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1
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EXHIBITS A-E
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EXTRACTED KEY WORDS
GRAPHICS DEPARTMENT REDUCER RELIEVER PROOTREADER PATH FUE LAME PNT PATH FUE SNUTTEST TYTHR HATA ROYDRM MLMNBFWNOMLRMSPMS NMNE8K FONTS IMAC IOUO XIIBM LXLYES HL-LMS IRR KKAILFTH FLEA WARNNET PMS OLI0 BLACK OVERPRINTS OLMULULLHW WTS ON0 LXL IBM IXIYES IN-HOUSE GRAPHICS DEPARTMENT KKDTH IHODUCTS |
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Exhibit A
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.Exhibit B
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2
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DECISION & ORDER
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EXTRACTED KEY WORDS
COMMISSION COMPLAINT FEDERAL TRADE COMMISSION REPRESENTATION VIOLATION ACT SUCCESSORS UNITED STATES MATTER THEREAFTER CONSUMER PROTECTION AGREEMENT JURISDICTION LABELING TERMINATE APPEALING INGREDIENTS RULING PRACTICES CONSENT JURISDICTIONAL FACTS OFFICERS AGENTS DIRECTORS SALE ADVERTISING PROMOTION DRUG COMMERCE |
012 3039
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
COMMISSIONERS: Timothy J. Muris, Chairman
Sheila F. Anthony
Mozelle W. Thompson
Orson Swindle
Thomas B. Leary
In the Matter of
LEINER HEALTH PRODUCTS, INC. DOCKET NO. C-4035
a corporation. DECISION AND ORDER
The Federal Trade Commission having initiated an investigation of certain acts and
the respondent named in the caption hereof, and the respondent having been furnished thereafter
copy of a draft complaint which the Bureau of Consumer Protection proposed to present to the
Commission for its consideration and which, if issued by the Commission, would charge respondent
with violations of the Federal Trade Commission Act; and
The respondent, its attorney, and counsel for the Commission having thereafter executed an
agreement containing a consent order, and admission by the respondent of all the jurisdictional
forth in the draft complaint, a statement that the signing of said agreement is for settlement
only and does not constitute an admission by respondent that the law has been violated as alleged in
such complaint, or that the facts as alleged in such complaint, other than jurisdictional facts,
and waivers and other provisions as required by the Commission's Rules; and
The Commission having thereafter considered the matter and having determined that it had
reason to believe that the respondent violated the said Act, and that a complaint should issue
charges in that respect, and having thereupon accepted the executed consent agreement and placed
such agreement on the public record for a period of thirty (30) days, and having duly considered the
comment filed thereafter by an interested person pursuant to Section 2.34 of its Rules, now in
conformity with the procedure prescribed in Section 2.34 of its Rules, the Commission hereby issues
complaint, makes the following jurisdictional findings, and enters the following order:
Page 1 of 4
1. Respondent Leiner Health Products, Inc. is a Delaware corporation with its
office or place of business at 901 233rd Street, Carson, California 90745.
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3
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COMPLAINT
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EXTRACTED KEY WORDS
RESPONDENT ACT EXHIBIT UNITED STATES LEINER HEALTH PRODUCTS ALLEGES MANUFACTURING ACETAMINOPHEN TABLETS PRACTICES COMPLAINT AFFECTING COMMERCE EXTRA STRENGTH INGREDIENTS AMERICA VIOLATION PACKAGING LABELING RELIEVER PAIN SAFEWAY PARAGRAPH REPRESENTATION LABOR TRUTH SIGNIFICANT PORTION FOREIGN ORIGIN ACTIVE INGREDIENT BULK ACETAMINOPHEN COMPOUND REPRESENTATION SET |
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
In the Matter of
LEINER HEALTH PRODUCTS, INC., a corporation.
DOCKET NO.
COMPLAINT
The Federal Trade Commission, having reason to believe that Leiner
Health Products, Inc. ("respondent") has violated the provisions of
the Federal Trade Commission Act, and it appearing to the Commission
that this proceeding is in the public interest, alleges:
1. Respondent is a Delaware corporation with its principal office or
place of business at 901 233^rd Street, Carson, California 90745.
2. Respondent has manufactured, labeled, offered for sale, sold, and
distributed acetaminophen tablets to the public, including but not
limited to private label acetaminophen brands.
3. The acts and practices of respondent alleged in this complaint have
been in or affecting commerce, as "commerce" is defined in Section 4
of the Federal Trade Commission Act.
4. Respondent has disseminated or has caused to be disseminated
packaging and labeling for certain of its acetaminophen products,
including but not necessarily limited to the attached Exhibits A
through E. The packaging and labeling contain the following statements
or depictions:
A. Equate Extra Strength PM Nighttime Sleep Aid/Pain Reliever,
Exhibit A
"Manufactured by Leiner Health Products Inc. . . . (image of
American flag) Made in the USA"
B. Kirkland Non-Drowsy Day-time Cold/Flu Medicine Soft Gels,
Exhibit B
"Distributed by: Leiner Health Products Inc. . . . Made in the
U.S.A."
C. Target Non-Aspirin Extra Strength, Exhibit C
"Distributed by Dayton Hudson Corporation . . . Made in U.S.A."
D. Member's Mark Pain Reliever o Fever Reducer Acetaminophen 500
mg, Exhibit D
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4
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ANALYSIS
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EXTRACTED KEY WORDS
RESPONDENT UNITED STATES PROPOSED CONSENT ORDER LEINER AGREEMENT COMMISSION PACKAGING COMPLAINT MANUFACTURING INGREDIENTS PROVISION COMPLIANCE PUBLIC RECORD LABELING ACETAMINOPHEN TABLETS PRIVATE BRAND ALLEGES MISREPRESENTING CUSTOMERS FOREIGN CHARGES ENGAGING ACTS PRACTICES NON-PRESCRIPTION DRUG PRODUCT AGENT PAIN LABOR |
Analysis of Proposed Consent Order to Aid Public Comment
_________________________________________________________________
The Federal Trade Commission has accepted an agreement, subject to
final approval, to a proposed consent order from respondent Leiner
Health Products, Inc. ("Leiner").
The proposed consent order has been placed on the public record for
thirty (30) days for reception 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 and take other appropriate action or make
final the agreement's proposed order.
This matter concerns "Made in U.S.A." claims on packaging and labeling
for Leiner's acetaminophen tablets sold at retail bearing private
brand names. The Commission's complaint alleges that respondent
misrepresented on packaging and labeling that certain of these
products, manufactured for customers such as Wal-Mart, Costco, Target,
and Safeway, are all or virtually all made in the United States.
According to the complaint, these products are actually made with
significant foreign content. The products' active ingredient, bulk
acetaminophen compound, that respondent processed into acetaminophen
tablets, is or was made outside the United States. The imported bulk
acetaminophen comprises a substantial percentage of total
manufacturing costs and imparts the crucial analgesic quality to the
OTC products at issue. The Commission's complaint does not allege that
all of Leiner's private label acetaminophen brands or products are
mislabeled, but only that certain products for certain customers have
been improperly labeled.
The proposed consent order contains a provision that is designed to
remedy the charges and to prevent the respondent from engaging in
similar acts and practices in the future. Part I of the proposed order
prohibits Leiner from misrepresenting the extent to which any
non-prescription drug product containing an analgesic is made in the
United States. The order defines "analgesic" as an agent used to
alleviate pain. The proposed order would allow Leiner to represent
that such products are made in the United States as long as all, or
virtually all, of the ingredients or component parts of such products
are made in the United States and all, or virtually all, of the labor
in manufacturing such products is performed in the United States. The
proposed order also would allow Leiner to represent that a product
containing imported active ingredient(s) is "Processed in the United
States with Foreign Ingredients" when describing a product that has
been "significantly processed" in the United States.
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5
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AGREEMENT
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EXTRACTED KEY WORDS
COMMISSION COMPLAINT FEDERAL TRADE COMMISSION PROPOSED RESPONDENT REPRESENTATION AGREEMENT UNITED STATES DRAFT COMPLAINT VIOLATION LEINER HEALTH PRODUCTS OFFICER ACCEPTANCE SUCCESSORS CONSENT ORDER ACTS COUNSEL FACTS MANNER LABELING CONSUMER PROTECTION TERMINATE APPEALING ENFORCEMENT RULING PRACTICES LAW PURSUANT PROCEEDING NOTIFY |
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
In the Matter of
LEINER HEALTH PRODUCTS, INC., a corporation.
File No. 012 3039
AGREEMENT CONTAINING CONSENT ORDER
The Federal Trade Commission has conducted an investigation of certain
acts and practices of Leiner Health Products, Inc., a corporation
("proposed respondent"). Proposed respondent, having been represented
by counsel, is willing to enter into an agreement containing a consent
order resolving the allegations contained in the attached draft
complaint. Therefore,
IT IS HEREBY AGREED by and between Leiner Health Products, Inc., by
its duly authorized officer, and counsel for the Federal Trade
Commission that:
1. Proposed respondent is a Delaware corporation with its
principal office or place of business at 901 233^rd Street,
Carson, California 90745.
2. Proposed respondent admits all the jurisdictional facts set
forth in the draft complaint.
3. Proposed respondent waives:
a. Any further procedural steps;
b. The requirement that the Commission's decision contain
a statement of findings of fact and conclusions of law;
and
c. All rights to seek judicial review or otherwise to
challenge or contest the validity of the order entered
pursuant to this agreement.
4. This agreement shall not become part of the public record of
the proceeding unless and until it is accepted by the
Commission. If this agreement is accepted by the Commission,
it, together with the draft complaint, will be placed on the
public record for a period of thirty (30) days and information
about it publicly released. The Commission thereafter may
either withdraw its acceptance of this agreement and so notify
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