Del Pharmaceuticals, Inc., et al.; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

[File No. 972-3084]

Del Pharmaceuticals, Inc., et al.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: The consent agreement in this matter settles alleged

violations of federal law prohibiting unfair or deceptive acts or

practices or unfair methods of competition. The attached Analysis to

Aid Public Comment describes both the allegation in the draft complaint

that accompanies the consent agreement and the terms of the consent

order--embodied in the consent agreement--that would settle these

allegations.

DATES: Comments must be received on or before November 27, 1998.

ADDRESSES: Comments should be directed to: FCC/Office of the Secretary,

Room 159, 6th St. and Pa. Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Linda Badger or Kerry O'Brien, San Francisco Regional Office, Federal

Trade Commission, 901 Market St., Suite 570, San Francisco, CA 94103.

(415) 356-5270.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal

Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Section 2.34 of

the Commission's Rules of Practice (16 CFR 2.34), notice hereby given

that the above-captioned consent agreement containing a consent order

to cease and desist, having been filed with and accepted, subject to

final approval, by the Commission, has been placed on the public record

for a period of sixty (60) days. The following Analysis to Aid Public

Comment

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describes the terms of the consent agreement, and the allegations in

the compliant. An electronic copy of the full text of the consent

agreement package can be obtained from the FTC Home Page (for September

18, 1998), on the World Wide Web, at ``http://www.ftcgov/os/

actions97.htm.'' A paper copy can be obtained from the FTC Public

Reference Room, Room H-130, Sixth Street and Pennsylvania Avenue, NW,

Washington, DC 20580, either in person or by calling (202) 326-3627.

Public comment is invited. Such comments or views will be considered by

the Commission and will available for inspection and copying at its

principal office in accordance with Section 4.9(b)(6)(ii) of the

Commission's Rules of Practice (16 CFR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To Aid Public Comment

The Federal Trade Commission has accepted an agreement, subject to

final approval, to a proposed consent order from respondents Del

Pharmaceuticals, Inc. and its parent, Del Laboratories, Inc., Delaware

corporations.

The proposed consent order has been placed on the public record for

sixty (60) days for reception of comments by interested persons.

Comments received during this period will become part of the public

record. After sixty (60) days, the Commission will again review the

agreement and the comments received and will decide whether it should

withdraw from the agreement or make final the agreement's proposed

order.

Del Pharmaceuticals, Inc. (``Del'') markets a variety of over-the-

counter pharmaceuticals. The Commission's complaint challenges claims

made for two of Del's products: ``Pronto Lice Treatment'' and ``Baby

Orajel Tooth & Gum Cleanser.'' Pronto is a shampoo (or

``pediculicide'') sold to treat people who suffer from head lice

infestations. The Commission's complaint charges that Del's advertising

for Pronto included false and unsubstantiated claims of efficacy in

curing head lice infestations. Specifically, the complaint alleges that

Del made false and unsubstantiated claims that: (1) Pronto kills one

hundred percent of lice eggs; (2) Pronto is one hundred percent

effective in killing lice and their eggs in a single treatment; and (3)

Pronto helps prevent reinfestation. The Complaint also alleges that the

claim that laboratory tests prove that Pronto is one hundred percent

effective in killing lice and their eggs is false.

In fact, the complaint alleges that Pronto is based on a pesticide

which is not one hundred percent effective against lice eggs. Consumers

should be aware of this limitation and make every effort to physically

remove lice eggs. In addition, when this type of pediculicide is used,

consumers are instructed to apply a second treatment in seven to ten

days to kill any newly hatched lice. Consumers also should also be

aware that this type of pediculicide does not leave a lasting

pesticidal residue that would help prevent reinfestation from post-

treatment contacts with other lice-infested people or things.

The complaint also challenges ``pediatrician recommended'' claims

made for Baby Orajel Tooth & Gum Cleanser. Del markets this product as

a toothpaste for young children. According to the complaint, Del made

false and unsubstantiated claims that: (1) competent and reliable

surveys show that nine out of ten pediatricians would recommend Baby

Orajel Tooth & Gum Cleanser; and (2) nine out of ten pediatricians

recommend Baby Orajel Tooth & Gum Cleanser. The complaint alleges that

the survey relied upon by the respondents was methodologically flawed,

and, that the greatest number of pediatricians who responded to the

survey said that they were only ``somewhat likely'' to recommend Baby

Orajel Tooth & Gum Cleanser. In addition, the survey merely asked

pediatricians how likely they would be to recommend such a product, and

not whether they actually do recommend Baby Orajel Tooth & Gum

Cleanser.

The proposed consent order contains provisions designed to remedy

the violations charged and to prevent the respondents from engaging in

similar acts and practices in the future. Part I of the proposed order

would prohibit Del from making certain efficacy claims about Pronto, or

any substantially similar product, unless at the time of making the

claims, they are true and substantiated by competent and reliable

scientific evidence. The specific claims covered by Part I include any

representation that: (1) such product kills one hundred percent of lice

eggs; (2) such product is one hundred percent effective in killing lice

and their eggs in a single treatment; or (3) such product prevents

reinfestation.

Parts II and III of the proposed order require that, for a period

of two years, the respondents make disclosures in its disclosures in

its advertisements anytime they make claims regarding the efficacy of

Pronto or any substantially similar product. Pursuant to Part II, the

following disclosure will be required in print ads and promotional

materials: ``Reapplication and egg removal are required to ensure

complete effectiveness. See label for important information.'' Part III

requires the disclosure, ``Two Treatments Required,'' be made in ads

communicated through an electronic medium, such as television. When the

ad makes any claims regarding directions for use of the product, this

disclosure must be in the audio as well as the video portion of the

advertisement.

Part IV of the proposed order addresses claims made for Baby Orajel

Tooth & Gum Cleanser. Under this provision, respondents are prohibited

from making claims for this product or any other topically applied oral

cleansing product about: (1) the extent to which doctors or other

health, childcare, or medical professionals recommend or would

recommend such product; or (2) the recommendation, approval, or

endorsement of such product by any health, childcare, or medical

professional, profession, group or other entity, unless, at the time

the representation is made, respondents posses and rely upon competent

and reliable evidence, which when appropriate must be competent and

reliable scientific evidence, that substantiates the representation.

Part V of the proposed order prohibits Del from misrepresenting the

existence, contents validity, results, conclusions, or interpretations

of any test, study, or research, for any drug or device for the

treatment of lice in humans, or any pesticide for treatment of lice, or

any topically applied oral cleansing product. Part VI of the proposed

order requires the respondents to have scientific support prior to

making any claims regarding the efficacy of any drug or device for the

treatment of lice in humans, or any pesticide for treatment of lice.

Part VII of the proposed order includes an inventory provision that

allows the respondents to sell Pronto boxes with the labeling unchanged

for approximately forty days after this order becomes final. Because

this matter involves a drug regulated by the FDA, Part VIII of the

order includes a safe harbor allowing the respondent to make any claim

permitted under a new drug application, or under a tentative final or

final standard promulgated by that agency.

The proposed order also requires the respondents to maintain

materials relied upon to substantiate claims covered by the order; to

provide copies of the order to certain personnel of the respondent; to

notify the Commission of any changes in corporate structure that might

affect compliance with the order; and to file one or more reports

detailing compliance with the order.

The purpose of this analysis is to facilitate public comment on the

proposed order. It is not intended to

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constitute an official interpretation of the agreement and proposed

order or to modify in any way their terms.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 98-25845 Filed 9-25-98; 8:45 am]

BILLING CODE 6750-01-M