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.
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrochemicals, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 52 locations worldwide. More than 2,500 highly-trained staff members work in over 2.5 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
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Tentamus Group GmbH
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Regulatory Affairs Specialist, Tentamus North America