Weighing Shortage Risk, FDA Clears Releasing Metabolic Formulas Made At Abbott’s Closed Plant

With Michigan facility closed as cause of bacterial contamination is investigated, FDA announces “has no objection” to Abbott releasing specialty and metabolic formulas “to individuals needing urgent, life-sustaining supplies” on a case-by-case basis.

• Source: Alamy

Abbott Laboratories Ltd is releasing, at the US Food and Drug Administration’s request, limited quantities of metabolic infant nutrition formulas distributed through medical referrals which were made at a facility it closed earlier in 2022 after recalling contaminated formula brands available in stores.

While the Sturgis, MI, facility remains closed as the cause of the bacterial contamination is investigated, the agency announced on...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

EFSA: ‘A Dose Of Estragole Without A Harmful Effect Cannot Be Established’

 
• By 

Dietary supplements containing estragole may have to be removed from the European Union market due to carcinogenic risk, according to a draft scientific opinion from EFSA that is currently out for consultation.

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By 

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

US FDA Extracts More Evidence To Ban Kratom

 

Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.

More from Policy & Regulation

US FDA’s Kratom Focus Pivots To ‘Concentrated Synthetic Byproduct That Is An Opioid’

 

Explaining he was a heroin addict for 14 years more than 40 years ago “because it was so available,” Secretary Kennedy says “our agencies have been asleep in the wheel” but “now we're going to wake up and we're going to start to stop this before it starts.”

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By 

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

US FDA Extracts More Evidence To Ban Kratom

 

Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.