NECOSA, Wisconsin (WAOW) — A local company is fighting back against the Food and Drug Administration in an attempt to expand access to infant formula.
The Bene Baby Company is a Nekoosa-based baby formula company that makes formula from goat milk.
The company was co-founded by local doctors and dentists and hopes to provide a healthy alternative to breast milk.
The FDA does not permit the sale of infant formula despite a national formula shortage.
“I am very frustrated with this,” said Dr. Nikos Linardakis, President of Bene Baby.
A few months ago, the FDA lifted import restrictions on foreign formula companies and gave them three years to meet federal standards in areas such as nutrition, manufacturing, labeling and clinical research. All progress was denied.
“We’re doing everything right, we’ve completed all the manufacturing requirements, all the nutritional requirements, we’re going through the clinical requirements, and we’re doing everything according to the process,” Rinaldakis said.
The FDA said the postponement of the request does not indicate that the prescription is unsafe, but “demonstrates that it has discovered problems that are unlikely to be resolved soon.” FDA said in a statement.
Bene Baby was told it was rejected due to lack of research because its infant formula is still in the clinical research stage, but it claims other companies in the same stage can market their product.
“We have not been given an equal opportunity. It has been blocked on our end and given three years before other companies are allowed to go ahead and collect that data. All we ask is to have it… the same ability.
Infant formula has been postponed, but the company’s infant formula is approved and available for purchase.