Guidance for Industry and FDA Staff – Mandatory Food Recalls

Tentamus North America offers various services to assist

Label Review
(PresseBox) ( Fredericksburg, VA, )
In November 2018, the FDA released guidance for both industry and FDA staff in the form of questions and answers for the execution of mandatory food recalls under section 423 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance identifies and answers common questions regarding mandatory 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:

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