In the Matter of

LEINER HEALTH PRODUCTS, INC., a corporation.

DOCKET NO.

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 • Fever Reducer Acetaminophen 500 mg, Exhibit D

"Distributed by: SWC . . . Made in the U.S.A."

E. Safeway Extra Strength Pain Relief Tablets, Exhibit E

"DISTRIBUTED BY SAFEWAY INC. . . . PRODUCT OF U.S.A."

5. Through the means described in Paragraph 4, respondent has represented, expressly or by implication, that certain of its acetaminophen products are made in the United States, i.e., that all, or virtually all, of the ingredients of such products are made in the United States, and that all, or virtually all, of the labor in manufacturing such products is performed in the United States.

6. In truth and in fact, a significant portion of the ingredients of certain of respondent's acetaminophen products is, or has been, of foreign origin. The active ingredient, bulk acetaminophen compound, that respondent processed into acetaminophen tablets is or was made outside the United States. Therefore, the representation set forth in Paragraph 5 was, and is, false or misleading.

7. The acts and practices of respondent as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act, 15 U.S.C. §§ 45(a) and 52.

THEREFORE, the Federal Trade Commission this __ day of __________ 2001, has issued this complaint against respondent.

By the Commission.

Donald S. Clark
Secretary

SEAL: