What is a cosmetic recall?
A recall is when a cosmetic distributor and/or manufacturer requests that a product be removed from the market. Recalls are based on either adulteration or misbranding. In the case of adulterations where there is a potential for harm to the consumer recalls are strongly recommended. Misbranding is a case by case situation for each manufacturer and/or distributor. Some manufacturers and/or distributors do not find that certain misbranded statements rise to the level to cause potential harm to the consumer and therefore do not see the need for a recall.
Can FDA mandate a recall?
FDA has no authority under the Federal Food, Drug & Cosmetic Act to order a recall of a cosmetic. However, when FDA feels there is a violation of the laws FDA can request that manufacturers, private labelers and/or distributors recall a product. Many companies feel obligated to comply with FDA's request for recall because of the potential for future retaliation by FDA, founded or unfounded.
What is the procedure to conduct a recall?
Recalls are sometimes determined through internal investigations, external complaints, or FDA inspections. The following are the procedures to follow:
- Determine whether or not the "issue" rises to the level of a recall.
- Conduct an investigation, documenting everything, including a root cause analysis if possible.
- Prepare a recall submission notification to your local FDA District Recall Coordinator including:
- Production Information
- Codes (Product Identification numbers)
- Recalling Firm
- Firm Responsible for the Violation/Problem
- Reason for Recall
- Health Hazard Assessment
- Volume of Recalled Product
- Distribution Pattern
- Recall Strategy
- Prepare Public Notification
- Press Release
- Recall letters to supply chain
- Conduct an evaluation of the Recall
- Conduct an effectiveness of the recall assessment
- Submit recall status reports on a monthly basis
- Finalize and submit a root cause analysis
- Finalize and submit a corrective action plan
- Conduct an analysis for termination of recall
- Terminate recall