Context

Why this matters

Laura Modi left Google and Airbnb to build Bobbie, a European-style infant formula, after her own breastfeeding struggle exposed how little the US formula category had changed in 40 years and how tightly it was controlled by two manufacturers, Abbott's Similac and Mead Johnson's Enfamil. Getting there took a public FDA shutdown, years of regulatory rebuilding, and eventually buying her own factory, and Bobbie now holds nearly 4% of a 6 billion dollar market.

The Big Idea

Bobbie's biggest crisis, a national FDA recall two weeks after its first product hit the market, became the reason it eventually got made at all: a genuine public apology, not a defiant defense, is what turned a regulator's shutdown into the manufacturer relationship and investor confidence the company needed to survive.

The category itself, a duopoly with nutritional standards last updated in the 1980s, was ripe for disruption. But entering a heavily regulated industry with a tech-startup instinct for cutting a corner nearly ended the company in its first two weeks.

Key Insights

A label workaround triggered a recall

Bobbie's German manufacturer couldn't meet US infant formula regulations, so Laura launched the product as a "companion formula," a different, less-regulated category. Within two weeks, an FDA inspector visited the warehouse, said the product functioned as infant formula regardless of its label, and issued a national recall of the entire pilot batch.

A public apology reopened doors

Laura's response was a public letter of apology, framed as compliance rather than defiance. That letter reached an internal champion at Perigo, the only US contract manufacturer for infant formula, who had already been pushing his own company to build a grass-fed, European-standard formula. He championed bringing Bobbie on as a client after watching how she handled the recall.

Unconventional hires built lasting culture

Every investor told Laura her co-founder had to be a scientist or technical counterpart. Instead she chose Sarah Hardy, a former Airbnb HR colleague, as co-founder and COO, followed by an Emmy-winning news anchor as chief brand officer. Her reasoning: culture built early is what carries a company through the hard times that inevitably come later.

Fast growth outran the supply chain

Bobbie launched direct-to-consumer in January 2021 and immediately hit product-market fit, doing $16 million in sales its first year against a $4 million forecast. But infant formula has a five-to-six-month production lead time, so the company ran out of inventory and had to throttle new signups to protect existing subscribers.

Turning off growth protected trust

During the 2022 Similac contamination recall, demand for Bobbie spiked further, but growing too fast risked breaking its promise to its own subscribers. Laura shut off new customer signups overnight rather than risk a subscriber getting an out-of-stock email, a call her own board pushed back on as leaving growth on the table.

Owning a factory didn't fix everything

After nearly losing supply during the 2022 shortage, Bobbie bought a completed but unused infant-formula facility from Nature's One in Ohio to reduce its dependence on a single contract manufacturer. The new facility still needed full FDA re-approval, a process that took about two years, during which Bobbie went out of stock again for almost seven months in 2024.

Mental Models & Frameworks

Single-supplier risk as existential threat

Depending on one contract manufacturer for a regulated, hard-to-substitute product means a capacity ceiling, a competing customer's demand spike, or a single phone call can put your own business at risk. Laura's response was to treat backup manufacturing capacity as core infrastructure to own, not a nice-to-have, once she saw how exposed that single point of failure left the company.

Pre-launch time is a one-time asset

The period before a regulated product can reach real customers, while it feels like dead time, is a unique opportunity to build community, hone brand positioning, and gather founding customers who later accelerate the business. That window disappears the moment the product actually ships and daily operations take over.

Decision Principles

Principle: Protect existing customers first

• When: demand is spiking faster than supply can be replenished, and taking on new customers risks failing the customers you already have.
• Why: for a product like infant formula, breaking a promise to an existing subscriber costs more in trust than any short-term growth is worth, even when a board is pushing to capture the moment.

Trade-offs & Nuance

Speed versus regulatory compliance

Launching under a "companion formula" label let Bobbie get real customer feedback faster than waiting years for full approval, echoing the launch-fast instincts Laura brought from tech. But in a category where mislabeling can put vulnerable infants at risk, that same workaround triggered the exact regulatory shutdown speed was meant to avoid, showing why compliance has to govern a regulated category before speed does.

Practical Application

Respond to setbacks with compliance

When a regulator flags a problem, choose a public, compliance-first response over a defensive or defiant one. Bobbie's apology letter, not a legal fight, is specifically what reached the internal champion at its future manufacturer and the investor who funded its recovery.

Hire for mission fit, not pedigree

Rather than defaulting to the "find a technical co-founder" advice every investor gave her, Laura hired people who deeply understood the mission and had proven they could build culture, a former HR colleague as COO, a news anchor as brand officer, trusting that domain expertise could be added around them.

Build backup supply capacity early

Don't wait until a single manufacturer relationship becomes an existential risk to start building redundancy. Bobbie only pursued owning its own facility after nearly losing the ability to serve customers, and even then the regulatory re-approval process took roughly two years to complete.

Build a founding community pre-launch

Before a regulated product can reach real customers, use the waiting period deliberately: publish content, meet prospective customers directly, and build the relationships that become word-of-mouth advocates the moment you launch, rather than treating the delay as dead time.

Bottom Line

The setback that looked like it would kill Bobbie, a national FDA recall two weeks after launch, became the reason it eventually survived, because a compliance-first, public response earned it the manufacturer relationship and investor trust a legal fight never would have.

When a regulator or crisis exposes a flaw, treat a genuine, public, compliant response as the fastest path back to trust, not the slowest.

Notable Quotes

"I turned to my husband and I said, I'm going to go do this full time. I'm not having this kid until there's a better formula in the market." (Laura Modi)

"If I signed up to feed my baby Bobbie and then one day received an email to say, sorry, we don't have product to send you this month, you've lost me. You've lost my loyalty." (Laura Modi)

"It looks like a duck, it cracks like a duck. This is infant formula." (an FDA inspector, quoted by Laura Modi)