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
 May 2009
In this Issue:
Upcoming EAS Events
  • EAS Dietary Supplement GMP Seminar [more]
  • Food Labeling in Four Easy Pieces - The Basics & Beyond [more]
  • NYSCC 2009 Supplier’s Day [more]
  • Institute of Food Technologists Food Expo [more]

From the Desk of the President:
FDA Shifts to Proactive Approach

Dear Reader:

Ed Steele, President Welcome to EAS-e-News, our free, monthly newsletter for industries regulated by the Food and Drug Administration. EAS-e-News provides a quick summary of FDA’s latest activities, along with a snapshot of what’s happening at EAS.

The new outbreak of Salmonella Saintpaul linked to raw alfalfa sprouts from multiple growers in multiple states highlights an ongoing problem with sprout seeds and the inability of sprout growers to reliably adhere to FDA’s Sprout Guidance issued ten years ago. The outbreak, which may be a continuation of one that began earlier this year, comes at a time when FDA officials are overextended as they attempt to cope with multiple recalls relating to peanut products and pistachios. Consumers, meanwhile, could be forgiven for saying “First tomatoes (peppers), then peanut butter, then pistachios, now sprouts. What’s next?”

I took part in an interesting panel discussion at the FDLI and FDA Annual Conference, held in Washington, D.C., April 22-23. The session featured Stephen Sundlof, director of FDA’s Center for Food Safety and Applied Nutrition, who has had quite a rollercoaster ride since taking that job last year. Not surprisingly, talk of the food recalls during the past year took up a considerable amount of the time. My take-home message from the session was that the Center will be more proactive in protecting public health and will not delay to await proof that suspect products have caused illness.

I was very pleased with last month’s response to our GMP Challenge Quiz, which is available free of charge on the EAS website. One company chose to have a group of its employees take the questions in order to individually assess their understanding of the new requirements. We have posted a new set of questions this month, so please feel free to take—or re-take—the quiz to help hone your knowledge of the Dietary Supplement GMP rule.

Because the agency’s new GMP requirements go into effect next month for dietary supplement companies with 20-500 employees, our “Issue of the Month” article focuses on typical weaknesses in compliance as seen by EAS Senior Consultant Robert C. Fish. Bob has conducted numerous gap analysis audits to assess compliance with the rule. An acknowledged expert in auditing and training related to FDA requirements, he is featured in our “Who’s Who at EAS” section this month.

They say it’s an ill wind that blows no one any good. And this is certainly true in the case of third-party audits of food processing facilities. Despite negative media reporting in connection with major recalls, auditing work has grown significantly during the economic downturn. I view the new attention to the quality of audits as a very positive trend.

I do hope you continue to find EAS-e-News updates useful and that you will feel free to use it interactively by sending me your comments or questions.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Are You Ready for the New GMP Rule?
By EAS Senior Consultant Robert C. Fish
Next month—the 25th to be precise—the Dietary Supplement GMP Rule, 21 CFR Part 111, goes into effect for dietary supplement firms that have 20 to 500 employees. As someone who has conducted “gap analysis” audits of many supplement manufacturers, I have seen that the new rules are presenting significant challenges.

What I have found in numerous audits conducted since the rule was published in June 2007—some as recent as the past few months--is that many companies still have a lot of work to do before they achieve compliance.

I have seen, for example, that some companies are finding it very challenging to establish component receipt and testing procedures, including qualifying Certificates of Analysis and conducting identity tests for all dietary ingredients.

Another frequent weakness I have seen is in documenting that production water at least meets the EPA Drinking Water Standard. Some manufacturers struggle to establish validated test methods for the testing of finished products or to develop reduced testing schemes for multi-ingredient products.

Another challenge I have found is in establishing Master Batch records that cover all of the rule’s required elements—including corrective action plans for whenever a specification is not met. Failing to document that all staff members are trained in compliance with the new regulation is another common weakness.

Some firms struggle with their laboratory requirements, such as establishing adequate procedures for the handling of reference standards, or for investigation of out-of-specification test results.

Are you sure your company is in compliance with the new requirements? Have you conducted a gap analysis or had one conducted to determine if you really are in compliance?

I am just one member of the experienced EAS Consulting Group auditing team, which is available for on-site gap analysis audits. In addition, EAS offers training on the new rule, either in-house or in public seminars. The next public course is scheduled for May 14-15. If you are too late to attend this one, keep checking the EAS website for the next seminar.

Who's Who at EAS:
Meet Senior Consultant Robert C. Fish

Robert (Bob) C. Fish Robert (Bob) C. Fish is a key member of the EAS consulting team and a recognized expert in auditing and training related to FDA regulatory requirements--especially for dietary supplements and pharmaceuticals.

Mr. Fish served 33-years with FDA in increasingly responsible roles as an investigator and manager, finally becoming the agency’s “chief inspector” as director of the Division of Field Investigations. In this role, he was responsible for general policy and guidance for the agency’s domestic and international investigational activities. He also managed the foreign inspection operations, and-- for four years--managed the oversight of field Import Operations.

Following his retirement from the agency in 1995, he joined AAC/Kendle as a Senior Consultant. He served as the Manager of Audits, provided regulatory advice to clients and performed audits of manufacturing facilities throughout the world. He joined EAS as a contract consultant in 2006.

At EAS, he continues his work as an auditor. In addition, he develops and implements training programs to address FDA regulatory requirements. He is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor.

“We are very fortunate to have someone of Bob’s caliber on our team of senior consultants,” says EAS Consulting Group President Ed Steele. “He is at your service for audits, training, or regulatory compliance advice.”

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of April, 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
  • April 30, 2009
    Joshua M. Sharfstein, M.D.
    Principal Deputy Commissioner and Acting Commissioner
    Subject: 2009-H1N1 Flu Virus
    Before: Subcommittee on Health
    Committee on Energy and Commerce
    House of Representatives
Enforcement Reports
What's New by Topic
EAS in Action:
Steele Joins FDLI Foods/Dietary Supplements Committee

FDLI and FDA Conference EAS President Ed Steele has joined the Food and Drug Law Institute’s Foods/Dietary Supplements Committee, which advises FDLI staff on policies, programs and publications of interest to the foods and dietary supplement industries. Prominent food and drug attorney Martin Hahn of Hogan & Hartson chairs the group, which includes other well-known attorneys, Steven Shapiro of Ullman, Shapiro and Ullman, and Marsha Wertzberger of Arent Fox. Other committee members include former USDA official Robert Post, now with the Center for Nutrition Policy and Promotion, and Dan Sowards, division director at the Texas Department of State Health Services. The group met in Washington, D.C., April 21—one day before the FDLI/FDA 52nd Annual Conference.

Reynolds Speaks on “Handling an FDA Inspection in the Age of GMPs” at Supplement Conference

EAS Consultant Carl Reynolds reviewed how to handle an FDA inspection “in the age of GMPs” during the SupplySide East meeting in Secaucus, N.J., April 27-29.

For example, it’s always a good idea to make any needed corrections during an inspection and to make sure the investigator is aware of the corrections. If that is not possible, it is best not to wait for a 483 Letter or Warning Letter, but to quickly send a letter to the agency committing to any needed corrective actions identified in the inspection, he advised.

Employees should not volunteer information. On the other hand, they should never give any misinformation or misleading information or guess in response to questions. Other advice on his list of common-sense preparations included:
  • Ensure that work areas kept in good order and that all equipment and instruments are kept clean and calibrated.
  • Make sure that logs and records are filled out completely and legibly.
  • Be professional, courteous and cooperative to inspectors and answer questions honestly and directly. It is usually acceptable to say “I don’t know” and to refer the inspector to the person who has the knowledge and the responsibility.
  • It is always best to be prepared, to know your job, your product and your procedures, as well as your equipment.
EAS Speaks to Food Processors on “Knowing Your Rights When Dealing with FDA”

Did you know that you are not required to sign any affidavits during an FDA inspection?

EAS Consultant Carl Reynolds discussed the limits of the agency’s authority in a presentation titled “Know Your Rights When Dealing with the FDA,” at the Texas Food Processors Association’s 32nd annual conference, held in Boerne, Texas, April 15-17.

He explained that it is important to know FDA’s authority with regard to access to records. For example, investigators must submit a written request for your shipping records. And they may not demand access to all records--unless they invoke the agency’s special authority under the Bioterrorism Act.

He also reviewed how to “manage” an inspection, and urged management to accompany the FDA investigators and take complete notes of all their activities. In addition, it is wise to keep duplicates of all FDA samples taken during an inspection. It is also prudent to keep matching sets of any labels or records supplied to the investigators. And remember to get receipts for any samples, he said.

Food Safety Summit Features Third-Party Audits

Food Safety SummitEAS Consulting Group was among the exhibitors at the Food Safety Summit, held in Washington, D.C., April 27-29. Despite the economic downturn, which has cut attendance at many trade shows, the event attracted the same number of participants as last year, according to the organizers. Capacity crowds attended educational sessions on third-party auditing and certification--a sure sign that audits are a priority issue for many food companies.

Two sessions focused on efforts to harmonize third-party audits and food safety and quality certification standards. The first explored the strong overlap between the Global Food Safety Initiative and the Codex Alimentarius Commission’s general principles of food hygiene. The second session featured a panel made up of federal officials, as well as industry and consumer representatives. It also included Codex Chair Karen Hulebak.

Many attendees who stopped at our booth were interested in the auditing services that EAS provides. And they were pleased to learn that EAS uses former FDA investigators with many years of regulatory experience to conduct our food safety audits.

Thanks to all who took time to stop by our booth to chat. And congratulations to Andrew Nichols, regional sales manager for National Quality Assurance in Waterford, Mich., winner of our drawing for an iPod Nano.

Upcoming Events
Seminars/Workshops

EAS Dietary Supplement GMP Seminar
  • May 14-15, 2009
    Evening Star Building
    Washington, D.C. 20004
    EAS Instructors: Robert Fish & William Ment
FDA’s new dietary supplement GMP Rule goes into effect on June 25, 2009 for firms of 20 to 500 employees. Are you prepared? Our final Dietary Supplement GMP Seminar before the deadline will be presented May 14-15 in Washington, D.C.

This program, presented by former FDA compliance officials, will provide all the information needed to comply with the agency’s final rule. It will also address the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved in testing, quality control and distribution of supplements.

EAS instructors Robert Fish and William Ment will present the seminar. Mr. Fish, a former agency investigator, has wide expertise in compliance matters and current GMPs as they relate to dietary supplements, pharmaceuticals, devices, and biologics manufacture. Mr. Ment, a former director in FDA’s Baltimore District Laboratory, has broad experience in auditing of QA programs for pharmaceutical and dietary supplement firms. He has been active in the training of industry personnel in FDA’s dietary supplement GMP regulations.

Click here for more details of this seminar.

Food Labeling in Four Easy Pieces - The Basics & Beyond
  • May 20, 2009
    Marriott Airport Hotel
    Newark, New Jersey
    EAS Instructors: Dr. James Hoadley and Beatrice Greenberg
EAS Senior Consultants Dr. James Hoadley and Beatrice Greenberg will be among the presenters at a Food Institute labeling workshop titled Food Labeling in Four Easy Pieces: The Basics & Beyond, at the Marriott Airport Hotel, Newark, N.J., May 20.

Ms. Greenberg will join Robert Post of USDA’s Center for Nutrition Policy and Promotion in a session on labeling “tough spots,” including allergens, flavors, country of origin, and state issues. Dr. Hoadley will present a session on label claims. Other instructors for the event will include attorney Robert Hahn, principal of Olsson Frank and Weeda, and Regina Hildwine, senior director for science policy, labeling and standards at the Grocery Manufacturers Association.

Click here for more details.

Tradeshows

NYSCC 2009 Supplier’s Day
  • May 12-13, 2009
    Edison, New Jersey
    Booth #933
Food Safety SummitEAS will also be among the exhibitors at the annual Society of Cosmetic Chemists Suppliers’ Day in Edison New Jersey on May 12-13. This two-day event sponsored by the New York Chapter, showcases the newest cosmetic products and the latest innovations from around the world. It is one of the largest events of its kind in the world! Visit us at booth 933 to learn how we can help with your U.S. regulatory requirements.

Institute of Food Technologists Food Expo
  • June 7-9, 2009
    Anaheim, Calif.
    Booth #419
Food Safety SummitThe IFT Annual Meeting and Food Expo is one of the biggest annual meetings for the food sector. Come visit us at booth 419.

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
To purchase any items listed above download our Order Form
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