Adam Lanzarotta earned a B.S. in forensic science from Eastern Kentucky University in 2005 and a Ph.D. in analytical chemistry from Miami University in 2010. He has been a member of the FDA Forensic Chemistry Center (FCC) Trace Examination Section (TES) for twelve years where he has been responsible for examining unknown, unapproved and misrepresented products under FDA purview for evidence of tampering, adulteration, counterfeiting and diversion, including over 500 adulterated e-liquid samples that were linked to the 2019 vaping crisis. Research interests include developing laboratory- and field-based methods to examine these types of products using a wide variety of vibrational spectroscopic instrumentation (e.g. macro, micro and imaging infrared and Raman spectrometers). Current projects include 1) helping to oversee FDA’s initiative to establish satellite laboratories at international mail facilities (IMFs) so that suspect imported drug products can be examined on site, 2) developing field-friendly methods that require little-or-no sample preparation to detect higher-concentration APIs in suspect products received at IMFs using handheld and field-portable vibrational spectroscopic instrumentation, and 3) creating field-friendly surface enhanced Raman scattering (SERS) spectroscopy methods using handheld spectrometers that require minimal sample preparation to detect lower-concentration APIs in samples received at IMFs.
The FDA Forensic Chemistry Center’s Role in the 2019 Vaping Crisis
Adam Lanzarotta, Travis M. Falconer, Rick Flurer, Robert A. Wilson, John Lynch, Lisa Lorenz, Jana L. Brueggemeyer, Laura Ciolino, Tracy Ranieri, Michael Thatcher, Martin Kimani, Mark Witkowski and Merrie Jackson, US Food & Drug Administration, Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, Cincinnati, OH 45237
According to the Centers for Disease Control and Prevention (CDC) 2,807 cases and 68 deaths related to e-cigarette, or vaping, product use associated lung injury (EVALI) have been reported in the United States as of February 25, 2020. Clinicians first linked this illness to vaping in September 2019 but a diagnosis has been debated. However, on November 8, 2019, CDC reported that vitamin E acetate (VEA) was detected in bronchoalveolar lavage (BAL) fluid samples received from 10 states in 29 out of 29 patients with EVALI.1,2 From this study and an additional follow-up study3 they concluded that “these findings provide direct evidence of vitamin E acetate at the primary site of injury within the lungs.” The FDA’s Forensic Chemistry Center (FCC) was tasked with examining the e-liquid products for major constituents, and the presence of diluents, pesticides, poisons, heavy metals and toxins using a combination of non-targeting and targeted screening methods. Based on the results of the screening methods, FCC focused on developing targeted analyses to identify and later quantify diluents such as vitamin E acetate (VEA) and medium chain triglycerides (MCT). In addition to examining e-liquid removed from these devices, this laboratory also examined vaped e-liquids and the aerosol produced from vaporizing the mixture to determine additional compounds that may be produced during the vaping process. This presentation will focus on the FCC’s role during the vaping crisis, which will include methods, results and trends with regard to the analysis of e-liquid-containing vaping products obtained during the investigation.
1. Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products, https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html (accessed August 20, 2020).
2. Blount, B. C.; Karwowski, M. P.; Morel-Espinosa, M.; Rees, J.; Sosnoff, C.; Cowan, E.; Gardner, M.; Wang, L.; Valentin-Blasini, L.; Silva, L.; et al. Morb. Mortal. Wkly. Rep. 2019, 68 (45), 1040−1041.
3. Blount, B. C.; Karwowski, M. P.; Shields, P. G.; Morel-Espinosa,M.; Valentin-Blasini, L.; Gardner, M.; Braselton, M.; Brosius, C. R.; Caron, K. T.; Chambers, D.; et al. N. Engl. J. Med. 2020, 382, 697-705.