This draft guidance is being distributed for comment purposes only; submit comments by 07/05/2019 (https://www.regulations.gov/document?D=FDA-2018-D-1398-0025).
FSMA’s Mitigation Strategies to Protect Food Against Intentional Adulteration (IA Rule) requires both domestic and foreign companies that are required to register with the FDA to develop strategies that prevent intentional adulteration of food.
Depending on business size, compliance dates vary. However, the next compliance date is July 26, 2019, for “Other businesses that do not qualify for exemptions.” This is just around the corner! See FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-mitigation-strategies-protect-food-against-intentional-adulteration) for other compliance dates.
This guidance draft, intended for food producers subject to the Intentional Adulteration rule (21 CFR part 121), was released to help guide companies in identifying weaknesses and in developing and implementing a food defense plan (FDP) for their facility.
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
- Product Food Safety Plan/HACCP creation and consultation
The revised draft guidance for Mitigation Strategies to Protect Food Against Intentional Adulteration can be found here: https://www.fda.gov/media/113684/download
Get in touch with our experts. We’re ready to discuss your requirements.
Vy Goddard, Regulatory Affairs Specialist
Tentamus North America