[Federal Register Volume 63, Number 187 (Monday, September 28, 1998)]
[Notices]
[Pages 51582-51583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25846]
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FEDERAL TRADE COMMISSION
[File No. 972-3159]
Pfizer Inc.; 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 allegations 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: FTC/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 is 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 describes the terms of the consent agreement, and the
allegations in the complaint. 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.ftc.gov/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 be 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 respondent Pfizer Inc.
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.
Pfizer Inc. (``Pfizer'') markets a variety of over-the-counter
pharmaceuticals, including ``RID Lice Killing Shampoo.'' RID is a
shampoo (or ``pediculicide'') sold to treat people who suffer from head
lice infestations. The RID package includes a comb for use in removing
lice eggs. The Commission's complaint alleges the Pfizer's advertising
for RID included false and unsubstantiated claims that: (1) RID Lice
Killing Shampoo cures lice infestations in a single treatment; (2) the
RID egg removal comb is one hundred percent effective; (3) clinical
studies prove that RID Lice Killing Shampoo cures lice infections in a
single treatment; and (4) clinical studies prove that the RID egg
removal comb is one hundred percent effective.
In fact, the complaint alleges that RID 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. In addition, the complaint
explains that the RID comb, included with the shampoo, is not
necessarily one hundred percent effective. Lice eggs are difficult to
see and to remove. The effectiveness of the comb is largely dependent
on the skill and tenacity of the comber.
The complaint further explains why clinical studies do not prove
that RID cures lice infestations in a single treatment. Specifically,
the complaint alleges that the study Pfizer relied upon to make this
claim included the application of a single treatment, along with a
thorough combing that removed all lice eggs. Moreover, the studies
relied upon the claim that the RID egg removal comb is one hundred
percent effective employed individuals trained in egg removal to comb
patients' hair. According to the complaint, there is no evidence that
the same results are achievable by an average consumer.
The proposed consent order contains provisions designed to remedy
the violations charged and to prevent the respondent from engaging in
similar acts and practices in the future. Part I of the proposed order
would prohibit the company from representing that RID Lice Killing
Shampoo or any substantially similar product cures a lice infestation
in a single application, unless the representation is true and, at the
time it is made, respondent possesses and relies upon competent and
reliable scientific evidence that substantiates the representation.
Parts II and III of the order require that, for a period of two
years, the company make disclosures in its advertisements anytime it
makes claims regarding the efficacy of RID 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 prohibits Pfizer 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. Part V of the proposed order requires the company 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. Because this matter involves a drug
regulated by the FDA, Part VI 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 respondent to maintain
materials relied
[[Page 51583]]
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.
The purpose of this analysis is to facilitate public comment on the
proposed order. It is not intended to 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.
Statement of Chairman Pitofsky and Commissioners Anthony and
Thompson
In the Matters of, Care Technologies, Inc., File No. 972-3136,
Del Pharmaceuticals, Inc., File No. 972-3084, Pfizer Inc., File No.
972-3159.
We write to express our view about the concerns Commissioner
Swindle raises regarding the disclosure remedy in these cases. The
orders require that, for two years, whenever a claim is made regarding
the efficacy of the lice removal products, the respondents include a
disclosure about the necessity for a second application of their
product. Commissioner Swindle is concerned that this amounts to
corrective advertising, and should not be imposed absent evidence that
consumers hold lingering misbeliefs.
Unlike corrective advertising that is designed to correct
misbeliefs caused by past advertising, the disclosure remedy in these
cases in fencing-in relief, designed to prevent purchasers of
respondents' products from being deceived by future advertising.\1\ The
triggered disclosure about the need for two treatments provides
additional assurance that consumers will not be misled by future ads.
We are satisfied that the triggered disclosures in these orders are
appropriate and reasonably related to the alleged violations of Section
5.
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\1\ It is also worth noting that the Commission has
distinguished triggered disclosures such as those in these cases
from corrective advertising, which is required regardless of the
contents of the ad. Removatron Int'l Corp., 111 F.T.C. 206, 311-12
n. 28 (1988), aff'd, 884 F.2d 1489 (1st Cir. 1989). See also
American Home Prods. Corp. v. FTC, 695 F.2d 681, 700 (3d Cir. 1982).
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Statement of Commissioner Orson Swindle
In the Matters of, Care Technologies, Inc., File No. 972-3136,
Del Pharmaceuticals, Inc., File No. 972-3084, Pfizer Inc., File No.
972-3159.
I have voted to accept these consent agreements for public comment
despite my reservations about the disclosure requirements. Advertising
for these lice treatment products has contained false and misleading
claims that the products can eradicate an infestation after a single
use. In truth, reapplication and careful combing are required to
complete the treatments. I have no doubt that the injunctive provisions
are needed and appropriate to address these misrepresentations.
The settlements, however, go further. Under the terms of the
consent orders, the respondents would be required for two years to
state, in any advertising for lice treatments that makes an efficacy
claim, that two applications of the treatment are necessary. The orders
would mandate this disclosure in addition to prohibiting the challenged
claims and requiring competent and reliable scientific evidence to
substantiate any representation about the efficacy of the products.
The disclosures cannot be justified as necessary to correct a
deception by omission. The orders prohibit the challenged claims and
require substantiation for future claims. Any representation--either
express or implied--that only one application will complete the
treatment would violate the terms of this order. The disclosures are
therefore not necessary to protect against false or misleading claims
about the efficacy of a single treatment.
The proposed consent orders in effect require that the respondents
include a corrective message in their advertising. We have no evidence
that the respondents' marketing substantially created or reinforced a
lingering misimpression about these products. Warner-Lambert Co. v.
FTC, 562 F.2d 749 (D.C. Cir. 1977), cert. denied, 435 U.S. 950 (1978).
The disclosure requirement cannot, therefore, be justified as
corrective advertising.
Fencing-in relief in a consent order could arguably require that
the respondent disseminate information to educate consumers. In these
cases, however, I fear that we are using our fencing-in authority to
justify what is actually corrective advertising. If we cannot meet the
standard for imposing this relief as corrective advertising, let us not
try to camouflage it as fencing-in.
I support the Commission's move toward stronger remedies. In this
case, the injunctive provisions, together with the FDA-mandated
labeling,\1\ 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.
\1\ The FDA requires the following statement on the label of any
shampoo formulated to treat head lice:
Apply to affected area until all the hair is thoroughly wet with
product. Allow product to remain on area for 10 minutes but no
longer. Add sufficient warm water to form a lather and shampoo as
usual. Rinse thoroughly. A fine-toothed comb or special lice/nit
removing comb may be used to help remove dead lice or their eggs
(nits) from hair. A second treatment must be done in 7 to 10 days to
kill any newly hatched lice.
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[FR Doc. 98-25846 Filed 9-25-98; 8:45 am]
BILLING CODE 8010-01-M
