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Know your components: FDA recalls, the Covid-19 pandemic, and unexpected ingredients

The past few weeks we have been tracking the increase of recalled hand sanitizer products by the FDA.

These recalls are the result of consumer complaints and the FDA (US Food and Drug Administration) finding a highly toxic form of alcohol present in the recalled products. Usually, alcohol-based hand sanitizers commonly use forms of alcohol proven safe for skin contact and use in hand sanitizer. Ethanol [CAS RN 64-17-5]—also known as ethyl alcohol—or isopropanol [CAS RN 67-63-0] also known as isopropyl alcohol and 2-propan-ol, are the commonly used alcohol active ingredients in hand sanitizer products.

Ethanol, the alcohol also found in adult beverages, is also used in many other applications, including hand sanitizer, but also as a fuel additive, and as a cleaning solvent. In these industrial applications, ethanol can include a second alcohol, methanol (aka wood alcohol), as an additive to render it poisonous.

In the rush to meet demand for hand sanitizers in response to the Covid-19 pandemic, some producers have not adequately screened their sources of ethanol. In some of these cases, hand sanitizers have been found with methanol present, making the product toxic if applied to skin and resulting in recalls.

This situation and the resulting FDA product recalls present an acute example of the need for formulators to fully understand the ingredients and impurities present in the components sourced for finished products.

To illustrate this point, you can find below an example Assessment Detail Report from SciveraLENS® Rapid Screen, presenting Scivera toxicologists’ verified chemical hazard assessment (CHA) results across 23 human and environmental endpoints. Can you tell which chemical is methanol and thus unacceptable as a hand sanitizer ingredient?

Hand Sanitizer Assessment Results

In SciveraLENS® reports, red indicates high hazard and black indicates very high hazard. The column heading abbreviations of atd, ati, and ato, are the Acute Toxicity endpoints for Oral ingestion, Dermal (skin) contact, and Inhalation. All three are high hazard for methanol. The column headings n and st are for Neurotoxicity and Systemic Toxicity. Both are very high hazard for methanol.

SciveraLENS® makes it easy for companies to achieve critical toxicology transparency from suppliers. Many retailers, brands, and formulators use SciveraLENS® to request component chemical information from suppliers to quickly and easily screen formulations against relevant lists, but also to see the deep toxicological insight on each chemical ingredient and impurity provided by Scivera’s toxicologists. Using SciveraLENS suppliers can deliver assessment results to customers while protecting trade secret ingredient information via a redacted report.

In addition, suppliers can subscribe to SciveraLENS to review assessment results and explore safer alternatives to chemicals of concern as part of this process.

You can take a free test drive of SciveraLENS® today to compare alternative chemicals and to see how you can engage your suppliers to achieve ingredient and impurity assessment transparency while protecting confidential information.

[photo credit: Kelly Sikkema on Unsplash]