Added: Deonte Swift - Date: 05.05.2022 20:20 - Views: 23249 - Clicks: 7835
As part of the U. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol also known as ethyl alcohol but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs. Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment.
As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U. This marks the first time the FDA has issued a countrywide import alert for any category of drug product. We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of U. In most cases, methanol does not appear as an ingredient on the product label.
The agency continues to take action to help prevent potentially dangerous or violative hand sanitizers from entering the United States by placing specific products on import alert, proactively working with companies to recall products and encouraging retailers to remove violative products from store shelves and online marketplaces. As part of these actions, the agency has also issued 14 warning letters since July for distributing hand sanitizer with undeclared methanol, inappropriate ethanol content, misleading claims—including incorrectly stating FDA approval—and improper manufacturing practices.
The FDA continues to proactively work with Mexican government authorities, manufacturers and retailers to ensure potentially dangerous or violative products are not distributed to consumers. The agency reminds manufacturers, distributors, repackagers and importers they are responsible for the quality of their products and urges manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination.
Methanol-contaminated hand sanitizers are a serious safety concern, and the FDA is aware of adverse events, including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death, primarily reported to poison control centers and state departments of health.
Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an alcohol substitute are most at risk. Consumers who have been exposed to hand sanitizer contaminated with methanol and are experiencing symptoms should contact their local poison control center and seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning.
Need help now? Call if the person is unconscious or has trouble breathing. Call Poison Help at to connect to your local poison center. The FDA, an agency within the U. 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.
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