FDA to allow small amounts of cancer-causing chemicals in sanitizers to meet demand amid coronavirus pandemic
The US Food and Drug Administration (FDA) said it would temporarily permit manufacturers to make sanitizers, bearing small quantities of impurities, including those that cause cancer, to meet the demands amid pandemic. The harmful chemicals were found as contaminants in a key ingredient: ethanol.
As coronavirus began gaining a foothold in the US, companies that were making ethanol for gasoline decided to produce them for hand sanitizers, instead. But the repurposed ethanol for hand applications contains impurities, forcing the federal agency to place restrictions in April. Now, the FDA has walked back on its restrictions in the face of growing demands. Against this backdrop, the FDA introduced the new regulations to provide further clarity on impurity limits for these manufacturers.
"Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the Covid-19 public health emergency," the FDA wrote on its website.
"As with everything we do, the FDA is committed to ensuring that we appropriately balance risk and benefit. We believe that our temporary guidance sets the proper level of flexibility at the current time to help protect Americans during this public health emergency," they added.
The ethanol produced by fuel ethanol manufacturers contains harmful chemicals, including benzene which is capable of causing cancer, the FDA found. According to the American Cancer Society, people can expose themselves to this harmful chemical through inhalation and absorption through the skin.
The FDA said it was working with industry to ensure that harmful levels of impurities are not present. Currently, about 27 plants are producing ethanol for sanitizers. The FDA guidance allows up to 2 parts per million (ppm) of benzene and 50 ppm of acetaldehyde. Geoff Cooper, the President of the Renewable Fuels Association, which represents the ethanol industry, said the limits are overly restrictive.
“We do not believe the new guidance will help alleviate the hand sanitizer shortage in any meaningful way,” he told Reuters. He further defended the industry, saying that ethanol produced by the fuel industry for sanitizers or other products does not contain benzene at any level. The pandemic has hit the fuel industry. Cooper earlier told Reuters that restrictions had halved the ethanol industry’s production capacity. As a result, they shifted focus to the sanitizer industry.
However, the federal agency recommends handwashing with soap and water. If the option is unavailable, the Centers for Disease Control and Prevention (CDC) recommends alcohol-based hand sanitizers that contain at least 60% alcohol. A preliminary study found that the World Health Organization's (WHO) DIY sanitizer recipe containing ethanol could effectively kill the new coronavirus. Furthermore, the team observed that the virus is sensitive to concentrations as low as 30%.
But WHO's formulations have a limitation: they take 30 seconds to kill the virus, making them impractical to use. "The defined inactivation time of exactly 30s, which is the time recommended but not routinely performed in practice," the authors of the study said.