By Presidential designation, the third week of March is National Poison Prevention Week.1 This week may sharpen the focus of consumer advocacy organizations and federal agencies, such as the Consumer Product Safety Commission ("CPSC"), on industry compliance with the requirements of the Poison Prevention Packaging Act ("PPPA")2 and the Federal Hazardous Substances Act ("FHSA").3 This is a good time, therefore, to ensure that your company’s products comply with the PPPA and the FHSA.
Poison Prevention Packaging Act and Federal Hazardous Substances Act Requirements
The PPPA requires certain household and other consumer products to be packaged in child-resistant packaging that is "significantly difficult" for children under the age of five to open within a reasonable time, but not difficult for adults to use properly.4 For a package to be considered child-resistant, a total of 80% of the children tested according to the procedure outlined in CPSC regulations must not open the package during a 10 minute test period.5 Covered products include over-the-counter drugs, prescription drugs, dietary supplements containing iron, some cosmetics, certain household chemicals, and some mouthwashes.6 If a product is covered by the PPPA, its manufacturer or importer must also issue a certificate of conformity with the packaging requirements.7
The FHSA requires precautionary labeling on hazardous household products to help consumers safely store those products and to relay information about first aid.8 The nature of the precautionary label varies depending on the nature of the hazard. For instance, the word "DANGER" must appear on substances which are extremely flammable, corrosive, or highly toxic.9 To require labeling, a product must be intended for use in a household or by children and must also be hazardous, which is defined to include substances that are toxic, corrosive, an irritant, flammable, or substances that may cause injury or illness as a proximate result of any foreseeable handling or use.10 The FHSA also bans children’s products containing concentrations of lead above a proscribed limit.11
CPSC Enforcement Activity
Courts have held that the PPPA and FHSA do not create private rights of action for purportedly injured consumers.12 However, plaintiffs have brought tort claims alleging injury to children caused by non-child-resistant packaging under a design defect theory, and courts have held that the PPPA does not preempt these claims.13 Although some courts have held that the FHSA preempts state law tort claims for breach of a duty to warn based on labeling requirements that differ from those of the FHSA,14 other courts have allowed private plaintiffs to bring state law negligence actions based on a violation of the FHSA’s labeling requirements.15
Moreover, under the Consumer Product Safety Act ("CPSA") and related laws, the CPSC has broad authority to enforce consumer product safety laws, including the PPPA and the FHSA. For example, the CPSC may mandate a recall if a product’s packaging or label fails to meet the requirements of the PPPA or the FHSA, or strongly encourage a voluntary recall. The CPSC has already announced at least two PPPA-related recalls in 2013, directed at over-the-counter drugs and dietary supplements containing iron.
Not only must covered products comply with the PPPA and FHSA, but also the PPPA and FHSA create additional compliance obligations under the CPSA. The CPSC has broad authority to impose civil and criminal penalties for failures timely to report substantial product hazards and for PPPA or FHSA noncompliance. For example, the CPSA prohibits:
- the sale, distribution, or importation of any product that is not in conformity with an applicable consumer product safety rule (including the PPPA and FHSA);16
- failure to inform the CPSC immediately of any defects, noncompliance, and substantial product hazards, including noncompliance with the PPPA or FHSA;17
- failure to furnish a certificate of conformity or issuing a false certificate;18 and
- misrepresentations to the CPSC regarding the scope of consumer products subject to a CPSC action or material misrepresentations during the course of a CPSC investigation.19
Under the Consumer Product Safety Improvement Act ("CPSIA"), the CPSC may impose enhanced civil and criminal penalties for violation of the CPSA and related laws, including civil penalties of up to $15,000,000 per related series of violations.20
In light of the risk of mandatory corrective action and civil and criminal penalties for violations of consumer product safety laws, companies that sell, manufacture, distribute, or import products covered by the PPPA or the FHSA should ensure that their products and practices are compliant. Covington & Burling LLP has extensive experience representing manufacturers, importers, and retailers before the CPSC, and our attorneys would be pleased to respond to any inquiries about consumer product safety laws.