From-the-farm regulatory & FDA
Regenerative ingredient sourcing: a case study
2-min read
Here’s a true story about regenerative ingredient sourcing and what to do when your ingredient use-case is not FDA approved.
It started when Serenity Carr wanted to make a better infant formula for her baby, did a ton of science work on breastmilk composition, but ran into regulatory restrictions when it came to marketing her formula for infants. She and her husband own Serenity Kids, an organic and regenerative food and nutrition brand which includes a toddler formula marketed to >12 mos.
Courtesy Serenity Kids
Why not infant formula?
Infant formula regulations say you must produce in a pharma-grade facility, and those facilities are to capacity in the U.S. Recall the tragic food safety violations that ultimately shut down Abbott Labs causing a shortage of formula? Infant formula in the U.S. is a monopoly with only two brands holding 80% of market share and dominating production. This was the first roadblock the Carrs ran into when readying their product to market.
Secondly, some of the ingredients the Carrs wished to use are not currently approved for use in infant formula. As I wrote about last week, you can market products with ingredients that have the GRAS (generally recognized as safe) FDA exemption, and other infant formulas do so, but at the risk of crossing the WHOs (World Health Organization) International Code of Marketing of Breast-milk Substitutes established to end the inappropriate marketing of infant formula and other food and drinks intended for children up to age two.Remember FDA approval takes years and costs tons of money, and there have been recent recalls on products marketed without approval.
An example is the concern many parents have about seed oils in infant formula. Industrial seed oils are currently the only approved fats in infant formula, so anyone wishing to formulate with another type of fat will not meet FDA requirements.
So, instead of going the infant route, Serenity Kids offers a formula marketed to >12 mos. But finding a milk source and processor that meets their specifications is where the direct farm partner story begins.
I learned about Serenity Kids in my interview with Blake Alexandre of Alexandre Family Farms – an organic, regenerative dairy farm and branded dairy company. You can hear all about their 30+ year dairy farming and now processing and product journey in today’s podcast episode of the Future of Agriculture.
The Alexandres are the single source of milk for Serenity Kids toddler formula, and the hope is more demand will come for this quality of milk and milk ingredients. (You can learn why A2 milk is better, and what it means to the quality of the milk coming from grass fed, organic and regeneratively raised cows here.)
Sourcing regenerative
Most regeneratively grown ingredients are not available from multinational ingredient suppliers, so like the Carrs, you’ll have to go direct to the source. When demand for regenerative ingredients (at a price that covers costs) increases, more upstream players will invest in regenerative farming and processing. The way to find these sources are:
Build relationships with regenerative farmers and learn who they process and sell to
Make friends with like-minded brands that also source high quality ingredients that are interested in regenerative
Support regenerative organizations by listing on their directories as procurers of potential ingredients.
All my best,
Jennifer
Big thanks to Tim Hammerich with The Future of Agriculture podcast for letting me co-host again!
—NEWS —————
It’s hard to be two things. Ingredient co Perfect Day’s investors grew tired of investing in brands, so they shut down Urgent Co, taking down newly acquired Cool Haus with it. I tell ag all the time: brands are a different business model — heavy upfront capital and longer cash conversion cycles. It takes a lot to build and run a brand.
Perfect Day Lays Off 15% of Workforce, Shutters Consumer Biz & Coolhaus, NOSH.COM
