CPSC, Miles Reach Consent Agreement On "One A Day Plus Iron"

WASHINGTON, D.C. (July 20) -- The U.S. Consumer Product Safety Commission (CPSC) today announced the filing of a consent decree against Miles Laboratories, Inc., Elkhart, Ind., in the United States District Court for the Northern District of Indiana. In this first case brought under testing requirements of the Poison Prevention Packaging Act (PPPA), Miles has agreed to stop distributing "One A Day Plus Iron" multiple vitamins in 60-, 100-, and 130- tablet packages having caps which the Commission found in testing did not meet some safety closure requirements. According to the Commission, the efficacy and safety of the tablets themselves are not in question.

Miles also has agreed to put new safety caps on about 1.5 million packages of the "One A Day Plus Iron" vitamins being held at its two factories in Elkhart, Ind., and West Haven, Conn., and its ten distribution warehouses. In its desire to meet all Federal requirements, the company has expressed an intent to use a different type of safety cap on all future packages of the iron-supplemented vitamins.

The PPPA was passed in 1970 to protect the public, particularly children, from accidental ingestion of potentially harmful household products.

United States District Court Northern District Of Indiana

United States Of America,
Plaintiff,
v.

Miles Laboratories, Inc.
a corporation
1127 Myrtle Street
Elkhart, Indiana 46514,
defendant

The United States of America, having filled its complaint herein on July, 1978, and defendant, Miles Laboratories, Inc., a corporation, having appeared and having consented, by its attorneys, to the entry of this decree and to each and every provision thereof without trial or adjudication of the issue of violation herein, without this decree constituting evidence with respect to such issue, and the United Sates Of America having consented to the entry of this decree and to each and every provision thereof, and having moved this Court for this injunction:

Now, Therefore,before the taking of any testimony and upon said consent of the parties hereto, the Court hereby determines that the proceeding herein is terminated and directs entry of final judgment as to all of plaintiff's claims herein against said defendant, and as to said defendant, it is hereby

Ordered, Adjudged And Decreed As Follows:

1. That the Court has jurisdiction over the subject matter herein, and over all parties hereto, ad the complaint states a cause of action against defendant under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301, et seq.

2. That the defendant, Miles Laboratories, Inc., its successors and assigns, and its directors, officers, employees, agents, and representatives, and their successors and assigns, and all persons in active concert or participation with it or any of them, be permanently enjoined from directly or indirectly introducing or causing the introduction or delivery for introduction into interstate commerce of ONE A DAY Plus Iron, or any other Miles product subject to the Poison Prevention Packaging Act, in packages utilizing the 24 mm size Consolidated Closure Corporation "RingGuard" closure until such time as testing pursuant to 16 C.F.R. §1700.20 (a)(4) demonstrates to the satisfaction of the enforcement staff of the Consumer Product Safety Commission that at least 90% of the adults tested open and properly resecure the safety feature of the closure.

3. That all ONE A DAY Plus Iron packaged using the 24 mm size Consolidated closure Corporation "RingGuard" closure held on July 8, 1978, at defendant's two factory warehouses and ten field warehouses listed in Exhibit A attached hereto be returned to one of defendant's factories and repackaged in compliance with the Poison Prevention Packaging Act, 15 U.S.C. §1471, et seq, and regulations thereunder prior to being shipped or delivered for shipment to any customer.

4. That defendant file written reports with the Consumer Product Safety Commission at 90-day intervals, the first being due on the 90th day following entry of this decree, describing the status of the repackaging program required under paragraph 3, the final report being due 30 days following completing of such repackaging.

5. That duly authorized representatives of the plaintiff shall be granted access to defendant's premises during working hours, upon request, to monitor compliance with paragraph 2 above and the repackaging program required under paragraph 3 above and shall be granted access to and the right to cope all records in defendant's possession related to compliance with paragraph 2 above and said repackaging program.

6. That the jurisdiction of this Court is retained for the purpose of enforcing or modifying this decree and for the purpose of granting such additional relief as may hereafter appear necessary or appropriate.

Metropolitan Warehouse Company 1321 Wholesale Street Los Angeles, CA 90021 Adams Transfer & Storage Co. 4127 Empire Road Kansas City, MD 64141 Elkhart Distribution Center 1301 Happanee Court Elkhart, IN 46514 Dauphin Distribution Services 420 Salem Church Road Mechanicsburg, PA 17055 Gulf Atlantic Distribution Services 5345 Old Dixie Road Forest Park, PA 30050

Retail Merchants Consolidation & Distribution Center 3275 Alum Creek Drive Columbus, OH 43216 Gulf Atlantic Distribution Service 600 109th Street Arlington, TX 76010 Dome laboratories Division of Miles Laboratories, Inc. 400 Morgan lane West Haven, CT 06516 Holman Transfer Company 2300 S. E. Beta Street Milwaukie, OR 97222 Craig Distribution & Consolidation 4860 Joliet Street Denver, CO 80239

Miles Laboratories, Inc. Plant Warehouses

Miles Laboratories, Inc. Plant Warehouse 1000 Randolph Street Elkhart, Indiana 46515

dome Laboratories Plant Warehouse division of Miles Laboratories, Inc. 400 Morgan Lane West Haven, CT 06516