FDA stops Hand Sanitizers with too low Alcohol Content at the US Border

Hand hygiene is an important part of the response to COVID-19. The Centers for Disease Control and Prevention (CDC) recommends that, if soap and water are not readily available, consumers use an alcohol-based hand sanitizer. Such an alcohol-based hand sanitizer must contain not less than 60% alcohol (ethanol) as the minimum active ingredient concentration.

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product called "Instant – Hand Sanitizer – Moisturizing" was detained and refused admission at the border because the active ingredient of ethanol was present at levels in the product lower than that which was declared on its label.

In a Warning Letter dated February 3, 2021, the FDA states that this drug product was declared to be manufactured by ShangRao Chunyu Technology Co., Ltd. in China. The product was labeled to contain 75% of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 58% ethanol volume.

The FDA came to the conclusion that the quality assurance within the company's facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements. In response to the Warning Letter, the FDA requests, besides others,

  • a detailed investigation into how the hand sanitizer drug product, which was labeled as containing 75% ethanol, in fact contained 58% ethanol,
  • a list of all raw materials used to manufacture the hand sanitizer drug products,
  • a third-party analysis using validated test methods for ethanol content for all batches distributed to the United States.

Moreover, the FDA requires "a complete, comprehensive, and independent assessment" of the companies' "laboratory practices, procedures, methods, equipment, documentation, and analyst competencies."

Based upon the nature of the violations, the FDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements. If the company wants to manufacture drugs for the United States in the future, a Regulatory Meeting to discuss corrective actions is required.

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