Revelations of another carcinogen in hand sanitizers puts more pressure on manufacturers

More than a year after the start of the COVID-19 pandemic, hand sanitizers are making headlines again. This time there are new revelations about the existence of high levels of the carcinogen benzene in sanitizers widely available to the public. An analysis by online pharmacy, Valisure of 260 sanitizer products from 168 brands revealed that 17% contained detectable levels of benzene. An alarming 8% tested above the temporary limit the Food and Drug Administration (FDA) set on an emergency basis at the start of the pandemic. Benzene is now the third toxic ingredient that has been found in hand sanitizer products in a little over a year.

Methanol and 1-Propanol were the first to be discovered in August of last year. While these incidents are newsworthy, they are not surprising. As demand for hand sanitizers exploded at the onset of the pandemic, supply chains fell behind and grocery store shelves were left empty for weeks. In response, the FDA eased restrictions and manufacturers sped up production. At the same time, numerous entrepreneurs — from distilleries to online skincare companies — jumped into the hand sanitizer business to fill the gap. In doing so, they entered uncharted territory with no prior experience working with the FDA, following the agency’s regulations or conducting a recall.

Combine all these factors and it’s no wonder the FDA’s list of recalled hand sanitizers is growing. It’s important for companies to understand that it doesn’t matter if you’re in new territory or not, you will face the consequences of selling a faulty product, even if the FDA gave you clearance to produce it. Activists, consumer groups and competitors will see to that.

Valisure, for example has filed a citizen’s petition calling on the FDA to recall the contaminated products and further investigate how they were manufactured. This is the same company that sounded the alarm after it discovered the nitrosamine compound, NDMA in popular blood pressure drugs in 2019 and most recently, released a study linking NDMA in ranitidine drugs to cancer. It’s clear that Valisure and other activists are pursuing companies they believe are placing consumers at risk. No doubt other studies are on the way.

While we don’t know how all of this will play out through 2021, the one thing we do know is companies that are emerging from this scrutiny successfully are the ones cooperating with the FDA. The best thing you can do is work with the agency to ensure the quality and safety of your products. In the event of a recall, work with the FDA to swiftly recall your products and notify your consumers.

You’re not alone if your product is among the scores caught up in this regulatory web. The industry is crowded with all the companies that jumped into sanitizer production, which means the chances that consumers will remember your company was involved in one of the scores of recalls is very low. But the regulatory, legal and financial risks will be just as serious whether you are one of a hundred companies to make a mistake or the only one.

So be proactive by evaluating your manufacturing processes and preparing your recall and crisis plans. In the event of a recall, work closely and respectfully with the FDA and in the end, your reputation should remain intact and your business will remain safe.

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