In February 2021, the U.S. Food and Drug Administration (FDA) issued an import alert on all alcohol-based hand sanitizers from Mexico. This means that most hand sanitizers exported to the United States from Mexico will be detained at the U.S. port of entry regardless of whether they are compliant with FDA requirements. This marks the first time FDA has issued a country-wide import alert for a drug product.

Most hand sanitizers are classified as over-the-counter (OTC) drugs by the FDA. During the COVID-19 pandemic, the demand for hand sanitizers greatly increased, so FDA created several temporary policies to allow non-traditional companies to create alcohol-based hand sanitizers. Facilities producing and selling hand sanitizers under these policies are still required to register with FDA and follow certain FDA guidelines, specifically those regarding the ingredients in these hand sanitizers.

Basis for Import Alert 62-08

Import Alerts occur when FDA notices a pattern of non-compliance from a particular company, country, or product type. All shipments of products listed on an Import Alert are subject to Detention Without Physical Examination (DWPE).

FDA issued Import Alert 62-08: Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico due to many sanitizer imports from Mexico containing unacceptable levels of methanol.

According to the alert, FDA found that 84% of sanitizers they sampled from Mexico were non-compliant. Of the 112 samples FDA tested, more than half contained dangerous amounts of methanol. Both isopropyl alcohol and ethyl (containing ethanol) alcohol sanitizers are safe for use. Methanol is a poisonous variant of alcohol. When absorbed through the skin, methanol can lead to blindness and other serious health concerns, and when ingested it can cause death.

With more people using alcohol-based hand sanitizers due to the pandemic, FDA has increased scrutiny on these products. FDA has continued issuing recalls for non-compliant hand sanitizers and has also issued 14 Warning Letters for hand sanitizer products since July 2020.

What This Means for Importers and Exporters

Import Alerts can cause major delays and costs for both importers and exporters. Import Alert 62-08 will apply to all sanitizers being shipped from Mexico to the U.S., including those that were manufactured in another country and sent to Mexico for labeling or other purposes before being shipped to the United States. Exporters of hand sanitizers from Mexico are now required to provide evidence that every shipment of sanitizers are manufactured under Current Good Manufacturing Practices (CGMPs) to be permitted entry into the US.

FDA often requires that shipments under Import Alert be held at the U.S. port of entry until the Agency decides whether to allow the shipment to proceed.  Many holding facilities will charge fees for holding a shipment at the border after a certain period of time. Who pays these fees is determined by the contract between the importer and exporter, but the costs can add up quickly.

For exporters, it is imperative to follow the necessary CGMPs in advance of shipping that will allow products to move more quickly through U.S. Customs. Without proper documentation of compliance with FDA’s temporary sanitizer policies, your products may be rejected and destroyed. Mexican hand sanitizer manufacturers may petition to be placed on the Green List for this alert, which will exempt their sanitizers from DWPE. The petition process for Import Alert 62-08 requires the company to provide records of all active ingredients in the sanitizer, records of the manufacturing site, proof that the hand sanitizer and the facility it is crafted in are meeting compliance standards, and more. Until a manufacturer is on the Green List, every one of their sanitizer shipments may be stopped at the U.S. port of entry. Cyan Labs S.A. de C.V. is currently the only establishment on the Green List for this alert.

If an importer wishes to continue buying from a supplier exporting from Mexico, it is important to make sure that the supplier has written evidence that they are following the proper CGMPs or is on the Green List. Even for suppliers with documentation, importers should expect delays and potential holding fees to account for FDA’s time spent reviewing of the shipment.

In many cases, it may be prudent for importers to seek alternative sources for sanitizer products. Registrar Corp’s FDA Compliance Monitor  can help evaluate a potential supplier’s compliance status, by informing you of whether the supplier is on an import alert, has a warning letter, and more. By verifying your new suppliers’ compliance statuses before importing from them, you can make informed buying decisions and reduce the risk that your shipments will be delayed or refused at entry to the US.

For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.