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                Tobacco Science & Research

Tobacco Science & Research

                        Safety Reporting Portal for Tobacco Products
          Tobacco Product Problem Reports
          Tobacco Regulatory Science Research Program


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          Tobacco Science & Research
          Tobacco Product Problem ReportsTobacco Science & Research Tobacco Product Problem Reports
  
  	
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What tobacco product problem reports have been submitted to FDA?
	Why is FDA posting this information?
	What should I know about the information posted here?
	How do I request a copy of an original report?
	How do I report a problem with a tobacco product?
	How can I get a tobacco product tested and find out what is in it?
	How do I report other concerns about tobacco products and tobacco product regulation?What tobacco product problem reports have been submitted to FDA?

Consumers, manufacturers, and health professionals submit reports about tobacco products that are damaged, defective, contaminated, smell or taste wrong, or cause undesireable health effects.* These reports are posted quarterly below, and also available for the public on openFDA.

**Download summary reports (compiled quarterly)***also available on openFDA

2023 July 1 - September 30
	2023 April 1 - June 30
	2023 January 1 - March 31
	2022 October 1 - December 31
	2022 July 1 - September 30
	2022 April 1 - June 30
	2022 January 1 - March 31
	2021 January 1 - December 31
	2020 January 1 - December 31
	2019 January 1 - December 31
	2018 January 1 - December 31
	2017 January 1 - December 31Peer-Reviewed Publications Using Data from CTP’s Voluntary Adverse Experience Reports
	**Peer-Reviewed Publications Using Data from CTP’s Voluntary Adverse Experience Reports***(in Chronological Order)*

Chen I-L. FDA Summary of adverse events on electronic cigarettes. *Nicotine & Tobacco Research*. 2013;15(2):615-616.
	Yang L, Rudy SF, Cheng JM, Durmowicz EL. Electronic cigarettes: incorporating human factors engineering into risk assessments. *Tobacco Control*. 2014;23(suppl 2):ii47-ii53.
	Durmowicz EL. The impact of electronic cigarettes on the paediatric population. *Tobacco Control*. 2014;23(suppl 2):ii41-ii46.
	Durmowicz EL, Rudy SF, Chen I-L. Electronic cigarettes: analysis of FDA adverse experience reports in non-users. *Tobacco Control*. 2016;25(2):242-242.
	Rudy SF, Durmowicz EL. Electronic nicotine delivery systems: overheating, fires and explosions. *Tobacco Control*. 2017;26(1):10-18.
	Weidner A-S, Rudy SF, Faulcon LM. Comment on Does vaping cause seizures? The need for comprehensive drug testing. *Clinical Toxicology*. 2019:1-2.
	Faulcon LM, Rudy S, Limpert J, Wang B, Murphy I. Adverse experience reports of seizures in youth and young adult electronic nicotine delivery systems users. *Journal of Adolescent Health*. 2020;66(1):15-17.

**Reports specific to electronic nicotine delivery system products (also known as ENDS, e-cigarettes or vapes)**

**Neurological events and e-cigarette use reports submitted 9/27/2011-6/30/2019**:The agency has identified additional reports of seizures or other serious neurological symptoms, including fainting or tremors, which may or may not be related to seizures. This does not necessarily indicate an increase in frequency or prevalence of such incidents. FDA has not identified any specific brand of tobacco product or product problem associated with these incidents. The agency is continuing to seek information to better understand the association between e-cigarette use and neurological events. FDA encourages the public to include as much detail as possible when reporting any adverse experience.

	View full redacted reports**Seizures and e-cigarette use reports submitted 12/19/2010-3/20/2019:**Since June 2018, the FDA observed a slight but noticeable increase in reports from people who use e-cigarettes and have experienced seizures. Many of these reports involve youth or young adult e-cigarette users. The FDA is continuing to seek more information about seizures following e-cigarette use to identify common risk factors and understand if any e-cigarette product attributes such as nicotine content or formulation may contribute to seizures.

	View full redacted reports
	**View reports about ENDS products submitted from 2009 - 2014, requested via FOIA.**
	Adverse Events 10/5/13 to 3/12/14
		Adverse Events 6/25/13 to 10/5/13
		Adverse Events 6/22/2009 to 6/25/13****Note***: Full redacted reports and summary reports with overlapping dates contain duplicate information. The posted data does not include information submitted by researchers, information submitted by manufacturers in response to FDA requirements or information reported as a potential tobacco product violation of the Tobacco Control Act.

Why is FDA posting this information?

FDA is making reports about tobacco product problems available on the website and in our openFDA database so the public can more easily access this information. The reports allow interested parties to learn more about commonly reported potential tobacco product problems. Previously, tobacco-associated health and product problems reported to FDA were available to the public upon request under the Freedom of Information Act (FOIA). Currently, these reports are made publicly available and posted quarterly to the Tobacco Product Problem page.

What should I know about the information posted here?

**Report identification (ID) numbers in summary reports**are randomly generated.
	**The information in summary reports comes directly from the submitted reports.**The posted information is directly from the submitted reports, without editing, and does not reflect analysis by FDA.
	**Submitted information may be inaccurate or incomplete**. Reports to FDA may include inaccurate or incomplete information. For example, reports may not include information about whether the product was used correctly, or whether an individual also suffered from other medical conditions or used other tobacco products or medications at the same time.
	**FDA has not determined causality**. The inclusion of a report in this collection does not represent any conclusion about whether the product caused the adverse experience or simply coincided with it.
	**Reporting adverse experiences is voluntary.**Information posted on this web page is from voluntarily submitted reports.
	**This adverse experience information cannot be used to estimate risk or incidence rates, or to compare products**. Reporting rates have many influences and vary over time. The volume of use or exposure to specific tobacco products is generally not well characterized. Therefore, the accumulated reports cannot be used to calculate incidence (occurrence rates), to estimate risk, or to compare products.
	**Report content may change over time**. Individuals reporting a problem with a tobacco product may correct or update their reports at a later date. Therefore, the content of reports may change after posting. FDA only posts information from initial reports.How do I request a copy of a submitted report?

If you submitted the report, you may view your submission by following the instructions found in the Frequently Asked Questions about the Safety Reporting Portal, see How do I view a submitted report?

You canrequest a copy of reportsfiled submitted by others under the Freedom of Information Act. Per the provisions of the FOIA and the Privacy Act, access to personally identifiable information cannot be given to unauthorized third parties without the individuals' written consent and will not be included in the responses to these requests.

How do I report a problem with a tobacco product?

Anyone can report a problem with any tobacco product, including damaged, defective, or contaminated tobacco products, or tobacco products that may have caused health or safety problems.

Report a tobacco product problem using the Safety Reporting Portal using its tobacco questions.

How can I get a tobacco product tested to find out what is in it?

You may wish to contact an independent testing laboratory. Your county or state health department or your state colleges and universities may be able to help you to find product testing laboratories that could meet your needs.

FDA may conduct focused product sample testing as part of a coordinated probe of a national public health threat. FDA informs the public of such probes through the media and through situation-specific web pages that may contain sample submission information.

How do I report other concerns about tobacco products?

Report a potential tobacco-related violation such as sales to minors, flavored cigarettes, or illegal marketing or advertising via the Potential Tobacco Product Violations Reporting System
	Report a human health or product problem with a product that claims to help with quitting tobacco to MedWatch Voluntary Reporting
	Report animal drug side effects and product problems affecting an animal
	Submit comments on tobacco products and proposed regulation
	Send a complaint about CTP, an existing tobacco law (final regulation), or the government (CTP Ombudsman)
	Share tobacco product information not related to health or a product problem by contacting the product’s manufacturer or contact CTP
	Send other questions or concerns related to tobacco products to CTPAdditional Resources

Tobacco Product Adverse Event Reporting at openFDA
	Safety Reporting Portal for Tobacco Products
	CTP FOIA Electronic Reading Room
	How to Make a FOIA Request
	FDA Freedom of Information Act Information
	Problems with Tobacco Products: Consumer Update
	FDA Information on Tobacco Products

                                                                                  Content current as of:
      10/31/2023
              
              
Regulated Product(s)
		 TobaccoTobacco Science & Research

          
                        Safety Reporting Portal for Tobacco Products
          Tobacco Product Problem Reports
          Tobacco Regulatory Science Research Program


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