Role of the FDA in Product Recalls
The Food and Drug Administration is one of the many government entities that have been charged with safe-guarding the public from harmful products. This doesn't include only food and drugs, but dietary supplements, blood products, medical devices, cosmetics and more. Their legal authority entitles them to enforce the way products are marketed to the public, as well as being able to force recalls of these products if they do harm. The FDA's list of legislation stretches back to laws created at the beginning of the 20th century.
Organized into several different divisions, including the Center for Drug Evaluation and Research and the Center for Veterinary Medicine, the FDA often works in conjunction with other federal agencies. And, like federal agencies are, the FDA has been a lightning rod for criticism. Because they have oversight on regulating products that affect the lives of every citizen in this country, they are sometimes blamed for failing to act soon enough, or acting at all, when these products injure and kill.
The role of the FDA when a product is recalled really depends on if the manufacturer of the company voluntarily takes action or not. While the FDA cannot “order” a company to recall a product, it will take serious action if they have notified that company their product is causing harm and the company continues to market the product to the consumer. This is done under the Federal Food, Drug, and Cosmetic Act. Ordering a court requested recall, injunction of the targeted firm, and seizure of the offending product are all actions the FDA can take with this law.
Guidelines
The FDA monitors manufacturers and companies for any sort of product that may be hazardous. They expect that the firms in the US will take responsibility for their products and that they will voluntarily recall them if there is a problem. These companies must also notify the FDA when they have initiated a recall. The FDA must then make sure that any defective product has been fixed or destroyed after it has been recalled. However, the FDA has created three classes that all recalls fall into and will notify the company of the class their recalled product falls into. The three class guidelines are:
Though the FDA's role in recalled products is to get the company to withdraw it if they won't voluntarily do so, as well as notify the public that a recall is under way, many people may have already been affected in a negative way. If someone is injured or has died as a result of a defective product, the FDA’s recall won’t do them any good. It is times like these when it may be in your best interest to contact an experienced product defect attorney.
If you are in the Oklahoma City, Oklahoma area, and you or a loved one has been harmed by a defective product, please contact Stipe & Belote, LLP.
Organized into several different divisions, including the Center for Drug Evaluation and Research and the Center for Veterinary Medicine, the FDA often works in conjunction with other federal agencies. And, like federal agencies are, the FDA has been a lightning rod for criticism. Because they have oversight on regulating products that affect the lives of every citizen in this country, they are sometimes blamed for failing to act soon enough, or acting at all, when these products injure and kill.
The role of the FDA when a product is recalled really depends on if the manufacturer of the company voluntarily takes action or not. While the FDA cannot “order” a company to recall a product, it will take serious action if they have notified that company their product is causing harm and the company continues to market the product to the consumer. This is done under the Federal Food, Drug, and Cosmetic Act. Ordering a court requested recall, injunction of the targeted firm, and seizure of the offending product are all actions the FDA can take with this law.
Guidelines
The FDA monitors manufacturers and companies for any sort of product that may be hazardous. They expect that the firms in the US will take responsibility for their products and that they will voluntarily recall them if there is a problem. These companies must also notify the FDA when they have initiated a recall. The FDA must then make sure that any defective product has been fixed or destroyed after it has been recalled. However, the FDA has created three classes that all recalls fall into and will notify the company of the class their recalled product falls into. The three class guidelines are:
- Class I - These recalls are for the most dangerous products that can cause serious health problems or death
- Class II - These recalls are for products that may cause health problems deemed temporary or may only pose a slight threat of more serious threats
- Class III - Although these recalls are for products that are unlikely to cause harm, the product in question may still violate FDA manufacturing or labeling regulations
Though the FDA's role in recalled products is to get the company to withdraw it if they won't voluntarily do so, as well as notify the public that a recall is under way, many people may have already been affected in a negative way. If someone is injured or has died as a result of a defective product, the FDA’s recall won’t do them any good. It is times like these when it may be in your best interest to contact an experienced product defect attorney.
If you are in the Oklahoma City, Oklahoma area, and you or a loved one has been harmed by a defective product, please contact Stipe & Belote, LLP.
