This client alert was also published in Product Safety Network News.
The U.S. Consumer Product Safety Commission (CPSC) is an independent federal agency that regulates the manufacture, distribution, and sale of consumer products in the United States. Specifically, the Commission is tasked with protecting consumers from unreasonable risks of injury associated with consumer products. CPSC does not regulate the safety of food, drugs, cosmetics, dietary supplements, or medical devices, and as a result, many companies that deal in these products incorrectly believe that CPSC's requirements cannot apply to them. This is a mistake that can get your company into legal trouble. Here is what you need to know.
CPSC aggressively pursues its mission by implementing and enforcing specific product safety rules (known as "mandatory standards"), flexing its recall authority, and requiring companies to self-report potential safety issues to the Commission.
At a high level, CPSC's reporting obligations require companies to file a detailed report within 24 hours of when the company became aware, or should have become aware, of information reasonably supporting the conclusion that a consumer product they manufacture, distribute, or sell:
- Violates a mandatory standard;
- Is defective in a way that could create a substantial risk of injury; or
- Even if not defective, creates an unreasonable risk of serious injury.
Failure to report to CPSC within that 24-hour period can result in significant civil penalties (and even criminal prosecution), unless the delay occurred because the company was conducting a brief internal investigation to determine whether the information is in fact reportable.
Since CPSC does not regulate the safety of food, drugs, cosmetics, dietary supplements, or medical devices, how is any of this relevant to companies that deal in those products? Here are three examples.
First, even where CPSC lacks jurisdiction over the safety of the underlying product, it may have jurisdiction under the Poison Prevention Packaging Act ("PPPA") to require that the product is packaged in child-resistant packaging. For example, the PPPA requires liquid preparations containing certain amounts of methyl salicylate (commonly known as wintergreen oil) to be packaged in child-resistant packaging.
Citing that provision, CPSC has recalled nearly 40 wintergreen essential oil products in the past two years alone. CPSC has also recalled numerous other FDA-regulated products that were not packaged in child-resistant packaging as required by the PPPA, including prescription drugs; dietary supplements containing iron; and mouthwashes, oral rinses, and gargles containing alcohol. As with other CPSC requirements, noncompliance with the PPPA can result in costly penalties, not just a product recall.
Second, CPSC has jurisdiction over mechanical hazards posed by packaging of many FDA-regulated products. For example, CPSC has recalled an instant ramen product that came in a paper cup that could catch fire when microwaved, and a hair styling spray in a can that could corrode over time and explode.
Third, it is common for companies that deal in food, drugs, cosmetics, dietary supplements, or medical devices to also deal in consumer products that fall within CPSC's jurisdiction, whether the product is a candle, a toy, an article of clothing, a hair dryer or other appliance, a bag or carrying case, or something else entirely. Indeed, with limited exceptions, CPSC has jurisdiction over nearly any product that is likely to be used by consumers, including promotional products that are given away free of charge.
If your company deals in FDA-regulated products, we know that the last thing you want is to add another set of government rules to your compliance schedule. However, as numerous companies can attest, it pays to familiarize yourself with CPSC's regulations.
If you have questions about how your company’s product may be regulated by the CPSC, get in touch with Claudia Lewis or Alex Rubel in Venable’s Venable's Food and Drug Law Group, or Melissa Steinman in the Advertising Group.