News from CRIS: Understanding Recalls - Food, Cosmetics, Medications

January 25, 2022

What is a recall?

When a product doesn't meet required quality or safety standards, a company will often voluntarily recall the item by ensuring retailers no longer sell the impacted goods and imploring consumers to discontinue using the recalled product. 

Why would a product need to be recalled?  

Manufacturers must meet quality and safety standards to ensure their products will not cause harm if used as intended.

Why would a product not meet safety or quality standards?

Many things can happen during the manufacturing and transportation processes that can impact quality and safety. This can include:

  • Contamination: We're familiar with ListeriaE. coli, and other bacterial contamination. But, any contaminant such as a foreign object or unintentional ingredient addition is considered contamination even if it's not harmful.  
  • Mislabeled product: Improperly labeled foods, cosmetics, and medicines can be recalled for incorrectly listing ingredients, having improper expiration dates, etc. 
  • Undeclared ingredient: For example, a product containing ingredients not present on the label, this can be especially impactful with potential allergens. 
  • Overall Safety: We'll see infant formula recalled for not maintaining the proper nutritional balance, dispensing medication properly, and many more potential safety issues. 

Which agencies oversee recalls?

In the United States, a few agencies oversee product recalls. 
Primarily, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture Food Safety Inspection Service (USDA FSIS) regulate food, cosmetic, and medicine product recalls (1). 
FDA Oversees: food recalls (non-meat products; fruits; vegetables; seafood; shelled eggs; infant formulas), medicines, medical devices, cosmetics, biologics, radiation-emitting products, veterinary drugs, and pet food recalls. 
US FSIS Oversees: meat, sausage, poultry, and processed egg product recalls.

Do the FDA and USDA FSIS recall items? 

Typically, a manufacturer recalls an item voluntarily with the support from federal agencies to get information to the public in the form of press releases and public notices. However, federal agencies have the power to warn the public and seize products if a manufacturer does not recall a potentially harmful item promptly. Additionally, the federal government can choose to take legal action if it's required (1,2,3).


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