Recall or Withdrawal: What’s the Difference?
Market withdrawals occur when a product is deemed to have a minor violation that the FDA or the manufacturers themselves believe is still important enough to justify removing the product from the marketplace. There are no FDA penalties in these situations.
Market withdrawals are different from product recalls, including food recalls and drug recalls, which occur when the use of or exposure to a product regulated by the FDA may cause harmful safety and health consequences or even death.
However, the significant difference in these levels of severity does not protect companies from suffering reputation damage in the Court of Public Opinion. As soon as the news breaks, the only thing consumers and the media hear is the word “recall.”
As such, market withdrawals deserve the same serious focused attention as any other threat to your reputation and brand. Typical violations that cause product withdrawals – including improper labels or packaging – are minor quality or regulatory infractions that, in most cases, are not subject to regulatory action by the FDA. There may possibly be a safety concern but no immediate safety threat to consumers.
Yet, because the media and general public usually don’t differentiate between product recalls and market withdrawals, the potential for revenue loss is still significant. Consumer instincts are to avoid all products with any sort of vague potential to cause illness or injury.
To minimize this risk, assume that a market withdrawal of one of your products is inevitable and prepare accordingly. Especially amid today’s ever-changing regulatory standards, it is critical that both manufacturers and retailers craft recall strategies and plans that address both product recalls and market withdrawals.
You’ll already be using essential communications tools and resources for recall management and recall logistics. There’s every reason to simultaneously utilize those tools to credibly explain why your market withdrawal poses no public safety threat.