What Now for FSMA Compliance?

The sky did not fall on September 19, 2016, the compliance date for larger human food facilities to meet FSMA preventive controls and Current Good Manufacturing Practice (CGMP) requirements, and for larger animal food facilities to comply with CGMPs.

In a September 19 poston the agency’s website, Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, gave some good insights about what agency oversight of compliance might look like in the next few months for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.

“We know that this is new territory for food companies; it’s new territory for us too,” she said. But the agency’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.

She cited the agency’s recently issued draft guidanceon implementation of preventive controls and CGMP requirements and promised there are more guidances to come, “about two dozen planned over the next few years.”

She advised that the best thing companies can do at this time is to “take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system.” This should include promptly responding to problems, “even if they aren’t yet violations,” to prevent them becoming food safety issues.

She also emphasized the need for “a thorough system” for companies to document what they do. “If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?”

It is up to the management of a company to make sure everyone in the production chain understands what is expected and has the training and education they need to get the job done, she said.

Speaking of guidance, I suggest you mark your calendar to attend FDA’s October 14, 2016webinarin which agency staff will discuss the draft guidances for current good manufacturing practices requirements for food for animalsand the human food by-products for use as animal food. The webinar will offer an overview of the two draft guidances and will also include a question and answer session. These Q&A sessions often provide key insights into the agency’s thinking on specific issues, so I encourage you to listen in.

EAS Reaches Ten Year Milestone

It is with great pride that I share EAS Consulting Group’s celebration of our milestone ten year anniversary!

Never had I imagined when I retired from FDA 22 years ago that I would own and operate one of the nation’s leading consulting firms that specializes in all FDA regulatory matters. I had no clue that when I acquired the food, dietary supplement and cosmetic services from Kendle International in 2006 that EAS would grow to offer regulatory assistance to all areas of FDA oversight, have access to the expertise of over 150 of the industry’s most qualified independent consultants and gain the trust of thousands of clients throughout the world.

I am truly privileged and humbled each day to work with companies large and small, from global leaders in the industry to a small mom-and-pop business just opening its doors. Navigating FDA’s, USDA’s and other federal and state agency’s many rules and regulations can be complex and we thank all our clients for trusting your regulatory assistance needs to EAS. We hope to continue to serve you long into the future.

As many of you know, EAS’s roots actually go back 1960 when Arthur A. Chechhi, a former FDA Associate Commissioner founded Arthur A. Checchi & Associates. After 25 years of service, Mr. Chechhi invited Tony Celeste, then a senior manager at FDA to assume the ownership and management of the company under the name of AAC Consulting Group (Mr. Chechhi’s initials). Tony and I were fellow analytical chemists at FDA’s New York District Office when we started our careers at FDA in the 60’s. When Tony asked me to join AAC in 1994 as a Vice President, after my 30-year career at FDA’s Center for Food Safety and Applied Nutrition, I was only too happy to join him. In 2001 AAC was acquired by Kendle International, one of the world’s largest global clinical research organizations, Tony retired, and I was appointed President of the consulting business. Then in 2006 I had the opportunity to acquire the food, dietary supplement and cosmetic businesses from Kendle, forming EAS Consulting Group, LLC as an independent company on October 1, 2006.

It wasn’t long after forming EAS that we began expanding services to all the FDA regulated areas in order to keep pace with the growing industry needs. As we expanded our services we also grew our network of independent consultants, many of which were former career FDA compliance officials and high level industry executives. I’m also proud to say a significant number of former clients who retired as industry leaders have also elected to join our ranks. Our respected and impressively credentialed consultants are a huge part of why EAS has been so successful. Our mission is to provide quality regulatory advice and service to our clients in an ethical, timely, and cost efficient manner. I am proud to say that everyone standing under the EAS banner embraces this whole-heartedly and always works in the best interest of our clients.

Beginning in 2011 EAS contracted with certain independent consultants with specialized credentials to serve as Senior Advisors (now referred to as Independent Advisors). At the present time our current list of Advisors are:

  • John Bailey, Ph.D., Colors and Cosmetics
  • Charles Breen, FSMA Consulting Services
  • Elizabeth “Betty” Campbell, Labeling and Claims
  • Nancy Chew, New Product Development and Submissions
  • Tara Couch, Ph.D., Dietary Supplements
  • Susan Crane, OTC Drugs and Labeling
  • Robert Fish, Quality and Compliance
  • Robert Martin, Ph.D., Food & Color Additive Safety
  • Jeffrey Springer, FDA Regulatory and Legal Matters
  • Stephen Sundlof, D.V.M, Ph.D., Animal and Human Food Safety
  • Domenic Veneziano, Import Operations

EAS has also established strategic partnerships with companies and independent contractors throughout the world in an effort to extend our services to the global needs of the FDA-regulated firms we support. We now have partners located in Canada, Mexico, Brazil, Chile, Ireland, UK, France, Netherlands, Korea, Japan, Australia, New Zealand and elsewhere.

On the business front, I am pleased to say that Dean Cirotta, President & COO and my son Brett Steele, Chief Financial Officer are now partners in EAS and play a critical role in running today’s business and will play a strategic role in leading us into the future. They, along with Cathryn Sacra, Senior Manager of Client Relations, Bryan Coleman, Senior Director, Pharmaceutical & Device Consulting Services, Victoria Pankovich, Regulatory Specialist, Amy Scanlin, Marketing Coordinator and Jason Steele, Creative Director and webmaster all play a key role in the integration of client services and project management on a daily basis.

EAS is also poised to meet new areas of needs, such as the launch of our most recent strategic consulting services on Product Development and Labeling, that we just announced at IFT 2016 in Chicago. FDA’s new regulatory initiatives are creating new opportunities for EAS to expand its services. For example, FSMA, the new Nutrition Label requirements and increased demand for GRAS determinations in the food area alone have increased opportunities. The new deeming regulations has telegraphed increased oversight for the tobacco industry and Congressional interest in increasing regulations within the cosmetic industry all bode well for increased need for quality consulting assistance. EAS will be taking increased advantage of our tremendous drug and device consulting resources that we have to expand our work in these areas as well.

As we look to the future, EAS is well positioned to build on our success. We thank you for trusting EAS with your ever important regulatory needs and engaging with us. I also want to personally thank all the staff and independent consultants who have contributed to our growth and accomplishments in the past 10 years. I particularly want to acknowledge the role that my friend and former lab colleague, Tony Celeste has played in my career after FDA.

We appreciate your business and look forward to the next ten years of service.