ByHeart CEO on launching new baby formula in a supply crisis

Aug 15, 2022, 7:10 AM | Updated: 7:22 am
This photo provided by ByHeart shows Ron Belldegrun.  The co-founders of baby formula startup ByHea...

This photo provided by ByHeart shows Ron Belldegrun. The co-founders of baby formula startup ByHeart began working on their product long before the current shortage that's rattled many American parents. It took Belldegrun and his sister Mia Funt six years to research, test and win regulatory approval for their company's formula. (ByHeart via AP)

(ByHeart via AP)

WASHINGTON (AP) — The co-founders of baby formula startup ByHeart began working on their product long before the current shortage that’s rattled many American parents.

It took Ron Belldegrun and his sister Mia Funt six years to research, test and win regulatory approval for their company’s formula. When the Pennsylvania-based company launched in March, it was first new formula to hit the U.S. market in 15 years.

Belldegrun spoke with the AP about the lack of competition in the formula industry and the ongoing shortage. His remarks have been edited for length and clarity

Q: Why is it so hard to introduce a new formula in the U.S.?

A: This is appropriately the most highly regulated food in the world. It’s the only food that requires clinical trials for a novel, new formula. Until us there were only four companies in this country that made it. So it’s a supply chain bottleneck for a new company because three companies have owned 90% of the category for decades.

We believed that the only way to really change that was to own our supply chain, and therefore build it from scratch. That meant delivering a truly new infant formula and new manufacturing capacity. We really desired to translate troves of advancements in breast milk research and nutrition science into products that would set the strongest foundation for health, while combining the functional benefits of breast milk with the cleanest ingredients. Ironically, we didn’t get into this because we saw a shortage like this coming. We got into this to innovate.

Q: What has demand been like?

A: Out of the gate, we saw unprecedented demand. We were pacing at levels 15 times our most aggressive yearly projections. That validated our approach to own our supply chain because we had levers in our control to ramp up.

We’ve been investing very heavily in manufacturing at our facility here in Reading, Pennsylvania. We are moving from 24 hours, five days a week to 24 hours, seven days a week. We’re very focused on building that infrastructure to be part of a sustainable solution.

Because of those moves we were recently able to announce we would reopen orders to new customers — taking customers off our waitlist.

Q: The Food and Drug Administration plans to allow some foreign manufacturers that entered the market under emergency terms to stay permanently. What’s your reaction?

A: The solution to this issue, in our view, shouldn’t come from relaxing standards. So it will be interesting to see the FDA put out more guidance on what will be required for companies to stay.

I’m hopeful that more companies will invest in doing the work we did. Hopefully one of the structural solutions here will be that other companies decide not to outsource manufacturing but build manufacturing here; so that one day it’s not five of us, it’s 10 of us manufacturing formula and we don’t have these issues again.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

Associated Press

Former Uber security chief guilty of data breach coverup

SAN FRANCISCO (AP) — The former chief security officer for Uber was convicted Wednesday of trying to cover up a 2016 data breach in which hackers accessed tens of millions of customer records from the ride-hailing service. A federal jury in San Francisco convicted Joseph Sullivan of obstructing justice and concealing knowledge that a federal […]
20 hours ago
FILE - Herschel Walker, Republican candidate for U.S. Senate for Georgia, speaks at a primary watch...
Associated Press

Report: Mom of Walker’s child says he paid for her abortion

ATLANTA (AP) — A woman who said Herschel Walker paid for her 2009 abortion is the mother of one of his children, according to a new report Wednesday, undercutting the Georgia Republican Senate candidate’s claims that he didn’t know who she was. The Daily Beast, which first reported Monday on the abortion, said it had […]
20 hours ago
A protester is hit by Los Angeles Rams defensive end Takkarist McKinley, middle left, and linebacke...
Associated Press

Protester subdued by Rams’ Wagner files police report

THOUSAND OAKS, Calif. (AP) — A protester who ran onto the field during the San Francisco 49ers’ Monday night home game against the Rams has filed a police report after being subdued by Los Angeles linebacker Bobby Wagner. Santa Clara Police Department Lt. Cuong Phan confirmed to The Associated Press on Wednesday that the department […]
20 hours ago
Rep. Liz Cheney, R-Wyo., vice-chair of the House committee investigating the Jan. 6, 2021, attack o...
Associated Press

Liz Cheney says Arizona GOP candidates threaten democracy

PHOENIX (AP) — Wyoming Rep. Liz Cheney on Wednesday said the Republican candidates for Arizona governor and secretary of state pose a huge risk for democracy because both say they will refuse to certify election results if they don’t like the results. Cheney, a prominent critic of former President Donald Trump and one of just […]
20 hours ago
The symbol for Twitter appears above a trading post on the floor of the New York Stock Exchange, Tu...
Associated Press

Musk says he wants Twitter again and will pay $44B price

Elon Musk wants Twitter again — and Twitter is game. The billionaire Tesla CEO has proposed to buy the company at the originally agreed-on price of $44 billion, bringing the tumultuous, monthslong saga another step closer to a conclusion. Musk made the surprising turnaround not on Twitter, as has been his custom, but in a […]
20 hours ago
A woman holds a child at a clinic in Dollow, Somalia, on Wednesday, Sept. 21, 2022. Somalia is in t...
Associated Press

Prolonged drought brings famine, death and fear to Somalia

DOLLOW, Somalia (AP) — A man in a donkey cart comes wheeling through the dust, carrying two small, silent boys. The sky is overcast. It could rain. It won’t. It hasn’t for a very long time. Mohamed Ahmed Diriye is 60 years old, and he’s completing the grimmest journey of his life. He set off […]
20 hours ago

Sponsored Articles

...
SCHWARTZ LASER EYE CENTER

Key dates for Arizona sports fans to look forward to this fall

Fall brings new beginnings in different ways for Arizona’s professional sports teams like the Cardinals and Coyotes.
...
Day & Night Air Conditioning, Heating and Plumbing

Ways to prevent clogged drains and what to do if you’re too late

While there are a variety of ways to prevent clogged drains, it's equally as important to know what to do when you're already too late.
...
Dr. Richard Carmona

Great news: Children under 5 can now get COVID-19 vaccine

After more than two years of battle with an invisible killer, we can now vaccinate the youngest among us against COVID-19. This is great news.
ByHeart CEO on launching new baby formula in a supply crisis