Evolus website: missing trial disclosure, NI prescribing info gaps, and mobile black triangle/generic name failures

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Key facts

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Case	AUTH/3882/2/24
Parties	Complainant v Evolus
Subject	Allegations about Evolus website (corporate homepage and HCP Nuceiva promotional pages; mobile rendering follow-up)
Medicine referenced	Nuceiva (botulinum toxin type A) (black triangle medicine)
Applicable Code year	2021
Complaint received	24 February 2024
Case completed	30 May 2025
Appeal	No appeal
Breach clauses	Clause 4.6; Clause 5.1 (x4); Clause 8.1; Clause 12.3; Clause 12.4; Clause 12.6; Clause 12.10
No breach clauses	Clause 2 (x2); Clause 5.1 (x4); Clause 6.1 (x3); Clause 6.2; Clause 11.2 (x4); Clause 12.4; Clause 12.6; Clause 26.4
Notable procedural point	Evolus withdrew its agreement (18 March 2025) to comply with the Code and accept PMCPA jurisdiction; did not provide an undertaking; MHRA and the Appeal Board were informed.

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

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What happened

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An unverified health professional complained about Evolus’ publicly accessible company website and HCP Nuceiva (botulinum toxin type A) pages, alleging the site blurred corporate “beauty” messaging with POM promotion and downplayed safety obligations.
The Panel considered the homepage to be a corporate page directed at both health professionals and the public (publicly accessible with separate routes to public vs HCP promotional content).
The homepage did not include information on where details of Evolus’ clinical trials could be found.
The website header stated it was for HCP audiences in the “U.K.”, but the site did not provide clearly labelled Northern Ireland prescribing information (PI) or a statement about where NI PI could be found.
On the Nuceiva promotional page, the adverse event reporting statement was presented in a way the Panel did not consider sufficiently prominent for a black triangle medicine (considered under high standards).
Imagery used in the HCP section (young adults / fashion-shoot style) was considered, on balance, to give an impression of “fashionable” cosmetic promotion and not to recognise the special nature of a black triangle POM (high standards).
In a follow-up complaint about the mobile view, the black triangle and generic name placement differed from desktop: the triangle could be misread as a downward arrow and the non-proprietary name was not immediately adjacent to the brand name.
The Panel considered the mobile version differed substantively and should have been certified separately; certification requirements were not met.
During the case, Evolus notified it would no longer accept PMCPA jurisdiction; it did not appeal and did not provide an undertaking due to withdrawal. MHRA and the Appeal Board were informed.

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Outcome

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Breach findings were made for clinical trial signposting, high standards (multiple aspects), certification, and specific digital requirements for black triangle, generic name adjacency, and UK/NI prescribing information presentation.
No breach findings were made for alleged misleading claims, substantiation, off-label/MA inconsistency, discredit, and patient side-effect statement requirements on the corporate homepage.
No appeal.

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Clauses

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Breach of Clause 4.6 Failing to include on the home page of their website information as to where details of their clinical trials can be found
Breach of Clause 5.1 (x4) Failing to maintain high standards
Breach of Clause 8.1 Failing to meet the requirements for certifying material
Breach of Clause 12.3 Failing to include the non-proprietary name of the medicine immediately adjacent to the most prominent display of the brand name
Breach of Clause 12.4 Failing to include the relevant prescribing information within the digital material or via a direct, single click link
Breach of Clause 12.6 Failing to include a clear, prominent statement as to where the relevant prescribing information could be found
Breach of Clause 12.10 Failing to include a black triangle adjacent to the first mention of the product in digital material
No Breach of Clause 2 (x2) Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 (x4) Requirement to maintain high standards at all times
No Breach of Clause 6.1 (x3) Requirement that claims/information/comparisons must not be misleading
No Breach of Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation
No Breach of Clause 11.2 (x4) Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics
No Breach of Clause 12.4 Requirement to include prescribing information within the digital material or via a clear and prominent direct, single click link
No Breach of Clause 12.6 Requirement to include a prominent statement as to where the prescribing information can be found on promotional material on the internet
No Breach of Clause 26.4 Requirement to include a statement on reporting side effects in any material relating to a medicine which is intended for patients taking that medicine

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Evolus website: missing trial disclosure, NI prescribing info gaps, and mobile black triangle/generic name failures

Key facts

What happened

Outcome

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