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  1. Regulatory News, Stories, and Features

All Hands on Safety

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The agency’s tireless and, at times, technical battle during the pandemic to protect Americans from potentially harmful hand sanitizers

“I think we have a problem here,” Emilio Escobar recalls telling a colleague at the FDA’s Office of Regulatory Affairs’ (ORA’s) headquarters in late Spring of 2020. The supervisory consumer safety officer and 20-year veteran of the agency was concerned about a shipment of hand sanitizer that had arrived only hours earlier at the port in Pharr, Texas, in the Lower Rio Grande Valley, a short 15-minute drive from Mexico. The mood at the agency was already cautious and focused, as officers at U.S. ports, like the members of Escobar’s team, continuously monitored the influx of much-needed masks, gloves, and other personal protective equipment into the U.S.

Hand sanitizers were also in great demand. As part of the FDA’s ongoing commitment to address the COVID-19 public health emergency and help facilitate getting more product into the market, the agency published three temporary guidance documents to provide regulatory flexibility for certain firms to help meet the demand for alcohol-based hand sanitizer during the public health emergency. (The agency has since withdrawn these guidance documents as demand dropped) 

With more and more companies filling the hand sanitizer gap to boost U.S. supplies, Emilio and his team, and other officers throughout ORA’s Division of Southwest Imports, closely monitored the imported hand sanitizer products. To address the increased demand for hand sanitizers, multiple FDA offices throughout the agency worked with manufacturers, compounders, state boards of pharmacy, distilleries, other non-conventional drug manufacturers, and multiple other government agencies to increase the safe supply of alcohol-based hand sanitizers.  

Meanwhile, at all U.S. ports of entry, ORA’s frontline import operations staff, along with U.S. Customs and Border Protection (CBP) colleagues, geared up to monitor the massive influx of food, drug, and medical product shipments, including hand sanitizers sourced from around the world and in high demand by American consumers. Because helping to facilitate the flow of products into the country is part of its mission, the call to safeguard public health, stopping the entry of potentially harmful consumer products, remains paramount to the work import operations staff do every day.      

The process of reviewing the hand sanitizer arriving at Pharr, though, proved to be anything but straightforward. Escobar had just been alerted that CBP, while conducting a routine screening of one of the hand sanitizer shipments, made an unusual finding. Often on a hunt for illegal drugs, CBP runs routine chemical screenings on a variety of products arriving in the country. The handheld screening device the CBP team used in Pharr didn’t detect any illicit drugs. However, the spectrometry-based technology it relies on—which measures how light interacts with molecules in an unknown substance and compares those results with an extensive database of spectral “fingerprints”—made a preliminary finding of methanol in certain hand sanitizer products. 

A Toxic Alcohol

With a background in pharmaceuticals, Escobar was immediately concerned. “Methanol, or wood alcohol as it’s commonly known, is a toxic alcohol, often used by industry to create fuel and antifreeze,” he explains. “It’s not an acceptable ingredient for use in hand sanitizers or any other drug.” 

Windshield wiper fluid, paint thinner, fuel additive…these are all typical industrial applications for methanol, an alcohol quite different in its metabolic byproducts from ethanol, which is the active ingredient in most hand sanitizers. What makes methanol so dangerous, if it is somehow ingested or absorbed in excess through inhalation or through the skin, is what it breaks down into: formaldehyde, then formic acid, which can lead to blindness, organ failure, even death. 

Because the initial results from CBP were preliminary and the amount of methanol present in the samples was unknown, Escobar knew they needed to get the product fully tested by scientists to confirm the field finding and take swift steps to protect the public. Soon, he was on the phone with Allison Scott, a supervisory consumer safety officer based in Silver Spring, Maryland, who could coordinate transit of the hand sanitizer to an ORA laboratory for complete analysis.  

Scott sensed Escobar’s urgency. “He was pretty adamant,” she recalls. “He kept saying, ‘We need to get this tested as soon as possible. There’s a real public health risk here.’” With full respect for her colleague’s instincts, Scott rushed Escobar’s request. She sent out emails to secure an ORA lab that could quickly run the analysis. The Forensic Chemistry Center (FCC), the FDA’s premier laboratory for detecting even the most elusive of harmful ingredients, answered that they could analyze the hand sanitizer sample. 

Back at the border, policies and procedures kicked in. Working collaboratively with experts across multiple offices in CDER, Escobar and his team held all incoming hand sanitizer that tested positive for methanol at the border, until documentation was in place for more definitive FDA actions. They also ensured proper refusal and destruction of any confirmed contaminated product being held at the port. For Escobar, though, it wasn’t enough. He appealed to CBP port leadership to have all imports of hand sanitizers screened. His request was granted, and over the next few weeks, Escobar, and his team of 12 officers worked alongside their CBP colleagues, focused on screening all hand sanitizer arriving from Mexico. And, again and again, the same undeclared ingredient continued to register on CBP’s screening tools: methanol.   

Pressure at the Lab

While field officers worked intently to screen incoming shipments of harmful hand sanitizers, ORA and FDA’s Center for Drug Evaluation and Research (CDER) chemists back at the laboratories were met with the challenge of rapidly analyzing dozens upon dozens of samples. Shipments were held while confirmatory testing was conducted.  Such confirmatory analysis is not only vital to frontline staff making decisions about what to intercept, reject, and destroy, but also to agency leadership who were now requesting play-by-play updates on the evolving hand sanitizer situation and take regulatory action to ensure optimal protection of the public. 

The first major impediment, from a scientist’s perspective, was the lack of a fully validated quantitative method for analyzing the concentration, or amount, of methanol in hand sanitizer. Laboratory best practices mandate a method be validated at the highest accuracy and precision levels required for the task it’s intended to fulfill. In this case, pulling together a step-by-step process, with the right instrumentation and follow-up data interpretation, was urgently needed. Additionally, hand sanitizers might contain other ingredients such as fillers, fragrances, colors, and more. And while current instrumentation, like gas chromatography, can “read” such samples, the tool is only as good as the instructions it's armed with. In other words, validation of the gas chromatography procedure is required to demonstrate the method is fit-for-purpose to identify and quantitate methanol, or any other toxic ingredient that a chemist might be looking for. 

Fortunately, the ORA’s Pacific Southwest Medical Products Laboratory (PSMPL) Director Jennifer Gogley and her team were among the first to develop a validated method for identifying and quantitating alcohols  in hand sanitizers—which by any ordinary sensory judgment look and smell the same, regardless of the type of alcohol they contain. Her Irvine, California-based team, including a chemist well-versed in method validation and an analyst with experience manipulating finicky gas chromatography instruments prone to gum up from sticky hand sanitizers, shared their proven process with other ORA labs in San Juan, Detroit, and New York. Now, along with FCC, over five ORA and CDER labs have the capability of finding any harmful methanol, as well as 12 other impurities that might be present. And it was needed. Packages containing samples of hand sanitizer kept arriving at the labs...each its own tedious affair.

Science for Public Health

While science’s capacity to aid public health is transformative, it has its shortcomings: namely, the time it takes to deliver answers when precious minutes are ticking. When the agency refuses a shipment that violates or appears to violate the FDA requirements, it is a formal process.

“I often tell my analysts,” Gogley says, “no matter what we do in the lab, all people will care about in the end is how accurate we were.”  

Gogley’s team brought every additional efficiency it could to the process, including scheduling instruments to run overnight. They adopted an assembly-line–like approach, with each staff member, based on expertise, assigned to a particular step. And while not a tactical element, acute awareness of what was at stake pressed them on. “We’re always working on deadline,” says Gogley, “that’s not unusual. But I think in this instance we understood what was happening…what we were reading about in the news.” She describes the agency’s public health duty as a “huge motivator,” one that’s helped drive her 22-year career with the FDA.   

Operation Dirty Hands

Back in Pharr, Escobar was leading what had become a division-wide blitz, 'Operation Dirty Hands,’ to stop harmful hand sanitizers from entering the five ports of entry on the Mexican border where ORA has boots on the ground and when we first encountered potentially harmful hand sanitizers. All U.S. borders were included in the all-hands agency initiative, and violative hand sanitizer from China, countries in Europe, and other countries were caught in the net. In addition to screening for methanol, officers paid special attention to hand sanitizers packaged in food and drink containers, with appealing fragrances and colors, which posed even greater risk to children who might be tempted to taste the products. A full FDA effort, led by the Office of Emergency Operations and supported by CDER, was intent on cracking down on any potentially harmful hand sanitizer coming into or being sold in the United States. 

FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency from April through December 2020 were not in compliance with FDA’s regulations. More than half of the samples were found to contain toxic ingredients, including methanol and 1-propanol, at dangerous levels. This led to a country-wide import alert for alcohol-based hand sanitizers from Mexico, the first time the FDA has issued a country-wide import alert for any category of drug. In addition, the FDA issued guidance on methanol testing for drug products and worked with the USP to update the alcohol quality standard to include specific testing of ethanol used in any drug for methanol. 

Ultimately, thanks to the dedication of ORA front-line officers and researchers, as well as our colleagues in CDER, the agency was able to make solid, scientifically grounded decisions to guard public health. During the summer of 2020, the FDA added products to import alerts to help stop harmful products from entering the U.S. and began issuing warning letters to firms. Most importantly, to protect consumers, the agency issued statements and social media messages, amplified by the media, warning the public not to use certain hand sanitizers, with a list that was updated almost daily, including warnings of hand sanitizer being sold in consumable (drinkable) packaging with added flavorings, like chocolate and raspberry, which could pose serious danger to young children. The quick-thinking, collaborative, and dedicated FDA staff—too often unseen by most Americans—were at the center of a public health emergency, within a looming health crisis to which they were already responding. And although the initial methanol crisis, resulting in the first-ever countrywide import alert for drugs from Mexico, has thankfully abated, ongoing efforts in sampling, testing, and warning letters continue to help keep potentially harmful products off the shelves. 

“I think most Americans would feel reassured knowing we have so many dedicated FDA staff working hard helping ensure that the foods, drugs, and other products coming into this country are safe,” says the agency’s Assistant Commissioner for Import Operations Dan Solis. “We couldn’t do this without our invaluable scientific colleagues too.” 

As for Escobar, he says this was probably the most challenging, but fulfilling, episode he’s experienced in his two-decade career with FDA. “Do I think we saved lives?” he muses out loud. “I do. But you know what, that’s my job...to protect American consumers.”

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