In the News

CPSIA Certification Requirement Delay Applies to Drug and Supplement Packaging

Apr 2, 2009

Manufacturers of over-the-counter (OTC) drugs and dietary supplements requiring child-resistant packaging will benefit from the Consumer Product Safety Commission's (CPSC) decision to delay some of the testing and certification requirements of the Consumer Product Safety Improvement Act (CPSIA).  (For more information on CPSC's stay of enforcement, please see the PackagingLaw.com article: One Year Stay Effective for Certain CPSIA Testing Requirements.)

CPSIA, signed into law in August 2008, established new requirements for consumer product manufacturers, particularly for those who make or distribute products intended for children 12 years of age and younger.  It included a new general certification requirement for all products subject to a CPSC standard and also mandated third-party testing and accreditation for some products under CPSC jurisdiction.  Specifically, CPSIA section 102 specifies that any product that is subject to CPSC jurisdiction is required to issue a "general conformity certification" that demonstrates the product is in compliance with all CPSC regulations.  Since the Poison Preventing Packaging Act authorizes CPSC to require that some manufacturers of prescription drugs, OTC drugs, and dietary supplements child-proof their packaging, manufacturers of these products were required to issue a general statement of conformity certifying compliance late last fall.  Once the general certifications were issued, they were supposed to accompany all product shipments, be furnished to distributors and retailers, and be furnished to CPSC upon request.

Due to the recently issued stay of enforcement, however, these manufacturers are no longer required to issue general certifications.  According to a CPSC press release on the stay of enforcement, the decision to delay certification requirements, including general certifications and some of the testing requirements under CPSIA, was made to give CPSC "more time to finalize four proposed rules which could relieve certain materials and products from lead testing and to issue more guidance on when testing is required and how it is to be conducted."

The stay is effective until February 10, 2010. At that time CPSA will vote on whether to terminate the stay.  While certifications are currently stayed, products must still be in compliance with all other consumer product safety requirements.