NORF 20 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use NORF 20, a product promoted for weight loss. This product was identified during an examination of international mail shipments. FDA laboratory analysis confirmed that NORF 20 contains acetaminophen, salicylic acid, and theophylline.
Acetaminophen is an active ingredient used to reduce pain and fever that is found in many prescription and over-the-counter (OTC) drug products. Use of the product NORF 20 poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. Victims of unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.
Salicylic acid is an active ingredient found in many prescription and OTC drug products. If ingested, salicylic acid can cause side effects including nausea, vomiting, and stomach discomfort. In addition, children or teenagers who ingest salicylic acid or other salicylates may risk developing Reye’s Syndrome, a rare but serious illness that causes swelling of the brain and liver damage. Children, teenagers, or adults should not ingest products with salicylic acid or salicylates without consulting a healthcare provider.
Theophylline is an active ingredient in FDA-approved prescription medicine used to prevent and treat breathing problems caused by asthma, chronic bronchitis, emphysema, and other lung diseases. Use of NORF 20 poses a serious threat to consumers because it may result in toxic levels of theophylline in the blood, which can lead to death. Signs of theophylline toxicity include, but are not limited to nausea, vomiting, stomach pain, agitation, irritability, heart rhythm problems (cardiac arrythmias), breathing problems, tremors, hallucinations, and seizures.
Healthcare professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or:
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
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