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
 February 2010
In this Issue:
Upcoming EAS Events
  • Food Safety Summit [more]
  • Dietary Supplement GMP Seminar [more]

From the Desk of the President:
FDA Seeks Transparency, Revisits BPA

Ed Steele, President Dear Reader,

Welcome to the February issue of EAS-e-News, our free monthly newsletter for industries regulated by the Food and Drug Administration.

The agency launched a transparency initiative last month aimed at making its inner workings more open to the public. Our “Issue of the Month” article, by EAS-e-News Editor Declan Conroy, looks at how future phases of this initiative may intersect with the Freedom of Information Act.

FDA’s recent response to concerns about the use of bisphenol A in food contact materials underscored that the agency faces a regulatory hurdle with regard to BPA, which was originally approved via a food additive regulation rather than the current approach for a food contact notification from each manufacturer. Because it is approved by food additive regulations, any manufacturer of food or food packaging may use it in compliance with those regulations without any requirement to notify the agency about each use, or to disclose various BPA-based formulations. It would require a lengthy process of rulemaking to revoke a regulation for one or more uses of BPA.

The agency is exploring its regulatory options, but says it will encourage manufacturers to voluntarily submit a food contact notification for currently marketed uses of BPA-containing materials, which would allow for increased oversight.

As you may know, the agency has appointed its first ever Deputy Commissioner for Foods, Michael Taylor. The move is part of a plan to elevate the status of food programs. Taylor, who is acknowledged to be one of the nation’s leading food policy experts, joined the agency last summer as senior advisor to Commissioner Margaret Hamburg. He formerly held senior positions at USDA and FDA, so he knows his way around.

At EAS, meanwhile, we continue to expand our own team of senior consultants. I am pleased to announce that former FDA staffer John Yount, an outstanding auditor and trainer, is the latest addition to the team (see details below).

In other EAS news, Senior Consultant William Ment reviewed frequent deficiencies in current GMP compliance by dietary supplement manufacturers, in a presentation at the FDLI Hot Topics session in Washington, D.C., January 27.

As always, I hope you find our quick round-up of FDA news useful in cutting through the clutter and I encourage you to share EAS-e-News with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
FDA Goes Transparent
By EAS Consulting Editor Declan Conroy
The Food and Drug Administration rolled out the first of a three-phase effort to increase the agency’s transparency, with the online release of “FDA Basics,” which offers answers to questions such as “who is the FDA and how does the agency work?” Principal Deputy Commissioner Joshua Sharfstein said the first phase was directed at consumers, not because that was a priority, but because it was easier to do quickly.

The transparency effort will get much more complicated in subsequent phases which will tackle the agency’s interaction with the regulated community. How, for example, will better transparency impact information that is currently available only by invoking the Freedom of Information Act? According to Sharfstein, the transparency activities should help indirectly with material that is currently covered by FOIA. But he said that the “incredible task of redaction” of information to remove sensitive commercial information is what causes most of the delay in supplying FOIA material. And that will still be required.

The second phase of the transparency effort, which the agency hopes to roll out at the end of February, will deal with information that is not currently available to the public. The third phase, planned for a couple of months later, according to Sharfstein, will address transparency with the regulated industry over such things as the status of applications.

As part of the transparency initiative, the agency’s centers and offices will host a series of online sessions in which senior staffers will discuss specific topics and answer questions. The tentative schedule for upcoming months includes:
  • February: Access to Investigational Drugs
  • March: The Inspection Process
  • April: Safeguarding the Food Supply Against BSE
  • May: Indoor Tanning: The Risks of Ultraviolet Rays
  • June: One Year Anniversary of the Tobacco Control Act
  • July: Protecting the Safety of the Blood Supply
  • August: Using a Food Label to Make Smart Food Choices

Who's Who at EAS:
Meet EAS-e-News Consulting Editor Declan Conroy

Declan Conroy Declan Conroy, a native of Dublin, Ireland, has been a regulatory reporter and editor in Washington, D.C., since 1989, specializing in the Food and Drug Administration and related agencies.

His work has included editorial roles in King Publishing Group, Food Chemical News, and Pike & Fischer (a Bureau of National Affairs subsidiary). In January 2004, he launched Setanta Publishing, LLC, a company specializing in regulatory information products. He currently publishes Food Protection Report, a regulatory round-up for food safety professionals, and Food Talk, which offers sanitation tips for food workers, based on the latest FDA model Food Code.

He is a member of the Specialized Information Publishers Association, the International Association for Food Protection, the Capitol Area Food Protection Association and the Alexandria Food Safety Advisory Council.

“As the editor of EAS-e-News and other EAS publications, Declan has been of tremendous value to our company”, says EAS President Ed Steele.

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of January, 2010. 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
Enforcement Reports
What's New by Topic
EAS in Action:
EAS Gains Access to FDA’s Electronic Gateway

EAS now has a secure connection with FDA’s Electronic Submission Gateway (ESG). This allows EAS to transmit electronic submissions to CDER, CBER, CDRH, CMV, OC, and the Center for Tobacco on behalf of our clients.

The Gateway operates as a central transmission point and automatically routes submissions to the proper FDA center or office. The agency plans to extend the Gateway’s capabilities to accept:
  • Electronic submissions for the Center for Food Safety and Applied Nutrition;
  • Electronic submissions for the Office of Orphan Product Designations; and
  • Vaccine Adverse Event Reports (VAERS).
The list of possible submissions will grow as FDA extends the Gateway’s capability to new operational units and issues new electronic submission guidance documents.

EAS Adds Yet More Pharmaceutical Power

John Yount Former FDA staffer John Yount, who is now a leading auditor and trainer for pharmaceutical firms, has joined the EAS network of senior consultants.

Mr. Yount began his 34-year FDA career as an inspector and advanced to become assistant regional director for FDA’s Southwest District. Prior to that role, he was director of investigations in the Denver District office and served as a supervisory investigator and investigator for several years. He held special credentials for clinical investigations and had extensive experience in all industries regulated by FDA. In addition, he served as a trainer for several of the agency’s national training programs, including courses on law and evidence development for FDA investigators and HACCP.

After leaving the agency in 1998, he joined AAC/Kendle as a senior consultant. Since 2005, he has been with J&L Pharmaceutical Consulting. His auditing work has included Good Clinical Practices, Good Manufacturing Practices--for finished dosage forms as well as active pharmaceuticals--and Good Laboratory Procedures. His international work has included audits of vaccine production facilities in Europe, including vaccine intermediates for phase I, and II clinical studies. He has considerable experience in audits of plants producing medical gas by air separation and by chemical production.

“I am delighted to welcome a former colleague to our team of senior consultants,” says EAS President Ed Steele. “With his broad experience and expertise, he is a valuable new resource, especially for our pharma clients.”

Dietary Supplement GMP Seminar Scheduled

As the Food and Drug Administration gears up for what is likely to be a more stringent compliance effort focused on good manufacturing practices (GMPs) for dietary supplements, EAS is conducting seminars to train the industry on the agency’s final rule. Our next dietary supplement GMP seminar will be held at the EAS headquarters in Alexandria, VA, April 27-28.

This intensive training program covers 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.

Instructors for the upcoming event will be EAS Senior Consultants William Ment and Dean Cirotta. Mr. Ment, a former FDA laboratory director, is a regular instructor in EAS seminars, where he shares his insights on the agency and its approach to regulation and compliance. Mr. Cirotta has 20 years of industry experience, including senior management roles with responsibility for regulatory affairs, compliance and quality assurance.

Check the EAS web site for program and registration details, or contact Cathryn Sacra at (703) 684-4438.

William Ment Speaks at FDLI Hot Topics Conference

William Ment EAS Senior Consultant William Ment reviewed the many dietary supplement cGMP deficiencies typically seen in EAS gap assessments, in a presentation at the Food and Drug Law Institute’s Food Hot Topics conference in Washington, D.C., January 27.

Attorney Martin Hahn of Hogan and Hartson moderated this half-day conference devoted to FDA’s Implementation of the Dietary Supplement GMP regulations. Brad Williams, manager of FDA’s Division of Dietary Supplement Programs, spoke about the requirements of the new rule and how FDA is going about its initial inspections of the industry. Small firms with 20 or less employees become subject to rule in June of this year.

Many of the issues identified in EAS gap assessments are the same as those uncovered by FDA during their initial inspections. According to Ment, frequent problems identified include SOP and recordkeeping deviations. Some manufacturers have no SOPs for significant GMP activities, such as master manufacturing and batch production records, for example. Ment also discussed other areas in which common deficiencies have been found including sanitation, personnel clothing and training issues, deficiencies in the equipment and utensils, product and process controls, and failures in packaging, labeling, and recordkeeping.
Upcoming Events

Food Safety Summit
April 13-14, 2010
Convention Center
Washington, D.C.
Booth 520

Dietary Supplement GMP Seminar
April 27-28, 2010
EAS Headquarters
Alexandria, VA
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
Share EAS-e-News with a colleague by email. Note the newsletter is copyright protected.
Contact EAS Consulting Group for permission to reuse any contents.
© EAS Consulting Group, LLC, 2010