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Tuesday, March 24, 2020 8:26:04 AM
Pensler's Korex faces regulatory roadblocks to produce hand sanitizer amid shortage
Grosse Pointe Park businessman runs into production red tape
Federal agencies said it would be 6-12 months to go to market
Michigan distilleries exploring how to produce hand sanitizer
Korex Cos.' manufacturing plant in Wixom.
A Michigan-based detergent and cleaning supplies manufacturer said federal regulators won't let the company mass produce hand sanitizer at a plant in Toronto for six months to a year amid the crushing demand for the product to combat the spread of coronavirus.
Sandy Pensler, the owner of Korex Cos., said Tuesday that he's been stymied by the U.S. Food and Drug Administration and the Environmental Protection Agency in restarting production of hand sanitizer.
"We haven't been able to get FDA or EPA clearance," Pensler told Crain's.
Federal regulators said it would take "six months to a year to get all of the testing completed," said Pensler, founder and president of Pensler Capital Corp., the Grosse Pointe Park-based parent company of Korex Cos.
Crain's contacted Pensler on Tuesday after Gov. Gretchen Whitmer disclosed during a conference call with reporters that "there is a company in Michigan that might be able to start producing in mass hand sanitizer."
State officials did not have immediate information Tuesday afternoon about the company the governor referenced.
Pensler said he has not been in contact with the governor's office.
The Korex Cos. plant in Toronto previously manufactured liquid hand sanitizer and it has the explosion-proof tanks needed to produce an alcohol-based disinfectant that kills 99.99 percent of germs and bacteria, Pensler said.
Sandy Pensler
Two months ago, following the early outbreaks of the coronavirus in China, Pensler said his company began trying to get the necessary government approvals in the U.S. and Canada to get back in the hand sanitizer business.
Pensler said he hired a consultant who struck out with federal regulators in a second attempt two weeks ago.
"We tried to use (the outbreak) to get back into the market, because there's shortage of (hand sanitizer)," Pensler said. "And we couldn't do it. We were told (two weeks ago) it was six months at a minimum and a year, more likely."
Pensler said it has been several years since Korex's Toronto plant manufactured hand sanitizer. He said he couldn't recall exactly when it stopped.
Korex needs FDA approval and an EPA registration number to import the product from Canada into the U.S., Pensler said.
"That takes the longest," he said.
Korex Cos. manufactures hand and dish soaps, dishwasher detergent, laundry detergent and other household cleaning supplies for Clorox, Ultra Shine, OxiClean, Walmart's Great Value and the private labels of Amazon, Wegmans Food Markets Inc. and Kroger.
Pensler has previously said Korex products are manufactured at three plants in Wixom, Toronto and Chicago and shipped all over North and South America.
The three Korex plants have been "busy" in recent weeks as American consumers stock up on soaps in response to the coronavirus outbreak.
"We have some challenges with suppliers," Pensler said.
In 2018, Pensler unsuccessfully ran for the Republican nomination for U.S. Senate.
He said Tuesday that he had not yet called Republican members of Michigan's congressional delegation to seek assistance navigating the regulatory process.
Distilleries explore sanitizer production
Pensler isn't the only Michigan entrepreneur trying to respond to scarce inventory of hand sanitizer in pharmacies and supermarkets — and finding difficulties in bringing a product to market.
A Grand Rapids distillery wants to make the seemingly short leap into making a hand sanitizer product amid the ongoing outbreak of COVID-19.
Jon O'Connor, co-owner of Long Road Distillers and president of the Michigan Craft Distillers Association, said his company has already had talks with federal regulators about taking some of its 190-proof base and making it into ethyl alcohol, an active ingredient in hand sanitizer that can be used to fight off the disease.
"We're confident we understand the manufacturing process to create it, we're confident we can do everything to make a product that works," O'Connor said, adding that he's hopeful for some regulatory flexibility depending on how the product is branded.
The bigger challenge, according to O'Connor, would be finding secondary materials needed to make the product — which could be a gel or a spray — and enough packaging.
Long Road Distillers has already secured a small quantity of plastic bottles to distribute the product, O'Connor said.
"However we can make it work the most efficient way," he told Crain's. "I don't think we're hoping to do this because we're hoping to get rich off this. It's something we can do as a public good (and) even at a small scale, we're willing to try."
Michael Forsyth, co-owner of Detroit City Distillery, said his distillery on Gratiot Avenue is capable of making hand sanitizer and disinfectant spray. In fact, he's already made some to be used around his building.
However, producing it for mass distribution presents a series of difficulties.
"There are challenges for licensing to do it by the book, but more importantly, the supply chain is super stressed, so procuring the necessary ingredients like aloe and containers would be difficult," he said.
"Obviously, we are in a very unique time. If the government called on us, we'd do our part. That's the Detroit way."
https://www.crainsdetroit.com/manufacturing/penslers-korex-faces-regulatory-roadblocks-produce-hand-sanitizer-amid-shortage
Grosse Pointe Park businessman runs into production red tape
Federal agencies said it would be 6-12 months to go to market
Michigan distilleries exploring how to produce hand sanitizer
Korex Cos.' manufacturing plant in Wixom.
A Michigan-based detergent and cleaning supplies manufacturer said federal regulators won't let the company mass produce hand sanitizer at a plant in Toronto for six months to a year amid the crushing demand for the product to combat the spread of coronavirus.
Sandy Pensler, the owner of Korex Cos., said Tuesday that he's been stymied by the U.S. Food and Drug Administration and the Environmental Protection Agency in restarting production of hand sanitizer.
"We haven't been able to get FDA or EPA clearance," Pensler told Crain's.
Federal regulators said it would take "six months to a year to get all of the testing completed," said Pensler, founder and president of Pensler Capital Corp., the Grosse Pointe Park-based parent company of Korex Cos.
Crain's contacted Pensler on Tuesday after Gov. Gretchen Whitmer disclosed during a conference call with reporters that "there is a company in Michigan that might be able to start producing in mass hand sanitizer."
State officials did not have immediate information Tuesday afternoon about the company the governor referenced.
Pensler said he has not been in contact with the governor's office.
The Korex Cos. plant in Toronto previously manufactured liquid hand sanitizer and it has the explosion-proof tanks needed to produce an alcohol-based disinfectant that kills 99.99 percent of germs and bacteria, Pensler said.
Sandy Pensler
Two months ago, following the early outbreaks of the coronavirus in China, Pensler said his company began trying to get the necessary government approvals in the U.S. and Canada to get back in the hand sanitizer business.
Pensler said he hired a consultant who struck out with federal regulators in a second attempt two weeks ago.
"We tried to use (the outbreak) to get back into the market, because there's shortage of (hand sanitizer)," Pensler said. "And we couldn't do it. We were told (two weeks ago) it was six months at a minimum and a year, more likely."
Pensler said it has been several years since Korex's Toronto plant manufactured hand sanitizer. He said he couldn't recall exactly when it stopped.
Korex needs FDA approval and an EPA registration number to import the product from Canada into the U.S., Pensler said.
"That takes the longest," he said.
Korex Cos. manufactures hand and dish soaps, dishwasher detergent, laundry detergent and other household cleaning supplies for Clorox, Ultra Shine, OxiClean, Walmart's Great Value and the private labels of Amazon, Wegmans Food Markets Inc. and Kroger.
Pensler has previously said Korex products are manufactured at three plants in Wixom, Toronto and Chicago and shipped all over North and South America.
The three Korex plants have been "busy" in recent weeks as American consumers stock up on soaps in response to the coronavirus outbreak.
"We have some challenges with suppliers," Pensler said.
In 2018, Pensler unsuccessfully ran for the Republican nomination for U.S. Senate.
He said Tuesday that he had not yet called Republican members of Michigan's congressional delegation to seek assistance navigating the regulatory process.
Distilleries explore sanitizer production
Pensler isn't the only Michigan entrepreneur trying to respond to scarce inventory of hand sanitizer in pharmacies and supermarkets — and finding difficulties in bringing a product to market.
A Grand Rapids distillery wants to make the seemingly short leap into making a hand sanitizer product amid the ongoing outbreak of COVID-19.
Jon O'Connor, co-owner of Long Road Distillers and president of the Michigan Craft Distillers Association, said his company has already had talks with federal regulators about taking some of its 190-proof base and making it into ethyl alcohol, an active ingredient in hand sanitizer that can be used to fight off the disease.
"We're confident we understand the manufacturing process to create it, we're confident we can do everything to make a product that works," O'Connor said, adding that he's hopeful for some regulatory flexibility depending on how the product is branded.
The bigger challenge, according to O'Connor, would be finding secondary materials needed to make the product — which could be a gel or a spray — and enough packaging.
Long Road Distillers has already secured a small quantity of plastic bottles to distribute the product, O'Connor said.
"However we can make it work the most efficient way," he told Crain's. "I don't think we're hoping to do this because we're hoping to get rich off this. It's something we can do as a public good (and) even at a small scale, we're willing to try."
Michael Forsyth, co-owner of Detroit City Distillery, said his distillery on Gratiot Avenue is capable of making hand sanitizer and disinfectant spray. In fact, he's already made some to be used around his building.
However, producing it for mass distribution presents a series of difficulties.
"There are challenges for licensing to do it by the book, but more importantly, the supply chain is super stressed, so procuring the necessary ingredients like aloe and containers would be difficult," he said.
"Obviously, we are in a very unique time. If the government called on us, we'd do our part. That's the Detroit way."
https://www.crainsdetroit.com/manufacturing/penslers-korex-faces-regulatory-roadblocks-produce-hand-sanitizer-amid-shortage
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