Personal Injury Newsletter

  • Parents' Responsibility for Minors' Actions
    In most states, the age of majority (when a person is recognized by law as an adult), is 18 years of age or older. A “minor” is a person who is under the age of 18. When a minor breaks the law or causes damage or injury to... Read more.
  • Franchisors Might be Liable for Franchisee Actions
    An increasing array of goods and services are offered through “franchises.” Franchising is not a new concept, but it has exploded in popularity; according to statistics compiled by Price Waterhouse Coopers in 2005 (the... Read more.
  • An Overview of Spectator Injuries
    The liability of property owners for injuries that occur to persons on their property is largely a creation of state law and court decisions. For this reason, the nature of a property owner’s duties to individuals on the... Read more.
  • Claims Procedure Under the Federal Tort Claims Act
    In most states, an individual who is injured by an employee’s negligent acts can generally sue the employer, if the negligent act was committed in the course of employment duties. Until 1946, however, “governmental... Read more.
Personal Injury News Links

FDA's Guidelines for Recalls

When a product is defective or harmful to the public, the Food and Drug Administration (FDA) may order or request a recall of the product from the market. Sometimes, the manufacturers of defective products will voluntarily recall the defective product, while other recalls are ordered by the FDA.

Can the FDA Order a Recall?

The FDA does not have the authority to “order” recalls. Instead, under the Federal Food, Drug, and Cosmetic Act, the FDA may “request” the recall of a harmful consumer product if the manufacturer is unwilling to recall the product without the FDA’s written request.

In April of 2008, the “Safe Food Enforcement, Assessment, Standards and Targeting Act of 2008” was proposed and immediately received the support of produce and food service industry leaders. The bill would enpower the FDA with the ability to initiate food recalls and would provide safety requirements to identify and prevent sources of foodborne illness.

FDA’s Guidelines Imposed on Companies for Product Recalls

Title 21 of the Code of Federal Regulations, Part 7 details the guidelines for companies to follow when recalling a harmful consumer product. Under these guidelines, companies are expected to:

  • Develop a recall plan in case there is a need for a recall
  • Notify the FDA of the recall and the starting date of the recall
  • Make progress reports to the FDA
  • Comply with the FDA’s request for a recall, if there is one
  • Undertake subsequent checks to make sure that the recall is successful

FDA’s Role and Duties in a Recall

The only instances where the FDA will order a recall are when the recall involves a medical device, human tissue products, or infant formula. Moreover, the FDA has the authority to determine the scope and extent of these recalls. Under the guidelines outlined in Title 21 of the Code of Federal Regulations, the FDA’s role is to:

  • Monitor the company recalls
  • Assess the company’s actions
  • Investigate the product for its defectiveness
  • Make sure the product is either destroyed or reconditioned

Types of FDA Recalls

There are three types of recalls. These classes are defined by the severity of the harm it may potentially cause the general public.

  • Class I – recalls dangerous or defective products that may cause serious health problems or even death
  • Class II – recalls less dangerous products than Class I, that may cause only temporary health problems
  • Class III – recalls products which may not cause severe health problems
Share This Page: