Page 1 of 4

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. 

 a corporation.

DOCKET NO. C-4035

DECISION AND ORDER

The Federal Trade Commission having initiated an investigation of certain acts and practices of

the respondent named in the caption hereof, and the respondent having been furnished thereafter with a

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 facts set

forth in the draft complaint, a statement that the signing of said agreement is for settlement purposes

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, are true,

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 stating its

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 further

conformity with the procedure prescribed in Section 2.34 of its Rules, the Commission hereby issues its

complaint, makes the following jurisdictional findings, and enters the following order:
Page 2 of 4

1. Respondent Leiner Health Products, Inc. is a Delaware corporation with its principal

office or place of business at 901 233rd Street, Carson, California 90745.

2. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding

and of the respondent, and the proceeding is in the public interest.

ORDER

I.

IT IS ORDERED that respondent, Leiner Health Products, Inc., its successors and assigns,

and its officers, agents, representatives, and employees, directly or through any corporation, subsidiary,

division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering

for sale, sale, or distribution of any non prescription drug product containing an analgesic in or affecting

commerce, as "commerce" is defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. §

44, shall not misrepresent, in any manner, directly or by implication, the extent to which any such

product is made in the United States. For purposes of this Order, “drug” shall mean as defined in

Section 15 of the Federal Trade Commission Act, 15 U.S.C. § 55, and “analgesic” shall mean an agent

used to alleviate pain.

PROVIDED, however, that a representation that any such product is made in the United States

will not be in violation of this order so long as all, or virtually all, of the ingredients or component parts

of such product are made in the United States and all, or virtually all, of the labor in manufacturing such

product is performed in the United States.

PROVIDED FURTHER, that a representation that any such product containing imported

active ingredient is “Processed in the United States with Foreign Ingredients” will not be in violation of

this Order when such representation is true and is used to describe a product that has been significantly

processed in the United States.

PROVIDED FURTHER, that nothing in the order shall prohibit respondent from depleting the

inventory of packaging and labeling for such products bearing a marking or labeling otherwise

prohibited by this order and existing on the date this order is signed, in the normal course of business,

provided that no such existing inventory is shipped from respondent later than December 31, 2001.

II.

IT IS FURTHER ORDERED that respondent, and its successors and assigns, shall, for five (5)

years after the last date of dissemination of any representation covered by this order, maintain and upon

request make available to the Federal Trade Commission for inspection and copying:
Page 3 of 4

A. All labeling, packaging, advertisements and promotional materials containing the

representation;

B. All materials that were relied upon in disseminating the representation; and

C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession

or control that contradict, qualify, or call into question the representation, or the basis

relied upon for the representation, including complaints and other communications with

consumers or with governmental or consumer protection organizations.

III.

IT IS FURTHER ORDERED that respondent, and its successors and assigns, shall deliver a

copy of this order to all current and future officers and directors, and to all current and future

employees, agents, and representatives having responsibilities with respect to the subject matter of this

order, and shall secure from each such person a signed and dated statement acknowledging receipt of

the order. Respondent shall deliver this order to current personnel within thirty (30) days after the date

of service of this order, and to future personnel within thirty (30) days after the person assumes such

position or responsibilities.

IV.

IT IS FURTHER ORDERED that respondent, and its successors and assigns, shall notify the

Commission at least thirty (30) days prior to any change in the corporation that may affect compliance

obligations arising under this order, including but not limited to a dissolution, assignment, sale, merger,

or other action that would result in the emergence of a successor corporation; the creation or

dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order;

the proposed filing of a bankruptcy petition; or a change in the corporate name or address. Provided,

however, that, with respect to any proposed change in the corporation about which respondent learns

less than thirty (30) days prior to the date such action is to take place, respondent shall notify the

Commission as soon as is practicable after obtaining such knowledge. All notices required by this Part

shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer

Protection, Federal Trade Commission, Washington, D.C. 20580.

V.

IT IS FURTHER ORDERED that respondent, and its successors and assigns, shall, within sixty

(60) days after the date of service of this order, and at such other times as the Federal Trade

Commission may require, file with the Commission a report, in writing, setting forth in detail the manner

and form in which it has complied with this order.
Page 4 of 4

VI.

This order will terminate on February 19, 2022, or twenty (20) years from the most recent date

that the United States or the Federal Trade Commission files a complaint (with or without an

accompanying consent decree) in federal court alleging any violation of the order, whichever comes

later; provided, however, that the filing of such a complaint will not affect the duration of this order if

such complaint is filed after the order has terminated pursuant to this Part. Provided, further, that if

such complaint is dismissed or a federal court rules that the respondent did not violate any provision of

the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will

terminate according to this Part as though the complaint had never been filed, except that the order will

not terminate between the date such complaint is filed and the later of the deadline for appealing such

dismissal or ruling and the date such dismissal or ruling is upheld on appeal.

By the Commission.

Donald S. Clark

Secretary

ISSUED: February 19, 2002