UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
WASHINGTON, D.C. 20580
Division of Enforcement
Bureau of Consumer Protection
September 25, 2002
Mr. Robert Kaminski
Chief Executive Officer
Leiner Health Products, Inc.
901 233rd Street
Carson, California 90745
Re: Leiner Health Products, Inc.
FTC Docket No. C-4035
Dear Mr. Kaminski:
The Division of Enforcement staff has reviewed your submissions of May 15, July 12 and August 15, 2002, which you have filed to show the manner and form of Leiner Health Products’s (“Leiner”) compliance with the order referenced above, which was issued on February 19, 2002.
Exhibits C and E to your submission contain packaging that bears “Product of U.S.A.” labeling in violation of Part I of the order. Accordingly, the packaging contained in Exhibits C and E to your submission of May 15, 2002 is rejected.
Leiner has assured the staff that the products with noncompliant packaging were shipped due to a one-time internal error. In addition, you have withdrawn a significant portion of the products with noncompliant packaging from the marketplace. Leiner has further assured the staff that it is no longer making any MUSA claims on any products.
The staff has concluded, on the assumption that the information submitted is accurate and complete, that no compliance action is indicated at this time. We will not be precluded, however, from recommending to the Commission an appropriate action if the submitted information is inaccurate or incomplete or if Leiner violates the terms of the order. The opinions expressed in this letter are those of the staff and not necessarily those of the Commission or any Commissioner.
Sincerely,
Elaine D. Kolish
Associate Director
cc: Harvey Applebaum, Esq.
Covington & Burling
1201 Pennsylvania Avenue, NW
Washington, DC 20044-7566