EAS Consulting Group, LLC — EAS-e-NEWS — Current FDA Issues of Interest
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EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 December 2009
In this Issue:

From the Desk of the President:
A Time for Creative Energy

Ed Steele, President Dear Reader,

Welcome to the December issue of EAS-e-News, our quick round-up of activities at the Food and Drug Administration—and a look at what's new at EAS.

As we enter the Holiday Season and prepare for a new year, I see some parallels between FDA and EAS Consulting Group. Both are experiencing a steady infusion of creative energy with the arrival of new and talented personnel. Both have had a good year in spite of a difficult economic climate. And both are looking at further expansion in 2010.

In this regard, I am delighted to welcome Charles "Chris" Celeste as EAS Director of Regulatory Information and Submissions. A former colleague, Chris joins us from Kendle Regulatory Affairs. He is featured in our "Who's Who at EAS" section and is the author of our Issue of the Month article on FDA's switch to electronic drug establishment registration and drug product listing.

Chris will soon be working from our new satellite office in Rockville, MD once final arrangements are made and the office is equipped to prepare and process submissions. Look for details in next month's edition of EAS-e-News.

I am also very pleased to announce the addition of two new EAS Senior Consultants, Dean Cirotta and Les Pounds, both of whom bring a wealth of talent and experience to our consulting team (see details below).

One issue that we will be tracking closely in the new year is FDA's handling of tobacco products. It is not clear how aggressive the agency will be in implementing its new regulatory authority under the Family Smoking Prevention and Tobacco Control Act (see below). But we can expect Commissioner Margaret Hamburg, with her strong public health background, to try to do as much as the law will allow to protect public health. This will likely result in new compliance initiatives and new labeling requirements. And the agency may take a similar consumer-oriented approach with regard to other product safety concerns.

The entire EAS team is looking forward to keeping you well-prepared for whatever compliance hurdles the regulators may create for your products

I would like to take this opportunity to wish you a peaceful Holiday Season and a most prosperous New Year!

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
FDA's Electronic Drug Establishment Registration and Drug Product Listing
By Chris Celeste, EAS Director of Regulatory Information and Submissions
Since the Food and Drug Administration's switch to electronic registration of drug establishment facilities and drug product listings on June 1, 2009, I have been hearing from clients who are concerned about the new registration process. As with any new procedure, it can be a challenge to get past the initial "deer in the headlights" stage.

The key change, of course, is that FDA's Drug Registration and Listing System Office will no longer be accepting paper registration (Form 2656) and product listings (Form 2657 and 2658). But the information that was traditionally required on forms 2656, 2657 and 2658 is still relevant for an electronic submission, with the addition of some new information.

A notable change is the requirement for a "D-U-N-S® Number." This is a proprietary number issued to firms by Dun & Bradstreet. Another change for foreign registrants is the requirement to provide the name, telephone number, e-mail address and D-U-N-S® Number of the importer.

There are three basic types of submissions in the registration and listing process: A Labeler Code Request, which can include a request for a labeler code or transmission of a firm's labeler code; An Establishment Registration Request, which can include a request for establishment registration or transmission of information on facilities previously registered with the FDA; and Product Listing, which includes listing of any new or previously listed products (Rx, OTC, API, etc.)

Once the forms are prepared and validated they can only be submitted to the FDA via the FDA Electronic Submissions Gateway (ESG), which provides a secure connection. FDA encourages firms to establish ESG accounts as soon as possible to avoid delays in the registration process.

The electronic information is coded using a standard called Structured Product Labeling (SPL), which is used in regulatory guidance documents and in software applications for the exchange of product labeling documents. The FDA has provided tools to help in completing the electronic registration process, including: an SPL Starter Pack; Pragmatic Validator Lite™ (for validation of SPL labeling, establishment registrations and product listings); and training sessions. In addition, it shares information on an SPL Work-Group Wiki page, which includes discussions and guidance on the SPL standard.

EAS Consulting Group is available to assist you in preparing and submitting all the necessary registration and listing forms and in obtaining your DUNS number. I highly recommend that you check your current registration status to ensure that your facility registration is up to date.

Who's Who at EAS:
Meet the EAS Director of Regulatory Information and Submissions

Charles EAS has greatly expanded its regulatory compliance services to the pharmaceutical industry with the addition of Charles "Chris" Celeste as Director of Regulatory Information and Submissions.

Chris joins EAS from Kendle Regulatory Affairs (formerly AAC Consulting Group). EAS was established as an independent company in October 2006, before which it was a division of AAC Consulting Group.

Chris was most recently Director of Regulatory Operations and Intelligence in Kendle's Rockville Office. In this position, he was responsible for preparing and coordinating the submission of various sponsor applications (INDs, ANDAs NDAs, DMFs, and VMFs in non-CTD, CTD, and eCTD formats) to FDA. He has assisted sponsors with the preparation and submission of electronic Drug Establishment Registration and Drug Product Listings, import issues and general regulatory questions. He began working at Kendle (then AAC) in 1990 as a Freedom of Information Act Coordinator. In this role, he was responsible for coordinating all of the activity of the Information Services Division, including, supervising the research associates and the weekly publication of the "FDA News & Information." He has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.

"We are thrilled to welcome Chris on board," says EAS President Ed Steele. "He brings a depth of regulatory knowledge and consulting experience that will enable EAS to significantly boost its activities in the pharmaceuticals arena. His expertise in regulatory submissions for INDs, NDAs, ANDAs, and DMFs, will be an enormous asset to our clients."

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of November, 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:
EAS Expands its Senior Consulting Team

EAS Consulting Group continues the steady expansion of its team of senior consultants with the addition of Dean Cirotta and Les Pounds.

Dean Cirotta Mr. Cirotta has 20 years of pharmaceuticals experience in regulatory affairs, corporate quality and operations. His early career included work with Glaxo, Shionogi Qualicaps, and Merz Pharmaceuticals. In 1999, he joined King Pharmaceuticals as a senior director of regulatory affairs. He subsequently became vice president of global regulatory affairs for the pharmaceutical division of Bausch & Lomb in Rochester, N.Y. Most recently, he was president and chief operating officer of UPM Pharmaceuticals in Baltimore, MD.

Les Pounds Mr. Pounds is an expert in product safety, who spent the early portion of his career with the Food and Drug Administration, as an investigator, supervisor and trainer. Later, he joined the U.S. Consumer Product Safety Commission, where he directed an office that enforced federal product safety laws in a ten-state region. From 1995 -1998, he worked as an international consultant with the Food and Agriculture Organization, where he advised leaders of developing nations on the creation of systems to ensure the safety and quality of food. Most recently, he has worked as an independent consultant. In this role, he has advised attorneys in law cases arising from dietary supplements alleged to have contained levels of metals in excess of label information and recommended daily allowances.

"I am delighted to welcome Dean and Les to the EAS team," says EAS President Ed Steele. "Because of their wide-ranging experience and their depth of regulatory knowledge, they will be most useful to our clients."

EAS Keeping on Top of Agency's Regulation of Tobacco

EAS will be closely monitoring FDA's moves to implement its new regulatory authority for tobacco products under the Family Smoking Prevention and Tobacco Control Act signed into law on June 22.

The new law authorizes the agency to restrict manufacturers from using terms such as "light," "mild" and "low," for example, unless they can show that the labeled product is less harmful than the standard product.

The bill calls on the agency to require the disclosure of ingredients in tobacco products for the first time. It also requires tobacco companies to expand the size of warning labels so that they cover 50 percent of a pack, and to include graphic images of the health effects of tobacco.

The legislation empowers the agency to control nicotine levels in tobacco products and to ban most cigarette flavorings, such as cherry and other fruit flavors, because of their appeal to children.

The legislation also calls for a new tobacco center within FDA, to be funded by new fees estimated to top $500 million by 2013.

The agency extended a September 29 deadline for public comment on its regulation of tobacco products (docket number FDA-2009-0294) and set December 28 as the new deadline. As of November 29, more than 800 comments had been submitted, many from private individuals urging the agency not to restrict their personal choices.

EAS Teaches Industry How to Comply With Dietary Supplement Labeling Regulations

Participants at the EAS Dietary Supplement Labeling seminar, which is being held at the EAS training facility in Alexandria, VA., December 2-3, will learn how to prepare labels that comply with FDA requirements, including mandatory labeling elements and allowable dietary supplement claims.

The seminar is designed for individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of dietary supplements, including those responsible for preparing or reviewing labels. Participants get an opportunity to apply learning in practical work sessions to facilitate their understanding of the regulations. They also receive the popular EAS Consulting Group hardback labeling reference, Dietary Supplement Labeling Compliance Review.

Instructors for the seminar are EAS Senior Consultant James Hoadley, Ph.D., and EAS Consultant Gisela Leon. Dr. Hoadley is a former senior regulatory scientist in FDA's Office of Nutritional Products, Labeling and Dietary Supplements. Prior to joining EAS, he was involved in the scientific review and drafting of authorizing regulation, or denials, of nearly all health claim petitions received by FDA's Center for food Safety and Applied Nutrition over the previous decade. Ms. Leon, a former director of quality management for Schöller Lebensmittel GmbH in Germany, is knowledgeable about labeling laws throughout the world, in addition to being an expert in U.S. regulations.

EAS seminars are also offered in-house by special arrangement, so the program to be tailored to your particular needs. This can be a cost-effective way to train numerous employees at one time.

Visit the EAS web site for more 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
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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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