HEATH, Ohio — There's a local facility in central Ohio that's been making organic formula for babies 1 year and older for more than two decades.
Any week now, Nature's One is anticipating the green light from the Food and Drug Administration to move forward with infant formula to help amid the nationwide shortage.
“Everyone is working to address this crisis in America right now,” said founder and CEO Jay Highman. “We’ve conducted a clinical feeding study and we’re in the process of working with the FDA now that goes through a review process. We’re hopeful to hear really any week now from the FDA in that process allowing us to move forward and label the product as an infant formula.”
Highman said there is no room for error when his consumers are the most vulnerable.
“The precision that we implement here and the science is critical to a baby's development,” he said.
He founded the company in 1998. It was truly a labor of love.
“I was in the organic food industry for 10 years previous and I believed there was an opportunity. I also have a son with cystic fibrosis who had a special need for nutrition,” he said. “A parent’s first responsibility is to provide nutrition for their children….and it’s the greatest responsibility we have.”
When it comes to making formula there's a lot that goes on inside the Nature’s One Heath facility, from the sanitization to the equipment. 10TV went inside for a tour to see what it takes to get the formula to store shelves.
The second you step in, you slip on shoe covers. No makeup, jewelry, or perfume is allowed. Next comes a hairnet and safety glasses. Then a full suit.
For 20 seconds we wash our hands. Then a special machine sanitizes our shoe covers and we sanitize our hands. This is what happens at one of several hygiene stations, and it’s a process we repeat several times throughout our tour.
Inside the walls are painted with antimicrobial paint, new air is pumped in every few minutes, rooms are under specific air pressures, and nothing is up against the walls.
"Allows us to wipe behind it,” said Highman pointing to the electrical work.
Ingredients undergo quality checks when they arrive.
“We trust but verify,” said Highman.
Samples are tested by a third-party company.
Some of the ingredients must be stored in a heated room at 115 degrees.
The ingredients are combined in another room inside big machines. The equipment includes technology that monitors for human error. Lights will turn red when there is an issue.
Eventually, the liquid goes to the spray dryer. Inside a tornado-shaped device, it's 350 degrees and a category 5 hurricane environment. That's where the liquid turns to powder.
“A perfectly formed particle,” said Highman.
From there it goes to massive totes where it awaits a quality inspection.
And then to the cans, where each one is sterilized and inspected.
Highman said if you were to follow the entire process for one can of formula – from inspection to testing, to the creation, and then packaging, it takes nearly a month.
“Now that we make it, and spray dry it here, package it here, then send it right out to retailers or distributors to consumer through our Nature’s One connect store allows us to be really in front of these out of stock issues nationwide,” Highman said.
The Heath facility opened in May 2020. Prior to that two facilities were utilized for two different parts of the process in two different states: Pennsylvania and Minnesota.