Consequences to Offering Misbranded Consumer Products Within the US
By: Dana Mladin, Sr. Laboratory Technician & Regulatory Affairs Specialist, email
It is the obligation of the manufacturer/distributor of a product to ensure that that product’s label is compliant with the current 16.CFR.1500 regulations before making the product available to consumers.
The Consumer Product Safety Act (CPSA) and the Federal Hazardous Substances Act (FHSA) make it unlawful to:
- Introduce or deliver for introduction a misbranded/banned hazardous substance (FHSA)
- Manufacture, distribute, import, sell, or offer for sale any product that does not comply with a mandatory standard (CPSA & FHSA)
- Fail to report as required by section 15(b) (CPSA)
- Fail to report under section 37 (CPSA)
- Sell a product that contains a defect which could create a substantial product hazard to consumers or unreasonable risk of serious injury or death
You must report, even if you think a recall may not be warranted. Ultimately it is the decision of the Consumer Product Safety Commission (CPSC) to determine the recall and the next steps to take.
Any product found in violation of the CPSC and FHSA requirements will be recalled.
A recall is a generic term used to describe a corrective action under section 15 of CPSA and may include some or all of the following:
- Stop of production/distribution
- Stop of retail sales
- Repair of the product
- Replacement or refund
- Notification to consumers
Recent CPSC Recalls can be found here.
The cost of a recall can be quite extensive. This can include, but it is not limited to, the following:
- Recall expenses
- Civil penalties
- Criminal penalties
- Product liability claims
- Consumer class actions
- Shareholder liabilities
In 2018, one of the penalty agreements was over 25 million + Civil Penalties.
How can we help keep your product in compliance? Contact us to hear about our CPSC services. We offer a standard CPSC report as well as an enhanced document that goes further into the requirements for States such as California.