[Federal Register Volume 62, Number 43 (Wednesday, March 5, 1997)]
[Notices]
[Pages 10059-10062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5344]
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 942-3341]
Schering-Plough Healthcare Products, Inc.; Analysis To Aid Public
Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed consent agreement.
-----------------------------------------------------------------------
SUMMARY: In settlement of alleged violations of federal law prohibiting
unfair or deceptive acts or practices and unfair methods of
competition, this consent agreement, accepted subject to final
Commission approval, would prohibit, among other things, the marketer
of Coppertone Kids sunscreens for children from making deceptive claims
about the effectiveness of sunscreens marketed for use on children. The
agreement will also require that the company produce and distribute
150,000 consumer education brochures to alert parents to the importance
of sunscreen protection for children and the need to reapply sunscreens
after toweling or sustained vigorous activity. The complaint
accompanying the consent agreement alleges that Schering's ads for
Coppertone Kids 6-Hour Waterproof Sunblock make unsubstantiated claims
that one application of Coppertone Kids provides six hours of
protection from the sun for children engaged in sustained vigorous
activity in and out of the water.
DATES: Comments must be received on or before May 5, 1997.
ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,
Room 159, 6th St. and Pa. Ave., N.W., Washington, D.C. 20580.
FOR FURTHER INFORMATION CONTACT:
Joel Winston, Federal Trade Commission, S-4002, 6th St. and Pa. Ave.,
N.W., Washington, D.C. 20580. (202) 326-3153; Toby Milgrom Levin,
Federal Trade Commission, S-4002, 6th St. and Pa. Ave., N.W.,
Washington, D.C. 20580. (202) 326-3156.
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 accompanying complaint. An electronic copy of the
full text of the consent agreement package can be obtained from the
Commission Actions section of the FTC Home Page (for February 18,
1997), on the World Wide Web, at ``http://www.ftc.gov/os/actions/htm.''
A paper copy can be obtained from the FTC Public Reference Room, Room
H-130, Sixth Street and Pennsylvania Avenue, N.W., Washington, D.C.
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 to a
proposed consent order from Schering-Plough Healthcare Products, Inc.
(``Schering-Plough Healthcare''). Schering-Plough Healthcare, a wholly-
owned subsidiary of the Schering-Plough Corporation, is a manufacturer
and distributor of health care products, including sunscreens.
The proposed consent order has been placed on the public record for
sixty (60) days for receipt of comments by interested persons. Comments
received
[[Page 10060]]
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.
This matter involves alleged deceptive representations made in
advertising for Coppertone Kids, a sunscreen product promoted for use
on children. According to the FTC complaint, Schering-Plough Healthcare
represented, without adequate substantiation, that a single application
of Coppertone Kids provides six hours of protection from the sun, at
the advertised SPF level, for children engaged in sustained vigorous
activity in and out of the water. The complaint also alleges that
Schering-Plough Healthcare falsely represented that it had conducted
tests demonstrating that the product provides such protection.
According to the complaint, among other things, the company's tests did
not evaluate a single application of the product under the advertised
conditions of use (sustained vigorous activity).
The consent order contains provisions designed to remedy the
violations charged and to prevent Schering-Plough Healthcare from
engaging in similar acts and practices in the future.
Part I of the proposed order prohibits Schering-Plough Healthcare
from representing: (a) the length of time that Coppertone Kids or any
other children's sun protection product will provide protection from
the sun for persons engaged in sustained vigorous activity in and out
of the water; or (b) the efficacy of any children's sun protection
product in providing protection against any harmful effect of sun
exposure or ultraviolet radiation, unless the company has scientific
substantiation for the representation.
The order defines a ``children's sun protection product'' as any
sun protection product that uses the word ``babies,'' ``children,''
``kids,'' or other similar words in the name or promotion of the
product, or that is advertised or promoted for use primarily on
children under the age of twelve.
Part II of the proposed order prohibits Schering-Plough Healthcare
from misrepresenting the existence, contents, validity, or conclusions
of any test or study concerning any sun protection product.
Part III of the order allows Schering-Plough Healthcare to make any
representation for a sun protection product that is specifically
permitted in labeling for that product under any tentative final or
final Food and Drug Administration standard or under any new drug
application approved by the Food and Drug Administration.
Part IV of the proposed order requires Schering-Plough Healthcare
to produce and disseminate a consumer brochure addressing the
importance of sunscreen usage to children and the health benefits
associated with it, and promoting the proper use and application of
sunscreens on children. The brochure, which is subject to FTC approval,
will be disseminated by Schering-Plough Healthcare to organizations
with direct access to parents or organizations with access to parents
or others who work with or care for children under the age of 12.
Parts V, VII, IX, and X of the proposed order require Schering-
Plough Healthcare to keep copies of all materials relied upon in making
any representations covered by Parts I and II of the order; to provide
copies of the order to certain of the company's personnel; to notify
the Commission of any change in corporate structure; and to file
compliance reports with the Commission. Part VI permits respondent to
use existing labeling for 100 days after the date of service of the
order. Part VIII provides that the order will terminate after twenty
(20) years under certain circumstances.
The purpose of this analysis is to facilitate public comment on the
proposed order, and it is not intended to constitute an official
interpretation of the agreement and proposed order or to modify in any
way their terms.
Donald S. Clark,
Secretary.
Separate Statement of Commissioner Mary L. Azcuenaga Concurring in Part
and Dissenting in Part in Schering-Plough Healthcare, File No. 942 3341
Today, the Commission accepts for public comment a proposed consent
agreement resolving allegations about certain claims in the advertising
of Coppertone Kids 6-Hour Waterproof Sunblock. I concur except with
respect to Part IV of the proposed order, which requires the respondent
to develop and disseminate a consumer education brochure addressing the
dangers of unprotected exposure to the sun. Consumer education
brochures are an integral part of the Commission's consumer protection
program, but they are not necessarily defensible adjuncts to Commission
orders.
A fencing-in provision will be sustained by the courts as long as
it is ``reasonably related'' to the violation found.\1\ Fencing-in
relief properly may include requirements beyond simply prohibiting the
challenged conduct that are designed to ``close all roads to the
prohibited goal, so that [the Commission's] order may not be by-passed
with impunity.'' \2\ The allegedly deceptive claim is that the
respondent's sunblock for children would remain effective for six hours
even if the children engaged in ``sustained vigorous activities in and
out of the water,'' such as playing in sand, taking off and putting on
clothes and toweling off after swimming. Complaint para.5. The proposed
order expressly enjoins the respondents from making the challenged
claim, either directly or indirectly, for the product at issue as well
as for ``any other children's sun protection product.'' Order para.I.
---------------------------------------------------------------------------
\1\ FTC v. Colgate-Palmolive Co., 380 U.S. 374, 394-95 (1965);
FTC v. National Lead Co., 352 U.S. 419, 428 (1957).
\2\ FTC v. Ruberoid Co., 343 U.S. 470, 473 (1952).
---------------------------------------------------------------------------
In addition, the proposed order requires the respondent to develop
and distribute 150,000 copies of a color brochure concerning the
importance of sunscreen usage by children. The order requires that the
brochure contain six messages or themes only one of which addresses the
issue in this case, the need to reapply so-called water-proof or water-
resistant sunblock after vigorous activity or after toweling off. Order
para. IV-E.
The brochure requirement, even the message that relates most
closely to the challenged claim, is not focused on preventing the
respondent from making the challenged claim or otherwise from avoiding
compliance with the order. The brochure would help educate consumers
regarding an important health issue, and, presumably, make them less
likely to be misled by the kind of implied claims challenged in this
action.\3\ There is no reason to think that it would enhance the
deterrent effect of the order on Schering.
---------------------------------------------------------------------------
\3\ The product label already contains the statement, ``Reapply
after toweling.''
---------------------------------------------------------------------------
Presumably, the brochure requirement will not be unduly burdensome
or costly for Schering because it will promote the use of its product,
and the brochure is undoubtedly commendable as a public health
initiative. Nevertheless, under the circumstances, it is an overly
broad order requirement as measured against the current standard for
ordering relief.\4\ There is a
[[Page 10061]]
value to the Commission in maintaining the integrity of the standard
for imposing a fencing-in remedy.
---------------------------------------------------------------------------
\4\ It would be even more difficult to justify Part IV of the
order as corrective advertising, because it is unlikely that the
implied claim challenged in the complaint would linger in the minds
of consumers long after it ceased being made. See Warner-Lambert Co.
v. FTC, 562 F.2d 749, 762 (D.C. Cir. 1977), cert. denied, 435 U.S.
950 (1978).
---------------------------------------------------------------------------
I respectfully dissent from Part IV of the order.
Separate Statement of Commissioner Roscoe B. Starek, III Concurring in
Part and Dissenting in Part in Schering-Plough Healthcare, File No.
9423341
I have voted to accept for public comment the consent agreement
with Schering-Plough Healthcare Products, Inc. (``Schering''), because
I have reason to believe that the challenged advertisements are
deceptive and I find that the proposed order, for the most part,
provides appropriate relief. I do not, however, support the requirement
that Schering produce and distribute a consumer education brochure that
includes numerous specified ``messages or themes.'' As set forth in the
proposed order, this consumer education remedy is overbroad and in any
event is unlikely to assist in the prevention of the violations alleged
in the complaint. Although I am an advocate of a strong Commission
consumer education program, and we can be proud of the valuable work
done by the Bureau of Consumer Protection's Office of Consumer and
Business Education, this remedy is a well-meaning but not legally
justifiable effort to fund a general consumer education campaign.
The Commission enjoys extensive authority to fashion fencing-in
relief for deceptive practices so long as the remedy has a reasonable
relation to the violations alleged in the complaint. See, e.g., FTC
versus Colgate-Palmolive Co., 380 U.S. 374, 394-95 (1965); FTC versus
National Lead Co., 352 U.S. 419, 428-29 (1957). With such authority,
however, comes the responsibility to exercise it judiciously. In my
view, the consumer education remedy mandated by this proposed order
bears no reasonable relationship to the violations alleged in the
complaint.
The proposed complaint alleges that Schering lacked a reasonable
basis for the claim that a single application of Coppertone Kids
provides six hours of protection from the sun for children engaged in
sustained vigorous activity in and out of the water.\1\ The order
addresses this allegation by requiring scientific substantiation for
claims about the efficacy of any children's sun protection product in
providing protection against any harmful effect of sun exposure or
ultraviolet radiation, or about the length of time that any such
product will provide sun protection for individuals engaged in
sustained vigorous activity in and out of the water.
---------------------------------------------------------------------------
\1\ The proposed complaint challenges as false the claim that
Schering has conducted tests demonstrating that a single application
of Coppertone Kids provides six hours of protection from the sun for
children engaged in sustained vigorous activity in and out of the
water. The proposed order broadly prohibits false establishment
claims for any sun protection product.
---------------------------------------------------------------------------
In addition, however, the order would require Schering to design,
produce and print a brochure--subject to the approval of the Associate
Director of the Division of Advertising Practices (``DAP'') in the
Commission's Bureau of Consumer Protection--about the importance of
sunscreen usage by children. The order mandates that the brochure
include all of the following ``messages or themes'':
(A) The importance of sunscreens in preventing skin damage,
including skin cancer, sunburn, and premature skin aging;
(B) Regular use of a high SPF sunscreen during childhood can
significantly reduce the risk of certain types of skin cancers later in
life;
(C) A single bad sunburn during childhood can significantly
increase a child's risk of developing skin cancer later in life;
(D) The importance of proper application of sunscreens;
(E) The need to reapply sunscreens after toweling or sustained
vigorous activity; and
(F) The need to use sunscreens during outdoor activities--not only
in connection with water activities.
Order para. IV. The respondent must disseminate 150,000 copies of this
brochure to parents or to organizations with access to parents or
others who work with or care for children under age twelve.\2\
---------------------------------------------------------------------------
\2\ Like the brochure, the dissemination plan is subject to the
approval of the Associate Director in charge of DAP.
---------------------------------------------------------------------------
Of the six required messages, only statement (E) seems likely to
assist in the prevention of future deception like or related to that
alleged in the complaint. Yet by including this key reapplication
information in an extensive list of other facts about sunscreen, the
order makes it less likely that consumers will see the reapplication
information. In my view, it is highly unlikely that a parent who
receives and reviews whatever brochure is approved will recall the one
piece of information related to the complaint allegation when the
parent makes a sunscreen purchase. Because the scope of the information
to be included in the brochure is so broad, the consumer education
remedy is not reasonably related to the violations alleged in the
proposed complaint.\3\
---------------------------------------------------------------------------
\3\ The consumer education remedy here stands in contrast to a
fencing-in provision contained in a consent order issued by the
Commission last year. See Blenheim Expositions, Inc., Docket No. C-
3633 (Jan. 18, 1996) (requiring a franchise show promoter to
undertake a limited distribution of an FTC consumer education
brochure to customers attending its franchise shows). The respondent
in Blenheim allegedly made unsubstantiated claims regarding the
earnings and success of franchise owners and false claims regarding
a poll of franchise owners. The brochure specifically identified FTC
requirements with which franchisors must comply, including
consumers' right to receive an earnings claims document, and it
provided instructions on how to evaluate earnings claims. It thus
contained information likely to assist the respondent's customers to
detect and protect themselves from possible future
misrepresentations of earnings like those alleged in the complaint.
Although the brochure also addressed other issues related to the
purchase of a franchise, all of the advice in the brochure at least
arguably would help prospective franchisees avoid becoming victims
of future violations by the respondent.
---------------------------------------------------------------------------
It is also troubling that if the Commission issues this order, it
essentially will be ordering the respondent to advertise that persons
should buy and use more of the respondent's products. Schering already
has every incentive to communicate the required messages to consumers.
In fact, the consumer education remedy is advertising (``use more
sunscreen'') that the company might wish to do in any event since the
conduct provisions of the order may prevent it from continuing to
distinguish its children's sun protection product from others by
claiming that it requires fewer applications. The deterrence value of
this remedy is minimal at best.
Finally, if this relief were sought in litigation, rather than
obtained through a consent agreement, it would not withstand scrutiny
under the First Amendment. For purposes of First Amendment analysis,
there is no difference between compelled speech and restrictions on
speech. Riley v. National Fed'n of the Blind, 487 U.S. 781, 796-97
(1988). A valid restriction on commercial speech must be no more
extensive than necessary to serve the substantial governmental interest
directly advanced by the restriction. Rubin v. Coors Brewing Co., 115
S. Ct. 1585, 1591 (1995) (discussing Central Hudson Gas & Elec. Corp.
v. Public Serv. Comm'n of N.Y., 447 U.S. 557, 566 (1980)). Thus,
disclosures compelled by the FTC can be no broader than necessary to
prevent future deception or to correct the effects of past deception.
See, e.g., National Comm'n on Egg Nutrition v. FTC, 570 F.2d 157, 164
(7th Cir. 1977), cert. denied, 439 U.S. 821 (1978). Additionally, the
government bears the burden of showing that a speech restriction will
advance its
[[Page 10062]]
interest ``to a material degree.'' 44 Liquormart, Inc. v. Rhode Island,
116 S. Ct. 1495, 1509 (1996) (plurality opinion of Justice Stevens)
(citing Edenfield v. Fane, 507 U.S. 761, 771 (1993)). A commercial
speech restriction that ``provides only ineffective or remote support
for the government's purpose'' does not pass this test. 44 Liquormart,
116 S. Ct. at 1509 (citing Central Hudson, 447 U.S. at 564).
The dubious efficacy of the proposed consumer education remedy
makes it unlikely that it will directly advance the asserted
governmental interest in preventing future deception by the respondent.
In addition, I doubt that a credible argument can be made that the
information that the order specifically requires be included in the
brochure is no more extensive than necessary to prevent future
violations by Schering. Certainly Schering has waived any First
Amendment objections to this relief by entering into the consent
agreement. Nonetheless, when a remedy implicates First Amendment
rights, the Commission should be particularly reluctant to obtain
through negotiations relief that it lacks at least a colorable chance
to obtain in litigation.
In my view, it would be better to have no consumer information
remedy in the consent order if the only alternative is an overbroad
remedy of doubtful efficacy that raises First Amendment concerns.
[FR Doc. 97-5344 Filed 3-4-97; 8:45 am]
BILLING CODE 6750-01-M