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January 5, 2021
Paustenbach and Asssociates
On November 23, 2021, the FDA announced that Proctor & Gamble Company had voluntarily recalled selected lots of Old Spice and Secret aerosol spray products after undisclosed concentrations of benzene had been detected in these products (FDA, 2021a).
The voluntary recall follows similar recalls of aerosol products including select Odor-Eaters® products on November 17, 2021, and Johnson & Johnson sunscreen products on July 14, 2021, due to the detection of benzene (FDA 2021b, FDA 2021c).
These recalls followed the release of analytical lab testing results performed by Valisure, an independent laboratory that performs assays on various pharmaceutical products (Valisure, 2021). Valisure tested 108 unique batches of body spray from 30 brands of body spray products and reported that 54% of the batches tested (or 59 product batches) were found to contain detectable concentrations of benzene (>0.1 ppm). Of these 59 product batches with detectable levels of benzene, 24 contained concentrations of benzene in excess of 2.0 ppm (range: 2.24-17.7 ppm) which is the conditional restriction level placed on over-the-counter drugs by the FDA.
Benzene is recognized by the International Agency for Research on Cancer as “carcinogenic to humans” based on evidence that exposure of adequate frequency, intensity, and duration may be attributed to the development of acute myeloid leukemia (AML) (IARC, 2021). Everyday exposures to benzene occur through exposure to tobacco smoke, visits to the gas station, exhaust from vehicles, and industrial emissions (ATSDR, 2019). Like all chemicals, the magnitude of risk is based on the absorbed dose and duration of exposure.
Our firm understands that personal injury litigation surrounding trace contamination of various consumer products by benzene have increased over the past two years. We recommend that those who have detected benzene impurities in their products conduct a thorough health risk assessment so they can fully characterize the possible health risks to users, as well as the strength of their defense if they are drawn into the courtroom.
Paustenbach and Associates scientists have more than 40 years of experience in conducting risk assessments of benzene in the workplace, the ambient environment, point source emissions, and consumer products (Gross & Paustenbach, 2018; Paustenbach et al., 2010; Hollins et al., 2013). Indeed, we believe we have conducted more of these types of analyses than any other consulting firm. Dr. Paustenbach, for example, has more than a dozen published papers on benzene and several book chapters (many addressing trace contamination in consumer products) (Haws et al., 2008; Williams et al., 2007; Galbraith et al., 2010). He has also given many depositions and trial testimony on this topic. Over the years, our scientists have conducted hundreds of risk assessments of various products. We have assisted many firms who have faced challenges involving benzene in their product(s) as they deal with the press, regulatory agencies, and litigation. Please contact us for more information regarding our capabilities.
Galbraith D., S.A. Gross, and D.J. Paustenbach. 2010. Benzene and human health: A historical review and appraisal of associations with various diseases. Crit Rev Toxicol. 40(S2):1-46.
Gross, S.A. and D.J. Paustenbach. 2018. Shanghai Health Study (2001-2009): What was learned about benzene health effects? Crit Rev Toxicol. 48(3):217-251.
Haws, L.C., J.A. Tachovsky, E.S. Williams, L.L.F. Scott, D.J. Paustenbach, and M.A. Harris. 2008. Assessment of potential human health risks posed by benzene in beverages. J Food Sci. 73(4):T33-41.
Hollins, D.M., B.D. Kerger, K.M. Unice, J.S. Knutsen, A.K. Madl, J.E. Sahmel, and D.J. Paustenbach. 2013. Airborne benzene exposures from cleaning metal surfaces with small volumes of petroleum solvents. Int J Hyg Env Health 216(3):324-332.
Paustenbach, D.J., J.S. Knutsen, D.M. Hollins, J.E. Sahmel, A.K. Madl. 2010. Comparison of modeled and measured concentrations of airborne benzene from the use of petroleum-based solvents spiked with low levels of benzene. Chemico-Bio Inter 184:296–298
Williams, P.R.D., J.S. Knutsen, C. Atkinson, A.K. Madl, and D.J. Paustenbach. 2007. Airborne concentrations of benzene associated with the historical use of some formulations of Liquid Wrench. J Occup Environ Hyg. 4(8):547-61.