The New Consumer Product Safety Improvements Act -- Implications for Pharmaceutical Manufacturers

This post was written by Stephen P. Murphy.

On Aug. 14, 2008, the President signed the Consumer Product Safety Improvements Act (the Act) into law. By an unfortunate and possibly unintended consequence of poor drafting by the Congress, all of the statutes enforced by the U.S. Consumer Products Safety Commission were brought within the coverage of the new Act. One of those statutes is the Poison Prevention Packaging Act, which requires a wide range of pharmaceuticals to be packaged in child-resistant packaging. Under the new Act, all such pharmaceuticals manufactured after Nov. 12, 2008 are now required to have general conformity certificates by which either the importer or the domestic manufacturer, on the basis of a reasonable testing program, attests that the products comply with the PPPA. These certificates are required to "accompany" each lot or batch of products manufactured. The CPSC has construed that an electronic certificate readily available to the CPSC or to the Customs and Border Patrol complies with the new Act. But the products must have on the shipping documents or the shipping package, a unique identifier and a URL to the website in order to facilitate review. The certificates are intended to be available through the chain of distribution, but not to patients. There are some exceptions to this statute. These rules become effective Feb. 19, 2009.

The CPSC has publicly stated that it does not have the resources to specifically enforce the new Act now, but will do so in the ordinary course of its regular activity. The CPSC expects to get supplemental funding for enforcement and other activities toward the middle of the second quarter of 2009. However, Customs is authorized by the Act to detain and destroy products that do not have the required general conformity certificate. Along with this new authority, the Act has increased the fines that CPSC can impose from $5,000 per violation to $1.25 million, and for a series of violations from $1.825 million to $15 million. In addition, the new Act introduces criminal penalties for knowing violations of the new Act and of the other statutes enforced by the CPSC.

CPSC Adopts New Regulation Effective Today Clarifying General Conformity Certificates Required By The Consumer Product Safety Improvement Act of 2008

This post was written by Stephen P. Murphy, Antony B. Klapper, Mark A. Brand, and Barry J. Thompson.

Among other things, the Consumer Product Safety Improvement Act of 2008 ("CPSIA"), signed August 14, 2008, will impose new transparency and public disclosure requirements on every importer, retailer and distributor of consumer products, and give the Consumer Product Safety Commission ("CPSC") increased power to enforce existing laws, as detailed in this summary of the bill's major provisions.

The life sciences industry is taking note and taking action to comply. But the new law is not without its drawbacks. One appeared to be that the disclosure requirements designed to document the source and supply chain for consumer goods threatened closely-guarded confidential business information, such as the names of foreign manufacturers and suppliers.

Yesterday, November 11, 2008, the CPSC posted a new regulation, approved by a 2-0 vote, narrowing the category of companies that need to issue general conformity certificates.

Prior to this regulation, the obligation to issue general conformity certificates applied to all importers, manufacturers and/or private labelers. Under the new regulation, which the CPSC explicitly recognized as a stop-gap measure to resolve confusion, the obligation to issue general certificates is now limited to the "importer" of foreign-sourced consumer goods and to the "manufacturer" (or packager in the case of products subject to the Poison Prevention Packaging Act) of domestically-produced consumer products.

Notably, companies that have confidentiality agreements with foreign vendors have no requirement to disclose the names of those foreign vendors in the general conformity certificate.

The new regulation goes further in recommending that companies issuing general conformity certificates utilize at least a three-year retention period for certificates. Of particular note is the fact that the prefatory language of the regulation acknowledges the sentiment expressed recently by the Chair of the CPSC that the Commission lacks current-year funding to engage in enforcement activity specifically targeted at the general conformity certificate requirement. Finally, the new regulation makes it clear that general conformity certificates can electronically "accompany" and be electronically "furnished" (to distributors and retailers) for consumer products subject to the CPSIA. It does, however, specify that the unique identifier information and the website URL must "be on the product or accompanying the product or shipment." This last item appears to disqualify mere posting of general conformity certificates on company websites without having website access information on the product (e.g., a shipping box) or accompanying the product (e.g., the bill of lading).

To its credit, the CPSC Staff has been dealing with an extraordinarily complicated new statute without additional funding or staffing. This has led to inevitable delays in administrative guidance, but not in any lack of effort by Commission Staff. Accordingly, many issues arising under the CPSIA will be resolved over the course of the next few months. During this period, the CPSC is expecting companies subject to the CPSIA to exercise best efforts to promptly comply the new general conformity certificate requirements.

California Assemblyman Introduces Legislation to Require Notice of Defective Foreign Products

It seems like a rare day when there is not a notice of a foreign-made defective product being recalled in the United States. In recent months, there have been more than 500 recalls of a variety of products including millions of toys coated with lead paint, thousands of illegal fireworks, contaminated meats, and tainted medicines.

The issue has become so enormous that the U.S. Government has created a website—www.recalls.gov—that provides information about recalls coordinated by a variety of agencies including the Consumer Product Safety Commission, the Food and Drug Administration, U.S. Department of Agriculture, the Environmental Protection Agency, and others.

It seems, too, that a common consumer complaint is that companies have not responded as quickly as they might have in the face of the need to conduct a recall. Companies importing products from foreign countries should now be aware that California is entering the regulatory mix.

Assembly Member Huffman has introduced California Assembly Bill 1860 that would govern the responsibility of the entire chain of distribution in dealing with an unsafe product.

Most notably, the bill would:

  • Make it a misdemeanor for any company in the chain of distribution to sell or distribute a “misbranded hazardous substance or banned hazardous substance.”
  • Make it illegal for any company in the chain of distribution to engage in any activity that involves an “unsafe product.” For the purposes of the Act, an unsafe product exists if:
  1. The product does not conform to state and federal laws and regulations setting forth standards for the product.
  2. The product has been recalled for any reason, or it has been recalled in cooperation with an agency of the federal government or the product's commercial dealer, manufacturer, importer, distributor, or wholesaler, and the recall has not been rescinded.
  3. A state or federal agency, or the product's commercial dealer, manufacturer, importer, distributor, or wholesaler, has issued a warning that the intended use of a specific product constitutes a safety hazard, and the warning has not been rescinded.
  • Permit distribution of a recall product if it has been “retrofitted” in a manner approved by the agency initiating or regulating the recall.
  • Once a recall or warning has been issued, the “commercial dealer, manufacturer, importer, distributor or wholesaler” must—within 24 hours after receiving the recall notice or warning:
    • Contact “customers, other than end consumers” about the recall and include the recall notice.
    • Place information about the recall on its website if one is maintained.
    • Send a notice of the recall, if having sold the product directly to an “end consumer,” if the consumer has provided a shipping address or e-mail address at the time of sale.
  • If the retailer receives notice of a recall or warning from someone in the chain of distribution:
    • Remove the product or program registers to “ensure that the product cannot be sold” within three days of the notice.
    • Remove the product from its website within three days of notice if the product is sold through the website.
    • Notify the consumer of the recall of warning if an e-mail or shipping address was provided at the time of sale.
    • Prominently post notice of the recall or warning again within three days of notice.
  • If the retailer is not “a first seller,” it has five days from notice to complete the above.

As well-intentioned as the bill might be, it is reminiscent of what a student in a crisis management course might outline in response to a recall hypothetical.

The draft legislation is defective for a number of reasons, including its failure to take into account the breadth of products that it captures, the competing regulatory requirements for recalls of each category of product, and the impracticality posed to the entire chain of distribution creating logistical nightmares in coordination of the horizontal and vertical chains, as well as issues of preemption.

The proposed legislation in California contrasts import safety efforts at the federal level. A number of bills introduced in Congress deal with issues related to the notification of defective products and their removal from the chain of distribution. Notably, only one has a chance of being enacted into law. Senate Bill 2045 (and its House counterpart H.R. 4040) would require manufacturers to place tracking labels on all children’s products to ascertain source, date of manufacture, and similar information. It also applies restrictions to the amount of lead that children’s products may contain, and requires importers, retailers, distributors, and manufacturers to give the CPSC the names of all others in the chain of distribution for products, but only if they are asked. The bill does not create new criminal liability, but does increase existing civil and criminal penalties for those who sell recalled products.

In addition to the measures set forth in Senate Bill 2045, the President has established the Interagency Working Group on Import Safety—www.importsafety.gov—which is an initiative that incorporates efforts by a number of agencies to foster an environment that facilitates import safety, thereby reducing the likelihood that recalls become necessary in the first place. For example, the CSPC and its Chinese counterpart agency have reached a memorandum of understanding establishing a system whereby testing facilities in China can go through an accreditation process. Accredited facilities can then provide U.S. importers with a reliable source of assurances that the products they import are safe. Thus, there are import safety developments at the federal level that are less burdensome at the recall stage and which aim to partner with industry to reduce the need for a recall in a way that the proposed California law does not.

Reed Smith’s Government Relations, Product Liability, and Import Safety Teams are available to counsel clients on an appropriate response to the legislation. In addition, we provide a full range of import safety services, from advising on import regulations and safety standards to handling recall strategies and litigation.