Guidance for Industry and FDA Staff – Mandatory Food Recalls

The FDA gained mandatory recall authority in 2011 when FDA’s Food Safety Modernization Act (FSMA) went into effect. If the agency determines that a food is adulterated or misbranded the FDA has the authority to order a recall for that food.

The guidance addresses important questions, a few are:

• Why is mandatory food recall authority important?
• What foods are subject to the FDA’s mandatory food recall authority?
• What is a responsible party under section 423 of the FD&C Act?
• What are the criteria for a mandatory recall?
• What process will FDA follow for a mandatory recall?
• When is a food considered adulterated under section 402 of the FD&C Act?
• When is a food considered misbranded under section 403(w) of the FD&C Act?

The Tentamus Group, in particular, Tentamus North America, offers various services to assist in ensuring your product is compliant and safe:

• Product analysis for microbial and chemical safety to ensure food is not adulterated
• Product full label review for compliance to avoid misbranding
• Product nutritional analysis and nutrition fact creation and review to avoid misbranding
• Product Food Safety Plan/HACCP creation and consultation for overall food safety and compliance

The Questions and Answers Regarding Mandatory Food Recalls can be found here: https://www.fda.gov/media/117429/download

Get in touch with our experts. We’re ready to discuss your requirements.