The Food and Drug Administration misled the public earlier this year about the risks posed by aerosol sunscreen products made by Johnson & Johnson that were found to be contaminated with benzene, a known carcinogen, a report suggests of the agency obtained by Consumer Reports. And while Johnson & Johnson says the levels found are not expected to pose a health risk to consumers, the FDA report and scientists CR spoke with say otherwise.
The products, including several of Johnson & Johnson’s Neutrogena and Aveeno spray sunscreens, were recalled in July after the company’s tests detected benzene in several samples. Short-term exposure to benzene can cause dizziness and headaches, while long-term exposure causes certain types of cancer and blood disorders.
Concerns about benzene in spray sunscreen were raised in the spring of 1221 when an independent testing organization, Valisure, published a study that detected the contaminant in dozens of those products. Johnson & Johnson’s products were the first to be recalled following the publication of the findings.
The FDA advises that manufacturers must limit the levels of benzene in consumer products and drugs to no more than 2 parts per million. That’s based on independent standards organizations stating that daily exposure above that threshold is associated with increased cancer risk.
It is not yet clear why benzene was found in the aerosol products. When the product was withdrawn from the market, Johnson & Johnson said it was looking into the matter, and a spokesman last week provided no new information.
Several aerosol personal care products from other manufacturers have since been recalled for the presence of benzene, but a broader explanation of how benzene contamination became widespread is, for now, a mystery. The FDA confirmed Thursday that it was investigating the problem and ordered manufacturers to test their products for the contaminant.
In a July statement announcing the recall, Johnson & Johnson advised consumers to avoid using the affected products. The company said its analysis found that the levels of benzene detected were “not expected to cause adverse health effects,” even with daily exposure. The recall, Johnson & Johnson said, was being done as “a precautionary measure.” The company refused to provide CR with a copy of its safety analysis.
The FDA posted Johnson & Johnson’s statement on the agency’s website without providing any additional information on the matter.
But an internal FDA report, completed before the announcement and obtained by CR through the Freedom of Information Act, came to a different conclusion.
The report (PDF), called a Health Risk Assessment, said Johnson & Johnson’s tests detected benzene levels from 5 to 11 times above the recommended limits established by two independent organizations: the United States Pharmacopeia (USP), a non-profit organization that publishes guidelines for contaminants in consumer products; and the International Council for the Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (ICH).
At this high level, the FDA’s internal report stated that “they were likely to occur” serious adverse effects, including the possibility of life-threatening problems or “permanent impairment of a bodily function”.
Johnson & Johnson vs. FDA risk assessment
Michael Hansen, PhD, Senior Scientist at CR, agrees that levels of benzene found are alarming. “Research clearly shows that regular exposure to benzene at levels above 2 ppm increases cancer risk, and the amount detected in these products was well above that,” he says. He points out that 2 ppm is many times higher than what is allowed in drinking water. “And remember that these sunscreens come in an aerosol form, so users are exposed not only when they are rubbed on their skin, but possibly also if they inhale it while applying it.”
FDA completes Health Risk Assessments to assess the safety risk of a contaminated product being recalled. Johnson & Johnson and the FDA met before the recall to discuss the “risk assessment to be completed by the FDA,” according to agency records.
But Donna Lorenson, vice president of communications for Johnson & Johnson Consumer Health, said in a statement that the meeting was to discuss the company’s analysis and not “the content or conclusions of any evaluation of the FDA”. Lorenson also said the agency did not tell the company that it had “concluded that adverse events were likely to occur.” He said Johnson & Johnson did not receive a copy of the report until late November, and is now “in discussions with the agency about its contents.”
FDA spokeswoman Courtney Rhodes would not confirm whether or not FDA officials had discussed the agency’s risk assessment with Johnson & Johnson, saying she does not disclose her communications with companies related to the product recall.
Lorenson also said that the FDA reviewed the company’s draft press release and urged Johnson & Johnson to issue it as soon as possible.
But experts and consumer advocates say the FDA should have made the details of the agency’s assessment of the problem public, especially for reasons of conflict with Johnson & Johnson’s public statement.
“The FDA needs to be reminded that its mission is to protect public health and that its own website should not serve as a platform for corporate disinformation,” says Dave Andrews, a scientist at the environmental advocacy organization, Environmental Working Group, which studies pollution problems from sunscreen products. “These products were withdrawn from the market, but instead of the FDA publishing their health concern, they let Johnson & Johnson publish a misleading press release.”
FDA’s Rhodes He also declined to comment specifically on the agency’s internal report. He says the agency is continually acquiring “new insights that allow us to quickly identify and address previously unknown risks.”
“When we identify flaws in the quality of drugs that pose potential risks to patients, we do everything possible to understand the problems and provide our best recommendation to the public as quickly and accurately as possible Rhodes says. “We will continue to investigate and work to ensure that these types of impurities do not exceed acceptable limits.”
Brian Ronholm, director of food policy for CR, affirms that the FDA must do more. “When the agency appears to prioritize industry concerns over public health concerns, it goes against its mission and does not create confidence that it can adequately protect consumers,” he says. “If the level of a harmful chemical in a product exceeds accepted limits, the FDA should not allow the company to say that the product is safe.”
High levels of benzene
The health risks associated with benzene, an industrial chemical that is not an ingredient in sunscreens, have been known for decades, and researchers have raised concerns, in particular, about its absorption through the skin.
The FDA report on Johnson & Johnson’s recalled sunscreens indicated that the results of the company’s tests for benzene showed a concentration range of 11.2 to 23.6 parts per million, above the limits established by the United States Pharmacopeia and the ICH.
The ICH based its limit on data relating to leukemia and benzene exposure, stating that a “daily intake” of 2 ppm was associated with an increased risk of cancer.
“These levels exceed the indicative value of the ICH and the USP of 2 ppm”, says the FDA report.
The agency indicates in the report that benzene has a sweet and aromatic smell, similar to that of gasoline. However, the report adds that this smell can go unnoticed by consumers who use contaminated sunscreens, which, on the other hand, are also scented.
The FDA echoes the company line
Conflicting assessments between the FDA’s internal report and the public announcement of Johnson & Johnson’s product recall raise questions about the agency’s decision-making process and on how to inform consumers about defective products.
When a problem arises with a product, the FDA often works with companies to have them conduct a “voluntary” recall of their products. (The agency’s ability to force a mandatory recall is limited, under federal law, to foods and controlled substances.)
To announce a recall, in many cases the agency publishes an exact copy of the manufacturer’s statement without providing any additional context, as it did with Johnson & Johnson. The agency says that voluntary recalls can be carried out at the initiative of the company or on the recommendation of the FDA, and that its role is limited to reviewing the proposed approach to the recall and evaluating its appropriateness.
But the Johnson & Johnson episode illustrates the limitations of that approach.
In fact, several additional recalls of benzene-contaminated hair and skin products have been announced in recent months, including as recently as last Friday. In each case, the FDA has republished the company’s statement on the matter, but has not provided any additional information, such as the amount of benzene detected.
“To gain credibility with the public and support its mission of promoting public health, the agency should stop publishing company press releases,” says EWG’s Andrews. Instead, it says, the agency should “make public all of its assessments and announce specific measures to ensure that other products are not similarly contaminated with benzene or other chemicals like PFAS,” referring to another group of compounds known as “chemicals that stay forever”.
Recommendation on sunscreens
It is not clear why benzene is being detected in various brands of personal care products. Johnson & Johnson declined to specifically answer questions about the number of consumers who have responded to the recall by requesting a refund or otherwise.
The FDA says it continues to monitor the issue of benzene in products, and is focused on ensuring that manufacturers promptly report unacceptable levels of benzene to the agency. Manufacturers are required to test their products to ensure they meet specifications and are free from harmful contamination.
Dermatologist groups and consumer advocates, including CR, recommend that consumers use sunscreens to protect themselves from the risks of skin cancer and skin aging. None of the CR-recommended sunscreens are affected by the recall.
The recalled Johnson & Johnson products are Neutrogena Beach Defense, Neutrogena Cool Dry Sport, Neutrogena Invisible Daily Defense , Neutrogena Ultra Sheer and Aveeno Protect + Refres h. These products were distributed throughout the country. If you still have any of these products, stop using them immediately and throw them away.
In September, Coppertone recalled certain lots of its products Pure & Simple SPF 50 Spray, Sport Mineral SPF 50 Spray and Sport SPF 12 Spray (travel size) after that tests revealed that these products contain benzene. (Coppertone also didn’t say how the benzene ended up in its products.)
Consumers who experience an adverse reaction to contaminated sunscreens may file a report with the FDA online, mail a pre-addressed form, or send a fax to 800-FDA-0178. Call your doctor if you are concerned about any potential symptoms.
Editor’s Note: This article was updated to reflect additional information received from Johnson & Johnson and the FDA.
Consumer Reports is an independent, nonprofit organization that works side by side with consumers to create a fairer, safer, and healthier world. CR does not endorse products or services, and does not accept advertising. Copyright © 2022, Consumer Reports, Inc.
Consumer Reports has no financial relationship with advertisers on this site. Consumer Reports is an independent, nonprofit organization that works with consumers to create a fair, safe, and healthy world. CR does not endorse products or services and does not accept advertising. Copyright © 2022, Consumer Reports, Inc.