FDA Temporary GuidelinesYou may not know it, but due to widespread shortages, the FDA has relaxed its regulations to allow more companies to make hand sanitizer. That’s why you may have heard about beer and liquor companies making it. There have also been some cosmetics and perfume companies producing it, too. We’re also seeing unknown manufactures from outside the US importing their products here as well. And for the most part, there isn’t a normal level of regulation happening to ensure it’s all safe, or that these products are effective at all. The FDA and CDC currently recommend that everyone wash their hands frequently to reduce the chances of contracting Covid-19. They also say the next-best option to hand washing is to use a hand sanitizer based on at least a 60% alcohol solution. Once this recommendation was made, alcohol-based hand sanitizer disappeared from store shelves due to people buying it all. Since then, the FDA-approved manufacturers that make hand sanitizer haven’t been able to keep up with demand. Every business that’s open or trying to reopen needs it because we can’t all constantly run to the bathroom to wash our hands. Put simply, it's just more convenient to use hand sanitizer. Hand sanitizers are regulated by the FDA, so in an attempt to increase the supply in the market, it issued temporary guidelines that allow unregistered manufacturers to make it. The guidance also states the FDA will not take action against them as long as they follow their guidelines. This means there is some wiggle room for errors, accidents, and unsafe things to happen and these companies will not need to worry too much about the consequences.
How Hand Sanitizer Is Made
A good way to understand how things can go wrong with unregistered hand sanitizer manufacturers is to look at where the alcohol they use comes from. The manufacturers that make hand sanitizers don’t normally make the alcohol that goes in them. They just combine alcohol they get from another source with moisturizer, possibly a fragrance and some other ingredients, then bottle the product to be distributed and sold. Obviously, the alcohol used in hand sanitizer is an important ingredient. And to allow a lot of new, unregistered companies to make hand sanitizer, there needs to be a lot of alcohol available for them to buy. The only problem is there wasn’t a stockpile available to draw from when Covid-19 struck. So the FDA also relaxed its regulations on manufacturing alcohol for hand sanitizer. This made it possible for fuel ethanol refineries to start producing alcohol for hand sanitizer. And since most people have been staying home in quarantine and not driving much, they jumped at the opportunity to make money during the crisis. You’ve probably already guessed the result hasn’t been as safe as what consumers need it to be. Before Covid-19, most alcohol-based hand sanitizers used isopropyl alcohol. If that sounds familiar, it’s because isopropyl alcohol is the primary ingredient used in rubbing alcohol. Most households keep a bottle to use as a disinfectant and sometimes to put on bumps and bruises. Another way to make a hand sanitizer is to use ethyl-alcohol, which is also known as ethanol. If you’ve ever put gas in a car, you’ve seen a label on the pump that explains its ethanol content. Most ethanol in the US is made from the starch in corn grain. Both isopropyl alcohol and ethyl-alcohol, when used for hand sanitizers, must be distilled to purify them. This process keeps cancer-causing contaminants out of the final product that consumers use. So as long as alcohol manufacturers use a safe distillation process, and check the final product to make sure it’s pure, there shouldn’t be any problems.
We’re Already Seeing ProblemsBy the end of April, the FDA was already sending letters to unregistered hand sanitizer manufacturers and alcohol producers telling them to stop production. The fuel ethanol refineries were not using a process that kept cancer-causing contaminants out of the alcohol they produced. These pollutants had made their way into finished hand sanitizer products that were being sold to consumers. But that doesn’t mean all the other hand sanitizer on the market is safe. The FDA has only stopped production for the products it has learned about. And remember, it is allowing unregistered companies to make hand sanitizer. That means these businesses are not listed with the FDA, so the FDA has no way to know—or regulate—who is making hand sanitizer or the safety of the processes they are using. Keep in mind: there are other ingredients being added to hand sanitizer, which isn’t just limited to fragrance and moisturizer. The FDA currently has no visibility on where those other ingredients are being sourced from. It’s a recipe for disaster. Just look at this photo as an example.
The staff at SONO personally bought the bottles pictured above from gas stations and local stores in California. You can see that they’re not being packaged in a normal way. The bottle on the far left is one that’s typically used for liquor. The one in the middle is typically a water bottle. And the two on the far right look like bottles for lotion. None of the brands are familiar to us or anyone else. Our suggestion: only buy from brands you trust.