[Federal Register Volume 61, Number 235 (Thursday, December 5, 1996)]
[Notices]
[Pages 64521-64524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30944]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 942-3218]
California SunCare, Inc.; Donald J. Christal; 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 require, among other things, the Los
Angeles, California-based company, and its president, to make certain
disclosures in future ads and labeling, cautioning consumers that
tanning, even without burning, can cause skin cancer and premature skin
aging. The agreement settles allegations that California SunCare made
false and unsubstantiated claims that moderate exposure to the
ultraviolet radiation of the sun and in indoor tanning salons, such as
those marketed by the company, is not harmful, and that such exposure
actually provides many health benefits.
DATES: Comments must be received on or before February 3, 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 and Pennsylvania Ave., NW, Washington, DC
20580. (202) 326-3153. Toby Milgrom Levin, Federal Trade Commission, S-
4002, 6th and
[[Page 64522]]
Pennsylvania Ave., NW, Washington, DC 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 November 19,
1996), 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 California Suncare, Inc., the manufacturer
and marketer of ``California Tan Heliotherapy'' tanning products, and
its president, Donald J. Christal (hereinafter sometimes referred to as
respondents).
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.
The Commission's complaint in this matter concerns representations
made by respondents for their Heliotherapy line of skin care products,
which are designed to be used in connection with tanning. The complaint
alleges that certain advertisements and promotional materials
disseminated by respondents have contained false or unsubstantiated
claims about the safety and health benefits of exposure to ultraviolet
radiation (``UVR'') from the sun or indoor tanning salons, and about
the benefits and efficacy of the Heliotherapy products.
More specifically, the complaint alleges that respondents falsely
represented that:
--The negative effects of UVR, including skin cancer and premature skin
aging, are caused only by overexposure and burning, and not by moderate
exposure;
--Tanning as a result of UVR exposure is not harmful to the skin;
--Use of Heliotherapy products prevents or minimizes the negative
effects of UVR; and
--Exposure to UVR reduces the risk of skin cancer.
The complaint further challenges as unsubstantiated respondents'
claims that exposure to UVR:
--Prevents or reduces the risk of colon and breast cancer;
--Lowers elevated blood pressure;
--Has benefits similar to those of exercise, including decreased blood
pressure and lower heart rate;
--Significantly reduces serum cholesterol;
--Is an effective treatment for AIDS;
--Enhances the immune system; and
--Is necessary for the general population to reduce the risk of bone
disorders such as osteoporosis and osteomalacia, which can be caused by
reduced winter sunlight.
The complaint also alleges that respondents' claim that exposure to
indoor UVR is an effective treatment for Seasonal Affective Disorder is
unsubstantiated.
In addition, the complaint challenges as unsubstantiated certain
claims about the tanning efficacy of certain Heliotherapy products,
including claims that Heliotherapy MAXIMIZERS help users achieve up to
forty-two percent better tanning results and that Heliotherapy products
with two percent VITATAN improve users' ability to tan by up to sixty-
seven percent.
Finally, the complaint charges that respondents falsely represented
that scientific studies demonstrate that exposure to UVR provides the
health benefits set forth above and that the American Medical
Association endorses exposure to UVR as an effective medical treatment.
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 order prohibits respondents from making the false
claims alleged in the complaint about the lack of harm from moderate
UVR exposure and tanning, and the benefits of UVR in reducing the risk
of skin cancer. Part I also prohibits misrepresentations about the
ability of any tanning products or services to prevent or minimize the
adverse effects of UVR exposure.
Part II requires scientific substantiation for the claims about
health benefits from UVR exposure challenged as unsubstantiated in the
complaint, and for any claims about the health benefits of sunlight or
indoor ultraviolet radiation. Part III of the order requires
substantiation for claims that any tanning product or service prevents
or minimizes the harms of UVR or will improve tanning or about the
performance, safety, benefits, or efficacy of any such product or
service.
Part IV prohibits misrepresentations about studies or official
endorsements for any product or service.
The order also requires certain clear and prominent disclosures in
future advertising and labeling for certain tanning products about the
risks of exposure to sunlight or indoor ultraviolet radiation. Part V.A
requires a disclosure in future ads and promotional materials for all
tanning products that do not contain a sunscreen ingredient providing a
minimum sun protection factor (SPF) of two. The disclosure reads as
follows:
CAUTION: Tanning in sunlight or under tanning lamps can cause
skin cancer and premature skin aging--even if you don't burn.
The disclosure is required in all advertising, with the exception
of television advertising, billboards, and publications directed
primarily to salon professionals. The exempted publications are limited
to periodicals sold only by subscription with a readership of at least
fifty percent salon professionals. The above disclosure must be made in
all nonexempt advertising until the respondents have spent $1,500,000
disseminating advertisements with the disclosure to consumers. If that
amount is not spent within two years and six months after the order
becomes effective, the exemptions no longer apply and the disclosure
must appear in all advertising until the amount above is expended.
Parts V.B and C require disclosures about the adverse effects of
tanning in advertising and product labeling for tanning products that
contain representations about the health benefits or safety of exposure
to UVR. The advertising disclosure becomes effective
[[Page 64523]]
immediately in the case of the three types of advertising that are
exempt from Part V.A as described above and becomes effective for all
other types of advertising once the requirements of Part V.A have been
satisfied. The labeling disclosure is required when the order becomes
effective and applies to any tanning product not containing a sunscreen
ingredient of at least SPF two. The label disclosure in addition to
cautioning about the harms of tanning, states that the product does not
contain a sunscreen and does not protect against burning.
Part VI requires respondents to send a letter (appended to the
order) to people who purchased Heliotherapy products for resale such as
distributors and retailers. The letter describes the Commission's
action and advises recipients to discontinue use of promotional
materials that contain the challenged claims. The record keeping
requirements for this part are laid out in Part VII. Part VII.C
requires the respondents to warn and ultimately to stop doing business
with recipients of the letter who continue to use materials that make
the challenged claims.
Part VII contains a provision permitting respondents to use old
labeling for 100 days after the effective date of the order. However,
it requires the removal of all the fold-out labels once the order
becomes effective.
The remaining parts of the order contain standard provisions with
respect to record keeping, safe harbors for claims approved by the Food
and Drug Administration, compliance, and sunsetting the order after
twenty years.
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.
Statement of Commissioner Roscoe B. Starek, III, Concurring in Part and
Dissenting in Part in California Suncare, Inc., File No. 942-3218
I have voted to accept for public comment the consent agreement
with California Suncare, Inc. (CSI) because, for the most part, it
provides appropriate relief for the extremely serious
misrepresentations alleged in the complaint about the health and safety
effects of ultraviolet radiation (UVR) exposure and the benefits and
efficacy of the company's tanning products. However, I do not support
including the ``untriggered'' disclosure in Part V.A. of the proposed
order.1 In my view this remedy constitutes corrective advertising,
and I am not convinced that the evidence here meets the standard for
imposing corrective advertising set forth in Warner-Lambert Co. v. FTC,
562 F.2d 749, 762 (D.C. Cir. 1977), cert. denied, 435 U.S. 950 (1978).
---------------------------------------------------------------------------
\1\ Part V.A. requires CSI to include the following statement in
all advertising and promotional materials disseminated directly to
consumers or through purchasers for resale (except television
advertising, billboards and advertising in magazines sold only by
subscription for which half or more of the readership is comprised
of tanning or beauty salon professionals): ``CAUTION: Tanning in
sunlight or under tanning lamps can cause skin cancer and premature
aging--even if you don't burn.'' This disclosure is applicable to
all of respondent's products that contain a sunscreen ingredient
providing a sun protection factor (SPF) of less than 2 and must be
made until CSI spends $1.5 million on dissemination. If CSI does not
expend this amount within 2\1/2\ years after the service of the
order, the untriggered disclosure then becomes applicable to all
forms of advertising until the required amount is spent.
---------------------------------------------------------------------------
Both the characteristics and scope of the untriggered disclosure
lead me to conclude that it is actually corrective advertising in
disguise. The disclosure requirement has certain characteristics
usually associated with corrective advertising: it runs until a
specific time period expires and a specific sum of money is exhausted,
and it must be made regardless of the representations CSI makes about
its products. See, e.g., American Home Products Corp. v. FTC, 695 F.2d
681, 700 (3d Cir. 1982) (``[A] genuine corrective advertising
requirement . . . demand[s] disclosure in future advertisements
regardless of the content of those advertisements.''). Most
significant, however, the scope of the untriggered disclosure far
exceeds its rationale. The disclosure must appear in CSI's general
advertising as well as in all promotional materials distributed
directly to consumers for any tanning product that does not contain a
sunscreen with a minimum SPF of 2. Yet the rationale advanced for this
untriggered disclosure is that it is necessary to protect prospective
purchasers from being misled by future misrepresentations about the
effects of UVR exposure, particularly misrepresentations that might
occur at ``the point of sale''--the tanning salons where consumers
purchase CSI products. I see no reason for the untriggered disclosure
to appear in general advertising if the disclosure's true intent is to
prevent possible future deception of consumers at the point of sale.
The disparity between the scope of the disclosure and its rationale
suggests to me that its primary purpose is more consistent with
corrective advertising than with an affirmative disclosure. The purpose
of corrective advertising is to dispel false beliefs in the public mind
created or reinforced by a challenged ad that are likely to endure (and
thus to influence purchase decisions) even after the ad stops running.
In contrast, the purpose of an affirmative disclosure remedy is to
prevent deception from future claims like or related to those
challenged.2 I recognize that the untriggered disclosure might
have some impact on potential future deceptive claims about UVR
exposure at the point of sale, but it is overbroad for this particular
purpose, and the need for it seems minimal in light of the extensive
other relief provided by the order.3 Thus, the main purpose of
this untriggered disclosure seems to be to ameliorate lingering false
beliefs that may have been created or reinforced by CSI's past claims
that UVR exposure not only is not harmful but is positively beneficial.
---------------------------------------------------------------------------
\2\ It is difficult to draw bright lines between these possible
forms of fencing-in relief, and I am not suggesting that the
Commission forgo ordering affirmative disclosures in all
circumstances in which the disclosures, while targeted primarily at
the prevention of deception from future claims, may also
incidentally affect a possible lingering public misimpression
created by past advertising. This situation is not the case
presented here.
\3\ In addition to prohibiting misrepresentations about the
effects of UVR exposure and tanning and unsubstantiated claims about
the performance, safety, benefits, or efficacy of products or
services used in connection with tanning, the proposed order
requires two additional affirmative disclosures (Parts V.B. and
V.C.) that are triggered by claims about the safety or health
benefits of exposure to sunlight or indoor UVR. The language of
these triggered disclosures is similar to that of the untriggered
disclosure. The triggered disclosures apply to labeling and
packaging--forms of advertising exempted from the untriggered
disclosure--and, after the untriggered disclosure requirement runs
out, to all other advertising and promotional material. The proposed
order (Part VI) also requires CSI to send a letter to distributors
and retailers of the company's tanning products that describes the
Commission's enforcement action and advises them to stop using ads
and promotional materials that contain any of the representations
prohibited by the order or face losing CSI's business.
---------------------------------------------------------------------------
Although both corrective advertising and affirmative disclosures
are forms of fencing-in relief that are well within the Commission's
remedial authority, the standard for imposing corrective advertising is
significantly more stringent than that for an affirmative disclosure.
In imposing corrective advertising, the Commission normally relies on
extrinsic evidence of the existence of lingering false beliefs created
by past advertising. In certain cases, however, it may be possible to
presume the existence of such false beliefs based on the nature and
extent of the advertising campaign. Warner-
[[Page 64524]]
Lambert, 562 F.2d at 762-63.4 An affirmative disclosure remedy, on
the other hand, requires only that the disclosure be ``reasonably
related'' to the alleged violations. In my view, it is important to
distinguish between corrective advertising and affirmative disclosures
because the Commission should not evade the more demanding standard for
corrective advertising where it is clearly applicable.
---------------------------------------------------------------------------
\4\ See, e.g., Eggland's Best, Inc., Docket No. C-3520 (Aug. 15,
1994) (Statement of Roscoe B. Starek, III).
---------------------------------------------------------------------------
There appears to be little basis for Part V.A. of the proposed
order when it is viewed as corrective advertising. There is no direct
evidence that CSI's ads and sales materials created or contributed to a
lingering false impression that UVR exposure through sunlight and
tanning has the health and safety benefits represented by the company.
Moreover, I am not persuaded that it would be appropriate to presume
that the company's message--that UVR exposure is beneficial--would
endure in light of pervasive messages to the contrary.
By accepting this consent agreement, the Commission is coming
perilously close to lowering its standard for imposing corrective
advertising by erasing the already blurred dividing line between that
form of fencing-in relief and affirmative disclosures. Such a change is
one that I cannot endorse.
[FR Doc. 96-30944 Filed 12-4-96; 8:45 am]
BILLING CODE 6750-01-P
