US FDA Eases Baby-Formula Import Rules to Boost US Supplies, page-22

Some excerpts from the Australian article "FDA eases import rules on formula":

US health regulators have taken steps to allow more foreign baby formula on American shelves, easing rules that had effectively prevented shipments from many overseas manufacturers.

The Food and Drug Administration on Monday said it encouraged the overseas manufacturers to apply to ship their formula to the US.Government officials said the moves would allow more formula products to enter the US baby market, which is dominated by Abbott Laboratories, Reckitt Benckiser and Nestle’s Gerber.

However, it could be weeks before the products come to store shelves in the US, an FDA official said. Manufacturers would first have to apply with the agency to be able to ship their products to the US, and then the agency would have to conduct a review to assure quality control and safety.

....

Easing the import rules could add to formula supplies, according to supporters, by allowing manufacturers overseas that have not been able to ship their products to the US access to the market if they can meet the FDA’s adjusted requirements.

It could also allow domestic manufacturers of formula destined for foreign shelves to sell their products in the US.The changed guidelines were a temporary measure valid for the next 180 days, said Susan Mayne, who leads the FDA’s food-safety division.

Under the changed guidelines, Dr Mayne said, the FDA would have more flexibility to allow more overseas formula products into the US after making sure they were safe, nutritious and properly labelled.

“We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants,” FDA commissioner Robert Califf said.

The White House had asked embassies, retailers and manufacturers to help find companies that could ship formula to the US under the new FDA importation rules, Ms Jeane-Pierre said.

Abbott said it was already importing millions of cans of formula from an Ireland plant, and was prepared to import from other company facilities if possible.


^^^
Seems like it would still take some time for reviews of safety to be undertaken, the change is temporary (180 days), and Abbott is already scrambling to maintain its dominance by bringing in formula it has produced overseas. But despite all that, it's still an undeniable opportunity for A2M to do something to get its foot in the door.