NAD Recommends Novartis Discontinue Onset-of-Action Claim for Theraflu, following Pfizer Challenge

New York, NY – Jan. 6, 2015 – The National Advertising Division has recommended that Novartis Consumer Health Inc., discontinue the advertising claim that “Theraflu Multi-Symptom Severe Cold”  “starts to get to work in your body in 5 minutes.” The claim was challenged by Pfizer Consumer Healthcare, a competing manufacturer of cold and cough relief products.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

By way of background, the challenger said that a number of companies offer over-the-counter severe-cold remedies containing acetaminophen, dextromethorphan and phenylephrine.  The products are sold pursuant to the Food and Drug Administration’s prior review and approval of the safety and efficacy of the active ingredients, and are permitted to be combined in a single, multi-ingredient product pursuant to an FDA Final Monograph.

The challenger argued that the active ingredients were standard and took issue with Novartis’s claims that its product relieves cold and flu symptoms especially quickly.

The advertiser contended that “starts to get to work in your body in 5 minutes” is a truthful and accurate absorption claim that does not expressly state or imply that the product starts to provide symptom relief in five minutes. Moreover, the company said, the limited claim is fully substantiated by clinical data.

In this case, the issue was whether the challenged claim was an onset-of-action claim, as the challenger contended, or an absorption claim, as the advertiser argued.

Following its review of the advertiser’s evidence, NAD determined that the claim “Starts to get to work in your body in 5 minutes” conveyed an unsupported onset-of-action message that Theraflu starts to provide perceptible flu symptom relief in five minutes.

NAD noted in its decision that the sole evidence in the record – a study conducted by Novartis – reliably demonstrated that acetaminophen could be observed in the bloodstream five minutes after product administration, but specifically stated that there was no correlation between the rapid absorption of acetaminophen and symptom relief.

NAD recommended that the claim be discontinued, and that, in future advertising, Novartis avoid conveying the message that its Theraflu product starts to provide flu symptom relief in five minutes.

Novartis, in its advertiser’s statement, said it launched an advertising campaign to convey a speed of absorption claim for acetaminophen in its Theraflu Multi-Symptom Severe Cold product, “based on strong scientific data.”

The company said that it believes it took the necessary steps to “convey only speed of acetaminophen absorption and not to suggest speed of symptom relief.”

However, while the company disagreed with NAD’s findings, “NCH respects the NAD self-regulatory process and will take NAD’s guidance into account for future advertising of the product.”