With that list nearly doubling in size over the summer, here’s what hand sanitizer producers and consumers need to know about product safety.
The dramatic pandemic-related increase in hand sanitizer sales is exposing Americans to another potentially deadly risk: products contaminated with chemicals that may be lethal if ingested.
These include 1-propanol, methanol, benzene, acetaldehyde as well as solvents found mainly in jet fuel. Now there is an even greater risk of accidental toxin ingestion.
The U.S. Food and Drug Administration (FDA) is warning consumers that some hand sanitizers are being sold in food-style packagings such as children’s food pouches, beer cans, and juice bottles. Some even contain food flavors such as raspberry and chocolate.
Between July and September, the number of hand sanitizers on the FDA’s warning list jumped from 90 to 194, with recalls even happening among some of the biggest vendors. Which leaves us to ask: what is going on?
“While hand sanitizers and associated claims are regulated by the FDA, the agency has a waiver program due to the unprecedented time of COVID-19 which doesn’t require manufacturers to substantiate label claims.
This was in an effort to allow hand sanitizers to get on shelves quickly, under the assumption manufacturers would continue good manufacturing practices,” explains Mike Sandoval, President of Santé Laboratories, a bio-hemp pharmaceutical contract research organization (CRO). “However, the lack of FDA regulatory oversight has opened the market to anyone wanting to get into this lucrative space, even the unscrupulous.”
Sandoval, whose company goes beyond the FDA’s current regulatory requirements for hand sanitizer testing, explains that when the pandemic hit, traditional hand sanitizer manufacturers with unparalleled track records could not keep up with the skyrocketing demand. Meanwhile, cannabis, hemp, and other manufacturers that were casualties of extraordinary revenue losses and employee turnover identified a new opportunity to survive.
“They had to pivot to and focus on creating and enhancing products such as hand sanitizers and disinfectants, especially those who were making high volumes of CBD oils as they have the amenity-rich infrastructure to make mass quantities with the same extraction equipment.”
Why these contamination problems are happening
Sandoval explains that the actual contamination problems can be traced to a shortage of two raw materials: ethanol and clean aloe. “Issues have arisen as manufacturers began procuring large volumes of non-tested raw materials and compounding hand sanitizers from non-qualified sources.
Even well-established manufacturers can no longer trust their regular suppliers because of the shortages,” he says.
Scented and moisturizing hand sanitizers can also be problematic. “Some essential oils tend to contain contaminants. The shortage of clean aloe, which is naturally moisturizing, is creating problems as well because we’re seeing more substitutions containing contaminants. Aloe can be very difficult to test for impurities when it is in gel form,” Sandoval continues.
“Until now, manufacturers could just approve the raw material certificates of analysis from their vendors, then test their final products. Now, they must retest their raw materials for purity before the manufacturing process begins.
Santé Laboratories can fix a lot of problems by testing the raw materials, which is important because if you don’t discover contaminants until you test the final product, it can be very expensive and tricky to remediate.”
Sandoval adds that impurities can also form during the hand sanitizer manufacturing process itself. “Gelling agents, thickeners, and other excipients can form acetaldehyde and benzene. We’re seeing a lot of that happening as well.”
Not all labs can test for all the impurities that are cropping up in hand sanitizers
Santé Laboratories, a leading CRO in nutraceuticals and bio-hemp, has jumped at the opportunity to help protect consumers. More equipped with advanced analytical instrumentation and subject matter capacity than other labs, they’ve been flooded with testing these products.
“Our expanded panel looks for class 1, 2, and 3 solvents. For example, we are able to test for chloroform, which is tightly regulated,” states Sandoval. “Santé Laboratories not only complies but exceeds expectations for the FDA’s criteria.”
Elevating the hand sanitizer market
An ISO/IEC 17025:2017 accredited facility, Santé Laboratories is not just a CBD testing lab. “We’re an end-to-end contract research organization with vast capabilities to accommodate bio-hemp testing research, testing, and product development.
Recreational CBD labs simply do not have our level of expertise and capacity,” Sandoval comments. “We are inspired and energized to address the hand sanitizer market. We have what it takes to gather the data, and the capacity to test a large number of products.”
Working with complex samples requires subject matter expertise to leverage existing methods to meet USP and ICH method validation requirements to produce scientifically valid test reports.
Recreational labs commonly use GC-FID to screen common classes of solvents used in the extraction industry, which are not commonly identified as hand sanitizer impurities.
“At Santé, we follow USP and ICH validation requirements, and leverage Thermo Fisher’s most advanced gas chromatography and mass spectrometer instruments to provide our customers trusted data,” explains Sandoval.
What retail buyers and end-consumers should be watchful for
While it is not always easy to tell if a finished product is both pure and contains what it says on the label, Sandoval has some basic recommendations that can help retail buyers and consumers protect themselves.
- Retail buyers: “Insist on transparency from the manufacturer. Ideally, ask for certificates of analysis for both the raw materials and the final product, because the FDA limits differ from one to the other. At the very least, review the certificate of analysis for the final product to ensure that it meets FDA limits.”
- Consumers: “Do not use products that look or smell funny, are discolored, or have crystals forming in the container. Also, while everyone thinks of hand sanitizers as being gels, a more liquid form may be perfectly okay to use. In fact, thickeners could create impurities, so more liquidity may be intentional. Finally, look on the label for antimicrobial testing. A product that says it has a 99.999% kill rate of germs and bacteria has probably undergone efficacy testing.”