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.
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EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 October 2009
In this Issue:
Upcoming EAS Events
  • Food Labeling Compliance Review and Update [more]
  • Dietary Supplement GMP Seminar [more]
  • Dietary Supplement Labeling [more]

From the Desk of the President:
New Initiatives at FDA

Ed Steele, President Welcome to the October issue of EAS-e-News, our free e-newsletter for companies regulated by the Food and Drug Administration.

With internal FDA probes uncovering problems with the 510(k) premarket approval process for medical devices, the process is now under intense scrutiny. In a related move, FDA has just commissioned the Institute of Medicine to study the 510(k) process. The IOM, part of the National Academy of Sciences, is expected to issue a report on its findings in March 2011. It will hold two public workshops during the next nine months as part of the review. In the meantime, a working group within FDA’s Center for Devices and Radiological Health will be considering ways to improve the program. The recent resignation of device division chief Daniel Schultz, and Commissioner Margaret Hamburg’s comment that she “felt we needed new leadership,” suggests that significant changes may be made as these reviews come in.

In another program area, FDA’s new Strategic Plan for Risk Communication, unveiled September 30, includes a commitment to deliver--within one year--detailed risk communication action plans at the center levels, including timelines, responsibilities and resource needs. So we can expect to see many new initiatives from the agency aimed at improving these activities.

EAS Senior Consultant Bill Schwemer led a September 24 pre-conference workshop on risk management at the 5th Annual Bio/Pharmaceutical and Medical Devices Product Recalls Summit, held in Alexandria, Va., in which he reviewed why the agency is overhauling its risk assessment thinking at this time.

This issue of EAS-e-News features another key program area--animal drug and chemical residue safety. EAS Senior Consultant Gloria Dunnavan, a former head of compliance in FDA’s Center for Veterinary Medicine, is a leading regulatory expert in this subject. Ms. Dunnavan is also featured in our Who’s Who at EAS section.

Our EAS In Action section includes a profile of the latest addition to our consulting team--Douglas R. Nelson, former FDA international low acid canned foods inspection coordinator. In his 30-year agency career, Doug acquired a wealth of experience in applying technological solutions to food safety problems. See details below.

I would like to remind those of you whose work involves dietary supplement GMPs that you may take our free GMP Challenge Quiz to check your understanding of FDA’s new requirements. In addition, you can view the free EAS GMP Challenge webinar to hear FDA and EAS experts discuss the new compliance requirements. And please feel free to share these links with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
The Impact of Animal Drug and Chemical Residues on Food Safety
By EAS Senior Consultant Gloria J. Dunnavan
The Food and Drug Administration is currently developing a comprehensive Animal Feed Safety System (AFSS) to help assure controls over the receipt, production, distribution and use of all animal feed. The agency believes that food safety controls must be applied from production on the farm to the consumer’s plate—and that controlling drug and chemical residues in edible animal products is part of that continuum. I expect to see continuing evaluation of drugs used for food-producing animals, along with the development of the AFSS and a robust farm-to-table enforcement program.

The term “farm-to-table” was still new when I began my career with the Food and Drug Administration. In 1979, I became a compliance officer in FDA’s Center for Veterinary Medicine and later the Director of the Division of Compliance in CVM. Although I worked on many significant issues, one of the most important--and something that I still feel strongly about today--is the control of drug and chemical residues in edible animal products. My work in the illegal tissue residue area helped establish the importance of the farm-to-table concept. I developed policy, educational materials, and training for state and federal inspectors. I dealt with numerous compliance actions involving tissue residues that helped establish the parameters for producers, animal dealers, haulers, auction markets, sale barns, and veterinarians, making the farm-to-table idea a household term.

Today, FDA‘s program includes the sharing of information between FDA and USDA, as well as collaborations with numerous state regulatory agencies, and an aggressive enforcement program. All the participants recognize the importance of protecting public health by controlling exposure to potentially unsafe drug and chemical residues in meat, milk, eggs, and honey.

They seek to assure that drugs being used with food-producing animals go through the appropriate pre-market approval process. They want to know that products are truthfully labeled and provide directions for use and precautions that allow producers of food animals to administer and use the drugs properly. The regulations call for safe meat and milk withdrawal times and require that drugs are manufactured under controls that assure a safe product. In addition, they require that distribution is controlled, especially when the drugs require a veterinarian’s prescription or when they are available through the internet.

Regulatory oversight in all of these areas will continue to be an important component of food safety. Manufacturers, distributors, and users of these products need to make sure they factor in the farm-to-table food safety concept as part of their marketing and use of these products on food animals.

EAS consultants are available to assist companies in ensuring their compliance with these requirements.

Who's Who at EAS:
Meet EAS Senior Consultant Gloria J. Dunnavan

Gloria Dunnavan EAS Senior Consultant Gloria Dunnavan is a leading expert in animal drug and feed regulations, and a former director of compliance for FDA’s Center for Veterinary Medicine. Ms. Dunnavan spent more than 35 years with the agency before becoming an independent consultant in 2008. She is a frequent speaker on CVM matters, and has been involved with planning and conducting numerous nationwide training sessions and workshops.

Her career began as a FDA Field Investigator in Nashville, Tennessee and Louisville, Kentucky. From 1979 to 1997, she worked as a Compliance Officer at CVM in Washington, D.C. In that role, she handled the Center’s most complicated and precedent-setting enforcement actions. For the next ten years, she served as CVM’s Director, Division of Compliance. She spent her final year in the Office of Compliance at FDA’s Center for Food Safety and Applied Nutrition, working on a special project for the agency’s Import Strategic Plan.

Ms. Dunnavan has had extensive experience working with organizations outside of FDA. For example, she collaborated with representatives of the European Union on a Mutual Recognition Agreement for drugs. In addition, she interacted with foreign government representatives on a BSE regulation and was the federal representative to intra and interagency work groups of federal, state and/or local officials. She was also active in several groups consisting of public and private participants including: the Food and Drug Law Institute, the Association of Food and Drug Officials, the Association of American Feed Control Officials, and the U.S. Animal Health Association. She has received numerous honors and awards including Vice President Gore’s Hammer Award, FDA’s Award of Merit, and the HHS Distinguished Service Awards.

She joined EAS as a contract consultant in November 2008.

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of September, 2009. 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
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action:
Former FDA International LACF Inspection Coordinator Joins EAS

Douglas R. Nelson Douglas R. Nelson, a former coordinator of FDA’s international low acid canned foods inspection efforts, is the newest addition to the growing EAS team of senior consultants. His thirty year career with the agency included 26 years with FDA’s Minneapolis District, based first in Milwaukee and later in Green Bay, Wis. In that role, he was involved in four major program areas: LACF and acidified canned foods; pesticides in food; mycotoxins and natural toxins in food; and food and animal feed contaminants.

He spent his last four years at FDA’s headquarters with the LACF team in the Center for Food Safety and Applied Nutrition, where his work included developing LACF inspection and training with FDA counterparts internationally and taking part in international inspections.

He is available to conduct audits and training related to acidified and low acid canneed foods, seafood HACCP, computerized process control,Part 11 compliance, import and export of foods, GMPs and quality assurance. “I am very pleased to have someone with Doug’s unique knowledge and experience to offer to our food and feed clients,” says EAS President Ed Steele.

Schwemer Leads Bio/Pharma Risk Management Workshop

Bill Schwemer EAS Senior Consultant Bill Schwemer led a pre-conference workshop on risk management at the 5th Annual Bio/Pharmaceutical and Medical Device Product Recalls Summit in Alexandria, Va., September 24-29. A former Associate Commissioner for Regulatory Affairs at FDA, Schwemer explored how the agency approaches risk assessment, risk management and risk communication. In addition, he offered practical advice on applying risk management models to bio/pharmaceuticals products.

Take the GMP Challenge Quiz
Upcoming Events
Food Labeling Compliance Review Seminar Rescheduled

The Food Labeling Compliance Review and Update scheduled for Oct 20-22 will be rescheduled for December 8-9,10. Please check the EAS website for the latest details.

The two-day food labeling seminar will be presented by Dr. James Hoadley and Ms. Gisela Leon. Dr. Hoadley was a senior regulatory scientist in the Office of Nutritional Products, Labeling and Dietary Supplements with primary responsibilities in food label claim regulations. In that position, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims. Gisela Leon is an EAS Consultant who is expert in U.S. labeling requirements, and is knowledgeable about the labeling laws in other nations throughout the world.

The Food Labeling Compliance Review Seminar is an ideal opportunity to apply learning in practical work sessions. The Update will explore issues that are not currently in the regulations but that may become requirements. The Update is also an opportunity to network with experienced label reviewers and to have your labeling questions addressed. Betty Campbell and other labeling experts will be on hand for the Update. Ms. Campbell served as the head of FDA's Office of Food Labeling and played a key role in writing and implementing the Nutrition Labeling and Education Act regulations.

In other upcoming EAS events:

The Dietary Supplement GMP Seminar, October 6-7, will review the current good manufacturing practice requirements for dietary supplements. This seminar will be presented by former FDA compliance officials, who will provide all the information needed to comply with the agency's new GMP rule, covering the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

The lab seminar originally scheduled for October 8-9 has been cancelled. Look out for future dates on which “Ensuring Regulatory Compliance of Dietary Supplement Laboratories” will be offered.

Other upcoming events include:

Dietary Supplement Labeling
December 2-3
Alexandria, VA

Check the EAS web site for details.
Order 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 valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell

Hardbound book		 $ 184.99
Food Labeling Compliance Review, 4th edition Food Labeling Compliance Review, 4th edition

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

Hardbound book and CD		 $ 209.99 / set
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