FDA in Brief: Readout of Acting FDA Commissioner Ned Sharpless, M.D., Visit to FDA’s Forensic Chemistry Center
October 11, 2019
“Over the past several weeks, FDA staff has worked with the U.S. Centers for Disease Control and Prevention (CDC) and other federal, state and local partners to investigate the distressing incidents of severe lung injuries and deaths associated with the use of vaping products. The latest numbers of reported cases and deaths underscores the need for us to gather critical information to address this outbreak,” said Acting FDA Commissioner Ned Sharpless, M.D. “From my visit to the FDA’s Forensic Chemistry Center today, I was able to see firsthand the efforts of our highly skilled staff who are working tirelessly to analyze samples in order to find answers about the cause or causes of these concerning illnesses. I was impressed with the breadth of experience our forensic chemists are bringing to this task and the cutting-edge technologies they are using, from rapid-response table-top instruments that can quickly identify contaminated or counterfeit products to large, highly complex mass spectrometers that can analyze products with incredible molecular precision. Our staff at the Forensic Chemistry Center have been cataloguing and testing samples for weeks to better understand the relationship between any specific product or substance and the reported illnesses. While we’re committed to answering these critical questions as quickly as possible this ongoing investigation is complex and evolving, especially given the demographic and geographic diversity of patients, the number of products associated with the outbreak, and the illicit nature of many of the substances being used. We will continue to share the results of our investigations with state and federal partners as well as consumers as quickly as possible. Because the majority of samples we have analyzed contain THC and because the majority of patients report vaping THC products, we are urging consumers to heed our warning not to use vaping products that contain THC, not to use vaping products of any kind obtained off the street or from unknown sources, and not to modify or add any substances, including THC or other oils, to vaping products.”
Today, Acting U.S. Food and Drug Administration Commissioner Ned Sharpless, M.D., visited the FDA’s Forensic Chemistry Center in Cincinnati, Ohio, to highlight the work being done by the agency’s staff to investigate the incidents of lung illnesses following vaping product use.
The Forensic Chemistry Center serves as the FDA’s premier national forensic laboratory for method development, research, and analyses related to criminal and regulatory investigations. The center is an accredited laboratory that provides expert technical support and analyses for the FDA’s Office of Criminal Investigations and for many high-profile and emergency FDA regulatory samples to protect consumers from fraudulent and harmful products. The center has a history of playing an important investigative role in major FDA investigations in the past, including contaminated medical and food products.
The Forensic Chemistry Center is playing a critical role in fact-gathering and analysis. With assistance from state health departments, the Forensic Chemistry Center is using state-of-the-art methods to assess collected samples for the presence of a broad range of chemicals including nicotine; tetrahydrocannabinol (THC) and other cannabinoids; opioids; cutting agents and other additives; pesticides, and toxins. The samples collected, at this time totaling more than 725, include vaping devices and products that contain liquid, packaging and nearly empty containers. Samples are being collected directly from consumers, hospitals, and from state offices. More than half of the vaping liquid products have undergone some form of evaluation, and additional testing on these and other samples continues daily. Many samples have contained little to no liquid, which limits the number and types of tests that are able to be conducted on each submission. The testing of the samples shows a mix of results and no one substance has been identified in all of the samples tested.
If any consumer experiences a problem with any tobacco product, such as an unexpected health or safety issue, the FDA encourages reporting online using the Safety Reporting Portal. The FDA website has more information on what to include in a report.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.