NEKOOSA, WI (WAOW TV-WSAU) — An area business is fighting back against the Food and Drug Administration in an effort to expand access to baby formula.
The Bene Baby Company is a Nekoosa-based baby formula company that makes powdered formula out of goat’s milk.
The company was co-founded by an area medical doctor and dentist and hopes to provide a healthy alternative for breastmilk. The FDA is not allowing them to sell their infant formula, despite the ongoing nationwide formula shortage.
“I have a great frustration with this.” said Dr. Nikos Linardakis, President of Bene Baby.
A few months ago, the FDA lifted import restrictions for foreign formula companies, giving them three years to meet federal standards in areas like nutrition, manufacturing, labeling, and clinical research, all while denying Bene Baby’s progress.
“We’re doing everything right, we’ve completed all the manufacturing requirements, all the nutrition requirements, we’re underway with the clinical requirements, we’re doing everything by the process.” said Linardakis.
The FDA said while deferred requests aren’t a sign that the formulas are unsafe, they “indicate that we have found issues that would be unlikely to be resolved quickly.” said the FDA in a statement.
Bene Baby was told they were denied because of a lack of research as their infant formula is still in clinical research stages, but they claim other companies in the same stages can sell their products.
“We haven’t been given that equal opportunity, it’s being blocked on our side, and it’s being given three years for other companies to be allowed to go ahead and gather that data. All we’re asking for is for us to have that same ability.’ said Linardakis.
While the infant formula was deferred, the company’s toddler formula was approved and is available for purchase.
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