Ohio company awaits FDA approval for infant formula

10TV took a tour inside the Heath-based facility which opened in 2020 to see what it takes to create a formula for the smallest consumers.

HEATH, Ohio – There’s a local facility in central Ohio that has been making organic formula for babies 1 year and older for more than two decades.

All week now, Nature’s One is waiting for the Food and Drug Administration’s green light to move forward with infant formula to help amid the nationwide shortage.

“Everyone is working to solve this crisis in America right now,” said founder and CEO Jay Highman. “We have conducted a clinical diet study and are working with the FDA which is going through a review process. We really hope to hear any week from now from the FDA in this process allowing us to go ahead and label the product as an infant formula.

Highman said there was no room for error when its consumers were most vulnerable.

“The precision that we implement here and the science is essential to the development of a baby,” 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 and thought 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 feed their children…and that is the greatest responsibility we have.”

When it comes to making formula, there’s a lot going on inside the Nature’s One Heath facility, from sanitizing to equipment. 10TV went inside for a tour to see what it takes to get the formula on store shelves.

As soon as you walk in, you put on shoe covers. No makeup, jewelry or perfume is allowed. Next comes a hair net and safety glasses. Then a full suit.

For 20 seconds we wash our hands. Then a special machine disinfects our shoe covers and we disinfect our hands. This happens at one of the many hygiene stations, and it’s a process we repeat many times throughout our tour.

Inside, the walls are painted with antimicrobial paint, fresh air is pumped in every few minutes, rooms have specific air pressures, and nothing is against the walls.

“It allows us to wipe our backs,” Highman said, pointing to the electrical work.

Ingredients are subject to quality checks upon arrival.

“We trust but verify,” Highman said.

Samples are tested by a third party company.

Some of the ingredients should be stored in a room heated to 115 degrees.

Ingredients are combined in another room inside large machines. The equipment includes technology that monitors human error. The lights will turn red when there is a problem.

Finally, the liquid goes to the spray dryer. Inside a tornado-shaped device, it’s 350 degrees and a Category 5 hurricane environment. This is where the liquid turns to powder.

“A perfectly formed particle,” Highman said.

From there it goes to massive bins where it awaits quality inspection.

And then to the boxes, where each is sterilized and inspected.

Highman said if you were to go through the entire process for a box of formula—from inspection, to testing, to creation, to packaging—it takes nearly a month.

“Now that we manufacture it and spray-dry it here, package it here, and then ship it directly to retailers or distributors to the consumer through our Nature’s One Connect store, allows us to really face those breakage issues. of stock nationwide,” says Highman.

The Heath facility opened in May 2020. Previously, two facilities were used for two different parts of the process in two different states: Pennsylvania and Minnesota.

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