Note: Graham Winfrey, senior editor at Inc., is stepping in for Cameron while he is away from the computer this week.
Good morning,
In 2019, just two weeks after launching their infant formula company Bobbie, co-founders Laura Modi and Sarah Hardy received a surprise visit from U.S. Food and Drug Administration. The FDA agents informed them that their product's labeling did not comply with FDA requirements. Bobbie would need to do a recall and completely rework production.
It's tough to imagine a product where quality matters more than formula for newborns, "the most vulnerable audience that exists, who you are responsible for keeping alive," says Modi. "Who recovers from a recall for infant formula?"
Some of the company's advisors suggested pivoting from breast milk substitute to baby food, an entirely different category with fierce competition. Modi and Hardy weren't interested, however. Instead, they decided to treat the FDA as partners, rather than adversaries, and do everything in their power to bring their product into compliance.
Check out the full story to learn how Bobbie scrambled to clear multiple regulatory hurdles and came out of the crisis an even stronger company. |
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