Consumers in the United States depend on the government to ensure the safety of products sold in the country. Given the volume and diversity of commodities available through various distribution channels across the nation, monitoring product safety is a monumental task. Product defects occur.
Recent news headlines have alerted us to tainted foods and defective medical devices that have been withdrawn from circulation because of their threats to public health. Each consumer needs to have reliable information necessary to take appropriate action when recalls happen . This article poses and answers five simple questions about the product recall process used in the United States.
1. Which agency has responsibility for product recalls?
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.
2. What products are subject to recall?
The FDA regulates and monitors the safety of a long list of products, including:
* Drugs used by humans and animals
* Vaccines
* Biologics, such as blood, blood-based products, and transplantable human tissue
* Animal feed
* Medical devices
* Radiation-emitting products
* Cosmetics
* Approximately 80% of the foods eaten in the U.S. (the FDA does not regulate meat, poultry, and egg products).
3 . Why does the agency recall products?
Yes, you guessed correctly. The primary reason for a recall is to protect public health and safety. When an FDA-regulated product is either defective or potentially harmful, it is removed from the market -- permanently, or until the problem is fixed.
According to FDA, it is rare for the agency to request a recall. Most product calls are voluntary. Sometimes a company discovers a problem and recalls a product on its own. In other situations, a company initiates the recall after FDA raises concerns about a product.
4. What criteria are used to determine product risks?
Regardless of the initiator, risks associated with product defects vary. Consequently, the FDA uses the level of hazard to categorize all recalls into one of three classes:
* Class I includes dangerous or defective products that predictably could cause serious health problems or death. Products, such as the recent cases of faulty pacemakers and bacteria-tainted peanut butter, fall under this category. Other examples include foods with undeclared allergens and a product label mix-up on a lifesaving drug.
* Class II products might cause a temporary health problem, or pose only a slight threat of a serious nature. An example would be an under-strength drug, which though sub-standard, may not be life threatening.
* Class III products are unlikely to cause any adverse health reaction, but they are recalled for violating FDA product labeling or manufacturing laws. An example would be minor defects in product packaging.
5. Where can consumers get updates on product recalls?
The FDA does not publicize all recalls in the media. It uses media publicity only when the public needs to be alerted to a serious hazard associated with a defective product. However, you can obtain full details about all recalled products in the FDA's weekly publication titled Enforcement Report. You can sign up for updates at the agency's website: .
Rachel Agheyisi is an economist with over 25 years of business research, writing, and corporate consulting experience. She is the Executive Director of Report Content Writer, a company that specializes in writing white papers and case studies used by IT companies for generating leads in the biotech, financial services, and health care industries.
Email me at rachel@reportcontentwriter.com on how I may help you develop content-rich white papers and case studies.
Added admin on August 29, 2009
Filed Under: National, State, Local
Tags: defective products, drug recalls, FDA, food recalls, product recalls, tainted foods
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