FDA to develop framework to support expanded access to US formula market

The US Food and Drug Administration (FDA) has announced plans to work with foreign formula manufacturers to allow them to sell their products in the country on a permanent basis.

Amid a nationwide shortage, the FDA announced in May that it would temporarily exercise enforcement discretion for certain requirements applying to infant formula.

The agency’s current guidance, which makes it easier to import some formula products, remains in effect until 14 November.

The FDA says that these flexibilities have resulted to date in the equivalent of more than 400 million 8oz bottles being shipped into the US from nine countries.

The agency now says that it will work with manufacturers looking to enter the market to make it easier for them to navigate the FDA’s regulatory review process. It will host meetings with manufacturers to establish next steps, and intends to “provide a pathway for companies that import, sell and/or distribute formula under the FDA’s temporary enforcement discretion policy to continue to supply infant formula to the US past November”.