mdi Consultants
Coronavirus (COVID-19) Update: 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 US to Protect U.S. Consumers
The FDA has just enacted a countrywide product alert on hand sanitizers being imported from Mexico. Many of these products appear to be in violation of US standards and are potentially dangerous or subpotent. This will remain in effect until the FDA has the opportunity to review the safety of these products and can test for methanol (wood alcohol) when the sanitizers advertise ethanol (ethyl alcohol). Methanol can be toxic upon skin absorption and life threatening if ingested.
This is the first time the FDA has had to issue a countrywide import alert for any category of drug product. Heightened scrutiny and detained shipments will be in play during this alert and FDA staff will analyze to determine if these products were manufactured according to US current good manufacturing practice requirements.
Thus far, 84% of Mexico imported alcohol-based hand sanitizers investigated between 4/20-12/20 have failed US compliance requirements. This analysis and the regulations are vital due to the increased usage of these products during the Covid-19 crisis. In fact, greater than 50% of the samples examined so far contained toxic ingredients. The FDA regularly posts a list of those hand sanitizers that consumers should avoid.
After issuing 14 warning letters since July 2020 for distributing tainted hand sanitizer, including misstating FDA approval, and improper manufacturing practices, the FDA is working with Mexican government authorities, manufacturers, and retailers to ensure that potentially dangerous products (in violation of product standards) are not distributed. Manufacturers must test their raw ingredients for labeling specifications to ensure they are free from contaminants. Guidance outlining the agency’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to usage has been made available by the FDA.
Methanol-contaminated hand sanitizers can be very dangerous and according to the FDA can lead to nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, cardiac effects, permanent effects on the central nervous system, hospitalizations, and death. This has been primarily reported to poison control centers and state departments of health. Young children may ingest these products and adolescents and adults who might drink these products as an alcohol substitute are at the greatest risk.
People who have been exposed to contaminated hand sanitizer containing methanol and are experiencing symptoms should contact their local poison control center to seek immediate medical treatment for the potential reversal of the toxic effects of methanol poisoning. Health care professionals, consumers and patients are encouraged by the FDA to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting. For more information, consumers should refer to the FDA’s guidelines on safe use of hand sanitizer as well as a question and answer page.
The FDA normally inspects foreign manufacturers as well as US manufacturers of all drug products for FDA cGMP compliance. Because of Covid-19 the FDA has halted all on-site inspections. All manufacturers will be subject to inspection as soon as the Covid-19 restrictions are lifted.
If you need assistance with understanding the FDA regulations for the manufacturing of drugs and/or if you have any questions about the guidance on testing of alcohol based drug products or the FDA cGMP’s for drug manufacturers, please email mdi Consultants at [email protected] RE: Alcohol.