[Federal Register Volume 63, Number 187 (Monday, September 28, 1998)]
[Notices]
[Pages 51580-51582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25845]


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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