• Claim Substantiation: FDA & NAD
  • July 26, 2005
  • Law Firm: Weil, Gotshal & Manges LLP - Office
  • Advertisers must have reasonable support for all express and implied objective claims that an advertisement conveys to consumers, though the type of evidence needed to substantiate a claim depends on the product, the claims and, in some instances, what experts believe is necessary. For example, the NAD recently found that a claim that an ear thermometer is "number one among doctors and mothers" was more than a mere sales superiority claim, and therefore required substantiation beyond mere sales data.1 Rejecting the comprehensiveness of the Healthcare Products Information Services (HPIS) market data and a privately-commissioned Usage & Attitudes Survey because both collected data from sources other than physicians, the NAD recommended that the "doctors" portion of the challenged claim be discontinued, but found that sales/purchasing data were determinative of use of these products by mothers and concluded that the "mothers" portion of the challenged claim was sufficiently substantiated.

    For advertisements that are subject to more than one reasonable interpretation, advertisers are well-served to have substantiation for each possible interpretation. This is particularly true in the context of governmental enforcement actions, where the burden of proof is squarely upon the advertiser.

    Earlier this month, the FDA issued a warning letter to Pfizer regarding advertising for its Zyrtec© allergy medicine.2 The Division of Drug Marketing, Advertising and Communications (DDMAC) reviewed several print ads with taglines such as, "Tired of your allergy medicine not working?" and "Maybe it's time to switch allergy medicines" and found that they made "superiority claims about Zyrtec by suggesting it is clinically superior to some other allergy medicines." In the absence of substantial evidence of such superiority, DDMAC informed Pfizer that the advertisements misbranded the drug product in violation of the Federal Food, Drug and Cosmetic Act and implementing regulations.3 The agency requested that Pfizer "immediately cease the dissemination of violative promotional materials for Zyrtec," and, because the violation is serious and repeated, required Pfizer to include "a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages."

    1 The Gillette Company, Case #4280 (1/24/05).
    2 April 13, 2005 letter to Henry A. McKinnell, Jr. re: Zyrtec© (centirizine HCl) Tablets, Syrup and Chewable Tablets, MACMIS #12799, available at http://www.fda.gov/foi/warning_letters/g5286d.htm
    3 21 U.S.C. A4 352(n); 21 CFR 202.1(e)(6).