New York, NY – Aug. 6, 2014 – The National Advertising Division has determined that sanofi-aventis, sanofi-aventis U.S. and Chattem, Inc., can support certain advertising claims for “Nasacort Allergy 24HR,” an over-the-counter allergy relief medication. The claims were challenged by MSD Consumer Care, Inc., a/k/a Merck Consumer Care.

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

NAD examined express claims that included:

•  “Nasacort will provide 24 hour relief of nasal congestion, sneezing, runny nose, itchy nose.”
•  “Nasacort is the only single active ingredient OTC medicine that relieves the full range of nasal allergy symptoms, including nasal congestion for 24 hours with a single dose.”
•  “Nasacort and nasal sprays in the same medication class are considered the most effective treatment for hay fever and respiratory allergies.”
•  “The most effective OTC medicine for the treatment of nasal allergy symptoms.”
•  “Nasacort “temporarily relieves these symptoms of hay fever or other upper respiratory allergies ■ nasal congestion ■ runny nose ■ sneezing ■ itchy nose.”

NAD also considered whether the advertising implied that Nasacort provides relief for ocular allergy symptoms, is more effective than medicines in other classes of allergy medication, including Claritin, or provides 24 hour relief with a single dose.

In this case, the key issue for NAD was whether the advertiser’s scientific evidence was sufficient to provide a reasonable basis for its claims that “Nasacort and nasal sprays in the same medication class are considered the most effective treatment for hay fever and other respiratory allergies” and that Nasacort is “The most effective OTC medicine for the treatment of nasal allergy symptoms.”

The challenger contended that Chattem offered no head-to-head testing to support its broad superiority claim regarding other over-the-counter medication, nor did it provide head-to-head testing against other oral antihistamines, oral nasal decongestants or decongestant nasal sprays. In addition, the challenger noted that Chattem failed to address commonly used combination drug products, like Claritin-D, which treat more symptoms of allergies, including nasal congestion and ocular symptoms.

It was the challenger’s position that, in order to substantiate its categorical claims that Nasacort is (a) the “most effective treatment for hay fever and other upper respiratory allergies” and (b) the “most effective OTC medicine for the treatment of nasal allergy symptoms,” Chattem must have head-to-head tests showing that Nasacort is statistically significantly superior to the products in every other class of medications on both points.

However, NAD noted in its decision that there can be “no question that when making comparative performance claims, head-to-head studies of the parties’ allergy relief products remain the gold standard of claim substantiation. At the same time, NAD recognizes that head-to-head testing is not the sole way to provide support for comparative performance claims, particularly when there is strong scientific consensus with regard to product efficacy.”

Following its review of the evidence in the record, NAD determined that the advertiser established a reasonable basis for each of the challenged claims.

NAD recommended that Chattem modify the claim that “INSs such as Nasacort Allergy 24HR can help clear up the full range of allergic rhinitis symptoms, including nasal congestion, for 24 hours,” to clearly convey that Nasacort is indicated for use in treating nasal allergy symptoms.

Chattem, in its advertiser’s statement, said the company “values the self-regulatory process and appreciates NAD’s close attention to the record in this matter.”