For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take 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. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.
Methanol is a nondrinking type of alcohol (also known as wood alcohol and methyl alcohol) which is mostly used to create fuel, solvents and antifreeze. A colorless liquid, it is volatile, flammable, and unlike ethanol, poisonous for human consumption. Methanol is also used to produce a variety of other chemicals, including acetic acid.
Since the advent of the COVID-19 pandemic, roughly a year ago, the importation of hand sanitizers into the United States has increased dramatically. As the importation of hand sanitizers sky-rocketed, so did importations of toxic, or tainted products. In particular, there has been a concerning rise in the use of methanol to produce hand sanitizers in Mexico.
In order to combat this potential public health crisis, the FDA has issued multiple warning letters to hand sanitizer producers since July. According to the FDA, however, analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA’s regulations, and more than 50% of samples were found to contain toxic ingredients at dangerous levels.
To further its effort in stopping violative products from entering the US, the FDA has now placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert. The import alert ensures that all shipments of imported hand sanitizer from Mexico are detained without physical examination (DWPE) upon entry into the U.S. For tips on getting off the Import Alert (AKA the Black List) see “How to Get Off the FDA ‘Black List’.”
Although the FDA now has more authority to identify these products, it stated in the import alert that it “reminds manufacturers, distributors, repackagers, and importers they are responsible for the quality of their products and urge manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination”. In order to aid the public in this effort, the FDA published a guidance document, which outlines the FDA’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.
For more information on FDA Import Alerts or assistance in requesting to be removed from an Import Alert, contact us today at info@diaztradelaw.com or 305-456-3830.
