,” FDA policy suggests.
That isn’t always the case, however. A 1999 report by the inspector general of the Department of Health and Human Services, which includes the FDA, found that less than 2 percent of reviews for warning letter recommendations are completed within the suggested 15-day window. The average time was 121 days, the report says. One case took more than a year. (More recent data was not available.)
CR’s Ronholm says the FDA should address Valisure’s response to the agency’s inspection report immediately.
"If the FDA possesses additional evidence or information that would shine a clearer light on this situation, it would seem it is long past the time for them to reveal it,” Ronholm says. “Any further delays would subject the agency to questions about the integrity of their investigative process."