| FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers Today, in the interest of public health and to protect consumers from potentially dangerous or subpotent hand sanitizers, FDA placed all alcohol-based hand sanitizers from Mexico on a country-wide import alert to help prevent entry of violative and potentially dangerous products from entering the U.S. until the agency is able to review the product's safety. FDA analyses of alcohol-based hand sanitizers imported from Mexico found 84 percent of the samples analyzed by the agency from April through December 2020 were not in compliance with FDA's regulations. More than half of the samples were found to contain toxic ingredients including methanol and/or 1-propanol at unacceptable levels. 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 the entry review, FDA staff will consider any specific evidence offered by importers or manufacturers to ensure hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements. FDA, with its Latin American office, is working with its regulatory counterparts in Mexico. | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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