What is a significant change to product recalls under FSMA?

• A. FDA can only request voluntary recalls
• B. FDA can levy penalties but not recall
• C. FDA has mandatory recall authority
• D. FDA can only recommend recalls

Answer: (C)

FSMA changed the landscape by giving the FDA the power to mandate recalls of foods when there is a reasonable probability of adulteration or misbranding and the responsible party fails to voluntarily recall. This makes the recall process enforceable, allowing quicker removal of unsafe products from the market and providing a legal mechanism to compel action if a voluntary recall doesn’t occur. Previously, recalls were largely voluntary, so the ability to order a recall is the significant shift. Options that imply recalls are only requested, merely penalized without recall, or only recommended do not reflect FSMA’s mandatory recall authority.