When the Food and Drug Administration last month identified the likely sources of a potent carcinogen that has been found in a myriad of personal care products, it was the latest development in a year of recalls that showed the potential dangers of everyday products that Americans have long assumed safe.
Benzene is a known carcinogen, linked to leukemia and other cancers of the blood, and traces of it have recently been identified in everything from sunscreen to antiperspirant. But determining its origin is not easy. The supply chains that bring American consumers their grooming products are so massive and complex that the benzene contamination could come from one of many places: a preservative, a propellant, a thickener – all targeted by US health officials. as possible sources.
The chemical is not supposed to be used to make such products, and companies such as Johnson & Johnson, Procter & Gamble Co. and Bayer AG that have launched recalls say they do not. Yet it nevertheless slipped through the cracks and in several commonly used grooming products. And no one noticed it until a small lab in New Haven, Connecticut called Valisure set out to search. Valisure’s discoveries that began in March sparked a series of benzene-related recalls that culminated in an FDA request on December 23 for companies to test all products at risk for contamination.
The agency’s request highlights one of the challenges inherent in its monitoring of consumer products: It does not test for contaminants, leaving labs like Valisure and the companies themselves to search for them.
“The agency aims to ensure that manufacturers meet their legal requirements for good manufacturing practices and to identify and promptly report unacceptable levels of benzene so that these products do not reach American homes,” said Audra Harrison, spokesperson, in an email.
Valisure began testing liquid and gel hand sanitizers last year, but recent benzene-related recalls have focused on aerosol products like certain Johnson & Johnson Neutrogena sunscreens, Old Spice and Secret antiperspirants. from P&G and foot sprays from Bayer Lotrimin and Tinactin. In December, P&G also extended its recall to dry shampoos and conditioners that do not require water to apply, including those sold under the Pantene and Herbal Essences brands. Not all companies that sell Valisure products found to be contaminated have recalls, and Valisure has only tested a small window of personal care products.
Sunscreens, antiperspirants, and foot sprays are all considered drugs by the FDA, while shampoos and conditioners are considered cosmetics. Only P&G gave an overview of its recalls, saying the propellants used by a manufacturing partner it declined to name were the source of the contamination. J&J did not respond to a request for comment. Beiersdorf AG, which has withdrawn some Coppertone aerosol sunscreens, and Bayer declined to comment on the cause of their recalls or what they are doing to ensure that benzene no longer affects their products.
Some companies have not recalled products even after Valisure identified benzene in them. These include Equate branded antiperspirant sprays from Walmart Inc. and Suave from Unilever PLC as well as Summer’s Eve vaginal spray from Prestige Consumer Healthcare Inc. The lab also found benzene in after-sun products. with aloe from CVS Health Corp. The company halted sales. on some aloe products, said Michael DeAngelis, a spokesperson, but declined to give more information on the cause of the contamination or what steps the company is taking to ensure it does not repeat itself. Unilever said in an emailed statement it had conducted a “serious investigation” into its antiperspirants and deodorants and was confident in their safety. Walmart and Prestige did not respond to requests for comment.
Aerosols are difficult to manufacture. Many are manufactured in bomb-proof facilities because the propellants, such as butane and propane, are derived from petroleum and are susceptible to explode. Companies that sell antiperspirants, sunscreens and other products to consumers can turn to specialist companies to make and refill their aerosol cans. They also rely on a network of suppliers who each provide a specific component of a product and often operate in remote countries where labor is inexpensive and regulations lax.
Aerosol manufacturers are reassessing many aspects of their industry, including its supply chain, and reviewing specifications for raw materials, including propellants, said Alexandra Hayes, spokesperson for the Household & Commercial Products Association, in an email. The lobby group represents companies that sell and manufacture consumer aerosol products.
“During the manufacturing process, traces of benzene can be present in various raw materials, which can include the propellant used to disperse the contents of an aerosol can,” said Hayes. “Although it is not intentionally added to consumer products, its exact source can be difficult to determine.
Consumer companies said they found only small traces of benzene that shouldn’t be enough to cause cancer. And the personal care industry was quick to point out that people are also routinely exposed to airborne benzene from other sources, primarily cigarette smoke and gasoline fumes.
Still, the FDA is asking consumer companies to recall anything that contains benzene levels above 2 parts per million. Valisure has found levels as high as 6 parts per million in sunscreens and tripling in antiperspirants. Experts advise reducing exposure to the chemical as far as possible.
“For known human carcinogens there is no safe amount, they increase our exposure to some extent,” said Peter Orris, head of occupational and environmental medicine at the hospital and system. of Health Sciences from the University of Illinois. “Reducing the amount of exposure to human carcinogens is important because we’re in a mix of different things. “
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Stephen Petty, president and founder of consulting firm Engineering & Environmental Services Group and expert on benzene contamination, has testified in hundreds of lawsuits on behalf of plaintiffs suing companies. Manufacturers often claim that the concentrations in their products are low, he said.
“But if you use it a lot and on a lot of the skin, it maybe doesn’t matter,” Petty said. “It really depends on the area of skin and how much you use it.”
Valisure initially decided to test hand sanitizers for benzene after its scientific director Kaury Kucera learned that the FDA temporarily allowed the cleaners to contain traces of the chemical to fill the supply shortage during the onset of the COVID-19 pandemic. The lab has found benzene levels as high as 16 parts per million in hand sanitizers recently on the market to make up for a shortage of well-known brands like Purell. Hand sanitizers that come in gel form often rely on a thickening agent called carbomer, one of the ingredients the FDA reported last month that could be the source of the benzene contamination.
Pharmaceuticals can also rely on carbomers as a binding agent to make pills or for use in sustained release formulations. The FDA has also stated that an antifungal preservative called sodium benzoate can form benzene under certain circumstances. Online research has found that many brand name body washes and liquid hand soaps list sodium benzoate as an ingredient. When questioned, the FDA refused to identify specific types of drugs containing carbomers or sodium benzoate.
The FDA has also reported isobutene and other hydrocarbons, including butane and propane, as a source of benzene contamination. Hydrocarbons are petroleum distillates, produced by refining crude oil, and benzene is known to be present in petroleum.
Butane and propane are powerful propellants, which makes them difficult for businesses to resist, said Ghasem Nasr, professor at the School of Science, Engineering and Environment at the University of Salford in England and expert in spray technology. . In fact, they’re 1,700 times more powerful than compressed gases, like nitrogen, according to Nasr. Nitrogen, an inert gas Guinness uses to make its canned beer taste like pouring from the tap, is considered more environmentally friendly than butane and propane.
Nasr, the founder of Salford Valve Company Ltd., invented the company’s Eco-Valve, an aerosol valve that makes nitrogen more attractive as a propellant for personal care products. Beiersdorf issued a statement in December detailing its new use of the “more climate-friendly aerosol valve system” with its Nivea-branded deodorants.
Regardless of the source of the contamination, the FDA’s rules on benzene are still unclear. While the agency calls on companies to recall products that contain more than 2 parts per million benzene, international FDA guidelines only allow this amount if “use is unavoidable in order to produce a drug product with significant therapeutic advance ”. The FDA did not respond to a question about why it was allowing any amount in products that, as Valisure’s testing has shown, can be made carcinogenic-free.
“It’s interesting how many aerosols do not contain benzene,” Orris said. “It looks like they can build them without benzene.”