Certain Drugs, Cosmetics, and Dietary Supplements Must Comply With New CPSC Certification Requirements

15 October 2008 Publication
Authors: Nathan A. Beaver

Legal News Alert: Life Sciences

On November 12, 2008, new product conformity certification requirements will go into effect for a wide range of consumer products, including some cosmetics, dietary supplements, and drugs.1 These new requirements are being implemented as a result of passage of the Consumer Product Safety Improvement Act (CPSIA). The requirements will apply to manufacturers, importers, and private labelers of the affected products.

Based upon our analysis of the new requirements as well as our discussions with staff in the Office of Regulatory Compliance at the U.S. Consumer Product Safety Commission (CPSC), the new requirements will apply to drugs, cosmetics, and dietary supplement products to the extent these products are subject currently to the Poison Prevention Packaging Act of 1970 (PPPA). We understand that CPSC staff is currently working on a guidance document that will enumerate the specific products that are subject to the new requirements established by the CPSIA. This guidance is expected to be issued later this week.

The new requirements apply to products manufactured on or after November 12, 2008. We have inquired whether the CPSC plans to exercise a period of “enforcement discretion” with regard to implementation of the new requirements. While CPSC staff indicated that no decision has been made at this time, we believe it likely that the CPSC will agree to allow for a period during which the industry may come into compliance with the new requirements.

What Are the Certificate Requirements?
Manufacturers, importers, or private labelers of products subject to the new conformity certification requirements under the CPSIA must issue a certification, based upon a test of each product or upon a “reasonable testing program,” that the product complies with all rules, bans, standards, or regulations applicable to the product and enforced by the CPSC, and that specifies the applicable rules, bans, standards, and regulations. The certificates must accompany the product (or shipment of products covered by the same certificate) and a copy of the certificate must be furnished to each distributor and retailer of the product. In addition, certificates must be made available to the CPSC upon request.

Where the CPSC has already prescribed the form of the certificate for certain of its standards, the certificate should take that form. In all other cases, the certificate could take one of many forms, depending on the product: an on-product label, an attachment to the shipping container, or a document included in another accompanying document such as a bill of lading. The CPSC staff has recommended a template for the certificates and the information to be included should:

  1. Identify the product covered by the certificate
  2. Provide a citation of each CPSC-enforced regulation to which the product is certified to conform
  3. Identify the manufacturer certifying compliance of the product (include the name, full mailing address, and telephone number)
  4. Identify the U.S. importer (if any) certifying compliance of the product (include the name, full mailing address, and telephone number)
  5. Identify the private labeler (if any) certifying compliance of the product (include the name, full mailing address, and telephone number)
  6. Provide contact information for the individual maintaining records of test results
  7. State the date and place where the product was manufactured
  8. State the date and place where the product was tested for compliance with the cited regulations
  9. Identify the third-party laboratory (if any) on whose testing the certificate depends

What Are the Penalties for Non-Compliance?
Failure to comply with general conformity certification requirements (either by failing to furnish a certificate or issuing a false certificate) may result in civil penalties or imprisonment in the case of willful or knowing violations. An import that is not accompanied by a required certificate will be refused admission and must be destroyed, at the expense of the owner.

We will continue to monitor this issue and will keep you informed of forthcoming regulations and guidance issued by the CPSC as it moves forward with implementation of the CPSIA. If you have any questions about the application of these new requirements to your products or if you need guidance about how to ensure that you are in compliance with this new law, please do not hesitate to contact us.

Legal News Alert is part of our ongoing commitment to providing up-to-minute information about pressing concerns or industry issues affecting our clients and colleagues. If you have any questions about this alert or would like to discuss this topic further, please contact your Foley attorney or any of the following individuals:

Nathan A. Beaver
Washington, D.C.

Sarah A. Key
Washington, D.C.

1 Note that the CPSIA also imposes third-party testing requirements on a wide segment of products manufactured for children 12 years of age or younger. The focus of this alert is to inform interested parties about the conformity certification requirements applicable to certain drugs, cosmetics, and dietary supplement products.

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