The Food and Drug Administration (FDA) has just issued an import alert against a number of hand sanitizer products that are coming from Mexico, following reports that the products are crossing the borders before they can be reviewed by the FDA.
The notice was posted on the FDA website Tuesday, which stated that the agency is taking action to place all alcohol-based hand sanitizers coming from Mexico on import alert in order to help in preventing the entry of "violative and potentially dangerous products" into the U.S.
The agency has noted a sharp increase in hand sanitizers from Mexico entering the U.S. due to the pandemic. The sanitizers were labelled as ethanol or ethyl alcohol based, however, the sanitizers tested positive for methanol contamination.
The FDA stated that methanol, otherwise known as wood alcohol, can be toxic when absorbed by the skin. It can even be life-threatening when ingested. Hence, this ingredient is not among the acceptable components of hand sanitizers or drugs.
The import alert noted that there will be tougher scrutiny on these products and that FDA personnel may be able to detain a shipment. However, the FDA will also be giving consideration to specific evidence that will be presented by manufacturers or importers, which would prove that the manufacture of the products follows the stringent requirements of the U.S.
Judy McMeekin, FDA Associate Commissioner for Regulatory Affairs said that the action of the agency is necessary to "protect the safe supply of alcohol-based hand sanitizers." She promised that the agency will continue working with stakeholders to ensure that only safe products are made available.
From April to December 2020, the agency analysed alcohol-based hand sanitizers that were imported from Mexico. They found out that 84 percent of the samples were not compliant with the regulations of the agency. More than 50 percent of the samples contained toxic ingredients like methanol, and were at dangerous levels.
There were already 14 warning letters that the FDA sent since July 2020. The letters warned against the distribution of hand sanitizers with methanol but were not declared as an ingredient, as well as hand sanitizers that had inappropriate ethanol content.
According to the CDC, ingestion of methanol may cause different adverse health effects. It can lead to neurological symptoms like dizziness, headache, and agitation. It could also cause gastrointestinal issues like vomiting and nausea.