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 2009
In this Issue:
Upcoming EAS Events
  • Institute of Food Technologists Food Expo [more]

From the Desk of the President:
We Celebrate Our First Anniversary!

Dear Reader:

Ed Steele, President EAS-e-News, our “easy” summary of what’s new at the Food and Drug Administration-- and at EAS Consulting Group--turns one this month. It’s been quite a year, with FDA constantly in the media spotlight. Ironically, because of all the negative reporting, the agency may soon get the biggest ever boost in its budget. The Administration’s FDA budget request for fiscal year 2010 calls for almost a 20 percent increase, including $260 million extra for food safety programs.

As you know, FDA’s new dietary supplement GMP rule goes into effect later this month for companies with 20-500 employees. If your area of activity includes supplements, I encourage you to take our free GMP Challenge Quiz to check your understanding of the new requirements. The quiz is an excellent training tool that allows companies to test how well their managers and staff know the requirements. We have added a new set of questions this month. In addition to taking the quiz, you may also view the free EAS GMP Challenge webinar (recorded February 5) to hear FDA and EAS compliance experts discuss the most often misunderstood GMP issues.

In our Issue of the Month article for June, EAS Senior Consultant Eduardo (Ed) March explores how FDA deals with new products that contain two or more FDA-regulated components. A leading expert in the regulation of medical devices, he believes the agency’s Office of Combination Products will struggle to keep up with the pace of new product development. Ed is the featured consultant in our “Who’s Who at EAS” section.

In our April issue, I mentioned that I had attended an invitation-only Produce Safety Summit in Washington, D.C., which explored the implications of introducing mandatory standards for produce. See below for a summary of the findings of the newly released report from the Summit, which is posted on our website.

Over the past year, our expert consultants have explored what supplement companies tend to get wrong in their cGMP compliance efforts. Among other timely topics, they have also discussed the regulatory status of allergens, cosmetics, and stevia-derived sweeteners, as well as FDA’s uncertainty about how to implement a ban on the interstate shipment of foods containing approved drugs. As we look forward to another year, EAS-e-News will continue to offer quick reviews of FDA’s activities along with expert analysis by the EAS consulting team. I hope you continue to find these updates useful. Please feel free to share them with your colleagues.

Ed Steele Signature
Ed Steele,

Issue of the Month
How FDA Deals with Combination Products
By EAS Senior Consultant Eduardo March
The Food and Drug Administration is facing tough regulatory challenges from new products that contain two or more FDA-regulated components. The agency’s Office of Combination Products (OCP)—established in 2002 to tackle this emerging product category—will be hard-pressed to keep up with the pace of product development.

So far, most combination products assessed by the agency have been combinations of drugs and devices, or drugs, devices and biologics, or device and biologics. But in the future, agency officials may also be confronted with review of products that combine foods or dietary supplements or cosmetics with drugs and/or devices to achieve medical purposes.

The OCP plays the role of a gatekeeper and assigns combination products to a lead Center within the agency for review and approval. In 2007, the OCP reviewed three device/biologic, 13 drug/device/biologic and 20 drug/device combination products. The OCP relies on agency guidance and regulation and on an evaluation of the product’s specific therapeutic actions and mode of action.

The agency has defined the primary mode of action of a regulated product to be the most important effect of the product considering: what the product does, what is most important about its effect, and how it works. If the most important therapeutic action cannot be determined with reasonable certainty, the OCP relies on an algorithm to determine which center will have primary jurisdiction.

Combination products have been explicitly defined by the agency as “a product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.” Industry has tended to prefer that combination products be assigned to the Center for Medical Devices, based on the perception that its requirements, standards and measures for product approval are less rigorous than those used by the other FDA Centers.

As science and technology move forward, other types of combination products can be expected. For example, one can envision foods or dietary supplements or cosmetics being developed that include new technologies, such as nanotechnology, that are based on primary modes of action and biological effects that address any number of medical conditions or diseases. Although the agency has developed a reasonably transparent process for determining which organizational component should have primary jurisdiction, these determinations are likely to become increasingly difficult.

Who's Who at EAS:
Meet EAS Senior Consultant Eduardo March

Eduardo (Ed) March Eduardo (Ed) March has more than 27 years of experience in the medical device regulatory arena, both inside the Food and Drug Administration and in the regulated industry.

He joined EAS Consulting Group as a Senior Consultant in September 2007. Prior to joining EAS, he was director for quality assurance and regulatory affairs for a Maryland-based biotech company. He previously served as a regulatory consultant for AAC/Kendle International Inc., for more than a decade.

While at FDA, he specialized in the review of medical devices during the premarket approval stage. From 1981 to 1989, he was a senior biomedical engineering reviewer in the Office of Device Evaluation. From 1989 to 1993, he was assistant director of the Division of Standards Enforcement. He finished his FDA career as a compliance officer in the Center for Devices and Radiological Health.

Mr. March has extensive knowledge of regulatory compliance and quality systems used by FDA to regulate the medical device industry. He conducts pre-approval audits, current Good Manufacturing Practice audits of medical device manufacturers, and clinical study audits. He also advises clients on the preparation of submissions to obtain pre-market approvals and investigational device exemptions, as well as securing 510(k) clearance to market medical devices. In addition, he helps develop quality assurance systems and procedures that comply with the agency’s medical device requirements. And he conducts training in FDA’s device compliance regulations and approval processes.

As FDA Associate Director for Standards, he helped develop device-specific voluntary standards for the American Society of Testing and Materials, and the Association for the Advancement of Medical Instrumentation.

Mr. March has a degree in engineering from Virginia Polytechnic Institute, and a post graduate engineering degree from the Polytechnic Institute of New York. In addition, he has a degree in management from Frostburg State University. He also received certification from the Regulatory Affairs Professional Society.

“We are fortunate to have Ed on our team of expert consultants,” says EAS President Ed Steele. “Our medical device clients find his depth of knowledge and expertise really helpful.”

Slow International Progress Toward Harmonized Audits

The recent Food Safety Summit in Washington, D.C.,--at which EAS Consulting Group exhibited-- included two technical sessions on third-party audits. Both dealt with the painfully slow process of harmonizing international audits and food safety and quality certification standards. The first session explored the strong overlap between the Global Food Safety Initiative (GFSI) and the Codex Alimentarius Commission’s general principles of food hygiene. Because 181 member countries have already accepted the Codex standards, GFSI’s proponents hope to use the overlap to gain easier international acceptance of GFSI’s criteria.

According to Mark Overland, corporate certification manager for Cargill, who moderated the sessions, general acceptance of the GFSI in the United States would require three key elements: a public audit standard instead of the numerous proprietary standards that exist; accreditation of audit bodies to the international standard; and auditors that are qualified to the international standard.

With the exception of requirements for specific countries and for quality systems, Codex and GFSI criteria overlap by about 98 percent. If the quality and country regulations are included, the overlap is roughly 91 percent, Overland explained.

Codex Chair Karen Hulebak expressed concern about any moves to expand the international use of proprietary standards for third-party auditing. Jill Hollingsworth, vice president of food safety programs for the Food Marketing Institute, asked Kevin Swoffer, chair of the GFSI Technical Committee about the openness of the GFSI participatory process. Swoffer responded that the GFSI structure has changed a lot in the last two years, as it has broadened its scope from a concentration on Europe to include the rest of the world. Approximately half of the companies signed on to the GFSI are now U.S.-based.

Another participant asked about checks and balances in the GFSI on national accreditation bodies. Swoffer said he is currently working with the American National Standards Institute to understand how this works in the U.S.

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of May, 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
  • 05/14/2009 Safety of Fresh Produce
    David Acheson, M.D., F.R.C.P., before the House Committee on Agriculture, Subcommittee on Horticulture and Organic Agriculture
  • 05/07/2009 H1N1 Flu Virus (2009)
    Joshua M. Sharfstein, M.D., before the Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Enforcement Reports
What's New by Topic

EAS in Action:
Two Expert Consultants Join EAS Team

Two former FDA staffers, Shelly L. Maifarth and Martina E. LaGrange, have joined the growing EAS team of expert consultants.

Shelly L. Maifarth Ms. Maifarth had a 33-year career with the agency as a microbiologist, investigator and compliance officer in the Denver District Office. She trained FDA staff in FDA law, policy and procedures. She received FDA’s Compliance Officer of the Year Award in 2002. She retired from the agency in 2007 and joined Ms. LaGrange as an independent consultant. Her work now includes consulting for clients in the dietary supplement and medical device industries, specializing in compliance assessments, FDA relations and communication, training, and assistance with FDA policy, procedures, laws and regulations.

Martina E. LaGrange Ms. LaGrange was an FDA field investigator for 14 years, specializing in medical devices--first in the Seattle District Office and later in the Denver District Office. Her work included the training of FDA investigators on dietary supplement, medical device, clinical investigator, and pharmaceutical regulations. She also provided classroom training to the Regulatory Affairs Professional Society (RAPS), Colorado Medical Device Association (CMDA), American Society for Quality (ASQ), the American Association of Medical Instrumentation (AMMI), as well as other trade organizations. As a field investigator, she performed complex inspections around the globe at some of the nation’s largest manufacturers. She left the agency in 2003 and became an independent consultant. She specializes in mock FDA audits, gap analysis, implementing quality systems, SOP development, Adverse Event Reporting, and training.

“I am delighted to welcome two such experienced consultants to the EAS team,” said EAS President Ed Steele.

On Mandatory Standards for Produce

The organizers of the March 5 Produce Safety Summit in Washington, D.C. have just released a report on the event, which used simulated scenarios to explore the implications of introducing mandatory standards for fresh leafy greens. EAS President Ed Steele was among the more than 50 participants at the invitation-only event, which was presented by Booz Allen Hamilton, in cooperation with the Produce Safety Project at Georgetown University and the Woodrow Wilson International Center for Scholars.

The summit divided the participants into five teams for the purposes of the simulations, including a federal government team, a state and local government team, a customers team, a producers team, and a consumer protection organization team.

The report concludes that it will not be easy to achieve a balance between universal application of standards and accounting for differences between commodities and growing regions. Also, there is a risk of introducing inflexible new standards that will be hard to quickly adjust to reflect the latest scientific information. But mandatory standards are foreseeable and they will certainly improve the integrity of the food safety system, the report concludes.

The full report is posted on our website.

High Energy at NYSCC Supplier’s Day

Food Safety Summit EAS Senior Consultants William Schwemer and Norma Skolnick, who represented EAS Consulting Group at the annual Society of Cosmetic Chemists Suppliers’ Day in Edison New Jersey, May 12-13, were impressed with the level of energy and enthusiasm at the event. This was the first time EAS exhibited at the huge show. The EAS booth was well-attended, with many enquiries from companies working on new product development.

Full House at EAS GMP Seminar

On May 14-15, EAS instructors Robert Fish and William Ment presented the last public EAS GMP seminar prior to the June 25 effective date of FDA’s new GMP rule for firms with 20 to 500 employees. The fully booked session in Washington, D.C., was well-received by participants. Additional public seminars will be scheduled in the coming months. In addition, EAS consultants are available to give private, in-house seminars at any time by special arrangement. Contact Cathryn Sacra at (703) 684-4408 for details.

Hoadley and Greenberg Discuss Food Labeling

EAS Senior Consultants Dr. James Hoadley and Beatrice Greenberg joined other labeling experts as presenters at the Food Institute’s May 20 workshop in Newark, N.J., titled Food Labeling in Four Easy Pieces: The Basics & Beyond. Dr. Hoadley presented a session on label claims. Ms. Greenberg discussed labeling “tough spots,” including allergens, flavors, country of origin, and state issues. The seminar included an interactive session of hands-on food labeling, with audience discussion of actual food labels, aimed at avoiding costly mistakes.

EAS Vice President Campbell to Speak at Health Claims Webinar

Elizabeth (Betty) Campbell EAS Vice President Elizabeth (Betty) Campbell, will join Barbara O. Schneeman, director of FDA’s Office of Nutrition, Labeling and Dietary Supplements, for a June 30 webinar organized by the Food and Drug Law Institute. The event will be from 1:00 to 2:30 ET. The panelists will present prepared remarks which will be simultaneously displayed via internet and, in turn, will be followed by an open discussion. The program will include a review of FDA’s recent Warning Letter questioning the lawfulness of prominent health benefit claims made on the box label of “Cheerios.” The webinar will be moderated by Christopher L. Hagenbush, Partner, Patton Boggs LLP. For more details, visit http://www.fdli.org/conf/june-programs/claims.html.

Upcoming Events

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
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