Bobbie Clinical Study
Our Bobbie Labs Motto: Always be evolving
Our Stance: In order to truly reform this industry from the ground up we need to continue to push the status quo. Science is evolving and it’s our responsibility to continue to evolve our products to meet the latest science.
A Little History: The Evolution of Bobbie Formulations
Companion Formula
EU Recipe, Made in Germany [Voluntary Recall 2019]
(Turns out you can't make it in Germany and sell it in America)
Flagship (EU Style)
Bobbie’s unique EU style recipe [FDA Greenlit 2020]
Gentle: (100% Lactose)
Only 100% Lactose ‘Partially Hydrolyzed Protein’ [FDA Greenlit 2022]
Flagship (New Fat Blend)
New Fat Blend ‘No Soy Oil/No Palm Oil’
Flagship (New Ingredients)
Recipe changes requiring a new Clinical Study
Science-backed and FDA regulated
All Formulas commercialized in the US need to meet the FDA requirements of Infant Formula, have growth study substantiation, and use GRAS approved ingredients. All current Bobbie products are supported by clinical data conducted by Perrigo.
Bobbie’s proprietary formulation has been substantiated by existing infant growth studies conducted by Perrigo PLC
Bobbie conducted new Protein Efficiency Ratio (PER) studies to support the IFN to FDA (Infant Formula Notification Filing)
All GRAS approved ingredients are used in Bobbie
Meet Our New Clinical
Our Bobbie Labs team of scientists and researchers (a majority of who are parents) have been formulating something new and now it’s time to study it.
As one of the first fully virtual clinical trials in the infant formula industry, Bobbie is optimizing and modernizing the experience with telehealth and a custom-built app for data collection to empower parents to participate and increase accessibility across all the country.
Study Snapshot
To substantiate a new formulation, a manufacturer of an infant formula must conduct a growth monitoring study (GMS). 21 CFR Part 106.121 details the components of a GMS.
How long is the study?
The study is 16 weeks long and infants must be no more than 11 days old at the time of enrollment.
What information do we collect?
- Formula intake
- Anthropometric measurements (weight, length, head circumference) at 6 timepoints throughout the study
- Questionnaires on baby's gastrointestinal tolerance and general disposition
- Urine sample (collected via a non-invasive, at-home collection bag)
What data do we analyze?
GMS studies compare the growth of babies consuming control formula and test formula using CDC growth charts. These studies are also required to compare formula intake of the babies consuming control and test formula and a scientifically appropriate reference
Questions?
Like all U.S. infant formulas, clinical data supporting the healthy growth and development of infants was submitted to the FDA for review in accordance with regulation prior to commercializing. Bobbie’s unique recipe was developed by pediatric nutritionists and food scientists from Johns Hopkins to mirror European nutritional standards and substantiated with an existing growth study. New clinical trials are needed for new ingredient introduction to the FDA.
We are looking to introduce net new ingredients to our infant formula to further evolve our recipe to meet the latest science. Clinical trials are mandatory for FDA approval of new ingredients, which also must meet GRAS approval. All infant formula clinical trials measure growth and tolerance of the formula compared to existing cow milk formulas. Since breastmilk is the optimal nutrition source for infants, this study includes a group of breastfed babies for additional comparison.
Yes, infant formula companies are accountable financially for their clinical trials. We are proud to be investing in new ingredients and science in formulas to continue to innovate and evolve the industry forward.
This is a randomized, double-blind, controlled trial meaning participants in the formula arm are randomly assigned to either the control or test formula and neither the participants nor the study team know which formula is assigned to the patient.
A contract research organization (CRO) will manage the study and Bobbie is the sponsor of this clinical trial. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Bobbie will conduct growth monitoring studies on any new formulations in accordance with FDA regulations. These studies will capture data related to the growth, development, tolerance, and safety of our new infant formulas.
The study is IRB approved and has been designed in accordance with Good Clinical Practice guidelines. This study is registered on clinicaltrials.gov for more information.
This study is testing a new ingredient that doesn't have previous substantiation. We're pushing to get this ingredient approved by the FDA!