Recently, Valisure, a private lab, came out with a shocking revelation that many popular acne products pose a risk of benzene exposure. Benzene, a known harmful ingredient in many products could cause cancer in humans. Isn’t it shocking that a mere acne treatment contains benzene? Recently many cosmetic products were recalled for having benzene and facing lawsuits. This legal conflicts surrounding beauty treatments or cosmetic products have drawn the attention of many.
Through this blog, let’s have some insights on how the acne products could turn out to be harmful, the adverse side effects of benzene and the legal tangles tightening around famous brands. We also analyze, how medical record review can boost such cosmetic product lawsuits by digging out valid evidence.
What’s behind the acne product controversy?
On March 5, 2024, Valisure sent a citizen petition to the FDA regarding the presence of benzene in drug products with benzoyl peroxide (BPO). The drug benzoyl peroxide is used in producing many acne products.
Valisure conducted research on around 99 acne products with benzoyl peroxide suspecting that it caused benzene contamination. This included creams, lotions, liquids, gels, washes and bars.
They incubated the products for 18 days at 50°C and checked at days 0, 4, 10, 14, and 18. The research revealed that 66 out of 99 BPO products contained high benzene levels.
Valisure found out that products available in the market that come with benzoyl peroxide when stored at temperatures higher than the normal room temperature can produce high amounts of benzene, the human carcinogen.
The products, which were proved to have more than 100-1800 ppm of benzene presence listed below:
- Proactive cream
- Up & UP cream, lotion and gel
- Harris Wash
- Clinique cream
- Clearasil cream
- La Roche-Posay cream
- Panoxil cream
- Sandra Lee MD lotion
- Walgreens Cream and bar
- Oxy cream
Other products from Galderma, Vie Naturelle, Equate, humane, Differin, Encube, Nixa, DR SONG, Cerave, Mylan, Zapzyt, Urban Skin Rx, Rugby, Perrigo, Glenmark, Oceanside, Taro, Teva, Sandoz, Prasco, Replenix, Neutregena, Aspexia and so on have concentrations below 100 ppm (100-2 ppm).
Acne products with salicylic acid or adapalene are found to be free from benzene.
Valisure claim that benzoyl peroxide decomposes into benzene in the below given mechanism.
The research revealed that the benzene formed in the products can be not only be present in the product but also in the air surrounding an unopened product. This can pose the risk of inhaling carcinogenic benzene without even using the product.
Homer Swei, Ph.D., from the Environmental Working Group (EWP) stated, “The fact benzoyl peroxide can decompose into benzene with extended temperatures is not new. What is shocking is that the majority of these over-the-counter acne products don’t seem to be properly stabilized to prevent benzene.”
The U.S. Food and Drug Administration (FDA) has regulated benzene in the use of drug products. It can be used in drug preparations only when it is an unavoidable component with a concentration limit of 2 ppm (parts per million). However, Valisure’s study has identified that many of the BPO-based products available in the market can produce 800 times more than the acceptable concentrations of benzene, when stored at higher temperatures.
The Environmental Protection Agency (EPA) has set 5 ppb as the safest permissible level of benzene in drinking water, while only a 0.2 ppm in water would be safe for the children during a 10 days exposure. However, when the study conducted by placing a BPO-based product in a hot car with more than 70°C, they identified that it caused 1,270 times the permitted EPA threshold of benzene in the air inside the car. This increases the inhalation risk in a multifold.
Valisure claim that “BPO products are similarly unstable and, at such temperatures of distribution and consumer handling, can form hundreds of times any FDA regulatory guidance for benzene levels.”
The Valisure petition requested the FDA to call for “recalls and a suspension of sales for products containing the active pharmaceutical ingredient benzoyl peroxide, consistent with FDA’s mandate to ensure the safety of prescription and over the counter the drugs in the United States”
Valisure studies had already found benzene presence in hand sanitizers, sunscreens, deodorants, antiperspirants, shampoos and conditioners earlier. This revelation had led to many product recalls in the recent past.
Valisure’s President, David Light stated,
This discovery of benzoyl peroxide’s fundamental instability and formation of benzene is substantially different than Valisure’s previous findings of benzene in sunscreens, hand sanitizers and other consumer products. The benzene we found in sunscreens and other consumer products were impurities that came from contaminated ingredients; however, the benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself, sometimes at hundreds of times the conditional FDA limit. This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action.
The CNN Health reports that manufacturers of Clearasil, Reckitt Benckiser claimed that they were confident of their product and the products were safe when stored and used following the label instructions. Their statement stressed, “Clearasil products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions. The findings presented by an independent lab today reflect unrealistic scenarios rather than real-world conditions.”
A senior scientist at EWG recommended reducing benzene exposure as much as possible due to its carcinogenicity.
The FDA had issued warnings to drug manufacturers to recall all drugs containing more than the permissible limits of benzene. Even the daily exposure of 2 ppm benzene in daily use products could be equal to causing 1 in 100,000 risk for cancer, which could lead to the risk of an estimated 3,000 people developing cancer during their life time.
What is Benzene?
Benzene, a colorless, yellow liquid is used as a solvent in many of the chemical as well as pharmaceutical industries. It’s also naturally found in crude oil, volcano emissions and wild fires. In the products we use in our day to day lives like adhesives, cleaners, paints, tobacco and so on have benzene in them. Knowingly or unknowingly, we are exposed to benzene through first or second-hand tobacco smoke, gasoline flames, vehicle and industrial emissions.
Evidence for Benzene’s Carcinogenic Nature
Numerous studies have established the carcinogenic properties of benzene. The International Agency for Research on Cancer (IARC), a specialized cancer agency of the World Health Organization (WHO), has classified benzene as a Group 1 carcinogen, indicating sufficient evidence of its carcinogenicity in humans. It has linked benzene exposure to cancers like acute lymphocytic leukemia, chronic lymphocytic leukemia, multiple myeloma, non-Hodgkin lymphoma and so on.
Epidemiological studies on occupational exposure to benzene have consistently linked benzene exposure to the development of various forms of leukemia, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and chronic lymphocytic leukemia (CLL). These studies have demonstrated dose-response relationships, indicating that higher levels of benzene exposure correlate with increased leukemia risk.
Mechanistic studies have elucidated several pathways through which benzene induces carcinogenesis. Benzene metabolites, such as benzene oxide and benzene diol epoxides, can form DNA adducts and cause genetic mutations, initiating the development of cancer. Benzene also disrupts hematopoietic stem cell function, leading to aberrant hematopoiesis and leukemia development.
Aftermath of Benzene Exposure
The aftermath of benzene exposure can be devastating, particularly concerning its carcinogenic effects. Individuals exposed to benzene may develop various types of leukemia, which can be life-threatening conditions requiring intensive medical treatment, including chemotherapy, radiation therapy, and stem cell transplantation.
Leukemia: Benzene exposure is strongly associated with the development of various types of leukemia, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
Aplastic Anemia: Benzene exposure can suppress bone marrow function, leading to a reduction in the production of blood cells, resulting in aplastic anemia. This condition can lead to fatigue, weakness, and an increased risk of infections and bleeding.
Myelodysplastic Syndrome (MDS): Benzene exposure is linked to the development of myelodysplastic syndrome, a group of disorders characterized by ineffective blood cell production and an increased risk of leukemia.
Non-Hodgkin Lymphoma (NHL): Benzene exposure has been associated with an increased risk of non-Hodgkin lymphoma, a type of cancer that affects the lymphatic system.
Immune System Suppression: Benzene exposure can suppress the immune system, increasing susceptibility to infections and impairing the body’s ability to fight off diseases.
Reproductive Effects: Benzene exposure may have adverse effects on reproductive health, including decreased fertility, miscarriages, or birth defects in the newborns.
Neurological Effects: Prolonged or high-level benzene exposure may cause neurological symptoms, such as headaches, dizziness, confusion, tremors, and drowsiness.
Respiratory Effects: Inhalation of benzene fumes can cause irritation in the respiratory tract, and lead to symptoms such as coughing, wheezing, and shortness of breath.
Skin Irritation: Direct contact with benzene-containing products may cause skin irritation, redness, and dermatitis.
Eye Irritation: Exposure to benzene vapors or contact with benzene-containing products can cause eye irritation, redness, and tearing.
The inhalation or ingestion high levels of benzene can lead to death. Ingestion of benzene contaminated food can cause irritation in stomach, vomiting, sleepiness, convulsion or quick breaths.
Moreover, benzene exposure can have long-term implications for health, as individuals may experience persistent health issues even after cessation of exposure. Long-term monitoring and surveillance are often necessary to detect and manage potential late-onset of health issues associated with benzene exposure.
Will there be a recall of acne products for cancer risk?
The discovery of benzene contamination in acne products has prompted widespread concern among consumers, healthcare professionals, and regulatory authorities. Due to the serious health risks associated with benzene exposure, including its carcinogenic effects, there is a strong likelihood of product recalls for affected acne products.
Regulatory agencies, such as the FDA, typically take swift action to address safety concerns related to drug products, including issuing recalls to remove potentially harmful products from the market. In this case, the presence of benzene in acne products exceeding permissible limits poses an unacceptable risk to public health, warranting immediate regulatory intervention.
According to the report from CNN Health, an FDA spokesperson stated that the agency would respond to the petitioner and added that it would verify the information to be accurate and reproducible before deciding on the regulatory decisions and recommending product recalls.
If the FDA goes on to announce regulatory actions or recall recommendations, the affected manufacturers may voluntarily recall their products fearing the strict regulatory actions by the agency. If failed, they would face mandatory acne product recalls initiated by regulatory authorities to mitigate the risk of harm to consumers. Recalls may involve removing products from store shelves, notifying consumers of the recall, and implementing corrective measures to prevent future contamination.
Claim Your Free Trial – Review Your Records
Benzene Class Action Lawsuits against L’Oreal
According to the Top Class Actions, a new class action lawsuit was filed against L’Oreal USA Inc. on March 18, 2024 in the Hawaii federal court. The lawsuit filed by Jennifer Snow claimed that L’Oreal’s acne products with benzoyl peroxide contains unsafe levels of carcinogenic benzene.
The lawsuit also accused that knowing the presence of benzene in their products, L’Oreal failed to list benzene in the ingredient list and warn the consumers through labels, ads or through their website.
The basic allegations in her lawsuit are listed below:
- Unjust enrichment
- Breach of express and implied warranty
- Violation deceptive trade practice and false advertising statutes
- Violation of California consumer protection laws
Cerave Benzene Class Action Lawsuit
Plaintiff Holly Grossenbacher filed a benzene class action lawsuit on March 20, 2024 in the federal court in Louisiana. The lawsuit filed against CeraVe parent company L’Oreal allege that CeraVe products with benzoyle peroxide contains high levels of carcinogenic benzene.
L’Oreal’s BPO cleansers include CeraVe Acne Foam Cream Cleanser with 4% benzoyl peroxide, and CeraVe Acne Foaming Cream Wash with 10% benzoyl peroxide. The CeraVe products contain more than 12 ppm of benzene, which is around 6 times higher than the permissible levels, says the class action.
This Cerave lawsuit blamed defendants of negligently manufacturing and marketing an unsafe product with benzene and failing to warn the consumers of its presence in the label.
La Roche-Posay Benzene Class Action Lawsuit
A La Roche-Posay benzene class action was filed by plaintiff Kayla Mraz on March 20, 2024 in the federal court in New York. The lawsuit alleges that La Roche-Posay benzoyl peroxide acne products contain high benzene levels.
The lawsuit professed the defendants of failing to list benzene in the ingredients list. As per Valisure’s petition, the La Roche-Posay products contain more than 150 ppm of benzene, which much higher than the safer permissible level.
The benzoyl peroxide lawsuit stated that the defendant could have manufactured acne products without benzene in them but failed in their duty to the consumers.
Johnson & Johnson Acne Product Class Actions
As per the report from the Top Class Actions, Johnson & Johnson faces a new class action lawsuit for having high level benzene presence in their acne products. Plaintiffs Alan Montenegro and Melissa Medina filed a class action lawsuit against Johnson & Johnson on March 13, 2024.
The lawsuit maintained that the acne products from Johnson & Johnson have benzoyl peroxide, which produces benzene when stored at higher temperature.
Neutrogena Acne Product Benzene Class Action Lawsuit
Plaintiff Samvardhan Vishnoi filed a class action lawsuit against Neutrogena acne treatment products from Johnson & Johnson Consumer Inc. in Illinois federal court. The lawsuit filed on March 21, 2024 accused Neutrogena for the presence of benzene. It also purported that selling products with benzoyl peroxide, which can potentially produce benzene makes the acne products “adulterated,” and “misbranded.”
The lawsuit contended that Johnson & Johnson violated the Illinois Consumer Fraud and Deceptive Trade Practices Act. It also added that the manufacturer is negligent in detecting the benzene presence in its products and failing to enlist benzene in its ingredients list. The plaintiff accused Johnson & Johnson of unjust enrichment. He also requested for class action representation.
He demanded the following as relief:
- Jury trial
- Injunctive relief
- Declaratory relief
- Compensatory damages
- Statutory damages
- Punitive damages
Acne Product Class action lawsuit against Walmart, Walgreens & Target
Walmart faces a class action lawsuit for selling Equate acne products containing high levels of benzene. Plaintiff Skylar Williams filed the class action lawsuit on March 20, 2024 in Illinois federal court. The lawsuit argued selling adulterated Equate acne products with benzene was illegal under the state and federal laws. The lawsuit professed that Walmart failed to disclose that Equate acne products contained benzene.
Another lawsuit was filed against Walgreens for selling tainted acne products with benzene. Plaintiffs Grace Navarro and Chatham Mullins filed a class action lawsuit in federal court in California on March 14, 2024. The lawsuit alleged that manufacturers should initiate a voluntary recall on the benzene adulterated acne products.
Plaintiff Grace Navarro filed a class action lawsuit on March 7, 2024 in California federal court. This lawsuit was filed against Target Corp. The lawsuit purported that the acne products sold by Target contained unsafe levels of benzene. Even low exposure to benzene can cause adverse health issues, says the benzoyl peroxide lawsuit.
June 2024 Acne Product Benzene Lawsuit Update
The U.S. Judicial Panel on Multidistrict Litigation (JPML) announced a hearing on June 14 to consider consolidating acne product benzene exposure lawsuits. The hearing is scheduled for July 25 at the Edward T. Gignoux Federal Courthouse in Portland, Maine. There are at least 29 complaints on benzene exposure across 10 federal district courts. The JPML often centralizes similar cases to streamline discovery, avoid conflicting rulings, and accommodate witnesses. If the cases are consolidated into a multidistrict litigation (MDL), pretrial proceedings will occur in a centralized location. If settlements aren’t reached during the MDL, cases may return to their original courts for trial.
August 2024 Benzoyl Peroxide Acne Cream Lawsuit Update
The U.S. Judicial Panel on Multidistrict Litigation (JPML) denied a motion to consolidate benzoyl peroxide acne cream lawsuits, despite similarities among the cases. The JPML ruled that consolidation was not necessary, as the cases involve different defendants, product formulations, and other specifics. With this decision, the lawsuits will continue individually, with only informal coordination among the parties and courts.
Boost Cosmetic Product Claims with Medical Record Reviews
Medical record reviews play a crucial role in supporting claims related to adverse health effects associated with cosmetic products, including those contaminated with benzene. By examining medical records, expert reviewers can document the onset and progression of symptoms, diagnostic findings, treatment interventions, and outcomes in individuals affected by benzene exposure.
Medical record reviews can provide valuable evidence linking exposure to contaminated cosmetic products to specific health outcomes, such as the development of leukemia or other cancers. Detailed documentation of medical histories, laboratory results, imaging studies, and pathology reports can strengthen lawsuits by establishing a causal relationship between product exposure and adverse health effects from benzene.
Moreover in legal proceedings, medical record reviews conducted by qualified medical record review professionals can serve as persuasive evidence to support claims for compensation, or damages against manufacturers or distributors of contaminated cosmetic products.
LezDo TechMed, an experienced medical record review partner for cosmetic product lawsuit attorneys can sift through voluminous medical records to identify evidence to bolster claims.
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In conclusion,
The evidence of benzene’s carcinogenic nature, coupled with the aftermath of benzene exposure presses on the need for regulatory interventions from the FDA to ensure consumer safety and stricter manufacturing regulations.
The chances of recalls of the affected acne products are high as the FDA regulatory actions are expected soon. Affected victims who used acne products can contact an experienced attorney to know the validity of their claim.
