BILLINGS - Dr. Jeff Golini has hit roadblock after roadblock while trying to curb the baby formula shortage.
U.S. Sen. Steve Daines reached out to the US Food and Drug Administration (FDA) on his behalf, but Golini says even the senator’s pull might not be enough to allow American businesses like his to sell baby formula.
“I told the FDA, this is affecting mothers. This isn’t our business, we don’t need this to make a living, we’re just trying to help out,” said Golini.
As families continue to search for baby formula, Golini's company All American Pharmaceutical in the Billings Heights remains in a holding pattern.
The company is churning out formula but can only market it to toddlers, not infants.
“There are people like All American Pharmaceutical and others probably in the USA that would be able to produce to the standards of the USA market,” Golini said.
Golini has had to sit back and watch as the FDA has approved imports of baby formula from international manufacturers to cope with the shortage, even though he says many aren’t held to the same FDA requirements that U.S. companies must follow.
“There’s no quality checks, there’s no safety checks, no one at customs is testing it to make sure it is what it is or safe. It’s just rolling in,” said Golini.
Golini’s frustrated that he can produce baby formula that meets the FDA’s requirements, but he can’t sell it because it hasn’t been approved for infants.
That approval process, Golini says, is time-consuming and would cost upwards of $2 million.
“To put one set of standards that you can import but then to say, ‘people who are registered to manufacture in the USA, oh you can’t, you have to do all these studies and stuff.' It just doesn’t make any sense,” said Golini.
Golini’s plight has caught the attention of Daines, who is now urging the FDA to approve All American Pharmaceutical’s formula for infants.
“Montana moms and dads have been struggling to find baby formula and feed their children—this is a crisis. We should be doing everything we can to cut red tape and revamp production here in the U.S. to quickly replenish the shelves for Montana families," Daines said in a statement to MTN News.
Even so, Golini doesn’t think it’ll be enough. Daines is "petitioning, but I don’t know how far that will go,” said Golini.
So now he waits for the FDA’s approval as he’s stuck in a maze of red tape.