Gulfstream Daily Brief

Regulatory intelligence and policy · Issue 044

FDA proposes infant formula changes, EMA and MHRA publish safety updates

Today’s regulatory updates span proposed US infant formula requirements, European product safety information, and UK authorization activity.

By Scott Morvay, Founder November 2, 2026 Official sources linked

FDA

FDA proposes changes to infant formula nutrient and labeling requirements

The proposed rule would revise minimum or maximum levels for four required nutrients, update certain units of measure and one permitted nutrient source, and amend required labeling. FDA also concluded that existing required levels remain appropriate for four other nutrients assessed.

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EMA

EMA publishes list of centrally authorized products with safety related information changes

EMA issued reference EMA/246449/2026, listing centrally authorized products with safety related changes to product information.

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MHRA

MHRA issues its October 2026 Safety Roundup

The roundup summarizes the latest safety advice for users of medicines and medical devices.

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MHRA

MHRA updates its list of registered orphan medicinal products

The authority published its list of authorized orphan medicinal products registered by the UK licensing authority.

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MHRA

MHRA approves triheptanoin for rare inherited disorders

MHRA approved triheptanoin (Dojolvi) to treat adult and pediatric patients with a group of rare inherited disorders.

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Why this matters

Regulatory affairs teams should note the scope of FDA’s proposed nutrient and labeling revisions, while monitoring EMA and MHRA publications for current safety related product information, UK safety advice, and authorization records.

Scott Morvay

Founder, Gulfstream Intelligence

This brief provides general regulatory news and educational information. It is not legal or regulatory advice.