Valisure is an independent testing laboratory in New Haven, Connecticut. Over the last several years it has been a thorn in the FDA’s side. That’s because this lab has discovered carcinogens in a wide range of products: valsartan blood pressure pills • ranitidine (Zantac) heartburn meds • some metformin diabetes drugs • a bunch of hand sanitizers • too many sunscreens • a bunch of deodorants and antiperspirants • and a lot of dry hair conditioners and shampoos. Some of those products contained unexpected nitrosamines. Others had benzene. The latest Valisure discovery: Many acne products with the active ingredient benzoyl peroxide (BPO) also contained benzene (Environmental Health Perspectives, March, 2024).
What’s the Big Deal About Benzene?
Benzene is a carcinogen…full stop! According to the American Cancer Society:
“Benzene is known to cause cancer, based on evidence from studies in both people and lab animals. The link between benzene and cancer has largely focused on leukemia and other cancers of blood cells.”
The International Agency for Research on Cancer (IARC) links benzene to multiple myeloma, non-Hodgkin’s lymphoma and a number of leukemias. The United States National Toxicology Program (NTP) and the Environmental Protection Agency (EPA) consider benzene a “known human carcinogen.”
Acne Products Containing Benzoyl Peroxide:
There are lots of OTC and prescription acne products that contain benzoyl peroxide (BPO). This compound is found in creams, gels, cleansers and a variety of other formulations. It is left on the skin. People use BPO products for months or years.
Researchers at Valisure together with colleagues at Yale University and Long Island University titled their investigation “Benzoyl Peroxide Drug Products Form Benzene.”
They report:
“This study raises substantial concerns about the safety of BPO products currently on the market, which appear to form benzene, a known human carcinogen and environmental hazard. Benzene was detected in all BPO product samples tested and levels increased during incubation at body and shelf-life performance temperatures to >2ppm [parts per million], which is the conditionally restricted FDA limit for benzene for drug products. Furthermore, BPO was detected in the environment surrounding two unopened primary product containers, which suggests that BPO products could emit substantial amounts of benzene from their original packaging prior to use.”
An article in Dermatology Times, March 11, 2024, quotes Christopher Bunick, MD, PhD, FAAD, associate professor of dermatology and physician-scientist at the Yale School of Medicine:
“’So, what does this all mean and what am I going to advise for patients? I will say we as a community have to see what is validated. I do not necessarily think at this moment that no one should use benzoyl peroxide. I think there has to be a proportional response until more data comes out,’ said Bunick.
“He concluded, ‘With Valisure’s agreement, that for those providers and patients who wish to continue benzoyl peroxide-containing products, that a proportional response at this time would be to keep the product refrigerated at all times, renew the medicine every 3 to 6 months, and avoid heated storage. This will not necessarily eliminate all benzene, but should slow its decomposition. This measure gives the medical community a chance to await further investigation and recommendations.’”
Dr. Bunick has pointed out that:
“…every time Valisure detected a carcinogen in consumer products, some form of a recall followed.”
Speaking of Recalls and Valisure Research:
On December 17, 2021 Procter and Gamble (P&G) announced a recall of hair care products contaminated with benzene. It involved aerosol hair products including dry shampoo or conditioners under brands such as Aussie, Herbal Essences, Old Spice and Pantene. You might think other manufacturers of such products would have paid close attention. But the testing laboratory Valisure announced on November 1, 2022 that it found benzene in 70% of the 148 batches of dry shampoo products it tested.
What Is Dry Shampoo?
When I think of shampoo, I imagine some sort of viscous liquid or gel that goes on in the shower. It foams and cleans your hair and then gets rinsed out.
Dry shampoo, on the other hand, can be applied anywhere. And yes, it is sprayed on while your hair is dry, not wet! It is not rinsed out. Such products often contain alcohol and/or starch that absorb oil or sweat.
Women often apply dry shampoo to maintain the look of a “blowout.” The bottom line seems to be that dry shampoo and conditioner help the hair look less greasy and serve as a quick fix after exercise. It won’t, however, clean the hair or scalp.
Where Have They Found Benzene?
You can find a list of hair products that contained benzene in Valisure’s FDA Citizen Petition on Drug Shampoo. Some of the products that were listed included Not Your Mother’s Clean Freak Refreshing Dry Shampoo, Paul Mitchell Invisiblewear Brunette Dry Shampoo, Batiste Dry Shampoo Bare and Redken Deep Clean Dry Shampoo.
Valisure pointed out that:
“Dry shampoo products are considered cosmetics that are regulated by the U.S. Food and Drug Administration (‘FDA’). Valisure has tested and detected high levels of benzene in specific batches of certain dry shampoo products.”
“This Petition requests that the Commissioner take the following actions:”
- “request a recall of identified batches of dry shampoo cosmetic products on the basis that, due to contamination with a known human carcinogen, these products are adulterated under Section 601 of the FDCA (21 U.S.C. § 361) and misbranded under Section 602 (21 U.S.C. § 362);”
We assume that most, if not all, of the products containing benzene were removed from the market.
When P&G Found Benzene in its Dry Shampoo and Conditioners:
Procter & Gamble voluntarily recalled aerosol dry conditioner spray products and aerosol dry shampoo spray products when it realized benzene was a problem.
It went on to describe why it took this action:
“Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening.”
Valisure points out that:
“A study from 1939 on benzene stated that ‘exposure over a long period of time to any concentration of benzene greater than zero is not safe,’ which is a comment reiterated in a 2010 review of benzene research specifically stating, ‘There is probably no safe level of exposure to benzene, and all exposures constitute some risk in a linear, if not supralinear, and additive fashion.’ In an October 15, 2021 recall of sunscreen products due to the presence of benzene, Canadian health regulator Health Canada stated ‘there is no safe level of benzene.’ According to the American Cancer Society:
“IARC classifies benzene as ‘carcinogenic to humans,’ based on sufficient evidence that benzene causes acute myeloid leukemia (AML). IARC also notes that benzene exposure has been linked with acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin lymphoma.”
In a nutshell, you would do better not to expose your body to benzene.
Where Else Have They Found Benzene?
These product recalls follow on the heels of earlier benzene-related recalls from many companies. Products pulled included hand sanitizers, spray-on sunscreens, aerosol antiperspirants and deodorants and athlete’s foot sprays.
Carcinogens have also been found in oral medications.
Valisure adds:
“There is a recent history of broad drug and consumer product recalls due to contamination with probable human carcinogens. Specifically, there have been a multitude of manufacturer recalls of medications, such as valsartan, irbesartan, losartan, ranitidine, nizatidine, and metformin, due to the detection of the Group 2, ‘probable human carcinogen’ N-Nitrosodimethylamine (“NDMA”) in excess of FDA limits.”
Ask most people what disease they fear most and it will likely be cancer. We do not need extra carcinogens in our pills or our cosmetic products.
Why Worry About a Little Found Benzene?
Drug manufacturers and cosmetic companies often downplay the risks of carcinogens in their products.
I always love it when a manufacturer of body care products adds this message:
“To date, The Procter & Gamble Company has not received any reports of adverse events related to this recall and is conducting this recall out of an abundance of caution.”
We have read similar messages from the makers of acid-suppressing drugs and blood pressure medications that contained nitrosamines. The problem with this kind of don’t-worry clause is that cancer does not happen overnight.
It takes years or even decades of exposure to cause malignancy. Proving that benzene exposure led to someone’s cancer is incredibly difficult. It hardly surprises us that big companies can say they have not received any reports of adverse events.
An In-Depth Overview in Chemical & Engineering News:
Craig Bettenhausen, a writer for Chemical & Engineering News (c&en), contacted me for an article he was writing about benzene. Here is a link to
“Finding Benzene Everywhere We Look:
Questions pile up as scientists find the carcinogen in more and more consumer products”
This in-depth report was published in c&en (Dec. 20, 2021).
If They Found Benzene, Where Is It Coming From?
There is quite a discussion about how the benzene gets into all these different products. Scientists aren’t sure where the found benzene is coming from. One hypothesis is that the propellants in aerosol products may be contributing. That’s because they often come from petroleum-based products such as propane or butane.
There is also controversy about the levels of benzene that have been discovered. Even if they found benzene as a contaminant, is it worrisome?
One of the messages from Valisure in its Citizen Petition to the FDA involves exposure. It’s not just the direct application to the skin or scalp that concerns us. When people use an aerosol spray product to apply an antiperspirant or hair product, they are often in a bathroom. That is a small contained space. They are likely inhaling some of the aerosolized particles. That could increase benzene exposure.
Craig Bettenhausen quoted me in our interview:
“The bottom line is, most people would prefer to avoid carcinogens, even in low doses, over long periods of time.”
Where’s the FDA?
Not all companies have been as proactive as P&G in removing contaminated products. The FDA has been slow to detect benzene in consumer products and even slower to take action. That leaves a lot of people wondering which of their acne or aerosol personal care products are safe.
Shouldn’t the Food and Drug Administration be more proactive? Most of the found benzene has not been discovered by FDA scientists. Why not?
We will put in a shameless product promotion for our own deodorants. As soon as we learned that some antiperspirants and deodorants contained benzene, we shipped our MoM (Milk of Magnesia and now Magnesium Rich) aluminum-free roll-on deodorants off to Valisure for testing.
We were relieved to learn that they found no benzene! So, our deodorants contain neither aluminum nor benzene. You can find them at this link. And if you would like to learn more about benzene in deodorants and antiperspirants, here is a link:
Are You Breathing Benzene or Putting It In Your Armpits?
Share your thoughts in the comment section below.
