153 Market St., Lexington, KY 40507 This is an advertisement phone: (859) 253-9999
Todd & Todd A Professional Limited Liability Company

Personal Injury Newsletter

FDA Recalls: An Overview

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
  • Commercial Motor Vehicles and Defective Brakes
    Because Commercial Motor Vehicles (CMVs) are generally larger and thus potentially more dangerous than other vehicles, CMV brake safety is imperative. In 2003, the Federal Motor Carrier Safety Administration (FMCSA) issued a new rule... Read more.
  • Crashworthiness and Automobile Safety
    The principles of product liability provide consumers with some protection against injury from defective products and a means of recovering damages for injuries resulting from the use of defective products. The protection is in general... Read more.
  • Photographs and Written Releases
    The right of a photographer to sell or commercially exploit a picture of a stranger depends on numerous factors. Much will depend on whether the subject’s consent was obtained. Further, the subject of the photograph might have a... Read more.
  • Liability for Employee Cellular Phone Use
    In one decade, cellular telephone use has gone from being a novelty for the fortunate few, to being commonplace in our society. Most Americans have a “cell phone” and many use them while driving. In light of the associated... Read more.
Personal Injury News Links
Share This Page:

Contact Information

Todd & Todd A Professional Limited Liability Company (859) 253-9999 153 Market Street, Lexington, KY 40507

COMMUNITIES WE SERVE

Todd & Todd, PLLC is located in Lexington, KY and serves clients in and around Lexington, Keene, Nicholasville, Versailles, Midway, Georgetown, Wilmore, Winchester, Ford, Paris, Stamping Ground, Richmond, Cynthiana, Sadieville, Frankfort, Burgin, Clark County, Fayette County, Franklin County, Harrison County, Jessamine County, Mercer County, Scott County and Woodford County.

Designed and Powered by NextClient

© 2014 - 2022 Todd & Todd, PLLC. All rights reserved.
Custom WebExpress™ attorney website design by NextClient.com.

Contact Form Tab