The FDA uses their recall system to disperse vital information to the public, when a product (drug, food, etc.) violates the law or poses a significant public health hazard. FDA recalls are only announced when the recall classification is determined. The way consumers can access potential recall information is changing though. Consumers can now learn if a product is being investigated, before a recall is announced.
How FDA Recalls are Changing
Every week, the FDA releases its enforcement report. This report includes all recalls monitored by the FDA. Previously, the FDA only alerted the public about a recall when the product had reached a specific classification. The FDA will now include “not-yet-classified” product information in their weekly report. This will allow consumers to act, before the FDA announces a recall.
Since, the FDA’s enforcement report is the public’s primary source of recall information, they’re seeing it as an important tool to increase transparency and empower consumers.
Moving forward, the FDA will now include recall information soon after they initiate an investigation. This is important, because the FDA needs complex evaluation to determine if a recall is necessary. This process can take weeks. By informing consumers that a product is under investigation, the public can now know if a product, still available on store shelves, is safe to use.
How the FDA recall process works
The FDA works closely with companies to ensure they quickly alert entities in the supply chain, as soon as they identify a problem with the product they are marketing. Furthermore, the FDA continues to monitor the company’s actions. This helps them correct or remove the products from the retailer, pharmacy, hospital or grocery store’s possession.
The FDA says the public needs to recognize that recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product. Other times a company acts after the FDA raises concerns. In every case, the FDA oversees a company’s recall strategy and assesses the quality of the recall. This happens, regardless of whether the FDA or the company discovers the problem.
How does the FDA announce recalls?
The FDA will always act quickly to widely publicize a recall. This includes products they believe pose an immediate, serious hazard, even before classification is complete. The FDA may distribute press releases, advisories, and updates to the FDA web site, among other alerts, to publicize a recall.
The FDA has been increasing coverage in recent years, in relation to certain brands and batches of medications, injection pens, and contaminated foods.
LowestMed’s Health Information Center is meant for educational purposes and is not intended for medical advice. If you would like to recommend any story ideas, feel free to contact us.