According to the Consumer Product Safety Commission (CPSC), aspirin, over-the-counter (OTC) and prescription drugs, and common household products subject to the special packaging requirements of the Poison Prevention Packaging Act (PPPA) and/or the cautionary labeling requirements under the Federal Hazardous Substances Act (FHSA) and manufactured after November 12, 2008 must be accompanied by a certificate of compliance prior to import or distribution in the United States. CPSC’s determination that a certificate is necessary is based upon Section 102 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), which requires all consumer products subject to a standard, regulation, ban, or rule to be accompanied by a certificate of compliance identifying all applicable CPSC requirements with which the product complies.

Pursuant to a Final Rule that CPSC issued yesterday, importers and domestic manufacturers of applicable products must issue the certificate of compliance.1 With respect to aspirin, OTC and prescription drugs, and other substances specified at 16 C.F.R. § 1700.14, domestic manufacturers and importers must issue a certificate of compliance to its distributors and retailers certifying that the packaging used for its product conforms to the poison prevention packaging requirements discussed at 16 C.F.R. Part 1700.  A certificate of compliance for products subject to the PPPA must be based upon “a test of each product or upon a reasonable testing program.” A “reasonable testing program” must provide reasonable assurance that the product meets all requirements of the applicable standard, and should be stringent enough to detect variations that would cause a product to fail. The testing is not required to be performed by an independent third party.

In addition, any importer and domestic manufacturer of a common household product required to bear an FHSA-mandated warning, such as certain detergents, cleaners and adhesives, must issue a certificate of compliance to its distributors and retailers certifying that the product complies with the FHSA’s labeling requirements. CPSC staff indicated it expects to issue guidance on certificates of compliance for products subject to the FHSA labeling requirements in the upcoming weeks.

The certificate of compliance, which is not required to be signed by the issuer, must include the following information, in English:

1. Identification of the product covered by the certificate.

2. Citation to each CPSC product safety regulation to which the product is being certified (e.g., 16 C.F.R. Part 1700). 

3. Identification of the importer or domestic manufacturer certifying compliance of the product, including the importer or domestic manufacturer’s name, full mailing address and telephone number. 

4. Contact information for the individual maintaining records of test results, including the custodian’s name, e-mail address, full mailing address and telephone number.

5. Date (month and year at a minimum) and place (including city and country or administrative region) where the product was manufactured. (If the same manufacturer operates more than one location in the same city, the street address of the factory in question should be provided).

6. Date and place (including city and country or administrative region) where the product was tested for compliance with the regulation(s) cited above.

7. Identification of any third-party laboratory on whose testing the certificate depends, including name, full mailing address and telephone number of the laboratory.

CPSC recommends that each issuer maintain test records supporting the certification for at least three years.

While the certificate of compliance does not have to be filed with US Customs and Border Protection (CBP) or CPSC, it must “accompany” the shipments (such as a paper certificate placed in a shipping carton or via an electronic certificate). That is, for imported products, the certificate must be available to the Commission as soon as the product or shipment is available for inspection in the United States. With respect to products produced in the United States, the certificate must be available to the Commission prior to introducing the product or shipment in question into domestic commerce. If the certificate of compliance is provided as an electronic certificate, it must be identified by a unique identifier and be made available via a World Wide Web URL or through other electronic means. The URL or other electronic format must be created in advance and be made available, along with access to the electronic certificate, to CPSC or CBP authorities. 

In addition, the certificate must be “furnished” to each distributor and retailer of the product. An electronic certificate will be considered “furnished” if the distributor(s) and retailer(s) of the product are provided a reasonable means to access the certificate. 

According to the Final Rule, CPSC “expects every company to make best efforts to comply” with the general certificate requirements, but acknowledges that its resource limitations require it to “focus more on a product’s compliance with [its] safety rules.” After an initial implementation period, an importer’s failure to comply with the general certificate requirements will subject the product to refusal of admission into the United States and potential destruction. In addition, failure to furnish a certificate of compliance or issuing a false certificate may result in civil penalties or even imprisonment for willful or knowing violations. 

We will continue to monitor CPSC’s activities with respect to the certificate of compliance requirements. Should you have any questions about these requirements, please do not hesitate to contact the following individuals:

Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939

James R. Ravitz
ravitz.james@arentfox.com
202.857.8903

Scott A. Cohn
cohn.scott@arentfox.com
212.484.3984

Amy S. Colvin
colvin.amy@arentfox.com
202.857.6338

1 The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires manufacturers (including importers) and private labelers of products manufactured on or after November 12, 2008 to issue a certificate certifying that the product complies with an applicable rule, ban, standard, and regulation. The Final Rule specifies that during an initial certification implementation phase, only domestic manufacturers and importers are required to issue the certificate.