EAS Consulting Group, LLC — EAS-e-NEWS — Current FDA Issues of Interest
A free monthly electronic newsletter published by EAS Consulting Group, LLC for the industries regulated by FDA.
Pharmaceuticals   ·   Medical Devices   ·   Foods   ·   Dietary Supplements   ·   Cosmetics
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408 June 2008
In this Issue:
Upcoming EAS Events
  • IFT08 Food Expo [more]
  • Natural Marketplace 2008 [more]
  • US Food Labeling Seminar [more]

From the Desk of the President:
Welcome to the First Issue of EAS-e-News

Dear Reader:

It is a pleasure to introduce you to the first issue of EAS-e-News. Since forming EAS Consulting Group as an independent consulting, training and auditing company in 2006 I have been searching for a way to stay in touch with regulatory professionals like you. EAS-e-News (pronounced “Easy” News) is an electronic newsletter designed to do just that.

It is a free monthly e-publication written for those of you who are interested in keeping current with new issues at FDA and in learning what is happening at EAS Consulting Group. We intend to provide you with valuable insights on regulatory issues written by EAS consultants in the “Issue of the Month” section of the newsletter that we hope you find informative. The “What’s New on FDA’s Website” section is designed to help you find information that has been posted on www.fda.gov during the past month and to make it “easy” for you to keep current on what is happening at FDA. The rest of the newsletter will highlight the people and activities of EAS so you are kept up to date on what we are doing to help you with your regulatory needs.

This publication is intended to meet your needs. I invite you to let us know what you like about EAS-e-News and I welcome any suggestions for improvement. Feel free to pass this along to others who may find EAS-e-News of interest.

Since EAS covers all the FDA-regulated industries it is not possible for EAS-e-News to be the only source of information for your particular area of responsibility. However, I do hope you find it to be a valuable source of news and information.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Commonly Found Gaps in Dietary Supplement cGMP Compliance
by EAS Senior Consultants William Ment and Robert Fish
Since the FDA published its long awaited final Dietary Supplement GMP regulations, EAS consultants have been performing gap analysis audits of dietary supplement manufacturers to determine compliance with 21 CFR Part 111. These assessments have revealed that dietary supplement companies, both large and intermediate size, have a considerable amount of work to do in order to be in compliance with the regulations. While we have found gaps in compliance with all of the subparts, companies are particularly struggling with:
  • complying with the sub lot testing of finished products
  • demonstrating that analytical methods are scientifically valid
  • establishing material review processes and performing well conducted investigations
  • qualifying manufacturing and analytical equipment
  • qualifying analytical reference standards
  • establishing employee skills and CGMP training records
  • setting up stability testing programs to support labeled expiry or “best if used by” dates, and
  • preparing master and batch production records, including how to comply with the requirement in 111.210 (h)(5) that the master manufacturing record must have corrective action plans for all specification failures.
EAS senior consultants have presented numerous training sessions at national seminars and on site at the manufacturer’s facility on the Current Good Manufacturing Practice for Dietary Supplement regulation, 21 CFR Part 111. The course, developed by our staff with many years experience with FDA, covers all subparts of the regulation. It also includes a considerable amount of information gleaned from the preamble to the final regulation, as well as guidance from the EAS staff, so participants are better able to understand the FDA intent of the regulation and expectations for compliance. EAS has also conducted training specially designed for quality control and analytical staff entitled Ensuring Regulatory Compliance of Dietary Supplement Laboratories.

Our training and audits have provided the necessary information for companies to construct an action plan to close the identified gaps. We not only identify the gaps, we also provide recommendations for how to close them. Our staff of former FDA managers have unique experience in conducting training and audits and can help you with your efforts to comply with the regulation.

We highly recommend that you take a good hard look at your current level of compliance and don’t wait until FDA begins its enforcement. You may be surprised about how much work it takes to become fully compliant with these new regulations. Give EAS a call if we can be of any assistance.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of May, 2008. Use of this section of EAS-e-News is intended to provide an “easy” way to keep current with FDA news and information.

FDA Press Releases
Recalls and Safety Alerts
May Archive of The FDA this Week: Andy's Take
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action:
EAS Conducts Food Labeling Seminar for Industry and Government Officials

EAS Conducts Food Labeling Seminar On May 20-22, 2008 EAS conducted a Food Labeling Compliance Review Seminar and Update at its training facility in Alexandria, VA. Twenty-two managers and staff from leading food manufacturers as well as FDA and State employees attended the training. The two-day Food Labeling Compliance Review Seminar concentrated on the US regulatory requirements for food labels while the Food Labeling Update addressed new requirements or issues that are currently being discussed and may well be required in the future. Labeling for USDA regulated products was added to the agenda for the first time so that firms regulated by both agencies understand how the requirements differ.

In addition to EAS consultants Dr. James Hoadley and Gisela Leon, current FDA and USDA officials participated as instructors. Beatrice Greenberg, Team Leader, Labeling Regulation Implementation Team and Geraldine June, Team Leader, Production Evaluation and Labeling Team from the Office of Nutrition, Labeling and Dietary Supplements, CFSAN, FDA spoke at the update and Dr. Robert Post, Deputy Director Center for Nutrition Policy and Promotion, USDA participated in both the seminar and update. EAS Vice President Elizabeth “Betty” Campbell attended as well.

Future seminars will be posted on the EAS website when scheduled. In the meantime your firm may find it cost effective to have EAS conduct the food labeling training or seminars on other regulatory issues as in-house programs for your employees. With the high cost of travel and considering the lost time to attend out of town training programs you may be surprised to find how cost effective it is to have us come to your facility to conduct training.

EAS Hosts Hubert H. Humphrey Fellow

Denis Pesut, Hubert H. Humphrey Fellow EAS Consulting Group is playing host to Denis Pesut for a 6 week internship as part of the Hubert H. Humphrey Fellowship Program. Mr. Pesut is a native of Rijeka, Croatia. He was selected for this highly competitive international program in March 2007. The Humphrey Fellowship is a professional fellowship intended to combine academic food safety education at Cornell University with a six week professional affiliation at an American institution or company related to food safety.

The Hubert H. Humphrey Fellowship Program was initiated in 1978 to honor the late Senator and Vice President Hubert H. Humphrey and his life-long commitment to international cooperation and public service. The program brings accomplished mid-career professionals from designated developing nations and emerging democracies to the United States for a year of professional development and related academic study and cultural exchange. The people-to-people approach to international understanding provides a basis for lasting ties between the U.S. citizens and their professional counterparts in other countries and strengthens the global exchange of knowledge and experience essential to a sustainable world.

Mr. Pesut graduated from the University of Rijeka, with a Bachelor of Science degree in environmental engineering. He is currently working on his master degree at the University of Zagreb. At the time he was selected for the Humphrey Fellowship Program he worked as a microbiologist at the Institute of Public Health, Department of Environmental Microbiology in Rijeka, Croatia.

Upon returning to Croatia he plans to continue his professional career in the field of food safety management and regulation. EAS President, Edward Steele hopes that the internship at EAS Consulting Group will give Mr. Pesut valuable experience to help advance his career. Steele said “Working side-by-side with EAS Consultants that were former FDA food safety compliance officials has to be a valuable learning experience for bright young scientists like Denis. We are pleased to participate in the Humphrey Fellowship Program and we hope that we will have the opportunity to host more interns in the future.”

EAS Exhibits at CRN’s Day of Science

As an Associate Member of the Council for Responsible Nutrition, EAS was invited to exhibit at the CRN’s Day of Science held at the Ritz Carlton Hotel in Pentagon City, VA on May 8, 2008. This workshop was an intense one-day symposium geared toward executive and director level research and development/discovery scientists from industry, universities, and government agencies.

EAS Exhibits at CRN's Day of Science The keynote speaker was Tieraona Low Dog, M.D., Director of Education, Program in Integrative Medicine, University of Arizona Health Sciences. She spoke on the topic of “Dietary Supplement Use in Private Practice: Promises and Pitfalls.” The rest of the day was divided into three separate topics, each covering distinct but related areas of dietary supplement research including Dietary Supplements and Disease Management; Continuing on the Paradigm of Prevention; and Ensuring the Integrity of Raw Materials.

Exhibiting at the workshop gave EAS an opportunity to chat with scientists and management personnel that play an active role in promoting sound science in the dietary supplement industry. Look for EAS at other industry tradeshows and conferences such as the IFT Food Expo in New Orleans, June 29-July 2; the NPA Natural Marketplace 2008 in Las Vegas, July 18-19; and, the HBA Global Exposition and Education Conference in New York City, September 9-11.

Who's Who at EAS:
Meet EAS Vice President, Carl Reynolds

Carl Reynolds, Vice President EAS Consulting Group is fortunate to have one of the country’s premier food regulatory experts in Carl Reynolds. With 44 years of FDA and consulting experience, he genuinely is a food compliance expert. His combination of 36 years with FDA and 7 years with AAC/Kendle has provided him a broad experience and knowledge base. He has extensive domestic and international experience in managing and investigating microbiological food safety concerns, policy development and implementation, and training activities. He is a specialist in the area of food safety, dietary supplements good manufacturing practices and low acid and acidified canned foods. He was considered as one of the early FDA experts in Hazard Analysis and Critical Control Point (HACCP) implementation.

Mr. Reynolds’ career began in 1962 as an Investigator in FDA’s Denver District where he conducted inspections and sample collections in all of the product areas regulated by the FDA. He next served as Resident in Charge in the FDA’s Albuquerque Resident Post where he also did training, testified in legal proceedings, and provided sworn statements in court depositions. He served 5 years as a Supervisory Investigator in the Dallas District, 11 years as the Director of the Investigations Branch in the Orlando District, and 5 years as the Detroit District Director. In these positions he managed staff assigned to investigative/ inspectional, compliance, research, and regulatory laboratory activities. He also reviewed legal recommendations, developed enforcement strategies, and directed a comprehensive import program.

His final role at the FDA was as the Director of the Office of Field Programs at the Center for Food Safety and Applied Nutrition (CFSAN). His staff was responsible for health hazard classification, level of effectiveness checks, and media coverage regarding recalls of food products. He was the Center contact for all food borne illness emergencies and outbreaks, and represented the FDA and CFSAN at both international and domestic meetings and training events. He is a member of the Association of Food and Drug Officials and was a former member of the U.S. delegation to the Codex Committee on Import and Export Food Inspection and Certification Systems.

Mr. Reynolds joined AAC/Kendle as a Senior Consultant in 1999. He conducted comprehensive audits of food manufacturing and warehousing facilities and dietary supplement manufacturers. He is an approved auditor by the Natural Products Association (NPA) for conducting audits of dietary supplement manufacturers. He has testified in Federal Court and provided dispositions in food safety and dietary supplement cGMP regulatory issues. He has been accepted during trial as an expert in the area of food safety. In October 2006 Mr. Reynolds became a Vice President of EAS Consulting Group.

Let his extensive regulatory expertise work for your company.

Upcoming Events

Tradeshows

Visit the EAS Consulting Group exhibit at the following tradeshows:
Seminar

EAS will be participating in the following seminar:
  • U.S. Food Labeling Seminar 2008 - Presented by The Food Institute
    June 3, 2008
    The Marriott Newark Liberty International Airport Hotel, Newark, NJ
    8:00AM-5:00PM

    Featuring:
    Robert Hahn, Esq., Olsson Frank Weeda Terman Bode Matz PC and James E. Hoadley, Ph.D., Senior Consultant, EAS Consulting Group, LLC

    This day-long seminar will update you about the latest developments impacting the labeling of food products, as well as provide an overview of the basics of food labeling. Learn what important changes in food labeling may lie ahead and could affect your products
Useful Publications and Regulatory Tools

EAS Labeling Type Size Guide EAS Labeling Type Size Guide

A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.		 $ 9.00
Code of Federal Regulations, A pocket Guide

Dietary Supplement GMP Regulation -
A Pocket Guide

A 4”x6” bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.

 < 25 $ 10.00 each
25-50 $ 9.00 each
50-100 $ 8.00 each
> 100 $ 7.00 each
Dietary Supplement Labeling Compliance Review, 3rd edition Dietary Supplement Labeling Compliance Review, 3rd edition

A value labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell

Hardbound book and CD		 $ 199.00 / set
Food Labeling Compliance Review, 4th edition Food Labeling Compliance Review, 4th edition

A value labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell.

Hardbound book and CD		 $ 199.00 / set
To purchase any items listed above download our Order Form
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© EAS Consulting Group, LLC, 2008