News about tainted and recalled products appear to be more frequent recently. While most of us are aware that the intent of product recall is public safety, few of us know what the process entails. Here are three things to fill the knowledge gap.
1. What is Product Recall?
A product recall is essentially removing the product from the market The Federal Drug Administration (FDA) is the federal agency responsible for ensuring the safety of a variety of products in widespread use in the U.S. When an FDA-regulated product is either defective or potentially harmful, it is recalled.
According to the FDA, product recalls are usually voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. The FDA’s role is to oversee a company’s strategy and assess the adequacy of the recall.
2. FDA-Regulated Products Subject to Recall
The FDA regulatory mandate covers a variety of products. In particular, FDA-regulated products subject to recall include:
- drugs manufactured for human and animal use
- vaccines
- blood and blood product
- transplantable human tissue
- radiation-emitting product
- animal feed
- medical devices
- cosmetics, and
- approximately 80% of foods consumed in the U.S.
3. FDA Product Recall Classifications
The FDA uses the following guidelines to categorize all recalls into one of three classes. The primary criterion is the level of hazard involved. The three categories are:
Class I: These are dangerous or defective products that predictably could cause serious health problems or death. Examples include:
- food found to contain botulinum toxin,
- food with undeclared allergens,
- a label mix-up on a lifesaving drug, or
- a defective artificial heart valve.
Class II: These are products that might cause a temporary health problem, or pose only a slight threat of a serious nature. An example would be
- a drug that is under-strength but that is not used to treat life-threatening situations.
Class III: These products are unlikely to cause any adverse health reaction, but they violate FDA labeling or manufacturing laws. Examples include:
- a minor container defect, and
- lack of English labeling in a retail food.
CLICK HERE for more information on the FDA product recall process.
Filed under: Consumer Protection Alerts, FDA Tagged: | Drug recalls, FDA, Food recalls, product recall process, Product recalls
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