[Federal Register Volume 66, Number 220 (Wednesday, November 14, 2001)]
[Notices]
[Pages 57102-57103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28442]


-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION

[File No. 012 3039]


Leiner Health Products, Inc.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

-----------------------------------------------------------------------

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 complaint that 
accompanies the consent agreement 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 December 6, 2001.

[[Page 57103]]


ADDRESSES: Comments should be directed to: FTC/Office of the Secretary, 
Room 159, 600 Pennsylvania Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT: Joni Lupovitz or Laura Koss, FTC/S-
4302, 600 Pennsylvania Ave., NW., Washington, DC 20580. (202) 326-3743 
or 326-2890.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and section 2.34 of 
the Commission's 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 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 compliant. 
An electronic copy of the full text of the consent agreement package 
can be obtained from the FTC homepage (for November 6, 2001), on the 
World Wide Web, at http://www.ftc.gov/os/2001/11/index.htm. A paper 
copy can be obtained from the FTC Public Reference Room, Room H-130, 
600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or 
by calling (202) 326-3627.
    Public comment is invited. Comments should be directed to: FTC/
Office of the Secretary, Room 159, 600 Pennsylvania Ave., NW., 
Washington, DC 20580. Two paper copies of each comment should be filed, 
and should be accompanied, if possible, by a 3\1/2\ inch diskette 
containing an electronic copy of the comment. Such comments or views 
will be considered by the Commission and will be available for 
inspection and copying at its principal office in accordance with 
Section 4.9(b)(6)(ii) of the Commission's Rules of Practice (16 CFR 
4.9(b)(6)(ii)).

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.
    The draft order also includes a provision that would allow Leiner 
to use its current packaging inventory until December 31, 2001.
    Part II of the proposed order requires the respondent to maintain 
materials relied upon in disseminating any representation covered by 
the order. Part III of the proposed order requires the respondent to 
distribute copies of the order to certain company officials and 
employees. Part IV of the proposed order requires the respondent to 
notify the Commission of any change in the corporation that may affect 
compliance obligations under the order. Part V of the proposed order 
requires the respondent to file one or more compliance reports. Part VI 
of the proposed order is a provision whereby the order, absent certain 
circumstances, terminates twenty years from the date of issuance.
    The purpose of this analysis is to facilitate public comment on the 
proposed consent order. It is not intended to constitute an official 
interpretation of the agreement and proposed order or to modify in any 
way their terms.

    By Direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 01-28442 Filed 11-13-01; 8:45 am]
BILLING CODE 6750-01-M