One of our core values is nurture the tension and this certainly rings true right now. We accept that our labeling and our marketing may have been misleading and for that we truly apologize to all of our customers. There is inherent tension between trying to do something new and navigating an established system. We anticipated this would be hard, and it should be! When it comes to our kids, safety comes first and every parent deserves peace of mind.
01. Has there been any customer concerns?
It is important to note that we have had no safety complaints or problems identified with the physical integrity of our product.
02. What is toddler formula?
In the US, toddler formula is categorized as a food, distinct from infant formulas which are subject to separate specific requirements. Toddler formulas are not intended for consumption by children 12 months or under. Our labeling and marketing will comply with the requirements of FDA to ensure we are not marketed as infant formulas.
03. Why isn’t Bobbie an infant formula?
The US has very specific requirements that must be met in order for a product to be marketed as an infant formula. Such as, meeting nutritional guidelines, ensuring that facilities are FDA vetted, and completing necessary growth studies. At this time, our product does not meet all these requirements and is intended only for consumption by toddlers older than 12 months.
04. Does Bobbie provide adequate iron levels, if it had been appropriately marketed as an infant formula?
Yes, for full term healthy babies. Bobbie contains .79 mg per 100 kilocalories (.53 ml). FDA regulations require that infant formulas contain between 0.15 to 3.0 mg of iron per 100 kilocalories. FDA regulations also require infant formulas that contain less than 1mg of iron per 100 kilocalories to contain a statement on the labeling that additional iron may be necessary.
These requirements will not apply to Bobbie moving forward as a toddler formula, intended for children older than 12 months.
05. Why aren’t all of Bobbie’s nutrients listed on the label?
In the US, the labeling for a food (including Bobbie toddler formula) and infant formula have different requirements. Food products must include a certain subset of nutrients in a Nutrition Facts panel, and a list of ingredients on the label. Infant formulas must provide a more exhaustive list of nutrients and ingredients on the label.
Below is a full list of our nutrient details in Bobbie, this can also be found on our website.
06. What is Bobbie doing to be compliant?
We are working with the FDA to identify any labeling and marketing changes that need to be made in order to comply with US regulations. We are committed to ensuring that our parent community understands our product is intended for toddlers (older than 12 months).
07. When will Bobbie be back?
We are moving as fast as possible to make the needed updates in cooperation with the FDA. Our top priority is our current customer community, and we will do what it takes to come into compliance so that we can welcome more parents to our village. Follow us at instagram.com/itshibobbie for more updates.
Need further context to the above? Here’s the FDA Notice.
This is Bobbie’s press response.