NAD Finds Comparative FDA-Approved Label Indications Claims For Claritin-D vs. Flonase Supported But Execution Of Claims Problematic.

New York, NY – April 29, 2019 – Following a challenge by GlaxoSmithKline Consumer Healthcare, Inc. (“GSK”), NAD concluded that Bayer Healthcare LLC provided a reasonable basis for its claim that, based on the parties’ respective FDA-approved labels, Claritin is indicated to relieve 8 symptoms of allergies (i.e., sneezing, runny nose, nasal congestion, itching of the nose, itchy eyes, watery eyes, itching of the throat, and sinus congestion and pressure) and the leading allergy spray (Flonase) is only indicated to relieve the first six of these symptoms (i.e., not sinus congestion and pressure or itchy throat.)

However, NAD concluded that the Bayer’s advertisements reasonably conveyed the broader, unsupported message that the challenger’s Flonase does not or cannot provide relief from “sinus congestion and pressure” and “itchy throat.” Therefore, NAD recommended that Bayer’s ads either be discontinued or sufficiently modified to strictly limit the message conveyed to a comparative “8 versus 6 FDA-approved indications” claim and avoid the implication that Flonase products do not or cannot relieve “sinus congestion and pressure” and “itchy throat.” Moreover, NAD recommended that the “8 versus 6 FDA-approved indications” distinction between the parties’ products be made part of the main claim.

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

Bayer’s television commercial depicts a woman standing in the “ALLERGY SPRAYS” section of a pharmacy in front of rows of product with GSK’s distinctive Flonase packaging. Her head is surrounded by a translucent bubble indicating that she is suffering from allergy symptoms (including congestion). As she examines the Flonase product, a voiceover states, “Allergies with sinus congestion and pressure? You won’t find relief here.”  Simultaneously, the text “Based on label indications” appears onscreen. The voiceover states “Go to the pharmacy counter for powerful Claritin-D.” The pharmacist hands the woman a package of Claritin-D and then uses a pen to pop the bubble as the screen cuts to the eight versus six symptom relief comparison. The voiceover states, “While the leading allergy spray only relieves six symptoms, Claritin-D relieves eight, including sinus congestion and pressure.” The “8 vs. 6” claim is echoed by a prominent on-screen graphic as text appears onscreen: “Based on label indications versus 50 mcg per spray fluticasone propionate.” During the second half of the voiceover, the same text appears along with additional text: “Claritin-D relieves the same 6 symptoms as the leading allergy spray plus sinus congestion & pressure, and itchy throat.” The screen peels away to reveal a new scene of the woman blowing bubbles outdoors with her child against a blue sky background. In the final frames the claim “Claritin-D relieves more” is made via voiceover and onscreen text. A super reads, “… More symptoms versus 50 mcg per spray fluticasone propionate.”

The print advertising similarly declares “8 vs. 6. Get relief from more symptoms with Claritin-D.”  The left side of the ad bears a large yellow “8,” Claritin-D, and a list of the eight symptoms Claritin-D relieves. The right side depicts a green “6”, a bottle resembling the Flonase product, and a list of the six symptoms the “leading allergy spray” relieves. The first six symptoms on both sides are the same.  Symptoms number 7 and 8 on the Claritin-D side (but not on the Flonase side) are “Itchy Throat” and “Sinus Congestion & Pressure,” and are highlighted in yellow. Below the list of symptoms, a disclosure reads: “Based on label indications versus 50 mcg per spray fluticasone propionate.” In the center of the advertisement, the headline reads, “Get Relief From More Symptoms With Claritin-D.”

NAD determined that the eight FDA-approved label indications for Claritin-D and six FDA-approved label indications for Flonase provide a reasonable basis for Bayer’s “8 vs. 6” claims. The record was clear that both products are indicated for the relief of sneezing, runny nose, nasal congestion, itchy nose, itchy eyes and watery eyes.  The record also made clear that the FDA approved Claritin-D products for the following: “temporarily relieves sinus congestion and pressure” and “itchy throat”—indications which are not present on the challenger’s Flonase products. The difference between the FDA approved indications, NAD concluded, is something that Bayer can truthfully advertise.

Notwithstanding the above, NAD determined that challenged commercials convey an overarching message of “relief” offered by the parties’ respective products beyond the supported “8 versus 6 FDA-approved indications” claim. NAD concluded, consumers could reasonably take away the unsupported message that not only does Flonase lack the FDA-indications for these two additional symptoms, but that, in fact, Flonase cannot relieve “sinus congestion and pressure” and “itchy throat.” While Bayer is free to compare FDA-approved label indications between the parties’ allergy relief products and claim that Flonase is not indicated for “sinus congestion and pressure” and “itchy throat”—the advertiser may not, in the absence of competent and reliable scientific evidence of its own, claim that GSK’s Flonase products do not or cannot relieve these two symptoms.

Notwithstanding the above, NAD did not find, among other things that the challenged ads reasonably convey a message of greater relief from allergy symptoms, that only products found behind the pharmacy counter can treat sinus congestion associated with nasal allergies, that Flonase does not relieve “congestion” including relief of nasal congestion or that such relief can only be obtained from the pharmacist, or that the commercial reasonably conveyed the message that Claritin-D provides immediate relief of the symptoms of sinus congestion and pressure, noting that onset of action or “time to relief” is never mentioned in the commercials.

In its statement, Bayer stated that it will comply with the NAD’s recommendations and that it was gratified that the NAD determined that its “8 versus 6” claim is supported by the FDA-approved label indications for Claritin-D and the challenger’s product.  Bayer further stated that it appreciated NAD’s view that it can continue to educate consumers regarding the important differences in FDA-approved labels and its findings that the implied claims urged by the challenger were not reasonably conveyed by its advertisements. Although Bayer stated that it may not agree with the scientific positions underlying the NAD’s recommendation to modify the advertisements, it stated that it will make the appropriate modifications and thanked the NAD for its thoughtful analysis and attention to this matter.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.