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Dear Readers,

Edward A. Steele

Welcome to the October issue of EASeNews, the free newsletter for industries regulated by FDA.

If you missed it FDA has released an online Food Defense Plan tool which will help companies think through the important requirements and action steps of developing this important protection against Intentional Adulteration. If you missed our webinar on Food Defense in September, our Independent Advisor for FSMA, Charles Breen and Independent Consultant, Kathy Knutson, Ph.D. did a fantastic job laying out FDA’s expectations, who is expected to comply and how to begin developing a food defense plan. I invite you to watch it free On-Demand.

Additionally, on the food front, a reminder to firms exporting seafood products from the U.S. to the EU that FDA updated three Export Listing Module (ELM) requirements. Effective September FDA has fully transitioned to the ELM for the EU dairy export list and all export lists maintained for Chile and China.

U.S. establishments that are currently included on the EU collagen, gelatin, or seafood export lists should submit applications in the ELM if they wish to remain on these lists and effective immediately, any U.S. establishment that wishes to be included on any FDA-maintained export list for food products should apply in the ELM. Contact EAS with any questions.

FDA also published final Guidance for medical device companies seeking to file a 510(k) based on Safety and Performance Criteria and draft guidance on a pilot program assessing consistency and predictability of premarket reviews for medical devices through a voluntary conformity assessment initiative, called the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. More information on both, as well as other FDA initiatives, can be found in the Drug Device Corner.

We have a very interesting issue of the month article written by Greg Weilersbacher that discusses the importance of equipment change control. How often do we purchase a new piece of equipment without fully vetting the additional or different requirements on utilities. Planning for these upgrades before they are installed can save countless hours, additional cost and frustration later.

Our Ask the Expert is answered by Cathryn Sacra and discusses the importance of restaurant menu labeling compliance. As you know EAS has a labeling team that helps clients with food and dietary supplement labeling issues. Our labeling team also includes experts in restaurant menu labeling, and services run the gamut of identification of qualified labs to reviewing product specs for label development and accuracy verification.

EAS is exhibiting and speaking at numerous trade shows and conferences this month, the details of which you’ll find in the EAS in Action section. I would also like to remind you of our complimentary webinars coming up on navigating Customs and Border Patrol for imported FDA products; a look at FDA observations related to dietary supplement compliance; a continuation of our food fraud webinar with a closer look at analytical tools; and an in-depth overview of what it takes to be a expert witness in legal proceedings. All of this information can be found in EAS in Action as well.

Lastly, if you have not already registered for our November food labeling, dietary supplement labeling and dietary supplement GMP seminars taking place in Irvine, CA I encourage you to do so. Seats are still available. We also have a one-day dietary supplement GMP refresher training in November in Long Island. You may find registration information on the EAS website.

Thank you as always for your interest in EAS and please reach out to me with any questions.


Edward A. Steele Signature


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