A Wisconsin goat dairy farmer says Joe Biden’s Food and Drug Administration is delaying approval for his company’s goat milk-based baby formula.
Dr. Nikos Linardakis, co-founder of Bêne Baby Co. said, “The FDA has blocked our entrance to market but has assisted the foreign products to be direct competitors.”
Bêne Baby Co. which already produces an FDA authorized toddler formulation (not authorized for infants), has been met with stalling tactics for their new infant formula.
“I’d leave voice messages and never get a call back,” Dr. Linardakis said. “This would be the first of its kind in the U.S.”
“We’ve been working with the FDA over the last three years,” he said. “Yet all the new streamlined process and dedicated teams from FDA were guided to the foreign companies and not to our U.S. companies. Then they made additional exceptions for foreign companies which were things we never had access to.”
Linardakis says his product would meet nutritional requirements and would be processed in an FDA licensed facility.
Linardakis received a letter from the FDA, but it did not give any specific reasons for the delay. “We believe these issues would be unlikely to be resolved quickly and, therefore, we are deferring further consideration of your request at this time,” the letter said.
The Journal Sentinel writes:
“The letters include a general list of issues the agency has identified with these requests,” the FDA said in an email to the Journal Sentinel.
“For firms that received letters, they do not mean that the infant formulas are unsafe,” the agency said, but more time was needed for evaluation.
“We have to be extremely detailed and specific in our work, but the FDA response was not,” Linardakis said. “It makes it appear like our company had several deficiencies, when in reality there was only one: we didn’t have previous sales of infant formula.”
Bêne Baby Co. has even won an award for innovation from the American Farm Bureau Federation:
Now in its eighth year, the Farm Bureau Ag Innovation Challenge is a national business competition that showcases U.S. startups developing innovative solutions to challenges facing America’s farmers, ranchers and rural communities.
This FBNews article features The Bêne Baby Company, a participant in the 2020 Challenge, which culminated at the American Farm Bureau Convention in Austin, Texas, in January 2020. As a semi-finalist, The Bêne Baby Company was awarded a total of $10,000.
Meet Dr. Nikos Linardakis
With a rich history in health care, Dr. Nikos Linardakis provides a depth of knowledge to his role as president and co-founder of The Bêne Baby Company in Nekoosa, Wisconsin. When raising his own children, Dr. Linardakis saw a gap in the formula market for a nutritious, cow milk-based formula alternative. In recent years, he evaluated the different types of milk, their nutritional profiles and benefits. Then, with the help of Dr. James Esselman, they created the Bêne Baby Formula.
As a physician executive for 25 years, Dr. Linardakis has been: an Open Innovation Champion for the world’s largest nutritional supplement company; CEO for Tharos Laboratories; series Editor-in-Chief with McGraw-Hill in New York; director of clinical research for The Natural Standard in Cambridge, Massachusetts; and past director of quality for Nutrativa Global. Dr. Linardakis graduated from Benedictine University with a bachelor’s of science in Biology (’87), attended a master’s degree program in Applied Physiology and received his medical doctorate from the University of Health Sciences/Chicago Medical School (’97). He has held executive board appointments at Blossom Health Care Center, The Children’s Museum of Utah, the University of Utah School of Business and the Utah Governor’s Office of Economic Development.
Dr. Linardakis is the published author of 11 medical textbooks with McGraw-Hill, “Ten Natural Ways to a Good Night’s Sleep,” and several health and journal articles. He is also a recipient of the 2014 Blossom Humanitarian Award for his hospital work in war-torn Afghanistan. Dr. Linardakis is the father of three young adults, and is fluent in three languages: English, Spanish and Greek.
Amidst the nation’s ongoing baby formula shortage, the Biden administration, as usual, is playing favorites with overseas companies and dumping American ingenuity down the drain.
