VALISURE DETECTS HIGH LEVELS OF KNOWN HUMAN CARCINOGEN BENZENE IN SEVERAL BODY SPRAY PRODUCTS AND REQUESTS FDA ACTIONS
59 antiperspirant and deodorant body spray products contained benzene, an industrial chemical known to cause leukemia and other potentially serious health risks
NEW HAVEN, CT – NOVEMBER 4, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as cosmetics. 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. The National Institute for Occupational Safety and Health (NIOSH) defines benzene as a carcinogen and lists “inhalation, skin absorption, ingestion, skin and/or eye contact” as exposure routes. 54% of samples tested by Valisure contained detectable benzene and some batches contained up to nine times the conditionally restricted FDA concentration limit of 2 parts per million (ppm).
Valisure is asking for a recall of the contaminated batches and requesting the FDA better define limits for benzene contamination in drug and cosmetic products. It is important to note that not all body spray products contain benzene and that uncontaminated products are available and can continue to be used without the potential risk from benzene.
Valisure’s FDA Citizen Petition: Valisure’s FDA Citizen Petition on Body Spray (all attachments and other resources linked below)
ConsumerLab.com has published a reviewa for its members of the Valisure data suggesting products to avoid and which might be safest with regard to the benzene results. Link to review
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 persons rate as FDA uses to set regulatory limits on other trace impurities like N-nitrosamines. N-Nitrosamines like “NDMA” have been detected by Valisure in drug products and this was followed by broad recalls of ranitidine (Zantac), metformin and other drugs. Although the EPA calculated concentration of 0.4 ppb in 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 body sprays that may regularly be used indoors and in enclosed spaces. Furthermore, many of the body sprays Valisure tested contain highly volatile propellants such as butane, propane and others, which could potentially evaporate and disperse benzene rapidly in the air.
Assuming a 5 gram application of a contaminated aerosol fully evaporates and dissipates into a one cubic meter volume (approximately 35.3 cubic feet), the most contaminated body spray Valisure analyzed could potentially raise the air concentration of benzene to 28 ppb, or approximately 69 times the EPA-estimated threshold for increased cancer risk. In the same scenario, if the contaminated aerosol were used in a bathroom with a total volume measuring 160 ft3 (20 sq ft with 8 ft ceiling), and given more time for the contaminated application to disseminate throughout the space, the entire bathroom air could potentially contain benzene at 6 ppb or approximately 15 times the EPA-estimated threshold for increased cancer risk. As aforementioned, the EPA’s calculation for cancer risk mirrors that of FDA’s analysis for other potentially carcinogenic impurities such as certain nitrosamines, like NDMA.
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. FDA allows this level of benzene only in extreme circumstances that would not typically apply to antiperspirant body sprays. Valisure has detected some batches up to 9 times this concentration, or 18 ppm. NIOSH recommends protective equipment be worn by workers expecting to be exposed to benzene at concentrations of 0.1 ppm.
The toxicity of benzene in humans has been well established for over 120 years. The hematotoxicity of benzene has been described as early as 1897. 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.” Many epidemiological studies of petroleum workers exposed to benzene have clearly associated the chemical with the development of cancers of blood tissues, such as leukemia.
“The detection of high levels of benzene in body sprays is cause for significant concern since these products are often used daily, by both adults and adolescents,” says David Light, Founder and CEO of Valisure. “These findings build upon our now validated discovery of benzene in sunscreens, after-sun care products, and hand sanitizers that have already been followed by national recalls earlier this year. With this latest development, we have identified a concerning trend of carcinogen contamination in consumer healthcare products.”
The FDA has determined that benzene should not be used in standard pharmaceutical production because of its unacceptable toxicity; however, FDA guidance is often confused with emergency limits that do not apply to traditional products like body sprays. Therefore, in addition to recalls, Valisure is also petitioning the FDA to clarify that there is no acceptable level of benzene in regulated healthcare products and define a reasonable limit of detection.
Valisure’s March 24, 2021 Citizen Petition on benzene contamination in hand sanitizer, its May 24, 2021 Citizen Petition on benzene contamination in sunscreens, and the recent recalls of contaminated hand sanitizers, sunscreens, and other consumer products due to the presence of benzene, further underscores the necessity to better regulate benzene and its apparent prevalence in the drug and consumer product supply chains.
Valisure analyzed 108 unique batches from 30 different brands. Significant variability from batch to batch was observed, even within a single brand. 24 lots of body spray products from 8 different brands contained between 2.24 – 17.7 ppm of benzene; 14 lots from 8 brands contained detectable benzene between 0.20 – 1.89 ppm; and 21 lots from 8 brands contained detectable benzene at < 0.1 ppm. Benzene was not detected in an additional 49 lots of body sprays from 19 different brands through initial analysis of at least one sample.
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 well 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 is well known to contaminate petroleum products.
Many petroleum products are used as raw materials or inactive ingredients in consumer healthcare products. In particular with body sprays, “propellants” like butane, isobutane, propane, and alcohol are commonly used and could potentially be sources of benzene contamination. Valisure evaluated the listed inactive ingredients in the 108 body spray products analyzed in the petition and found the prevalence of contamination in five major propellants:
|Propellant||# of Products||% Products with Benzene|
“It is, unfortunately, apparent that benzene contamination is a widespread and concerning issue in the American consumer product supply chain and underscores the critical need for independent testing,” states David Light. “The global supply chain is incredibly complex and has many vulnerabilities. We believe some of these contamination issues, like benzene in consumer products, might be traced all the way back to the raw materials supplied to manufacturers. Increased vigilance and quality assurance is needed more than ever.”
Attachment A – Resolution from the American College of Cardiology regarding independent testing.
Please read about Responsible Disposal of Potentially Contaminated Products.
Full Petition – Contains lists of products where benzene was detected and not detected.
aThe views and opinions contained at ConsumerLab.com and its related reports on body spray products are that of ConsumerLab.com, LLC and do not reflect the opinions and beliefs of Valisure, LLC or its members.
Valisure’s core mission is to independently check the chemical composition of medications and healthcare products before they reach consumers and deliver that transparency throughout the supply chain as a differentiating partner for quality. In response to rising concerns about counterfeits, generics, and overseas manufacturing, Valisure’s team of Harvard- and Yale-trained scientists developed proprietary analytical technologies to screen products, identify critical issues, and offer certification to help distinguish quality stakeholders and products. Valisure has ISO 17025 accreditation and is DEA and FDA registered. For more information, please visit www.valisure.com and follow on Twitter and Instagram.