Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

CHATTEM PAMPRIN CHILD-RESISTANT PACKAGING URGED BY CPSC

This article was originally published in The Tan Sheet

Executive Summary

CHATTEM PAMPRIN CHILD-RESISTANT PACKAGING URGED BY CPSC in a complaint published in the Nov. 4 Federal Register. The Consumer Product Safety Commission issued an order on Oct. 15 that requires Chattem to put certain Pamprin SKUs in child-resistant packaging according to the requirements of the Poison Prevention Packaging Act (PPPA). CPSC is required to publish all the complaints it issues in the Federal Register. CPSC asserted in the complaint that child-resistant packaging is necessary because Pamprin products are "specifically marketed for use by women of child-bearing age who may have young children or who may come in contact with such children." The commission declared that the number of Pamprin products that Chattem sells in child-resistant packaging is "insufficient" given the number of purchasers with young children or who come into contact with young children. In addition, CPSC said that the "number of elderly or handicapped purchasers" of Pamprin "unable to use child-resistant packaging is substantially less than the quantities of those products packaged in packages that are not child-resistant." Under the PPPA, companies customarily are allowed to put one size of a product in packaging that is not child resistant in order to meet the needs of elderly or handicapped persons unable to use products in child-resistant packages. According to the complaint, Chattem currently packages 12- and 48-tablet bottles of Maximum Strength Pamprin Tablets, 48-caplet bottles of Maximum Strength Pamprin Caplets, and 32-caplet bottles of Pain Relief Pamprin Caplets in child-proof packaging. However, 24-tablet bottles of Maximum Strength Pamprin Tablets, 24-caplet bottles of Maximum Strength Pamprin Caplets, and 16-caplet bottles of Pain Relief Pamprin Caplets are not sold in child-resistant packaging, CPSC found. The Maximum Strength Pamprin formulas contain 500 mg acetaminophen, and the Pain Relief Pamprin formulas contain 250 mg acetaminophen. In a July 14 letter to Chattem, CPSC told the firm that the Pamprin SKUs that had child-resistant packaging were not sold in popular sizes and gave Chattem "the opportunity to comply with the purposes of the PPPA." CPSC also requested that Chattem "alter its packaging practices" to remedy the situation, the complaint states. Chattem responded in an Aug. 2 letter that "it would not alter its packaging." The July request was made under a PPPA provision that if CPSC "determines that the manufacturer or packer is not supplying the substance in 'popular size' packages which are child-resistant, the commission may, after giving the manufacturer or packer an opportunity to comply with the purposes of the PPPA, order the manufacturer or packer to package the substance exclusively in child-resistant packaging," the complaint explains.

You may also be interested in...



Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

In Brief

Combe sells most of its OTC brands

People In Brief

Perrigo promotes in pricing, planning

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS082104

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel