WASHINGTON (AP) — US regulators on Friday unveiled their plan to allow foreign baby formula manufacturers to stay on the market long term, an effort to diversify the nation’s tightly concentrated industry and prevent future shortages.
The Food and Drug Administration said recent entrants to the US market will have until October 2025 to make sure their formulas comply with federal standards for nutrition, labelling and manufacturing. The agency noted that some companies should be able to meet those requirements sooner.
The US has been forced to turn to foreign manufacturers to boost formula supplies since February, when FDA inspectors temporarily shuttered the nation’s largest domestic formula factory due to bacterial contamination.
In May, the FDA eased federal import regulations and President Joe Biden authorized the airlift of millions of pounds of powdered formula from overseas. Together those actions have brought the equivalent of 300 million bottles of formula into the country, according to the FDA.
“Manufacturers from around the world have demonstrated their commitment to helping bolster US supply and, in turn, we are committed to continuing these flexibilities for their products to safely remain on the market,” FDA Commissioner Robert Califf said in a statement.
The policy allowing importation was set to expire in November, but the FDA said it would be extended to January, after which companies can ask to stay on the market longer.
For decades, the US formula industry has been dominated by a handful of companies with domestic production facilities, excluding similar products from Europe, Australia and Latin America. The US system evolved to prioritise safety and low pricing, favoring a few large players.
Foreign formula companies seeking to remain in the US must meet specific thresholds for 30 nutrients and undergo manufacturing inspections by FDA staff, among other steps.
Earlier this month the FDA formally acknowledged several shortcomings in its response to the shortage, including outdated information technology systems and inadequate training among its food facility inspectors.
HOUSE RULES
- We welcome reader comments on the top stories of the day. Some comments may be republished on the website or in the newspaper; email addresses will not be published.
- Please understand that comments are moderated and it is not always possible to publish all that have been submitted. We will, however, try to publish comments that are representative of all received.
- We ask that comments are civil and free of libellous or hateful material. Also please stick to the topic under discussion.
- Please do not write in block capitals since this makes your comment hard to read.
- Please don't use the comments to advertise. However, our advertising department can be more than accommodating if emailed: advertising@jamaicaobserver.com.
- If readers wish to report offensive comments, suggest a correction or share a story then please email: community@jamaicaobserver.com.
- Lastly, read our Terms and Conditions and Privacy Policy
