The Federal Trade Commission has ordered the makers of Doan's Pills to run ads to correct misbeliefs resulting from their unsubstantiated claim that Doan's Pills are superior to other over-the-counter analgesics for treating back pain. The Order, contained in a Commission opinion announced today, would require advertising and packaging to carry the message, "Although Doan's is an effective pain reliever, there is no evidence that Doan's is more effective than other pain relievers for back pain." The order also would prohibit Novartis Corporation and Novartis Consumer Health, Inc., the marketers of Doan's, from representing that the product is more effective than other over-the-counter products unless they possess and rely upon competent and reliable scientific evidence -- including at least two clinical studies -- to substantiate their claims. In addition, the order would require Novartis to have scientific substantiation for any claims made regarding the efficacy, safety, benefits or performance of any over-the counter analgesic they market. Doan's has been marketed and sold for over 90 years and always has been advertised as a backache product.
Novartis, headquartered in Summit, New Jersey, is a subsidiary of Novartis AG, a Swiss pharmaceutical company.
In June 1996, the FTC charged the marketers of Doan's Pills with making deceptive back-pain relief claims in violation of federal law and announced it would seek an order prohibiting the claims in an administrative trial. The FTC charged that, contrary to the advertising claims for Doan's, there was no evidence that Novartis' pills are better than competing over-the-counter analgesics in relieving back pain. The complaint cited ads that displayed packages of Doan's and other pain relievers that contained statements such as:
- "Doan's is made for back pain relief with an ingredient [other] pain relievers don't have. Doan's makes back pain go away. ...The Back Specialist.";
- "If nothing seems to help, try Doan's. It relieves back pain no matter where it hurts. Doan's has an ingredient these pain relievers don't have."; and
- "Back pain is different. Why use these pain relievers? Doan's is just for back pain."
Through these and similar statements, the FTC alleged, Novartis claimed that Doan's analgesic products were more effective than other analgesics, including Advil, Aleve, Bayer, Motrin, and Tylenol, for relieving back pain. The agency charged that the claims were unsubstantiated.
In March 1998, Administrative Law Judge (ALJ) Lewis F. Parker upheld the FTC charges that the Doan's ads were unsubstantiated and false but did not impose a corrective ad remedy sought by complaint counsel. Both parties appealed the ALJ's decision to the full Commission.
The Commission Opinion, written by FTC Commissioner Sheila F. Anthony, says, "We reverse the ALJ's holding regarding corrective advertising. . . . Contrary to the ALJ's suggestion, corrective advertising is not a drastic remedy. Requiring the dissemination of a truthful message to counteract beliefs created or reinforced by a respondent's deceptive message is an appropriate method of restoring the status quo ante and denying a respondent the ability to continue to profit from its deception. . . . Corrective advertising is an appropriate remedy if (1) the challenged ads have substantially created or reinforced a misbelief; and (2) the misbelief is likely to linger into the future."
The opinion concludes that the false belief that Doan's was a superior product for treating backache was likely to endure, because the claims were ". . .(1) very salient to consumers (because superior efficacy is among the primary considerations for a consumer in selecting a back pain remedy), (2) clearly and consistently conveyed in the challenged ads, and (3) an integral part of an eight-year campaign." The respondent spent approximately $65,000,000 disseminating these claims, primarily in fifteen-second television and radio ads whose primary message was the false superiority claim, the opinion says.
"The record establishes that consumers held misbeliefs about Doan's superior efficacy, that such beliefs were created by or substantially reinforced by the challenged advertising campaign, and that those beliefs are likely to linger into the future. Therefore, we find that the elements for corrective advertising are satisfied, and that corrective advertising is appropriate and necessary," the majority wrote.
The Order requires ads and packaging for Doan's pills to include, clearly and conspicuously, the message, "Although Doan's is an effective pain reliever, there is no evidence that Doan's is more effective than other pain relievers for back pain." The statement will be carried on all packaging and advertising for one year, except radio and television ads of 15 seconds or less, and until Novartis has expended on Doan's advertising an amount equal to the average spent annually during the eight-year campaign - $8 million.
Responding to arguments by attorneys for Novartis that corrective advertising would be punitive, Anthony wrote, ". . . it is not punitive to require respondent to tell the truth."
The Commission vote to issue the Order was 4-0, with Commissioner Orson Swindle concurring in part and dissenting in part.
Commissioner Swindle issued a separate statement, dissenting from the imposition of the corrective advertising requirement. He said that corrective advertising is "intended to prevent the harm to consumers and competition that is caused when a false belief engendered by prior deceptive advertising lingers." The majority concluded that the implied superior efficacy claim that Novartis made in ads that ceased in May 1996 have created a false belief that is likely to linger until the corrective advertising requirement ends in July 2000 or beyond. Commissioner Swindle disagreed, explaining that "the evidence offered to prove lingering effect is extremely weak, consisting mainly of inconclusive extrinsic evidence, indefinite expert testimony and broad inferences." He noted that, "The eight-year $65 million advertising campaign here pales in comparison with other deceptive advertising campaigns (especially when advertising expenditures are measured in constant dollars) that have not resulted in the Commission imposing corrective advertising." Commissioner Swindle also emphasized that the "evidence is certainly far weaker than the evidence that proved the existence of a lingering effect in Warner-Lambert," the only other adjudicated case in the last 25 years in which the Commission has ordered corrective advertising. Without adequate proof of a lingering effect, Commissioner Swindle concluded that the Commission cannot, as a matter of law, order corrective advertising, an "extraordinary remedy."
Commissioner Swindle further concluded that "the corrective advertising requirement, which is a form of compelled speech, infringes on Novartis's right to engage in commercial speech under the First Amendment to the United States Constitution." The First Amendment requires that restrictions on commercial speech must directly advance a substantial government interest and be no more extensive than necessary to serve that interest. Commissioner Swindle explained that "[b]ecause it has not been proven that the false superior efficacy belief in this case is likely to linger, there is no false belief that needs to be corrected to prevent deception; therefore, corrective advertising cannot directly advance any substantial governmental interest." Moreover, he said that the majority had not shown that the corrective advertising requirement here was no more extensive than necessary to prevent deception because the majority had "not given adequate consideration to alternatives to corrective advertising or to less restrictive alternatives to the all-media corrective advertising remedy imposed (such as a corrective statement [only] on the product label or [in] point-of-sale materials)."
The FTC Order may be appealed to a U. S. Court of Appeals.
Copies of the Commission opinion and news releases about previous FTC actions in this case are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; 202-FTC-HELP (202-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
Office of Public Affairs