[Federal Register Volume 75, Number 140 (Thursday, July 22, 2010)]
[Notices]
[Pages 42752-42754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17838]
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FEDERAL TRADE COMMISSION
[File No. 092 3087]
Nestle' HealthCare Nutrition, 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 August 16, 2010.
ADDRESSES: Interested parties are invited to submit written comments
electronically or in paper form. Comments should refer to ``Nestle,
File No. 092 3087'' 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 website, 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/nestle) 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/nestle). If this Notice
appears at (http://www.regulations.gov/search/index.jsp), you may also
file an electronic comment through that website. The Commission will
consider all comments that regulations.gov forwards to it. You may also
visit the FTC website at (http://www.ftc.gov/) to read the Notice and
the news release describing it.
A comment filed in paper form should include the ``Nestle, File No.
092 3087'' 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 website, 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 website. 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: Karen Mandel (202-326-2491), Bureau of
Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C.
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 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 July 14, 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,
D.C. 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 Nestle; HealthCare Nutrition, 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.
[[Page 42753]]
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 BOOST Kid
Essentials, a children's nutritional drink that also delivers
probiotics via an attached straw. According to the FTC complaint,
respondent represented, in various advertisements, that BOOST Kid
Essentials prevents upper respiratory tract infections in children;
strengthens the immune system, thereby providing protection against
cold and flu viruses; and reduces absences from daycare or school due
to illness. The complaint alleges that these claims are unsubstantiated
and thus violate the FTC Act.
The FTC complaint further charges that respondent represented that
clinical studies prove that BOOST Kid Essentials reduces the general
incidence of illness in children, including upper respiratory tract
infections; reduces the duration of acute diarrhea in children up to
age thirteen (the age group for which the product is marketed); and
strengthens the immune system, thereby providing protection against
cold and flu viruses. 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 BOOST Kid Essentials, any drink
product containing probiotics, or any nutritionally complete drink,
other than infant formula, medical foods, and any product not sold
primarily through conventional retail channels.
Part I of the consent order is designed to address the complaint
allegations concerning respondent's allegedly unsubstantiated
representations that its products prevent upper respiratory tract
infections (URTIs). Part I prohibits respondent from making
representations that a covered product prevents or reduces the risk of
URTIs, including, but not limited to, cold or flu viruses, 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 make a claim of URTI
risk reduction 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 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 Commission has determined that requiring FDA pre-
approval before respondent makes a URTI risk-reduction claim for its
covered products will facilitate compliance with the order and is
reasonably related to the enforcement of this order.
Respondent may decide to make an advertising claim characterizing
limited scientific evidence supporting the relationship between a
covered product and URTIs. However, if the net impression is that a
covered product prevents or reduces the risk of URTIs, 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 prevent or reduce the risk of URTIs, 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 prevent or reduce the risk of URTIs, then that
claim would be covered under the relevant subsequent parts of the
order.
Although Part I requires FDA approval before respondent can make
claims that a covered product prevents or reduces the risk of URTIs,
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 can
prevent or reduce the risk of URTIs, respondent may use a variety of
words and images to communicate that claim in its advertising.
Likewise, regardless of the particular words or images used, if the net
impression of an advertisement is that a covered product prevents or
reduces the risk of URTIs, 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 a covered product reduces the duration of acute
diarrhea in children up to the age of thirteen, or reduces absences
from daycare or school due to illness, 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 substantiates that the 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 if reliable scientific evidence generally accepted by
experts in the field demonstrates that the amount and combination of
additional ingredients is 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, other than representations covered under Parts I or
II, about the health benefits, performance, or efficacy of any covered
product, unless the representation is
[[Page 42754]]
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 III, 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 IV of the consent order prohibits respondent from
misrepresenting the existence, contents, validity, results,
conclusions, or interpretations of any test, study, or research.
Part V 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 VI, VII, VIII, and IX 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 corporate
structure that might affect compliance obligations under the order; and
to file compliance reports with the Commission.
Part X 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.
Richard C. Donohue
Acting Secretary.
[FR Doc. 2010-17838 Filed 7-21-10: 8:45 am]
BILLING CODE 6750-01-S