[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