[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Notices]
[Pages 80051-80054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31936]
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FEDERAL TRADE COMMISSION
[File No. 082 3158]
The Dannon Company, Inc.; Analysis of Proposed Consent Order 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 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 January 18, 2011.
ADDRESSES: Interested parties are invited to submit written comments
electronically or in paper form. Comments should refer to ``Dannon,
File No. 082 3158'' to facilitate the organization of comments. Please
note that your comment--including your name and your state--will be
placed on the public record of this proceeding, including on the
publicly accessible FTC Web site, at http://www.ftc.gov/os/publiccomments.shtm.
Because comments will be made public, they should not include any
sensitive personal information, such as an individual's Social Security
Number; date of birth; driver's license number or other state
identification number, or foreign country equivalent; passport number;
financial account number; or credit or debit card number. Comments also
should not include any sensitive health information, such as medical
records or other individually identifiable health information. In
addition, comments should not include any ``[t]rade secret or any
commercial or financial information which is obtained from any person
and which is privileged or confidential * * *.,'' as provided in
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule
4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which
confidential treatment is requested must be filed in paper form, must
be clearly labeled ``Confidential,'' and must comply with FTC Rule
4.9(c), 16 CFR 4.9(c).\1\
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\1\ The comment must be accompanied by an explicit request for
confidential treatment, including the factual and legal basis for
the request, and must identify the specific portions of the comment
to be withheld from the public record. The request will be granted
or denied by the Commission's General Counsel, consistent with
applicable law and the public interest. See FTC Rule 4.9(c), 16 CFR
4.9(c).
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Because paper mail addressed to the FTC is subject to delay due to
heightened security screening, please consider submitting your comments
in electronic form. Comments filed in electronic form should be
submitted by using the following weblink: https://ftcpublic.commentworks.com/ftc/dannon and following the instructions on
the web-based form. To ensure that the Commission considers an
electronic comment, you must file it on the web-based form at the
weblink: https://ftcpublic.commentworks.com/ftc/dannon. If this Notice
appears at http://www.regulations.gov/search/index.jsp, you may also
file an electronic comment through that Web site. The Commission will
consider all comments that regulations.gov forwards to it. You may also
visit the FTC Web site at http://www.ftc.gov/ to read the Notice and
the news release describing it.
A comment filed in paper form should include the ``Dannon, File No.
082 3158'' reference both in the text and on the envelope, and should
be mailed or delivered to the following address: Federal Trade
Commission, Office of the Secretary, Room H-135 (Annex D), 600
Pennsylvania Avenue, NW., Washington, DC 20580. The FTC is requesting
that any comment filed in paper form be sent by courier or overnight
service, if possible, because U.S. postal mail in the Washington area
and at the Commission is subject to delay due to heightened security
precautions.
The Federal Trade Commission Act (``FTC Act'') and other laws the
Commission administers permit the collection of public comments to
consider and use in this proceeding as appropriate. The Commission will
consider all timely and responsive public comments that it receives,
whether filed in paper or electronic form. Comments received will be
available to the public on the FTC Web site, to the extent practicable,
at http://www.ftc.gov/os/publiccomments.shtm. As a matter of
discretion, the Commission makes every effort to remove home contact
information for individuals from the public comments it receives before
placing those comments on the FTC Web site. More information, including
routine uses permitted by the Privacy Act, may be found in the FTC's
privacy policy, at http://www.ftc.gov/ftc/privacy.shtm.
FOR FURTHER INFORMATION CONTACT: Richard Cleland (202-326-3088), Bureau
of Consumer Protection, 600 Pennsylvania Avenue, NW., Washington, DC
20580.
SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec. 2.34 of
the Commission 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 thirty (30) 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 December 15, 2010), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. A paper copy can be obtained from the FTC Public
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington,
DC 20580, either in person or by calling (202) 326-2222.
Public comments are invited, and may be filed with the Commission
in either paper or electronic form. All comments should be filed as
prescribed in the ADDRESSES section above, and must be received on or
before the date specified in the DATES section.
Analysis of Agreement Containing Consent Order To Aid Public Comment
The Federal Trade Commission (``FTC'' or ``Commission'') has
accepted, subject to final approval, an agreement containing a consent
order from The Dannon Company, Inc. (``respondent''). The proposed
consent order has been placed on the public record for thirty (30) days
for receipt of comments by interested persons. Comments received during
this period will become part of the public record. After thirty (30)
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 the advertising and promotion of DanActive, a
probiotic dairy drink, and Activia, a probiotic yogurt. According to
the FTC complaint, respondent represented, in various advertisements,
that drinking DanActive reduces the likelihood of getting a cold or the
flu. The complaint alleges that these claims are unsubstantiated and
thus violate the FTC Act. The complaint also alleges that respondent
represented that clinical studies prove that drinking DanActive reduces
the likelihood of getting a cold or the flu. The complaint alleges that
these claims are false and thus violate the FTC Act.
With respect to Activia, the complaint alleges that respondent
represented, in various advertisements, that eating one serving of
Activia daily relieves temporary irregularity and helps with slow
intestinal transit time. The complaint alleges that these claims are
unsubstantiated and thus violate the FTC Act. The complaint also
alleges that respondent represented that clinical studies prove that
eating one serving of Activia daily relieves temporary irregularity and
helps with slow intestinal transit time. The complaint alleges that
these claims are false and thus violate the FTC Act.
The proposed consent order contains provisions designed to prevent
respondent from engaging in similar acts or practices in the future.
The order covers representations made in connection with the
manufacturing, labeling, advertising, promotion, offering for sale,
sale, or distribution of any covered product, in or affecting commerce.
The order defines a covered product as: (a) Any yogurt, including but
not limited to, Activia yogurt; (b) any dairy drink; and (c) any food
or drink not covered by the foregoing that contains a probiotic,
including, but not limited to, DanActive.
Part I of the consent order is designed to address the complaint
allegations concerning respondent's allegedly unsubstantiated
representations that drinking DanActive reduces the likelihood of
getting a cold or the flu. Part I prohibits respondent from making
representations that any covered product reduces the likelihood of
getting a cold or the flu unless the representation is specifically
permitted in labeling for such product by regulations promulgated by
the Food and Drug Administration (``FDA'') pursuant to the Nutrition
Labeling and Education Act of 1990 (``NLEA''). Under this provision,
therefore, respondent cannot claim that a covered product reduces the
likelihood of getting a cold or the flu unless the FDA has issued a
regulation authorizing the claim based on a finding that there is
significant scientific agreement among experts qualified by scientific
training and experience to evaluate such claims, considering the
totality of publicly available scientific evidence. As noted in the
Commission's Enforcement Policy Statement on Food Advertising, ``[t]he
Commission regards the `significant scientific agreement' standard, as
set forth in the NLEA and FDA's regulations, to be the principal guide
to
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what experts in the field of diet-disease relationships would consider
reasonable substantiation for an unqualified health claim.''
Enforcement Policy Statement on Food Advertising (1994), available at
http://www.ftc.gov/bcp/policystmt/ad-food.shtm. Thus, although the
Enforcement Policy Statement does not say that the only way a food
advertiser can adequately substantiate a disease risk-reduction claim
is through FDA authorization, the consent order provision requiring FDA
pre-approval before respondent makes a reduced cold or flu likelihood
claim for its covered products in the future will facilitate compliance
with and enforcement of the order and is reasonably related to the
violations alleged.
Respondent may decide to make an advertising claim characterizing
limited scientific evidence supporting the relationship between a
covered product and a reduced likelihood of getting a cold or the flu.
However, if the net impression of that advertising is that the covered
product reduces the likelihood of getting a cold or the flu, and not
merely that there is limited scientific evidence supporting the claim,
the advertisement would be covered under Part I. The Commission notes
that its experience and research show that it is very difficult to
adequately qualify a disease risk-reduction claim in advertising to
indicate that the science supporting the claimed effect is limited. In
other words, reasonable consumers may interpret an advertisement to
mean that the product will reduce the likelihood of getting a cold or
the flu, even if respondent includes language indicating that the
science supporting the effect is limited in some way. However, if
respondent possesses reliable empirical testing demonstrating that the
net impression of an advertisement making a qualified claim for a
covered product does not convey that it will reduce the likelihood of
getting a cold or the flu, then that claim would be covered under Part
IV of the order.
Although Part I requires FDA approval before respondent can make
claims that a covered product reduces the likelihood of getting a cold
or the flu, the Commission does not intend Part I to limit respondent
to using the precise language specified in an FDA-approved health
claim. To the contrary, if the FDA has approved a claim that a covered
product reduces the likelihood of getting a cold or the flu, respondent
may use a variety of words and images to communicate that claim in its
advertising. Conversely, regardless of the particular words or images
used, if the net impression of an advertisement is that a covered
product reduces the likelihood of getting a cold or the flu, then for
the ad to comply with the order, the FDA must have authorized a health
claim based on significant scientific agreement that such product
provides such a benefit.
Part II of the consent order prohibits respondent from making
representations that eating one serving of Activia yogurt daily
relieves temporary irregularity and helps with slow intestinal transit
time unless the representation is non-misleading and it conveys that
eating three servings a day is required to obtain the benefit. Part II
further provides, however, that the order does not prohibit respondent
from representing that the benefit can be achieved from eating less
than three servings a day if such claim is non-misleading and
respondent possesses and relies upon competent and reliable scientific
evidence that substantiates that such representation is true.
For purposes of Part II, competent and reliable scientific evidence
means at least two adequate and well-controlled human clinical studies
of the product, or of an essentially equivalent product, conducted by
different researchers, independently of each other, that conform to
acceptable designs and protocols and whose results, when considered in
light of the entire body of relevant and reliable scientific evidence,
are sufficient to substantiate that the representation is true. For
purposes of the order, essentially equivalent product means a product
that contains the identical ingredients, except for inactive
ingredients (e.g., inactive binders, flavors, preservatives, colors,
fillers, excipients), in the same form and dosage, and with the same
route of administration (e.g., orally, sublingually), as the covered
product; provided that the covered product may contain additional
ingredients or other differences in formulation to affect taste,
texture, or nutritional value (so long as the other differences do not
change the form of the product or involve the ingredients from which
the functional benefit is derived), if reliable scientific evidence
generally accepted by experts in the field demonstrates that the amount
of additional ingredients, combination of additional ingredients, and
any other differences in formulation are unlikely to impede or inhibit
the effectiveness of the ingredients in the essentially equivalent
product.
Part III of the consent order prohibits respondent from making
representations that any covered product other than Activia yogurt
relieves temporary irregularity and helps with slow intestinal transit
time unless the representation is non-misleading and respondent
possesses and relies upon competent and reliable scientific evidence
that substantiates that such representation is true. For purposes of
Part III, competent and reliable scientific evidence means at least two
adequate and well-controlled human clinical studies of the product, or
of an essentially equivalent product, conducted by different
researchers, independently of each other, that conform to acceptable
designs and protocols and whose results, when considered in light of
the entire body of relevant and reliable scientific evidence, are
sufficient to substantiate that the representation is true.
Part IV of the consent order prohibits respondent from making
representations, other than representations covered under Parts I
through III, about the health benefits, performance, or efficacy of any
covered product, unless the representation is non-misleading, and, at
the time of making such representation, respondent possesses and relies
upon competent and reliable scientific evidence that is sufficient in
quality and quantity based on standards generally accepted in the
relevant scientific fields, when considered in light of the entire body
of relevant and reliable scientific evidence, to substantiate that the
representation is true. For purposes of Part IV, competent and reliable
scientific evidence means tests, analyses, research, studies, or other
evidence that have been conducted and evaluated in an objective manner
by qualified persons, that are generally accepted in the profession to
yield accurate and reliable results.
Part V of the consent order prohibits respondent from
misrepresenting the existence, contents, validity, results,
conclusions, or interpretations of any test, study, or research,
including but not limited to any misrepresentation that a covered
product is clinically proven (1) to reduce the likelihood of getting a
cold or flu, or (2) to relieve temporary irregularity or help with slow
intestinal transit time.
Part VI of the consent order provides that nothing in the order
shall prohibit respondent from making any representation for any
product that is specifically permitted in labeling for such product by
regulations promulgated by the FDA pursuant to the NLEA.
Parts VII, VIII, IX, and X of the consent order require respondent
to keep copies of relevant advertisements and materials substantiating
claims made in the advertisements; to provide copies of the order to
its personnel; to notify the Commission of changes in
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corporate structure that might affect compliance obligations under the
order; and to file compliance reports with the Commission. Part XI
provides that the order will terminate after twenty (20) years, with
certain exceptions.
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 their
terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2010-31936 Filed 12-20-10; 8:45 am]
BILLING CODE 6750-01-P