Three producers of over-the-counter head lice treatments would modify their advertising to respond to the Federal Trade Commission's allegations that they made false and unsubstantiated claims, according to proposed consent orders the agency announced today.
"With six to 10 million kids a year dealing with head lice infestations, parents and care givers must be able to trust the ads they see for over-the-counter treatments," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection. "Having head lice is uncomfortable, annoying, and frankly, a painful ordeal for kids and their families. False and misleading claims about the treatments just add insult to injury. These proposed orders would prohibit false and misleading claims about lice treatments and improve the disclosures the companies make to consumers about how to use their products."
According to the complaints, Del Pharmaceuticals, Inc., Pfizer, Inc., and Care Technologies, Inc. each marketed lice treatment shampoos containing the same active ingredients. The FTC alleged that these ingredients are not 100 percent effective against lice eggs, and that consumers should be aware of this limitation. In using these shampoos, consumers need to apply a second treatment in seven to 10 days to kill the lice that have hatched since the first treatment, and should make every effort to physically remove lice eggs, the agency said.
The FTC alleged that the companies' claims about the effectiveness of their products were false and unsubstantiated. For example, the complaint against Del, and its parent company, Del Laboratories, Inc., states that the company falsely claimed that its shampoo -- "Pronto" -- kills 100 percent of lice eggs, cures an infestation in a single treatment, and helps prevent reinfestation. In addition, the FTC alleged that Del falsely stated that laboratory tests prove that Pronto kills 100 percent of lice and their eggs.
The complaint against Pfizer alleges that advertisements for its "RID Lice Killing Shampoo" included false and unsubstantiated claims that its shampoo cures a lice infestation in a single application, and that the egg removal comb included with the shampoo is 100 percent effective. In addition, the FTC alleged that Pfizer falsely stated that clinical studies proved that RID cures lice in one treatment and that the comb is 100 percent effective. According to the complaint, the study relied upon to make the "single treatment" efficacy claim included a single application of RID in addition to a thorough combing that removed all lice eggs. The study used to support the efficacy of RID employed individuals trained in egg removal to comb patients' hair. There is no evidence that the same results are achievable by an average consumer, the complaint states.
In the third case, the FTC alleged that Care Technologies, Inc., which markets two products for the treatment of head lice, "Clear Lice Egg Remover" and "Clear Lice Killing Shampoo," falsely claimed that the remover loosens or unglues lice eggs from hair, and that the shampoo kills 100 percent of the lice eggs. In addition, the complaint charges that the company falsely claimed that its egg remover's efficacy was proven by laboratory and field testing.
The proposed consent orders in all three cases would prohibit the companies from making claims about the effectiveness of their lice treatment products unless the claims are supported by competent and reliable scientific evidence. The orders also would prohibit misrepresentations about tests or research for any lice treatment products.
In addition, the consent orders would require that for the next two years, all three companies make certain prominent disclosures in advertisements for their lice treatment products. For example, print ads and promotional materials (other than product labeling) that make lice treatment claims would be required to disclose: "Reapplication and egg removal are required to ensure complete effectiveness. See label for important information." The video, and in some circumstances the audio, portions of television ads and other electronic media advertising would be required to include the following disclosure: "Two Treatments Required." These disclosures are not required if the companies can show that their product does completely eliminate lice and lice eggs in a single application.
As part of the complaint against Del, the FTC also challenged its "pediatrician recommended" claims made about Baby Orajel Tooth & Gum Cleanser-- a toothpaste marketed specifically for toddlers. According to the agency, Del made false and unsubstantiated claims that nine out of 10 pediatricians recommend Baby Orajel, and that competent surveys show this. The complaint states that the survey relied upon by respondents was methodologically flawed, that the greatest number of respondents to that survey said they were only "somewhat likely" to recommend Baby Orajel, and that the survey did not elicit whether pediatricians actually do recommend Baby Orajel. The proposed consent order contains provisions that would prohibit Del from making claims about the extent to which health care, child care, or other medical professionals recommend or would recommend Baby Orajel or any other topically applied oral cleanser, unless the company has adequate substantiation to support its claims.
The Commission vote to issue the consent orders for public comment was 4-0.
Chairman Robert Pitofsky, Commissioner Sheila Anthony, and Commission Mozelle W. Thompson wrote to express their views that "Unlike corrective advertising that is designed to correct misbeliefs caused by past advertising, the disclosure remedy in these cases is fencing-in relief, designed to prevent purchasers of respondents' products from being deceived by future advertising. ... We are satisfied that the triggered disclosures in these orders are appropriate and reasonably related to the alleged violations of Section 5."
Commissioner Orson Swindle who voted to accept the proposed settlements issued a separate statement. In his statement Swindle said, "The proposed consent orders in effect require that the respondents include a corrective message in their advertising. ... I support the Commission's move toward stronger remedies. In this case, the injunctive provisions, together with the FDA-mandated labeling, should ensure that consumers have truthful and accurate information before and after purchase. The disclosure requirement, however, is superfluous and the facts do not justify corrective advertising."
An announcement regarding the proposed consent orders will be published in the Federal Register shortly. The orders will be subject to public comment for 60 days, after which the Commission will decide whether to make them final. Comments should be addressed to the FTC, Office of the Secretary, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580.
NOTE: Consent agreements are for settlement purposes only and do not constitute an admission of a law violation. When the Commission issues consent orders on a final basis, they carry the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the complaints, proposed consent orders, and an analysis to aid public comment are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580; 202-FTC-HELP (202-382-4357); TDD for the hearing impaired 1-866-653-4261. Consent agreements subject to public comment also are available by calling 202-326-3627. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
(FTC File No. Del Pharmaceuticals, Inc., 972-3084; Baby Orajel, 972-3183; Pfizer, Inc., 972-3159; Care Technologies, Inc., 972-3136)