Shield and Norgine: Feraccru website claims, animal data not disclosed and public advertising of a POM (AUTH/3231/7/19 & AUTH/3255/7/19)

📊

Key facts

⌄

Case numbers	AUTH/3231/7/19 and AUTH/3255/7/19
Parties	Complainant v Shield and Norgine
Product	Feraccru (ferric maltol)
Channel	Website
Complaint received	26 July 2019
Case completed	28 January 2020
Applicable Code year	2019
Core issues	Tolerability claim; misleading MOA/extrapolation from animal/indirect data; public advertising of a POM via disease page linking to product information
No breach clauses	Clause(s) 3.2, 7.2
Breach clauses	Clause(s) 7.2, 7.4, 26.1
Sanctions applied	Undertaking received
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A UK health professional complained about content on the Feraccru (ferric maltol) website (Feraccru used to treat adults with iron deficiency).
The website stated “Feraccru is well tolerated”, which the complainant said was inconsistent with the SPC adverse reaction profile.
A “how Feraccru works” page claimed Feraccru prevented gastrointestinal mucosal damage by free radicals that may cause inflammation, citing references.
Two cited papers were rat-model studies, but this was not made clear on the website; a third cited paper did not involve Feraccru.
A page aimed at the general public about iron deficiency/anaemia appeared to link to Feraccru product information, which the complainant alleged promoted a prescription-only medicine (POM) to the public.
Shield and Norgine responded jointly; Norgine became MAH in Feb 2019 and website management transferred in April; the site was being updated when the complaint was received.
The companies accepted the public page, as accessed, promoted Feraccru to the general public and took the website down on notification.

⚖️

⌄

No breach for the claim “Feraccru is well tolerated”.
Breach for misleading mechanism-of-action content that implied direct human/Feraccru evidence and did not make clear the animal basis and irrelevance of one reference.
Breach for advertising a POM to the public via a disease-awareness page linked to the product.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access