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Dear Readers,

Edward A. Steele

Welcome to the September 2019 edition of EASeNews, the free news publication dedicated to FDA regulated industries.

FDA issued its first warning letter related to FSVP Final Rule enforcement of FSMA. The industry has long been anticipating FDA’s enforcement vs educational-based approach to FSVP. After two years of working to ensure importers of foreign foods and foreign food ingredients understand their requirements to verify supplier safety policies and track records, the Agency will now begin cracking down on those firms still not in compliance. EAS’ Team FSMA offers comprehensive services in the area of FSMA and FSVP. From desk audits of current policies to mock-FDA inspections of facilities, our experts help you to identify gaps and develop actions plans to mitigate risks. Learn more about our services by viewing our short promotional videos and reviewing our industry services sheets.

Additionally, FDA has indicated that drug firms that do not certify updated information or that no changes have taken place since the last renewal cycle can expect FDA to begin delisting products which can lead to misbranding. FDA has been taking an educational-based​ approach to the enforcement of product and facility renewals, however in a constituent update dated August 13, 2019, the Agency confirmed firms can expect greater hardships for not complying. EAS offers assistance with registrations and listings of both facilities and products as well as proactive annual updates and renewals. We invite you to contact us to learn more about our services and how we may assist you.

I am pleased that EAS has been invited to participate in educational sessions at a number of industry events this month. From FDLI to CHPA to NCBFAA to a keynote speaker at an international dairy event in Turkey, our experts will be traveling the globe in September ensuring FDA compliance is at the top of everyone’s agenda.

Additionally, we are offering a number of complimentary regulatory webinars with topics ranging from Food Defense, (September 12); to Quality Management Systems for medical devices (September 25) and a reintroduction to our expert witness training via webinar on November 6. There is always something new happening at EAS and we look forward to your participation in any of our regulatory events.

Our issue of the month is written by Tom Jonaitis and discusses common pitfalls with GRAS submissions. If you missed our recent webinar on GRAS submissions, presented by Robin Guy and Robert Kapp, you may now view it on demand. EAS has a dedicated team of toxicologists and regulatory scientists who regularly assist EAS clients with both GRAS and independent GRAS submissions.

Finally, we welcome new consultant, Penny Vyskocil, an expert in food safety in a variety of product types, from cereal, snacks, dry meals, IQF vegetables, Low Acid Canned Food (LACF) and milling.

Thank you for your interest in EAS and as always please feel free to contact me if you have any questions or if EAS can be of assistance.


Edward A. Steele Signature


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