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Health professionals, consumers, and patients are encouraged to voluntarily report observed or suspected adverse events related to human medical products to the NoPEG Project. Voluntary reporting plays a crucial role in helping the NoPEG Project identify previously unrecognized risks associated with PEG and other approved medical products and substances. You can submit reports through our online reporting portal or by downloading, completing, and submitting NoPEG Project Form 001 (For Health Professional) or 002 (Consumer/Patient) to NoPEG Project Safety Information and Adverse Event Reporting Program.
While providing contact information is not mandatory, the NoPEG Project encourages reporters to do so, as it may be necessary for gathering additional information. Please note that reporters have the option to request that the NoPEG Project not disclose their contact information to the manufacturer within the report.
Begin Online Report
Thank you for taking the time to submit a NoPEG report. If you wish to download and print a copy of your report please review the NoPEG Voluntary Report Frequently Asked Questions.
NoPEG Online now allows reporters to start a report and complete it within 3 days. Reporters can save an incomplete report and provide an email address to receive instructions on how to complete & submit a report with Report ID and Report Date.
Information You Should Report to NoPEG
- Unexpected side effects or adverse events can include everything from skin rashes to more serious complications.
- Product quality problems such as information if a product isn’t working properly or if it has a defect.
- Product Use/Medication Errors that can be prevented. These can be caused by various issues, including choosing the wrong product because of labels or packaging that look alike or have similar brand or generic names. Mistakes also can be caused by difficulty with a device due to hard-to-read controls or displays, which may cause you to record a test result that is not correct.
- Therapeutic failures. These problems can include when a medical product does not seem to work as well when you switch from one generic to another.
Types of FDA Regulated Products You Can Report Through NoPEG
- Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
- Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.
- Medical devices such as diabetes glucose-test kit, hearing aids, breast pumps, and many more products.
- Combination products such as prefilled drug syringe, auto-injectors, metered-dose inhalers, contact lens coated with a drug and nasal-spray.
- Special nutritional products such as dietary supplements, medical foods and infant formulas.
- Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes and tattoos.
- Food such as beverages and ingredients added to foods.
Where to Report Other FDA Regulated Product Safety Information
Other products that the FDA regulates such as Tobacco Products, Vaccines and Animal/Livestock medicine and feed utilize different reporting pathways. It is recommended that reports concerning these products be submitted directly to the appropriate portals below.
- Tobacco, E-cigarettes or Vaping: Report problems or adverse health events and tobacco product problems, include problems with e-cigarettes (also known as “vapes”), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus. Report issues to the Safety Reporting Portal.
- Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html.
- Animal Drug, Device, Pet Food and Livestock Feed Problems (pet food and livestock feed): For information on how to report visit www.fda.gov/vetproductreporting.
Note that submissions for these products through NoPEG will be accepted and directed to the correct center or office.