On 30 September 2020, having first attempted inter-company dialogue, RB UK Commercial Ltd (“RB”) raised formal concerns with PAGB about advertising for Infirst’s product Flarin. The Claim, “Unique lipid formulation helps shield the stomach from damage” has been used in various adverts throughout 2020.
RB objected that:
In its response, Infirst noted that the claim is supported by non-clinical and clinical evidence that has been reviewed by PAGB prior to the claim being approved. Furthermore the additional concerns raised by RB were refuted as:
RB’s complaint was considered formally by members of the PAGB Senior Management Team (“PSMT”) against PAGB Professional Code rules 3, 4, 8, 9, 15 and 23, and Consumer Code rules 3, 4, 5, 6, 20, 26, 37 and 38. The PSMT concluded there were no breaches of the Codes.
PSMT noted that the claim had been approved by PAGB copy clearance team in 2016 and has been utilised and approved since the Flarin product launched in 2018 in both consumer and HCP advertising.
PSMT reviewed the Copy Clearance report, the material provided by the member companies and relevant guidance. It was noted that the original supporting data for the claim had been revisited and reviewed by PAGB’s external independent medical assessor, whose opinion is contained with the copy clearance report.
It is important to first summarise the formulation of the Flarin and why it has an impact related to the claim. In summary, PAGB understands, the formulation of Flarin contains lipids (hard fat and glycerol monolinoleate). The dissolution study provided as evidence, demonstrated that release of acidic ibuprofen when in simulated gastric acid was delayed for at least 60 minutes with Flarin. This will allow gastric emptying into the duodenum and small bowel before the ibuprofen is released and absorbed in the stomach, and so reduce the risk of the ibuprofen causing irritation of the gastric mucosa. The external medical assessor has confirmed that this data provides adequate support to the claim that the lipid formulation helps shield the stomach from damage.
Furthermore the additional clinical data generated in the FLARE study confirmed a reduced number of gastrointestinal AEs at both prescription and non-prescription levels, thereby adding further support to the dissolution data. Overall, the medical opinion supports, and is endorsed by the copy clearance team that Infirst have adequately demonstrated that Flarin reduces the risk of ibuprofen causing irritation of the gastric mucosa, and that the lipid formulation can therefore be said to shield the stomach from damage.
From reviewing the data and the report, the PMST is aligned with this opinion and therefore believes there is adequate data to support to the claim. Therefore there is not a breach of the Consumer Code Rule 5 or Professional Code Rule 9.
PAGB understands that there are no other ibuprofen products formulated in this way and therefore consider the claim that the formulation is unique and can therefore utilise the claim. This claim does not breach Consumer Code Rule 4 or Professional Code Rule 4.
RB has made reference to the special warnings contained in Section 4.4 of the SPC. These warnings, as well as those also referenced in Section 4.8 of the Flarin SmPC which list adverse reactions, are included as minimum clinical particulars in all ibuprofen containing non-prescription products, as detailed in the link below:
https://webarchive.nationalarchives.gov.uk/20101116104456/http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Legalstatusandreclassification/Listsofsubstances/CON2015073 (accessed by PAGB 8th October 2020 – Ibuprofen P product)
These are warnings required for all products containing ibuprofen. The frequency is stated as “very rare”, occurring in less than 1/10,000 cases. The figure refers to all forms of ibuprofen, and it is possible that the frequency of these effects is less with Flarin that with other form of ibuprofen, while remaining within these parameters. Indeed the FLARE study confirms a reduction in these side effects for the Flarin products when compared to standard ibuprofen products. The approved claim “Unique lipid formulation helps shield the stomach from damage” neither guarantees that there are no side effects, nor does it imply a complete absence of damage, only that the products “helps shield” from damage. There is no reference or implication that the product is side-effect free or completely safe. As such it does not break Consumer Code Rule 26 or Professional Code Rule 15.
Having reviewed the response and reports, PMST could not identify a specific comparison against any other product within the advertising, although it is recognised that there are factual references to how the lipid formulation differs from water based ibuprofen. It is PAGB opinion that this is factual content, balanced, fair and supportable. It does not break Consumer Code Rule 37.
Following on from this, it is noted that the claim does highlights the benefits of the lipid formulation, we do not consider the claim implies that other OTC medicines will cause stomach damage. Indeed RB themselves state “risk of damage does not constitute actual damage”, and Infirst do not state that actual damage is likely, all that has been said is that the risk of damage is reduced with Flarin. On balance PMST consider consumers will understand that the risk of damage is reduced with Flarin, but not that damage is likely with other formations. Therefore the claim is not denigratory and does not break Consumer Code Rule 38 and Professional Code Rule 23.
The PMST opinion, in line with that of the external medical assessor and the copy clearance report, is that the claim is in line with Flarin’s SmPC as the phrasing of the claim does not exaggerate or mislead as to the nature of the product. It does not suggest that the product completely protects the stomach from damage and so does not break Consumer Code Rule 3, 4 or 20 and Professional Code Rule 2, 4 or 8. As such PAGB do not believe that this claim brings the OTC medicine into disrepute and therefore does not break Consumer Code Rule 6.
PMST would also like to highlight the comment mentioned in the copy clearance report:
“RB has included additional breaches of the code, that were not originally included in the inter-company resolution stage. RB should ensure that all concerns are addressed and presented at the intercompany stage to allow proper response from the other company before referring the matter to PAGB. PAGB ask that RB note this for the future and ensure due process is followed in any further complaint process.”
More information about the PAGB Complaints Procedure is available here.