FDA Works To Increase Availability Of Alcohol-Based Hand Sanitizer, While Warning About Fraudulent Claims

To confront shortages caused by the ongoing coronavirus outbreak, federal regulators have become more flexible in approving new hand sanitizer products, while still trying to consumers from harm caused by fraudulent claims made by some manufacturers.

In a press release issued on April 27, the FDA announced that 1,500 new manufacturers have registered with the agency to produce alcohol-based hand sanitizers.

The new registrations and flexibility with manufacturing guidelines are designed to ensure public demand for hand sanitizer is met during the COVID-19 pandemic, according to the agency. However, despite the expanded approvals, the FDA warned it is still adhering to certain manufacturing and labeling guidelines to protect consumers from harm and unproven claims.

According to the agency, many manufacturers have questioned the need for denatured alcohol in hand sanitizer. The agency emphasized this requirement is key because denatured alcohol gives hand sanitizer a bitter taste, helping to discourage young children from accidental ingestion.

“While the agency understands the economic and business reasons behind foregoing this step in the manufacturing process, such an approach undermines the agency’s mission of helping to ensure the safety of FDA-regulated products for consumer use, which is the FDA’s top priority,” the press release states. “This approach is consistent with the FDA’s policies prior to the COVID-19 pandemic on including denatured alcohol in hand sanitizer and is even more important now as more consumers rely on its use as a mitigation tool against the deadly virus.”

Calls to poison control centers related to hand sanitizer have increased 79% in recent months, compared to the same time last year. The majority of problems involve unintentional exposures among children under five years old.

If a young child ingests even a small amount, it can lead to serious harm, including vomiting, abdominal pain, coma, seizures, and respiratory depression.

Additionally, the FDA wants manufacturers to adhere to strict labeling guidelines. The guidelines require manufacturers to include a Drug Facts label and clear warnings to keep out of the reach of children.

This month the FDA received a report of a 13-year-old drinking hand sanitizer packaged in a liquor bottle from a distiller. The sanitizer did not contain denatured alcohol so it tasted like normal drinking alcohol and the product did not follow the labeling requirements, so it looked like a regular bottle of alcohol.

The agency also announced it issued a warning letter this month to Pretense LLC, a manufacturer of hand sanitizer, because the company was making false claims regarding the products effectiveness against COVID-19.

According to the FDA the product was sold with misleading claims indicating, “Pretense…protects you from germs with just one application per day! It’s like wearing an invisible glove.” The website also made claims the product can protect from pathogens for up to 24 hours or for 10 hand washes.

Hand sanitizers are not proven to treat COVID-19 and are meant only for external use. They are not meant to be ingested and inhaled.