[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
