For Immediate Release: October 04, 2019 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Norman E. "Ned" Sharpless MD

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Over the past several weeks, the U.S. Food and Drug Administration has been working tirelessly along 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 number of reported cases and deaths, released by the CDC yesterday, continues to underscore the need for us to gather critical information and provide consumers with actionable information to help best protect themselves and their loved ones.

This is why today, we’re strengthening our message to the public in an updated consumer alert stating that they should not use vaping products containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. Additionally, consumers who choose to use any vaping products should not modify or add any substances such as THC or other oils to products purchased in stores and should not purchase any vaping products, including those containing THC, off the street or from other illicit channels.

This is a complex, ongoing and evolving investigation. In addition to our own analyses, we are also diligently reviewing published literature of third-party analyses of samples and data, which are beneficial to our ongoing investigation. At this time, the FDA does not have enough data to identify the cause, or causes, of the lung injuries in these cases. Additionally, while no one compound or ingredient has emerged as a singular culprit, we do know that THC is present in most of the samples being tested. Because of this, the agency believes it is prudent to stop using vaping products that contain THC or that have had any substances added to them, including those purchased from retail establishments. Simply put, inhaling harmful contaminants in the lungs could put a patient’s health at risk and should be avoided.

For those who choose to continue the use of vaping products, particularly those containing THC, we urge you to monitor for symptoms and promptly seek medical attention if you have concerns about your health. We are also continuing to encourage the public to submit detailed reports of any unexpected tobacco- or vaping-related health or product issues to the FDA via the online Safety Reporting Portal. And, importantly, no youth or women who are pregnant should be using any vaping product, regardless of the substance.

This alert builds on initial recommendations the FDA issued several weeks ago and is based on new information we’re continuing to learn from both patients and the samples that have been tested so far. For example, additional testing revealed that a majority of the hundreds of samples of vaping products tested by the states or by the FDA so far have been identified as containing THC. Additionally, according to recent findings, most of the patients impacted by these illnesses reported using THC-containing products, suggesting THC products are playing a role in the these illnesses. That said, some patients have reported using both THC products and nicotine products, as well as a smaller number reporting using only nicotine products. Similarly, testing on the samples collected or received by the FDA shows a variety of products, or product components, with different ingredients or delivery systems making this investigation especially challenging.

Federal, state and local agencies will continue to work as quickly as possible to get to the bottom of what’s causing people to become ill by following up with patients and doctors to collect important details about the products or substances involved, where they were purchased and how they were being used. In particular, the FDA’s work to investigate the illnesses includes sample collections in coordination with states, sample analysis, criminal and civil investigations, and coordination with state and federal partners.

Although these cases present similarly in patients, it is not clear if they have a common cause, or if they have differing pathogenesis with similar presentation. The investigation has not identified any specific substance or product that is linked to all cases. The FDA is using state-of-the-art methods to assess the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids along with opioids, cutting agents/diluents and other additives, pesticides, poisons and toxins. To date, the agency has collected or received more than 440 samples from 18 states – and that number continues to grow. The FDA is working quickly and thoroughly in testing the samples, prioritizing those associated directly with patient illnesses. More than half of the vaping liquid products have undergone some form of evaluation, with additional testing on these and other samples continuing daily.

We are leaving no stone unturned in following all potential leads regarding any particular product, constituent or compound that may be at issue. In that spirit, the FDA’s Office of Criminal Investigations (OCI) began parallel investigative efforts shortly after the emergence of the associated illnesses.

Our OCI agents are focused on identifying the products that are making people ill and following the supply chain to the source. We are not pursuing any enforcement actions associated with personal use of any vaping products; our interest is in the suppliers. And as I previously said, if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act. We are prepared to use our authorities to the fullest extent possible, and will work with other federal, state and local authorities to take appropriate action as the facts emerge in order to protect the public health.

What we’ve learned so far is that this ongoing investigation is complex and evolving. Every day we’re gathering more information, and every day we seek to use that information to better understand the relationship between any specific products or substances and the reported illnesses.

We’re committed to working to answer these and other critical questions as quickly as possible, but we also recognize that it will likely take some time. Importantly, the demographic diversity of the patients, as well as the products or substances they’ve reported using and the samples being tested may mean there are multiple causes of these illnesses—some of which may escape us or may never be fully understood.

As this complex investigation continues, we urge consumers to take heed of our warning and stop using THC vaping products, and to not use vaping products of any kind that are purchased off the street or from unknown sources. And we remain steadfast in our commitment to work with our federal, state and local partners to identify the cause or causes of these illnesses.

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.

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Inquiries Media: Stephanie Caccomo 301-348-1956 Consumer: 888-INFO-FDA

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