The FDA’s Warnings Aren’t Sanitized

Hand sanitizer is big business. It is everywhere – especially in the places we trust the most (and need to be clean) hospitals, schools, restaurants, etc. Many believe the product is the only thing standing between them and deadly (or at least incredibly harmful) bacteria. The Centers for Disease Control and Prevention (CDC) even recommends that health care professionals use sanitizer to decontaminate their hands before and after patient contact to prevent infection.

GOJO Industries, the producer of Purell has profited for years – literally billions of dollars – from its promises that its product protects users from norovirus, influenza, MRSA, and other ailments.  With claims like that, it is no wonder that predicted, “the global market for Hand Sanitizer at $2.4 billion in 2017 is anticipated to reach $5.5 billion in 2024.”

“The Food and Drug Administration (“FDA”) takes labeling and advertising claims seriously. Companies would be wise to strictly comply with the federal Food, Drug, and Cosmetic Act and ensure that claims on the labels of their products and on their website are not false or misleading and do not violate federal or state law, stated Stewart Fried a Principal Attorney at OFW Law.

On January 17, 2020, FDA issued a Warning Letter to GOJO.  FDA’s Warning Letter’s concluded that the claims are on the Purell website were unapproved new drugs that were marketed in violation of the Food, Drug, and Cosmetic Act. FDA gave GOJO 15 days to clean up its website and social media properties. “Failure to promptly correct these violations,” the letter warns, “may result in legal action without further notice, including, without limitation, seizure and injunction.”

That’s a major threat – one GOJO took seriously.  Samantha Williams, a senior spokeswoman for GOJO said in a statement that the company took immediate action following receipt of the letter and emphasized that “the FDA letter was not related to the safety or quality of our products, or our manufacturing processes.”

“Warning Letters can be devastating to a brand’s reputation and a company’s bottom line,” Fried said. “Class action litigation under state consumer protection law frequently is triggered by FDA warning letters. Ensuring that advertising and labeling claims are accurate and consistent with applicable law and regulations is far less expensive than having to respond to federal enforcement actions and defending class action litigation.”

While GOJO is doing the right thing, and cleaning up its website, time will tell how much damage was done to the brand – or if getting caught will impact sales.

Like the bacteria it claims to kill, the company will be under a microscope for a long time to come.

The good news for GOJO is that most consumers are not aware of FDA’s Warning Letter.  Moreover, the company has an opportunity to recover and may be forgiven by consumers.  When a manufacturer of consumer products know they will be under increased scrutiny by regulators, they can use the situation to their advantage. By working with regulators, the company can inventory its messages and distribution strategy – and rebuild relationships with customers and stakeholders – relationships built on trust and verified claims.

Any message, in order to be effective, must be true. Executives, communicators, and marketers should look at the Purell story and learn a valuable lesson – that exaggerating a message or making a claim loosely can have dangerous consequences.

Losing control of a company’s message could result in losing control of a company.

The most effective messages aren’t always sensational – often they are (pun-intended) sanitized. How is your company cleaning up its communication strategy?

Up Next

Want the latest in public relations and public affairs right in your inbox?