Valisure Detects Benzene in Dry Shampoo

VALISURE DETECTS HIGH LEVELS OF BENZENE IN SEVERAL DRY SHAMPOO PRODUCTS AND REQUESTS FDA ACTIONS

Benzene, a Known Human Carcinogen, Detected in 70% of Dry Shampoo Samples Tested

NEW HAVEN, CT – NOVEMBER 1, 2022 – Valisure has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans, according to the U.S. Centers for Disease Control and Prevention, the Environmental Protection Agency (EPA), the World Health Organization, and other regulatory agencies.  

70% of samples tested by Valisure in its recently filed FDA Citizen Petition showed quantifiable levels of benzene, and some samples analyzed directly from contaminated air suggest the sprayed product contained up to 170 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) (intended for certain drugs, when the use of benzene is unavoidable to produce a product that has a significant therapeutic advance). 11 samples tested by Valisure showed over 10 times this FDA limit. These findings are the highest and most broadly detected levels of benzene observed by Valisure to-date in a consumer product category. Valisure is asking for a recall of the contaminated batches and requesting the FDA better define limits for benzene contamination in cosmetics and other regulated products.  

“The detection of high levels of benzene in dry shampoos should be cause for significant concern since these products are likely used indoors, where benzene may linger and be inhaled for prolonged periods of time,” says David Light, Chief Executive Officer of Valisure. “These and other issues identified by Valisure, including the detection of benzene in body spray, hand sanitizer, and sunscreen products, strongly underscore the importance of independent testing and its need to be better integrated into an increasingly complex and vulnerable global supply chain.”

Valisure’s FDA Citizen Petition: Valisure’s FDA Citizen Petition on Dry Shampoo (all attachments and other resources linked below)
Background on Benzene

Benzene is a colorless or light-yellow liquid chemical at room temperature. It has been used primarily as a solvent in the chemical and pharmaceutical industries and is known to cause cancer in humans. Trace levels of benzene may be found in cigarette smoke, gasoline, glues, adhesives, cleaning products, and paint strippers, and it is a known contaminant in the petroleum industry.

Many petroleum products are used as raw materials or inactive ingredients in consumer healthcare products. In particular, with dry shampoos and body sprays, as mentioned in Valisure’s November, 2021 press release, “propellants” like butane, isobutane, propane, and alcohol are commonly used and could potentially be sources of benzene contamination. In December, 2021, FDA released a statement asking the industry to test for benzene and also proposed that propellants could be a source of contamination.

FDA currently recognizes the serious danger of benzene and lists it as a “Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity. However, if their use is unavoidable to produce a drug product with a significant therapeutic advance, then their levels should be restricted,” and benzene is restricted to 2 ppm for these particular circumstances.

Risk of Benzene Exposure

Benzene toxicity in humans has been well-established for over 120 years. A study from 1939 on benzene stated that “exposure over a long period 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.” Many epidemiological studies of petroleum workers exposed to benzene by inhalation have clearly associated the chemical with the development of cancers of blood tissues, such as leukemia, at continued exposure to levels as low as 1 ppm.

The FDA has determined that benzene should not be used in standard pharmaceutical production because of its unacceptable toxicity; however, FDA guidance can be confused with emergency limits that do not apply to cosmetic products like dry shampoos. Therefore, in addition, to recalls, Valisure is also petitioning the FDA to consider clarifying that there is no acceptable level of benzene in cosmetic products and define a reasonable detec limit. Valisure notes that many dry shampoo products tested had no detectable level of benzene, so it appears that such products can adhere to strict limits.

The EPA has estimated that lifetime exposure to benzene at 0.4 parts per billion (“ppb”), or 0.0004 ppm, will increase the risk of developing cancer in humans at the same 1 in 100,000 exposed person rate as FDA uses to set regulatory limits on other trace impurities like N-nitrosamines. Valisure detected N-Nitrosamines like “NDMA” in multiple drug products, which were followed by broad recalls of ranitidine (Zantac), metformin, and other drugs. Although the EPA-calculated concentration of 0.4 ppb in the air does not directly apply to the level of contamination inside an aerosol product, which is not likely inhaled in its entirety, it does provide rational guidance for calculations of potential exposure for such products as dry shampoo that may regularly be used indoors and in enclosed spaces.

Valisure’s Analysis of Dry Shampoo Products Contamination

In Valisure’s Petition, 148 unique batches from 34 different brands were analyzed using industry-standard GC-MS technology. Significant variability from batch to batch was observed, even within a single brand. There was also significant variability between subsequent sprays from some bottles, suggesting inconsistent product mixtures in some products. Therefore, the analysis of the first spray from each product’s bottle is detailed in this summary, and further data is presented in the full FDA Citizen Petition on Dry Shampoo.

3 lots of dry shampoo products from 1 brand contained spray with over 100 ppm of benzene; 11 lots from 3 brands contained spray with detectable benzene over 20 ppm; 18 lots from 10 brands showed levels between 2 - 20 ppm; and 71 lots from 20 brands contained quantifiable benzene between 0.18 - 2.0 ppm. Benzene was not detected or below the limit of quantitation in an additional 45 lots of dry shampoos from 23 different brands.

SIFT-MS Analysis of Contaminated Air and Potential Inhalation Exposure Risk

To investigate benzene levels directly from air contaminated by spray from dry shampoo products containing benzene, Valisure collaborated with Syft Technologies to utilize their novel “SIFT-MS” analysis system on dry shampoo products. Syft Technologies, a New Zealand-based company, revolutionized the trace analysis world with the Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) technology, which is a new form of direct mass spectrometry that directly analyzes volatile organic compounds (VOCs) and inorganic gasses in the air, including benzene. Being an ideal tool for real-time gas analysis applications, the detection of benzene in dry shampoo products was continuously monitored at 4-second intervals and with parts-per-trillion sensitivity.

“We are pleased to have collaborated with Valisure, whom we recognize as quality assurance leaders in the healthcare and consumer products industries,” stated Alex Fala, Chief Executive Officer of Syft Technologies. “SIFT-MS is the ideal technology for monitoring trace compounds in gases, and Syft is proud to have contributed to this critical safety study. We envision SIFT-MS becoming the gold standard for detecting dangerous, volatile compounds in consumer products and pharmaceuticals.“ 

Valisure’s past analyses of consumer products, and its new study of dry shampoo, were conducted with standard gas chromatography-mass spectrometry or “GC-MS” systems. In this process, a sample of the product being tested must be manually transferred to a vial and prepared before being analyzed. Although standard practice across the industry, sample preparation leaves the potential for some benzene to escape detection, especially when attempting to sample a gaseous aerosol product. Therefore, there is the potential to underestimate the amount of contamination when using GC-MS systems that require sample preparation. Syft Technologies systems eliminate the need for sample preparation, thereby enabling quantitative analysis of spray from dry shampoo directly. This allows the investigation of real-world conditions and the potential risks consumers are exposed to with contaminated aerosol products.

“We are excited to be working with Syft Technologies to identify new ways to understand the extent of benzene contamination in consumer products,” David Light comments.“Independent testing has the flexibility to quickly incorporate novel technologies like SIFT-MS that can address unique analytical challenges by directly testing gases from contaminated products.”

Pictured below is the graph of Syft Technologies’ analysis of two dry shampoo products, with benzene concentration shown in parts per billion (ppb). The unique experimental setup used for this dry shampoo research included placing a SIFT-MS machine in a mobile laboratory with an air volume of approximately 550 cubic feet, similar to a large bathroom's air volume. A Syft operator inside the closed vehicle then sprayed a contaminated dry shampoo approximately one foot away from the SIFT-MS detector. This created a measurable spike of benzene as the contaminated “cloud” of spray hit the machine and also established how much benzene fills the closed space and lingers after the initial spray.

This data suggests short-term exposure of approximately1,600 ppb of benzene from the “cloud” of sprayed dry shampoo and potential long-term exposure up to about 36 ppb of benzene by raising the baseline benzene level within the 550 cubic foot space. 36 ppb is 90 times the previously mentioned EPA estimated threshold for increased cancer risk by long-term inhalation exposure to benzene. Utilizing the amount of benzene that the 550cubic foot volume of air was increased by, the total amount of benzene contained in a roughly 10-second spray was calculated and resulted in a benzene concentration in the sprayed product of up to 340 ppm, which is 170 times the FDA’s conditionally restricted limit.  

Such high detections of benzene from a direct SIFT-MS measurement suggests that Valisure’s GC-MS analyses in this study, which require sample prep, and perhaps previous Valisure studies investigating aerosol products like sunscreens and body sprays, may significantly underestimate the concentrations of benzene in such aerosol products. Data presented in Valisure’s petition suggests benzene concentrations could be roughly 10 – 50 times higher in aerosol products than Valisure has detected using GC-MS approaches. Therefore, the widespread benzene contamination observed in aerosol consumer products may be of even greater risk to consumers than previously presented to FDA by Valisure’s petitions.

Benzene: A Pervasive Contaminant in Consumer Products

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene and also broadened the type of products it was analyzing in its pharmacy and for pharmacy partners, to include over-the-counter items and consumer healthcare products. In 2021, Valisure sold its pharmacy subsidiary to a pharmacy chain and continued to work with pharmacies and other stakeholders throughout the healthcare industry to incorporate the benefits of independent quality assurance.

Valisure’s detection of benzene in dry shampoo builds upon the growing list of the company’s detection of benzene in consumer products, including Valisure’s March 24, 2021, Citizen Petition on benzene contamination in hand sanitizer, its May 24, 2021, Citizen Petition on benzene contamination in sunscreens, its November 4th, 2021 Citizen Petition on benzene contamination in body sprays, and the recent recall of contaminated hand sanitizers, sunscreens, body sprays, and other consumer products due to the presence of benzene. These alarming developments strongly underscore the necessity to better regulate benzene and its apparent prevalence in the drug and consumer product supply chains.

“Consumer healthcare products are manufactured through an incredibly complex, global supply chain where the quality of products and raw materials are often only occasionally checked, and analytical testing is generally self-reported by the suppliers themselves,” states David Light. “This system of self-regulation leaves many vulnerabilities to quality issues, and we at Valisure believe that adding independent testing and certification into the supply chain could significantly improve the overall quality and help prevent these contamination issues from reaching consumers.”

Summary Timeline of consumer product recalls due to benzene

Please read about Responsible Disposal of Potentially Contaminated Products.

Full Petition – Contains lists of products and levels of benzene detected, if any.

About Valisure

Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and quality issues in the global supply chain, Valisure’s team of Harvard- and Yale-trained scientists developed proprietary analytical technologies to independently test products, identify critical issues, and offer services to help distinguish quality stakeholders and products. Valisure’s novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and private industry to help improve public health. For further information, please visit www.valisure.com and follow us on Twitter and Instagram.

About Syft Technologies

Syft Technologies, the pioneer of Selected Ion Flow Tube Mass Spectrometry (SIFT-MS technology, is the leading platform for high-throughput, real-time gas analysis. Originally developed in New Zealand, Syft Technologies has grown and proven its technology over the past 20 years in high-stakes commercial environments. Providing customer solutions is at the core of Syft Technologies, with a deep focus on operational robustness, speed, and support. To learn more about Syft Technologies and how this innovative technology can help your business, visit www.syft.com.

Valisure Detects Benzene in Dry Shampoo

November 1, 2022

VALISURE DETECTS HIGH LEVELS OF BENZENE IN SEVERAL DRY SHAMPOO PRODUCTS AND REQUESTS FDA ACTIONS

Benzene, a Known Human Carcinogen, Detected in 70% of Dry Shampoo Samples Tested

NEW HAVEN, CT – NOVEMBER 1, 2022 – Valisure has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans, according to the U.S. Centers for Disease Control and Prevention, the Environmental Protection Agency (EPA), the World Health Organization, and other regulatory agencies.  

70% of samples tested by Valisure in its recently filed FDA Citizen Petition showed quantifiable levels of benzene, and some samples analyzed directly from contaminated air suggest the sprayed product contained up to 170 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) (intended for certain drugs, when the use of benzene is unavoidable to produce a product that has a significant therapeutic advance). 11 samples tested by Valisure showed over 10 times this FDA limit. These findings are the highest and most broadly detected levels of benzene observed by Valisure to-date in a consumer product category. Valisure is asking for a recall of the contaminated batches and requesting the FDA better define limits for benzene contamination in cosmetics and other regulated products.  

“The detection of high levels of benzene in dry shampoos should be cause for significant concern since these products are likely used indoors, where benzene may linger and be inhaled for prolonged periods of time,” says David Light, Chief Executive Officer of Valisure. “These and other issues identified by Valisure, including the detection of benzene in body spray, hand sanitizer, and sunscreen products, strongly underscore the importance of independent testing and its need to be better integrated into an increasingly complex and vulnerable global supply chain.”

Valisure’s FDA Citizen Petition: Valisure’s FDA Citizen Petition on Dry Shampoo (all attachments and other resources linked below)
Background on Benzene

Benzene is a colorless or light-yellow liquid chemical at room temperature. It has been used primarily as a solvent in the chemical and pharmaceutical industries and is known to cause cancer in humans. Trace levels of benzene may be found in cigarette smoke, gasoline, glues, adhesives, cleaning products, and paint strippers, and it is a known contaminant in the petroleum industry.

Many petroleum products are used as raw materials or inactive ingredients in consumer healthcare products. In particular, with dry shampoos and body sprays, as mentioned in Valisure’s November, 2021 press release, “propellants” like butane, isobutane, propane, and alcohol are commonly used and could potentially be sources of benzene contamination. In December, 2021, FDA released a statement asking the industry to test for benzene and also proposed that propellants could be a source of contamination.

FDA currently recognizes the serious danger of benzene and lists it as a “Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity. However, if their use is unavoidable to produce a drug product with a significant therapeutic advance, then their levels should be restricted,” and benzene is restricted to 2 ppm for these particular circumstances.

Risk of Benzene Exposure

Benzene toxicity in humans has been well-established for over 120 years. A study from 1939 on benzene stated that “exposure over a long period 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.” Many epidemiological studies of petroleum workers exposed to benzene by inhalation have clearly associated the chemical with the development of cancers of blood tissues, such as leukemia, at continued exposure to levels as low as 1 ppm.

The FDA has determined that benzene should not be used in standard pharmaceutical production because of its unacceptable toxicity; however, FDA guidance can be confused with emergency limits that do not apply to cosmetic products like dry shampoos. Therefore, in addition, to recalls, Valisure is also petitioning the FDA to consider clarifying that there is no acceptable level of benzene in cosmetic products and define a reasonable detec limit. Valisure notes that many dry shampoo products tested had no detectable level of benzene, so it appears that such products can adhere to strict limits.

The EPA has estimated that lifetime exposure to benzene at 0.4 parts per billion (“ppb”), or 0.0004 ppm, will increase the risk of developing cancer in humans at the same 1 in 100,000 exposed person rate as FDA uses to set regulatory limits on other trace impurities like N-nitrosamines. Valisure detected N-Nitrosamines like “NDMA” in multiple drug products, which were followed by broad recalls of ranitidine (Zantac), metformin, and other drugs. Although the EPA-calculated concentration of 0.4 ppb in the air does not directly apply to the level of contamination inside an aerosol product, which is not likely inhaled in its entirety, it does provide rational guidance for calculations of potential exposure for such products as dry shampoo that may regularly be used indoors and in enclosed spaces.

Valisure’s Analysis of Dry Shampoo Products Contamination

In Valisure’s Petition, 148 unique batches from 34 different brands were analyzed using industry-standard GC-MS technology. Significant variability from batch to batch was observed, even within a single brand. There was also significant variability between subsequent sprays from some bottles, suggesting inconsistent product mixtures in some products. Therefore, the analysis of the first spray from each product’s bottle is detailed in this summary, and further data is presented in the full FDA Citizen Petition on Dry Shampoo.

3 lots of dry shampoo products from 1 brand contained spray with over 100 ppm of benzene; 11 lots from 3 brands contained spray with detectable benzene over 20 ppm; 18 lots from 10 brands showed levels between 2 - 20 ppm; and 71 lots from 20 brands contained quantifiable benzene between 0.18 - 2.0 ppm. Benzene was not detected or below the limit of quantitation in an additional 45 lots of dry shampoos from 23 different brands.

SIFT-MS Analysis of Contaminated Air and Potential Inhalation Exposure Risk

To investigate benzene levels directly from air contaminated by spray from dry shampoo products containing benzene, Valisure collaborated with Syft Technologies to utilize their novel “SIFT-MS” analysis system on dry shampoo products. Syft Technologies, a New Zealand-based company, revolutionized the trace analysis world with the Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) technology, which is a new form of direct mass spectrometry that directly analyzes volatile organic compounds (VOCs) and inorganic gasses in the air, including benzene. Being an ideal tool for real-time gas analysis applications, the detection of benzene in dry shampoo products was continuously monitored at 4-second intervals and with parts-per-trillion sensitivity.

“We are pleased to have collaborated with Valisure, whom we recognize as quality assurance leaders in the healthcare and consumer products industries,” stated Alex Fala, Chief Executive Officer of Syft Technologies. “SIFT-MS is the ideal technology for monitoring trace compounds in gases, and Syft is proud to have contributed to this critical safety study. We envision SIFT-MS becoming the gold standard for detecting dangerous, volatile compounds in consumer products and pharmaceuticals.“ 

Valisure’s past analyses of consumer products, and its new study of dry shampoo, were conducted with standard gas chromatography-mass spectrometry or “GC-MS” systems. In this process, a sample of the product being tested must be manually transferred to a vial and prepared before being analyzed. Although standard practice across the industry, sample preparation leaves the potential for some benzene to escape detection, especially when attempting to sample a gaseous aerosol product. Therefore, there is the potential to underestimate the amount of contamination when using GC-MS systems that require sample preparation. Syft Technologies systems eliminate the need for sample preparation, thereby enabling quantitative analysis of spray from dry shampoo directly. This allows the investigation of real-world conditions and the potential risks consumers are exposed to with contaminated aerosol products.

“We are excited to be working with Syft Technologies to identify new ways to understand the extent of benzene contamination in consumer products,” David Light comments.“Independent testing has the flexibility to quickly incorporate novel technologies like SIFT-MS that can address unique analytical challenges by directly testing gases from contaminated products.”

Pictured below is the graph of Syft Technologies’ analysis of two dry shampoo products, with benzene concentration shown in parts per billion (ppb). The unique experimental setup used for this dry shampoo research included placing a SIFT-MS machine in a mobile laboratory with an air volume of approximately 550 cubic feet, similar to a large bathroom's air volume. A Syft operator inside the closed vehicle then sprayed a contaminated dry shampoo approximately one foot away from the SIFT-MS detector. This created a measurable spike of benzene as the contaminated “cloud” of spray hit the machine and also established how much benzene fills the closed space and lingers after the initial spray.

This data suggests short-term exposure of approximately1,600 ppb of benzene from the “cloud” of sprayed dry shampoo and potential long-term exposure up to about 36 ppb of benzene by raising the baseline benzene level within the 550 cubic foot space. 36 ppb is 90 times the previously mentioned EPA estimated threshold for increased cancer risk by long-term inhalation exposure to benzene. Utilizing the amount of benzene that the 550cubic foot volume of air was increased by, the total amount of benzene contained in a roughly 10-second spray was calculated and resulted in a benzene concentration in the sprayed product of up to 340 ppm, which is 170 times the FDA’s conditionally restricted limit.  

Such high detections of benzene from a direct SIFT-MS measurement suggests that Valisure’s GC-MS analyses in this study, which require sample prep, and perhaps previous Valisure studies investigating aerosol products like sunscreens and body sprays, may significantly underestimate the concentrations of benzene in such aerosol products. Data presented in Valisure’s petition suggests benzene concentrations could be roughly 10 – 50 times higher in aerosol products than Valisure has detected using GC-MS approaches. Therefore, the widespread benzene contamination observed in aerosol consumer products may be of even greater risk to consumers than previously presented to FDA by Valisure’s petitions.

Benzene: A Pervasive Contaminant in Consumer Products

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene and also broadened the type of products it was analyzing in its pharmacy and for pharmacy partners, to include over-the-counter items and consumer healthcare products. In 2021, Valisure sold its pharmacy subsidiary to a pharmacy chain and continued to work with pharmacies and other stakeholders throughout the healthcare industry to incorporate the benefits of independent quality assurance.

Valisure’s detection of benzene in dry shampoo builds upon the growing list of the company’s detection of benzene in consumer products, including Valisure’s March 24, 2021, Citizen Petition on benzene contamination in hand sanitizer, its May 24, 2021, Citizen Petition on benzene contamination in sunscreens, its November 4th, 2021 Citizen Petition on benzene contamination in body sprays, and the recent recall of contaminated hand sanitizers, sunscreens, body sprays, and other consumer products due to the presence of benzene. These alarming developments strongly underscore the necessity to better regulate benzene and its apparent prevalence in the drug and consumer product supply chains.

“Consumer healthcare products are manufactured through an incredibly complex, global supply chain where the quality of products and raw materials are often only occasionally checked, and analytical testing is generally self-reported by the suppliers themselves,” states David Light. “This system of self-regulation leaves many vulnerabilities to quality issues, and we at Valisure believe that adding independent testing and certification into the supply chain could significantly improve the overall quality and help prevent these contamination issues from reaching consumers.”

Summary Timeline of consumer product recalls due to benzene

Please read about Responsible Disposal of Potentially Contaminated Products.

Full Petition – Contains lists of products and levels of benzene detected, if any.

About Valisure

Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and quality issues in the global supply chain, Valisure’s team of Harvard- and Yale-trained scientists developed proprietary analytical technologies to independently test products, identify critical issues, and offer services to help distinguish quality stakeholders and products. Valisure’s novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and private industry to help improve public health. For further information, please visit www.valisure.com and follow us on Twitter and Instagram.

About Syft Technologies

Syft Technologies, the pioneer of Selected Ion Flow Tube Mass Spectrometry (SIFT-MS technology, is the leading platform for high-throughput, real-time gas analysis. Originally developed in New Zealand, Syft Technologies has grown and proven its technology over the past 20 years in high-stakes commercial environments. Providing customer solutions is at the core of Syft Technologies, with a deep focus on operational robustness, speed, and support. To learn more about Syft Technologies and how this innovative technology can help your business, visit www.syft.com.

Valisure Detects Benzene in Dry Shampoo

VALISURE DETECTS HIGH LEVELS OF BENZENE IN SEVERAL DRY SHAMPOO PRODUCTS AND REQUESTS FDA ACTIONS

Benzene, a Known Human Carcinogen, Detected in 70% of Dry Shampoo Samples Tested

NEW HAVEN, CT – NOVEMBER 1, 2022 – Valisure has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans, according to the U.S. Centers for Disease Control and Prevention, the Environmental Protection Agency (EPA), the World Health Organization, and other regulatory agencies.  

70% of samples tested by Valisure in its recently filed FDA Citizen Petition showed quantifiable levels of benzene, and some samples analyzed directly from contaminated air suggest the sprayed product contained up to 170 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) (intended for certain drugs, when the use of benzene is unavoidable to produce a product that has a significant therapeutic advance). 11 samples tested by Valisure showed over 10 times this FDA limit. These findings are the highest and most broadly detected levels of benzene observed by Valisure to-date in a consumer product category. Valisure is asking for a recall of the contaminated batches and requesting the FDA better define limits for benzene contamination in cosmetics and other regulated products.  

“The detection of high levels of benzene in dry shampoos should be cause for significant concern since these products are likely used indoors, where benzene may linger and be inhaled for prolonged periods of time,” says David Light, Chief Executive Officer of Valisure. “These and other issues identified by Valisure, including the detection of benzene in body spray, hand sanitizer, and sunscreen products, strongly underscore the importance of independent testing and its need to be better integrated into an increasingly complex and vulnerable global supply chain.”

Valisure’s FDA Citizen Petition: Valisure’s FDA Citizen Petition on Dry Shampoo (all attachments and other resources linked below)
Background on Benzene

Benzene is a colorless or light-yellow liquid chemical at room temperature. It has been used primarily as a solvent in the chemical and pharmaceutical industries and is known to cause cancer in humans. Trace levels of benzene may be found in cigarette smoke, gasoline, glues, adhesives, cleaning products, and paint strippers, and it is a known contaminant in the petroleum industry.

Many petroleum products are used as raw materials or inactive ingredients in consumer healthcare products. In particular, with dry shampoos and body sprays, as mentioned in Valisure’s November, 2021 press release, “propellants” like butane, isobutane, propane, and alcohol are commonly used and could potentially be sources of benzene contamination. In December, 2021, FDA released a statement asking the industry to test for benzene and also proposed that propellants could be a source of contamination.

FDA currently recognizes the serious danger of benzene and lists it as a “Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity. However, if their use is unavoidable to produce a drug product with a significant therapeutic advance, then their levels should be restricted,” and benzene is restricted to 2 ppm for these particular circumstances.

Risk of Benzene Exposure

Benzene toxicity in humans has been well-established for over 120 years. A study from 1939 on benzene stated that “exposure over a long period 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.” Many epidemiological studies of petroleum workers exposed to benzene by inhalation have clearly associated the chemical with the development of cancers of blood tissues, such as leukemia, at continued exposure to levels as low as 1 ppm.

The FDA has determined that benzene should not be used in standard pharmaceutical production because of its unacceptable toxicity; however, FDA guidance can be confused with emergency limits that do not apply to cosmetic products like dry shampoos. Therefore, in addition, to recalls, Valisure is also petitioning the FDA to consider clarifying that there is no acceptable level of benzene in cosmetic products and define a reasonable detec limit. Valisure notes that many dry shampoo products tested had no detectable level of benzene, so it appears that such products can adhere to strict limits.

The EPA has estimated that lifetime exposure to benzene at 0.4 parts per billion (“ppb”), or 0.0004 ppm, will increase the risk of developing cancer in humans at the same 1 in 100,000 exposed person rate as FDA uses to set regulatory limits on other trace impurities like N-nitrosamines. Valisure detected N-Nitrosamines like “NDMA” in multiple drug products, which were followed by broad recalls of ranitidine (Zantac), metformin, and other drugs. Although the EPA-calculated concentration of 0.4 ppb in the air does not directly apply to the level of contamination inside an aerosol product, which is not likely inhaled in its entirety, it does provide rational guidance for calculations of potential exposure for such products as dry shampoo that may regularly be used indoors and in enclosed spaces.

Valisure’s Analysis of Dry Shampoo Products Contamination

In Valisure’s Petition, 148 unique batches from 34 different brands were analyzed using industry-standard GC-MS technology. Significant variability from batch to batch was observed, even within a single brand. There was also significant variability between subsequent sprays from some bottles, suggesting inconsistent product mixtures in some products. Therefore, the analysis of the first spray from each product’s bottle is detailed in this summary, and further data is presented in the full FDA Citizen Petition on Dry Shampoo.

3 lots of dry shampoo products from 1 brand contained spray with over 100 ppm of benzene; 11 lots from 3 brands contained spray with detectable benzene over 20 ppm; 18 lots from 10 brands showed levels between 2 - 20 ppm; and 71 lots from 20 brands contained quantifiable benzene between 0.18 - 2.0 ppm. Benzene was not detected or below the limit of quantitation in an additional 45 lots of dry shampoos from 23 different brands.

SIFT-MS Analysis of Contaminated Air and Potential Inhalation Exposure Risk

To investigate benzene levels directly from air contaminated by spray from dry shampoo products containing benzene, Valisure collaborated with Syft Technologies to utilize their novel “SIFT-MS” analysis system on dry shampoo products. Syft Technologies, a New Zealand-based company, revolutionized the trace analysis world with the Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) technology, which is a new form of direct mass spectrometry that directly analyzes volatile organic compounds (VOCs) and inorganic gasses in the air, including benzene. Being an ideal tool for real-time gas analysis applications, the detection of benzene in dry shampoo products was continuously monitored at 4-second intervals and with parts-per-trillion sensitivity.

“We are pleased to have collaborated with Valisure, whom we recognize as quality assurance leaders in the healthcare and consumer products industries,” stated Alex Fala, Chief Executive Officer of Syft Technologies. “SIFT-MS is the ideal technology for monitoring trace compounds in gases, and Syft is proud to have contributed to this critical safety study. We envision SIFT-MS becoming the gold standard for detecting dangerous, volatile compounds in consumer products and pharmaceuticals.“ 

Valisure’s past analyses of consumer products, and its new study of dry shampoo, were conducted with standard gas chromatography-mass spectrometry or “GC-MS” systems. In this process, a sample of the product being tested must be manually transferred to a vial and prepared before being analyzed. Although standard practice across the industry, sample preparation leaves the potential for some benzene to escape detection, especially when attempting to sample a gaseous aerosol product. Therefore, there is the potential to underestimate the amount of contamination when using GC-MS systems that require sample preparation. Syft Technologies systems eliminate the need for sample preparation, thereby enabling quantitative analysis of spray from dry shampoo directly. This allows the investigation of real-world conditions and the potential risks consumers are exposed to with contaminated aerosol products.

“We are excited to be working with Syft Technologies to identify new ways to understand the extent of benzene contamination in consumer products,” David Light comments.“Independent testing has the flexibility to quickly incorporate novel technologies like SIFT-MS that can address unique analytical challenges by directly testing gases from contaminated products.”

Pictured below is the graph of Syft Technologies’ analysis of two dry shampoo products, with benzene concentration shown in parts per billion (ppb). The unique experimental setup used for this dry shampoo research included placing a SIFT-MS machine in a mobile laboratory with an air volume of approximately 550 cubic feet, similar to a large bathroom's air volume. A Syft operator inside the closed vehicle then sprayed a contaminated dry shampoo approximately one foot away from the SIFT-MS detector. This created a measurable spike of benzene as the contaminated “cloud” of spray hit the machine and also established how much benzene fills the closed space and lingers after the initial spray.

This data suggests short-term exposure of approximately1,600 ppb of benzene from the “cloud” of sprayed dry shampoo and potential long-term exposure up to about 36 ppb of benzene by raising the baseline benzene level within the 550 cubic foot space. 36 ppb is 90 times the previously mentioned EPA estimated threshold for increased cancer risk by long-term inhalation exposure to benzene. Utilizing the amount of benzene that the 550cubic foot volume of air was increased by, the total amount of benzene contained in a roughly 10-second spray was calculated and resulted in a benzene concentration in the sprayed product of up to 340 ppm, which is 170 times the FDA’s conditionally restricted limit.  

Such high detections of benzene from a direct SIFT-MS measurement suggests that Valisure’s GC-MS analyses in this study, which require sample prep, and perhaps previous Valisure studies investigating aerosol products like sunscreens and body sprays, may significantly underestimate the concentrations of benzene in such aerosol products. Data presented in Valisure’s petition suggests benzene concentrations could be roughly 10 – 50 times higher in aerosol products than Valisure has detected using GC-MS approaches. Therefore, the widespread benzene contamination observed in aerosol consumer products may be of even greater risk to consumers than previously presented to FDA by Valisure’s petitions.

Benzene: A Pervasive Contaminant in Consumer Products

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene and also broadened the type of products it was analyzing in its pharmacy and for pharmacy partners, to include over-the-counter items and consumer healthcare products. In 2021, Valisure sold its pharmacy subsidiary to a pharmacy chain and continued to work with pharmacies and other stakeholders throughout the healthcare industry to incorporate the benefits of independent quality assurance.

Valisure’s detection of benzene in dry shampoo builds upon the growing list of the company’s detection of benzene in consumer products, including Valisure’s March 24, 2021, Citizen Petition on benzene contamination in hand sanitizer, its May 24, 2021, Citizen Petition on benzene contamination in sunscreens, its November 4th, 2021 Citizen Petition on benzene contamination in body sprays, and the recent recall of contaminated hand sanitizers, sunscreens, body sprays, and other consumer products due to the presence of benzene. These alarming developments strongly underscore the necessity to better regulate benzene and its apparent prevalence in the drug and consumer product supply chains.

“Consumer healthcare products are manufactured through an incredibly complex, global supply chain where the quality of products and raw materials are often only occasionally checked, and analytical testing is generally self-reported by the suppliers themselves,” states David Light. “This system of self-regulation leaves many vulnerabilities to quality issues, and we at Valisure believe that adding independent testing and certification into the supply chain could significantly improve the overall quality and help prevent these contamination issues from reaching consumers.”

Summary Timeline of consumer product recalls due to benzene

Please read about Responsible Disposal of Potentially Contaminated Products.

Full Petition – Contains lists of products and levels of benzene detected, if any.

About Valisure

Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and quality issues in the global supply chain, Valisure’s team of Harvard- and Yale-trained scientists developed proprietary analytical technologies to independently test products, identify critical issues, and offer services to help distinguish quality stakeholders and products. Valisure’s novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and private industry to help improve public health. For further information, please visit www.valisure.com and follow us on Twitter and Instagram.

About Syft Technologies

Syft Technologies, the pioneer of Selected Ion Flow Tube Mass Spectrometry (SIFT-MS technology, is the leading platform for high-throughput, real-time gas analysis. Originally developed in New Zealand, Syft Technologies has grown and proven its technology over the past 20 years in high-stakes commercial environments. Providing customer solutions is at the core of Syft Technologies, with a deep focus on operational robustness, speed, and support. To learn more about Syft Technologies and how this innovative technology can help your business, visit www.syft.com.

VALISURE DETECTS HIGH LEVELS OF BENZENE IN SEVERAL DRY SHAMPOO PRODUCTS AND REQUESTS FDA ACTIONS

Benzene, a Known Human Carcinogen, Detected in 70% of Dry Shampoo Samples Tested

NEW HAVEN, CT – NOVEMBER 1, 2022 – Valisure has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans, according to the U.S. Centers for Disease Control and Prevention, the Environmental Protection Agency (EPA), the World Health Organization, and other regulatory agencies.  

70% of samples tested by Valisure in its recently filed FDA Citizen Petition showed quantifiable levels of benzene, and some samples analyzed directly from contaminated air suggest the sprayed product contained up to 170 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) (intended for certain drugs, when the use of benzene is unavoidable to produce a product that has a significant therapeutic advance). 11 samples tested by Valisure showed over 10 times this FDA limit. These findings are the highest and most broadly detected levels of benzene observed by Valisure to-date in a consumer product category. Valisure is asking for a recall of the contaminated batches and requesting the FDA better define limits for benzene contamination in cosmetics and other regulated products.  

“The detection of high levels of benzene in dry shampoos should be cause for significant concern since these products are likely used indoors, where benzene may linger and be inhaled for prolonged periods of time,” says David Light, Chief Executive Officer of Valisure. “These and other issues identified by Valisure, including the detection of benzene in body spray, hand sanitizer, and sunscreen products, strongly underscore the importance of independent testing and its need to be better integrated into an increasingly complex and vulnerable global supply chain.”

Valisure’s FDA Citizen Petition: Valisure’s FDA Citizen Petition on Dry Shampoo (all attachments and other resources linked below)
Background on Benzene

Benzene is a colorless or light-yellow liquid chemical at room temperature. It has been used primarily as a solvent in the chemical and pharmaceutical industries and is known to cause cancer in humans. Trace levels of benzene may be found in cigarette smoke, gasoline, glues, adhesives, cleaning products, and paint strippers, and it is a known contaminant in the petroleum industry.

Many petroleum products are used as raw materials or inactive ingredients in consumer healthcare products. In particular, with dry shampoos and body sprays, as mentioned in Valisure’s November, 2021 press release, “propellants” like butane, isobutane, propane, and alcohol are commonly used and could potentially be sources of benzene contamination. In December, 2021, FDA released a statement asking the industry to test for benzene and also proposed that propellants could be a source of contamination.

FDA currently recognizes the serious danger of benzene and lists it as a “Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity. However, if their use is unavoidable to produce a drug product with a significant therapeutic advance, then their levels should be restricted,” and benzene is restricted to 2 ppm for these particular circumstances.

Risk of Benzene Exposure

Benzene toxicity in humans has been well-established for over 120 years. A study from 1939 on benzene stated that “exposure over a long period 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.” Many epidemiological studies of petroleum workers exposed to benzene by inhalation have clearly associated the chemical with the development of cancers of blood tissues, such as leukemia, at continued exposure to levels as low as 1 ppm.

The FDA has determined that benzene should not be used in standard pharmaceutical production because of its unacceptable toxicity; however, FDA guidance can be confused with emergency limits that do not apply to cosmetic products like dry shampoos. Therefore, in addition, to recalls, Valisure is also petitioning the FDA to consider clarifying that there is no acceptable level of benzene in cosmetic products and define a reasonable detec limit. Valisure notes that many dry shampoo products tested had no detectable level of benzene, so it appears that such products can adhere to strict limits.

The EPA has estimated that lifetime exposure to benzene at 0.4 parts per billion (“ppb”), or 0.0004 ppm, will increase the risk of developing cancer in humans at the same 1 in 100,000 exposed person rate as FDA uses to set regulatory limits on other trace impurities like N-nitrosamines. Valisure detected N-Nitrosamines like “NDMA” in multiple drug products, which were followed by broad recalls of ranitidine (Zantac), metformin, and other drugs. Although the EPA-calculated concentration of 0.4 ppb in the air does not directly apply to the level of contamination inside an aerosol product, which is not likely inhaled in its entirety, it does provide rational guidance for calculations of potential exposure for such products as dry shampoo that may regularly be used indoors and in enclosed spaces.

Valisure’s Analysis of Dry Shampoo Products Contamination

In Valisure’s Petition, 148 unique batches from 34 different brands were analyzed using industry-standard GC-MS technology. Significant variability from batch to batch was observed, even within a single brand. There was also significant variability between subsequent sprays from some bottles, suggesting inconsistent product mixtures in some products. Therefore, the analysis of the first spray from each product’s bottle is detailed in this summary, and further data is presented in the full FDA Citizen Petition on Dry Shampoo.

3 lots of dry shampoo products from 1 brand contained spray with over 100 ppm of benzene; 11 lots from 3 brands contained spray with detectable benzene over 20 ppm; 18 lots from 10 brands showed levels between 2 - 20 ppm; and 71 lots from 20 brands contained quantifiable benzene between 0.18 - 2.0 ppm. Benzene was not detected or below the limit of quantitation in an additional 45 lots of dry shampoos from 23 different brands.

SIFT-MS Analysis of Contaminated Air and Potential Inhalation Exposure Risk

To investigate benzene levels directly from air contaminated by spray from dry shampoo products containing benzene, Valisure collaborated with Syft Technologies to utilize their novel “SIFT-MS” analysis system on dry shampoo products. Syft Technologies, a New Zealand-based company, revolutionized the trace analysis world with the Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) technology, which is a new form of direct mass spectrometry that directly analyzes volatile organic compounds (VOCs) and inorganic gasses in the air, including benzene. Being an ideal tool for real-time gas analysis applications, the detection of benzene in dry shampoo products was continuously monitored at 4-second intervals and with parts-per-trillion sensitivity.

“We are pleased to have collaborated with Valisure, whom we recognize as quality assurance leaders in the healthcare and consumer products industries,” stated Alex Fala, Chief Executive Officer of Syft Technologies. “SIFT-MS is the ideal technology for monitoring trace compounds in gases, and Syft is proud to have contributed to this critical safety study. We envision SIFT-MS becoming the gold standard for detecting dangerous, volatile compounds in consumer products and pharmaceuticals.“ 

Valisure’s past analyses of consumer products, and its new study of dry shampoo, were conducted with standard gas chromatography-mass spectrometry or “GC-MS” systems. In this process, a sample of the product being tested must be manually transferred to a vial and prepared before being analyzed. Although standard practice across the industry, sample preparation leaves the potential for some benzene to escape detection, especially when attempting to sample a gaseous aerosol product. Therefore, there is the potential to underestimate the amount of contamination when using GC-MS systems that require sample preparation. Syft Technologies systems eliminate the need for sample preparation, thereby enabling quantitative analysis of spray from dry shampoo directly. This allows the investigation of real-world conditions and the potential risks consumers are exposed to with contaminated aerosol products.

“We are excited to be working with Syft Technologies to identify new ways to understand the extent of benzene contamination in consumer products,” David Light comments.“Independent testing has the flexibility to quickly incorporate novel technologies like SIFT-MS that can address unique analytical challenges by directly testing gases from contaminated products.”

Pictured below is the graph of Syft Technologies’ analysis of two dry shampoo products, with benzene concentration shown in parts per billion (ppb). The unique experimental setup used for this dry shampoo research included placing a SIFT-MS machine in a mobile laboratory with an air volume of approximately 550 cubic feet, similar to a large bathroom's air volume. A Syft operator inside the closed vehicle then sprayed a contaminated dry shampoo approximately one foot away from the SIFT-MS detector. This created a measurable spike of benzene as the contaminated “cloud” of spray hit the machine and also established how much benzene fills the closed space and lingers after the initial spray.

This data suggests short-term exposure of approximately1,600 ppb of benzene from the “cloud” of sprayed dry shampoo and potential long-term exposure up to about 36 ppb of benzene by raising the baseline benzene level within the 550 cubic foot space. 36 ppb is 90 times the previously mentioned EPA estimated threshold for increased cancer risk by long-term inhalation exposure to benzene. Utilizing the amount of benzene that the 550cubic foot volume of air was increased by, the total amount of benzene contained in a roughly 10-second spray was calculated and resulted in a benzene concentration in the sprayed product of up to 340 ppm, which is 170 times the FDA’s conditionally restricted limit.  

Such high detections of benzene from a direct SIFT-MS measurement suggests that Valisure’s GC-MS analyses in this study, which require sample prep, and perhaps previous Valisure studies investigating aerosol products like sunscreens and body sprays, may significantly underestimate the concentrations of benzene in such aerosol products. Data presented in Valisure’s petition suggests benzene concentrations could be roughly 10 – 50 times higher in aerosol products than Valisure has detected using GC-MS approaches. Therefore, the widespread benzene contamination observed in aerosol consumer products may be of even greater risk to consumers than previously presented to FDA by Valisure’s petitions.

Benzene: A Pervasive Contaminant in Consumer Products

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene and also broadened the type of products it was analyzing in its pharmacy and for pharmacy partners, to include over-the-counter items and consumer healthcare products. In 2021, Valisure sold its pharmacy subsidiary to a pharmacy chain and continued to work with pharmacies and other stakeholders throughout the healthcare industry to incorporate the benefits of independent quality assurance.

Valisure’s detection of benzene in dry shampoo builds upon the growing list of the company’s detection of benzene in consumer products, including Valisure’s March 24, 2021, Citizen Petition on benzene contamination in hand sanitizer, its May 24, 2021, Citizen Petition on benzene contamination in sunscreens, its November 4th, 2021 Citizen Petition on benzene contamination in body sprays, and the recent recall of contaminated hand sanitizers, sunscreens, body sprays, and other consumer products due to the presence of benzene. These alarming developments strongly underscore the necessity to better regulate benzene and its apparent prevalence in the drug and consumer product supply chains.

“Consumer healthcare products are manufactured through an incredibly complex, global supply chain where the quality of products and raw materials are often only occasionally checked, and analytical testing is generally self-reported by the suppliers themselves,” states David Light. “This system of self-regulation leaves many vulnerabilities to quality issues, and we at Valisure believe that adding independent testing and certification into the supply chain could significantly improve the overall quality and help prevent these contamination issues from reaching consumers.”

Summary Timeline of consumer product recalls due to benzene

Please read about Responsible Disposal of Potentially Contaminated Products.

Full Petition – Contains lists of products and levels of benzene detected, if any.

About Valisure

Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and quality issues in the global supply chain, Valisure’s team of Harvard- and Yale-trained scientists developed proprietary analytical technologies to independently test products, identify critical issues, and offer services to help distinguish quality stakeholders and products. Valisure’s novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and private industry to help improve public health. For further information, please visit www.valisure.com and follow us on Twitter and Instagram.

About Syft Technologies

Syft Technologies, the pioneer of Selected Ion Flow Tube Mass Spectrometry (SIFT-MS technology, is the leading platform for high-throughput, real-time gas analysis. Originally developed in New Zealand, Syft Technologies has grown and proven its technology over the past 20 years in high-stakes commercial environments. Providing customer solutions is at the core of Syft Technologies, with a deep focus on operational robustness, speed, and support. To learn more about Syft Technologies and how this innovative technology can help your business, visit www.syft.com.

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