Causes and Solutions to the Formula Crisis

I’m SO ANGRY about this formula crisis; I’m angry there are babies in the hospital. I’m angry new mamas are spending extra time trying to find formula to keep their babies alive. I’m angry this country doesn’t have decent maternity leave so some could choose to nurse. I’m angry the FDA is making things harder for moms rather than helping keep our babies safe. We're speaking up to the FTC about the formula shortage crisis; read more on that and how to join us in advocating here. 

Repost the photo above if you're fired up about the formula shortage crisis and are joining us in speaking up and out to the FTC.

     MAKE YOUR VOICE HEARD     

When Della weaned herself at 9 months old, I had no choice but to feed her formula. I can’t imagine how stressful it would have been to not be able to find any. I was lucky enough to be able to buy high-quality European formulas, but even those required compromises in nutrition, which made me angry. That is why I led a team of moms for two years to create a formula that is closer to breastmilk than any other. 

I believe in the power of moms- especially ones trying to protect their children. If moms really understood the cause of this situation, there would be nothing to stop us from demanding change. Naturally, I have been following this situation from the very beginning, and here is what I see as the flow of events leading up to this crisis. 

Barriers to Entry Limit Innovation and Competition

Three large corporations make 90% of US infant formula, which is called an oligopoly and can lead to crises like we see now. The FDA regulates infant formula according to the Infant Formula Act of 1980, which is rooted in 50–year old science. To achieve infant formula certification, the FDA requires infant feeding studies that can take several years and millions of dollars to complete. This makes it very difficult for small companies to have infant-certified products. 

Serenity Kids formula meets all the FDA’s requirements for infant formula, except we have not completed the long and expensive infant feeding studies. Therefore, we are not allowed to recommend it for infants under 12 months old. 

Europe leads the world in food safety requirements and formula regulations, and they don’t require full-scale clinical trials as long ingredient benefits can be proven through scientific evidence. Because of this, formulas composed of these ingredients that meet their safety and nutritional standards are approved and brought to market faster. That is why there is more innovation and market diversification in Europe than there is in the US. 

We are calling for the infant feeding study requirement to be removed if a formula’s ingredients have already been proven safe, so that small companies like ours can bring more nutritious, innovative products to the market and chip away at Big Formula. 

FDA Cracked Down on Imports of Better-Quality European Products

Throughout 2021, the FDA cracked down on imported European formulas because they didn’t meet antiquated FDA regulations, so now they’re nearly impossible to purchase in the U.S. I used European formula for my baby because the ingredients and quality standards are much higher. In Europe, infant formula regulations are updated every few years based on cutting-edge science. The FDA chose to put their time and resources towards cracking down on European formula imports rather than focusing on the quality and safety of US formulas. Now they are back pedaling on this and working to fast-track approval for imported formulas to help alleviate this shortage.

We believe any infant formula approved in Europe should receive blanket approval in the US.  

FDA Failed to Regulate Quality of U.S. Formula

In February 2022, it became public knowledge that a cronobacter outbreak at Similac’s Sturgis, MI formula facility was making babies sick, which is tragic for those families affected. The FDA was initially made aware of this problem in September 2021 and failed to inform the public immediately. After the FDA finally shut down the manufacturing facility, there has been a dramatic shortage. This has caused many retailers to ration infant and toddler formulas. Members of Congress are questioning the FDA’s ability to effectively regulate the infant formula marketplace.

We believe congress must overhaul FDA mandates for infant formula regulation to ensure they act faster on quality concerns. 

Serenity Kids Is Part of the Solution 

Our Grass Fed A2 Whole Milk Formula is still in stock and we are not gouging prices! 

Our formula contains a macronutrient profile (high-quality proteins, fats, carb), and fortifications (HMOs and nucleotides; prebiotics) that make it more similar to breastmilk than any other. We partnered with Dr. Sarah Ballantyne, a medical biophysicist, who read global studies of breastmilk composition and distilled that knowledge into an outline of the ideal nutritional makeup and best ingredients.

Ours is the only formula that DOES NOT have industrial seed oils or synthetic folic acid. It is one of very few to contain organic A2 whole milk and is grain free, whereas most other brands contain corn, rice, or both. Our formula contains the 29 key nutrients required by the FDA for an infant formula, plus ours contains premium ingredients like organic lactose, making it more similar to European formulas. We manufacture it using Good Manufacturing Practices which ensures its consistent quality and safety. After all, we feed this to our little ones! 

The FDA has not approved our formula as an infant formula. Presently ours is classified as a “Toddler Formula” and we can only recommend it for children 12+ months. We are currently in the process of applying for fast-track temporary approval to market to infants according to the FDA’s Infant Formula Enforcement Discretion Policy, and we’re hopeful we will be granted it. In the meantime, we recommend you consult your health professional to see if our product might be right for your child. 

Feel free to reach out to us if you have any questions about this crisis or our products. We are moms like you- trying to stay educated. So hang in there and stay in touch.