FDA Gives Greenlight for Bobbie’s First of its Kind Tolerance Formula, Expanding Product Offering and Supporting More American Babies with High-Quality, Domestically Manufactured Organic Infant Formula

Bobbie Labs, the research and development hub of formula brand Bobbie, today announced a new infant formula – the second since the company’s launch in 2021. Bobbie Organic Gentle, slated for a late Spring 2023 due date, will be the first and only American-made, EU-style organic product with 100% lactose, instead of other carbohydrates like corn syrup. Lactose is the primary source of carbohydrate found in breast milk and provides energy to fuel growth, yet nearly 90% of all tolerance formulas in the U.S. use corn syrup solids, rice syrup or corn derivatives like maltodextrin as a carb source.

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Meet our new baby, Bobbie® Organic Gentle® -- due late Spring 2023. (Photo: Business Wire)

Bobbie has never sacrificed their commitment to high-quality, organic ingredients—and are proud to expand this promise to parents seeking a tolerance formula with partially hydrolyzed protein. Bobbie's team of scientists, dietitians, regulatory experts–all of them parents–refused to compromise on high quality ingredient choices with Bobbie Gentle. Bobbie Labs worked with Perrigo Company plc, a trusted infant formula co-manufacturer in the United States with decades of experience to bring this unique recipe to market.

Bobbie’s VP of Regulatory, Christina Berberich, PharmD, MPH, RD, and Mother worked with Perrigo to bring this ideal product into existence with Bobbie’s Organic Gentle Infant Formula. “I have worked with infants and infant feeding for nearly 20 years, and I’ve seen firsthand how gentle and tolerance formulas have relied on ingredients like corn syrup as a cost-effective alternative to lactose,” Berberich said. “Emerging research* has found however that formulas with non-lactose-based carbohydrates have potential impacts on gut microbiome development, blood sugar alterations and excessive weight gain in toddlerhood. As moms and as scientists, knowing a better option existed fueled the creation of this groundbreaking gentle formula that we’re proud to bring to American parents and babies who deserve better.”

In true Bobbie form, the European-style recipe meets all FDA nutritional and quality standards for infant formula and many EU standards (like DHA and ARA levels), starting with simple, high-quality ingredients designed to nourish babies who have difficulty digesting intact proteins.

“This new gentle formula is formulated with 100% partially hydrolyzed whey proteins instead of intact whey and casein protein and contains 100% lactose. This means that the protein is smaller in size and easier to digest and contains lactose over sweeter carbohydrate alternatives since the majority of infants can tolerate lactose, the major carbohydrate found in human milk,” said Anthony Porto, MD, MPH, FAAP, Bobbie Labs Chief Medical Director.

“New research shows that babies fed any lactose-reduced infant formula with corn syrup solids have a 10% higher obesity risk at two-years-old, with associations remaining at four-years-old – it is our duty to provide a better formula for American parents and their babies,” said Dina DiMaggio, MD, FAAP, Bobbie Labs Medical Research Director.

Tolerance formulas are the second fastest-growing infant formula category with a 9% year-over-year growth that is likely to surpass the routine category in the next five years. As the infant formula shortage this past year has proven, tolerance formulas like Gentle have been the hardest to come by and parents are looking for a high-quality option here in the U.S. Bobbie, a company founded by two moms, believes that American companies have a responsibility to uplevel the first food for our babies, infant formula, and that quality products should be developed, manufactured, and sourced on American soil.

This new product is just the first of several new products that will be released by the Bobbie Labs team in 2023 as the company invests heavily in R&D and building a world class suite of innovative products in nutrition.

“We established Bobbie Labs to evolve infant feeding while shaking the formula stigma within the research community and beyond. Our Organic Gentle Formula is just one way we’re already bringing this mission to life. Parents no longer have to compromise between a formula their babies tolerate and the ingredients they want,” said Laura Modi, CEO, Co-Founder of Bobbie and Mom of three. “But as always, Bobbie supports the individual choices made by parents surrounding feeding. There is no such thing as a bad formula—and we firmly believe that we can innovate and provide new options while simultaneously supporting what is accessible, affordable and available to parents based on their unique circumstances.”

In order to evolve infant feeding, we have to start with the science, which is why we're making an investment to support scientific research grants that examine the nutritional, social, and environmental questions related to an infant's feeding journey. Bobbie Labs is again soliciting research proposals within three critical areas within infant feeding - nutrition, sustainability, and behavioral research. To apply, visit BobbieLabs.com

The established scientific experts leading the Bobbie Labs team:

Chief Medical Director: Anthony Porto, MD, MPH, FAAP is a dad, board-certified pediatric gastroenterologist, Associate Professor of Pediatrics, Associate Chief of Pediatric GI at Yale University, and co-author of The Pediatrician’s Guide to Feeding Babies and Toddlers, and an AAP spokesperson.

Medical Research Director: Dina DiMaggio, MD, FAAP is a mom, board-certified pediatrician, co-author of The Pediatrician’s Guide to Feeding Babies and Toddlers, and an AAP spokesperson.

Scientific Advisory Board: a group of 14 scientific thought leaders whose collective published work has been cited in more than 30,971 peer-reviewed scientific journals and textbooks.

To learn more about Bobbie Gentle, visit Bobbie Labs.

About Bobbie:

Bobbie is an Organic Infant Formula company that exists to build a parenting culture of confidence, not comparison, where every parent is supported in the feeding choice that is right for them and their baby. Bobbie launched in 2021 as the first direct-to-consumer, subscription-based infant formula company in the US. Today, Bobbie is the only mom-founded and led infant formula in the country and the fastest growing infant formula to enter the US market since the 1980’s. Bobbie’s recipe is modeled after breastmilk and designed to meet the most recent EU nutritional standards for critical ingredients like DHA and iron, while also complying with all FDA nutritional standards for infant formula. Bobbie is focused on providing a purposefully sourced, USDA Organic infant formula with Organic Valley milk from pasture raised cows. It was the first-ever infant formula to receive the Clean Label Project Purity Award and certification as a Pesticide-Free Product. Bobbie was founded in 2018, is based in San Francisco, and is venture-backed. For more information on Bobbie, visit www.hibobbie.com, and follow Bobbie on Instagram @bobbie.

*Cited Research:

Jones, Roshonda B., et al. "Lactose-reduced infant formula with added corn syrup solids is associated with a distinct gut microbiota in Hispanic infants." Gut microbes 12.1 (2020)

Anderson, Christopher E., Shannon E. Whaley, and Michael I. Goran. "Lactose-reduced infant formula with corn syrup solids and obesity risk among participants in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)." The American Journal of Clinical Nutrition (2022).

Gentle is a registered trademark. Used under license from PBM Nutritionals, LLC.

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