The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. The press release notes that alcohol-based hand sanitizers from Mexico will now be subject to heightened scrutiny and potential detainment by FDA staff.
Import alerts allow FDA field staff to detain without physical examination products that appear to be in violation of the law. Notably, this is the first time FDA has issued a countrywide import alert for any category of drug product.
The import alert (Import Alert 62-08) follows a June 2020 FDA Advisory Notice to avoid certain hand sanitizer products manufactured in Mexico because they may contain methanol, a substance that can be toxic when absorbed through the skin and life-threatening when ingested. For this reason, FDA recently issued guidance requiring the testing of alcohol in hand sanitizers for methanol. The press release notes that, from April through December 2020, FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed did not comply with regulations. Further, over half of the samples were found to contain toxic ingredients.
Over-the-counter (OTC) hand sanitizer products are regulated pursuant to a temporary policy on the production of hand sanitizers during the COVID-19 pandemic and an OTC drug tentative final monograph. Both strictly limit the active ingredients that may be used in the manufacture of OTC alcohol-based hand sanitizers. Under the Federal Food, Drug and Cosmetic Act (FFDCA), manufacturers, distributors, repackagers, and importers are responsible for the quality of their products and for ensuring they are made under good manufacturing practices. They may be subject to FDA enforcement action if the products are adulterated or misbranded.
The imposition of the import alert will disrupt global supply chains for hand sanitizers, not only with regard to products manufactured in Mexico but also with regard to increased demand for other products from other global suppliers. Wholesalers, private label distributors, and retailers with suppliers in Mexico will need to consider their legal options under their supply contracts and assess their access to alternative sources. Products from Mexico that have not yet entered U.S. commerce or are being held by customs will not be able to enter under Import Alert 62-08. Further, import alerts frequently remain in place for years, so it is likely this policy will not be revoked by FDA in the short term.
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