UPDATE: MAY 18, 2020
The U.S. Food and Drug Administration has cleared an Iowa hand sanitizer company of making misleading claims about its product’s ability to “mitigate, prevent, treat, diagnose, or cure COVID-19.” It notified the company on May 18, 2020
An Iowa-based hand sanitizer manufacturer the Food and Drug Administration cited in April for saying its products could “mitigate, prevent, treat, diagnose, or cure COVID-19” says the federal agency is wrong.
An attorney for Prefense LLC, of Muscatine, also said the company told the FDA that before the agency announced its April 23 complaint against the firm on April 27, and that the FDA hasn’t acknowledged that response.
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Prefense was the first hand sanitizer manufacturer to get an FDA warning letter for marketing a hand sanitizer with unproven COVID-19-related claims, in violation of federal law, the FDA reported. More than three dozen firms have received warning letters since then.
The complaint against Prefense was the result of independent distributors marketing Prefense’s foam hand sanitizer, including on social media, with misleading claims about how the product could fight COVID-19, Prefense attorney Cassie Edgar said. Prefense board member and secretary John Patchett sent distributors a letter March 12 – more than a month before the FDA filed its complaint – saying they could not make these statements, a copy of the letter the company shared with IowaWatch shows.
“But the FDA considers any statement made in social media as labeling,” Edgar, a patent attorney with the Des Moines law firm McKee, Voorhees & Sease, said in an interview. “So, they looked at that and said, ‘OK, this product is out there being marketed against COVID-19.’ But it wasn’t being marketed against COVID-19 by Prefense directly.”
The interpretation of what consists of labeling is important in this case because the FDA can refer to a product’s label as part of its role regulating the interstate sale of drugs intended to diagnose, cure, mitigate, treat or prevent disease.
Labels on the over-the-counter Prefense sanitizer bottle labels do not claim any of those things, Edgar said, and the FDA’s complaint doesn’t allege it does. But the complaint accuses the company of having links from its own website, www.prefense.com, to the websites of three distributors where the sanitizer can be purchased and that made claims about treatment and cures before Patchett told them to stop: Safety-Med, MDS Associates and Apollo Safety Products.
A written Prefense response sent to the FDA the day after the complaint was filed said company officials agree with the FDA that their product should not be marketed as mitigating, preventing, treating, diagnosing or curing COVID-19 and had taken action that was sought.
The FDA complaint said claims of treating COVID-19 subjected the sanitizer to the FDA definition of being a drug, which it can regulate. The FDA wrote that the sanitizer could be called a new drug, with an active ingredient – benzalkonium chloride/silica complex – that would need safety and effectiveness data to show it is reliable and safe for over-the-counter use as an antiseptic rub. Such data do not exist, the FDA complaint stated.
Other problems, the complaint stated, were that no new applications for FDA approval of the hand sanitizer exist and no approved studies show the sanitizer can curb the spread of COVID-19.
Users of the product might get a false impression that they don’t have to rely on measures like social distancing or good hygiene that curb COVID-19’s spread, the complaint stated. “Users who do not follow these interventions are at increased risk for contracting COVID-19 and for spreading disease if they have been exposed to the virus, thereby prolonging the pandemic and increasing its associated morbidity and mortality,” the complaint stated.
Edgar said no new applications exist because neither the product nor its intent has changed since it was introduced into the market in 2009. The active ingredient the FDA cited in its April complaint letter to Prefense is in other manufacturers’ products that are similar to the Prefense sanitizer, she said. Those manufacturers claim their product will work for 24 hours but have not been cited by the FDA, she said.
“The letter reads like this is a brand-new company that’s looking to capitalize on the pandemic and sell this product. Nothing was actually further from the truth,” Edgar said.
“It’s actually that one company was singled out by the FDA here when there’s a whole class that’s using the same active ingredient that are making the same claims.”
The FDA complaint cited Prefense for posting Jan. 24 on the company’s Twitter page, “We hate to say it, but coronavirus is in the U.S. and close to home in Chicago. Nasty stuff but that’s why the best defense is Prefense!” And, on Jan. 30: “Coronavirus now a global emergency! . . . Be safe out there – the best defense is Prefense hand sanitizer – up to 24 hour protection from one application – it works when it dries!”
The complaint also cited a statement on Prefense’s LinkedIn page: “Prefense Hand and Skin Sanitizer offers an alternative to Alcohol based Gels. Prefense has a unique formulation that bonds to you [sic] skin forming a physical barrier between your skin and pathogens found in everyday life. These bonds last up to 24 hours or through 10 hand washing cycles. One application lasts all day.”
Edgar said the company took down the social media posts. “The company didn’t believe that those were making statements that this product was being put out there as a cure for COVID-19 but they were taken down to comply with the FDA because this was a very serious letter. There was a 48-hour window to reply. It was most prudent to just take everything down that they referenced.”
An early May review of the three distributors’ websites cited in the FDA complaint showed statements about COVID-19 or coronavirus missing or, in the case of Apollo Safety Products, in a warning. “This product is not intended to mitigate, diagnose, treat, cure or prevent COVID19,” a write-up at the Apollo web page for Prefense Foam Hand Sanitizer in 8-ounce and 1.5-ounce bottles read.
Prefense was founded in 2008. It is a small, private company with seven employees, John Patchett, a lawyer, said. He declined to release information on its annual sales.
Patchett’s March letter to distributors stated that Prefense has been effective against several pathogens. “However no testing has yet been concluded that specifically demonstrates its effectiveness against similar viruses – so there is good reason to infer it is likely effective vs. coronavirus,” the letter stated in one part, with the word “however” underlined. “But we cannot currently state that affirmatively or determinatively. So do not do so until further notice.”
Jeremy Kahn, an FDA press officer, declined to comment on Prefense’s case. “The FDA cannot discuss open compliance matters, except with the company involved.” Kahn wrote in an email to IowaWatch.
Company officials said they are eager to hear from the FDA. Edgar noted that even though the company responded to the April 23 warning on April 24, the FDA’s website does not indicate a response or a note that corrective action has been taken. On May 7, the FDA posted the warning against Prefense again in a news release.
“I don’t even know if they received and read our response and just decided to issue the press release anyway, or if they haven’t received it and it just went into a bulk email box and it’s waiting in queue to be reviewed,” Edgar said.
“The FDA is the gatekeeper of the marketplace for these products, so, really, the company is awaiting FDA’s response to our response to the warning letter so we can work together and make sure that there are no remaining issues.”
The most recent FDA news release said 42 letters have been sent to companies making products connected to false information the government agency said was being used to capitalize on the COVID-19 outbreak. “While we seek to ensure access to critical medical products, it is imperative that we continue our efforts to find and prevent the sale and distribution of products that may be harmful to the public health,” the news release quoted FDA Associate Commissioner for Regulatory Affairs Judy McMeekin saying.
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This story was published by The Des Moines Register and information from it was published in a Fairwarning.org story under IowaWatch’s mission of sharing stories with media partners.