Three Marketers of Head LiceTreatments Agree to Settle FTC Charges

Agency Alleges Claims Misled Consumers AboutProduct Use and Effectiveness

Three producers of over-the-counter head lice treatments would modifytheir advertising to respond to the Federal Trade Commission's allegationsthat they made false and unsubstantiated claims, according to proposedconsent 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-countertreatments," said Jodie Bernstein, Director of the FTC's Bureau of ConsumerProtection. "Having head lice is uncomfortable, annoying, and frankly,a painful ordeal for kids and their families. False and misleading claimsabout the treatments just add insult to injury. These proposed orders wouldprohibit false and misleading claims about lice treatments and improvethe disclosures the companies make to consumers about how to use theirproducts."

According to the complaints, Del Pharmaceuticals, Inc., Pfizer, Inc.,and Care Technologies, Inc. each marketed lice treatment shampoos containingthe same active ingredients. The FTC alleged that these ingredients arenot 100 percent effective against lice eggs, and that consumers shouldbe aware of this limitation. In using these shampoos, consumers need toapply a second treatment in seven to 10 days to kill the lice that havehatched since the first treatment, and should make every effort to physicallyremove lice eggs, the agency said.

The FTC alleged that the companies' claims about the effectiveness oftheir products were false and unsubstantiated. For example, the complaintagainst Del, and its parent company, Del Laboratories, Inc., states thatthe 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 Delfalsely stated that laboratory tests prove that Pronto kills 100 percentof lice and their eggs.

The complaint against Pfizer alleges that advertisements for its "RIDLice Killing Shampoo" included false and unsubstantiated claims thatits shampoo cures a lice infestation in a single application, and thatthe egg removal comb included with the shampoo is 100 percent effective.In addition, the FTC alleged that Pfizer falsely stated that clinical studiesproved that RID cures lice in one treatment and that the comb is 100 percenteffective. According to the complaint, the study relied upon to make the"single treatment" efficacy claim included a single application of RIDin addition to a thorough combing that removed all lice eggs. Thestudy used to support the efficacy of RID employed individuals trainedin egg removal to comb patients' hair. There is no evidence that the sameresults are achievable by an average consumer, the complaint states.

In the third case, the FTC alleged that CareTechnologies, Inc., which markets two products for the treatment of headlice, "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, thecomplaint charges that the company falsely claimed that its egg remover'sefficacy was proven by laboratory and field testing.

The proposed consent orders in all three cases would prohibit the companiesfrom making claims about the effectiveness of their lice treatment productsunless the claims are supported by competent and reliable scientific evidence.The orders also would prohibit misrepresentations about tests or researchfor any lice treatment products.

In addition, the consent orders would require that for the next twoyears, all three companies make certain prominent disclosures in advertisementsfor their lice treatment products. For example, print ads and promotionalmaterials (other than product labeling) that make lice treatment claimswould be required to disclose: "Reapplication and egg removal are requiredto ensure complete effectiveness. See label for important information."The video, and in some circumstances the audio, portions of televisionads and other electronic media advertising would be required to includethe following disclosure: "Two Treatments Required." These disclosuresare not required if the companies can show that their product does completelyeliminate lice and lice eggs in a single application.

As part of the complaint against Del, the FTC also challenged its "pediatricianrecommended" claims made about Baby Orajel Tooth & Gum Cleanser-- atoothpaste marketed specifically for toddlers. According to the agency,Del made false and unsubstantiated claims that nine out of 10 pediatriciansrecommend Baby Orajel, and that competent surveys show this. The complaintstates that the survey relied upon by respondents was methodologicallyflawed, that the greatest number of respondents to that survey said theywere only "somewhat likely" to recommend Baby Orajel, and that the surveydid not elicit whether pediatricians actually do recommend Baby Orajel.The proposed consent order contains provisions that would prohibit Delfrom making claims about the extent to which health care, child care, orother medical professionals recommend or would recommend Baby Orajel orany other topically applied oral cleanser, unless the company has adequatesubstantiation 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 CommissionMozelle W. Thompson wrote to express their views that "Unlike correctiveadvertising that is designed to correct misbeliefs caused by pastadvertising, the disclosure remedy in these cases is fencing-in relief,designed to prevent purchasers of respondents' products from being deceivedby future advertising. ... We are satisfied that the triggered disclosuresin these orders are appropriate and reasonably related to the alleged violationsof Section 5."

Commissioner Orson Swindle who voted to accept the proposed settlementsissued a separate statement. In his statement Swindle said, "The proposedconsent orders in effect require that the respondents include a correctivemessage in their advertising. ... I support the Commission's move towardstronger remedies. In this case, the injunctive provisions, together withthe FDA-mandated labeling, should ensure that consumers have truthful andaccurate 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 publishedin the Federal Register shortly. The orders will be subject to public commentfor 60 days, after which the Commission will decide whether to make themfinal. Comments should be addressed to the FTC, Office of the Secretary,6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580.