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 October 2008
In this Issue:
Upcoming EAS Events
  • Dietary Supplement Labeling Compliance Review Seminar [more]

From the Desk of the President:
FDA and the Regulation of New Products

Dear Reader:

Ed Steele, President Welcome to the October issue of EAS-e-News, our snapshot of what’s going on within the Food and Drug Administration and our update on the latest activities at EAS.

In this issue, we lead with a look at the agency’s uncertainty about how to implement a ban on the interstate shipment of foods containing approved drugs. EAS Senior Consultant Jeffrey Springer says now is the time for food and drug firms to let the regulators know how best to proceed with implementation of Section 912 of the Federal Food Drug and Cosmetic Act. Mr. Springer, a former senior attorney in FDA’s Office of the Chief Counsel, is also the subject of our “Who’s Who at EAS” section this month.

The combination of drugs with foods has its counterpart trend in the personal care arena, where manufacturers are developing “beauty from the inside” products using nutritional components. EAS Senior Consultants William Schwemer and James Hoadley discussed FDA’s regulatory approach to these products, in presentations at a special summit held during the HBA expo in New York last month. At FDA, meanwhile, a six-month FDA hiring spree has boosted the agency’s workforce by 1,300 staffers. But the government’s expensive moves to restore equilibrium to financial markets are likely to result in a tougher overall budget environment, which will make it harder to find additional funding for FDA in future years. Without more funding, the agency may be unable to properly implement major new initiatives such as its expanded oversight of imports or its Sentinel Initiative for monitoring medical product safety.

Our “EAS in Action” section features a commemoration of the 50th anniversary of the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The anniversary had a special significance for us at EAS since Arthur A. Checchi, the founder of AAC Consulting Group—the company from which we were formed—played a key role in the development of the Amendment. It happens to coincide with our second anniversary since EAS Consulting Group was established as an independent company on October 1, 2006.

The September 15 commemoration drew senior attorneys, FDA staffers and others who have worked with the implementation of the landmark legislation throughout much of their careers. I attended the event along with EAS Senior Consultant George Pauli.

On a lighter note, we feature a walk in the woods by EAS Senior Consultant James Hoadley. A former senior regulatory scientist in FDA’s Office of Nutritional Products, Labeling and Dietary Supplements, Mr. Hoadley brings the same energy to his work on behalf of our clients. I am very pleased to have him on the EAS team.

This is a very busy time at EAS, with two dietary supplement seminars scheduled early this month and another planned for early December. See the full details below. Once again, I hope you enjoy our free, monthly publication and I invite you share it with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Who's Who at EAS:
Meet EAS Senior Consultant Jeffrey B. Springer

Jeffrey B. Springer Jeff Springer is a key member of the EAS team. He joined the group as a contract consultant in 2006, bringing 33 years of experience as an attorney in FDA’s Office of the Chief Counsel. With a broad background in managing legal reviews and litigation, Mr. Springer provides a wide range of regulatory consulting services, especially for product compliance and general strategy.

After he received his law degree in 1968 from the Georgetown University Law Center, he became a trial attorney for the FDA, representing the agency in civil and criminal enforcement cases as well as in defensive and appellate litigation in court. He went on to become Special Assistant to the Chief Counsel.

In 1975 he became the Deputy for Regulations and Hearings. This required him to manage the legal review and clearance of agency regulations, the program review services, and administrative hearings. He became the Deputy Chief Counsel in 1979, a position he held for 20 years. In that position, he provided legal service and advice to high-ranking FDA officials, and represented the FDA for activities involving other federal agencies.

His final role at the FDA was as a Senior Advisor to the Chief Counsel. He was responsible for the redesign and reorganization of the agency’s law office and also managed the attorney recruitment and selection program.

Mr. Springer can provide regulatory expertise on a wide range of issues, including the implications for your business of the Food and Drug Administration Amendments Act.

Issue of the Month
Section 912 – An Enigma for FDA
By Jeffrey B. Springer, Senior Consultant
About one year ago, on September 27, 2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85). This law represented a very significant addition to FDA authority. The primary purpose of the law (commonly referred to as the FDAAA) was to reauthorize four existing laws that were set to expire and enhance the postmarket authorities of FDA concerning the safety of drugs. FDA has been diligently working to implement the new law.

One of the provisions of the FDAAA that is being implemented by the agency is section 912. This provision added a new prohibition [21 U.S.C. 331(ll)] to the Federal Food, Drug, and Cosmetic Act. Section 912 prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 912 also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been public. Section 912 provides four exemptions from the prohibitions. Although there is congressional legislative history of the FDAAA, section 912 is not addressed in that history.

Section 912 was effective upon the enactment of the FDAAA. However, approximately ten months after enactment, FDA indicated that the agency was having difficulty implementing the new prohibition. In the Federal Register of July 29, 2008 (73 Fed. Reg. 43937), the agency acknowledged that section 912 “presents a number of questions of statutory interpretation for FDA to consider.”

FDA included a series of questions concerning factors for the agency to consider and the impact of various interpretations. The agency requested that “interested persons submit data, information, and other comments that will help provide a context for the agency‘s decisions on implementation of this provision.” Written or electronic comments are due by October 27, 2008.

When the language of a statute is silent or ambiguous on a particular issue, an administrative agency is permitted to give the statute a reasonable construction, and that construction is entitled to judicial deference.

In light of the impact and consequences of section 912, we recommend that the food and drug industries take advantage of the opportunity to participate in this important regulatory proceeding that will resolve the uncertainty and mystery of section 912.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of September, 2008. 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
September Archive of The FDA this Week: Andy's Take
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action:
Food Additives Amendment Turns Fifty

Food Additives Amendment Turns Fifty Many prominent regulators, lawyers and other food industry professionals have spent much of their careers dealing with the consequences of the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act.

EAS Senior Consultant George Pauli joined his former colleagues, Bob Lake and Al Rulis, as panelists at a September 15 event in College Park, MD, held to commemorate the 50th anniversary of the passage of the landmark bill.

Speakers at the anniversary event included Suzanne White Junod, FDA's historian, who discussed chemicals added to food prior to 1958.

Frederick Degnan, now a partner in the law firm King & Spalding, who spent more than eleven years as Associate Chief Counsel in FDA’s Office of General Counsel, shared his experience as a food additive litigator.

Former Director of FDA’s Center for Food Safety and Applied Nutrition Joseph Levitt, made a presentation on behalf of the FDA Alumni Association. Levitt left the agency in December 2003 to become a partner in Hogan & Hartson.

Other featured speakers included another former CFSAN Director, Sanford Miller, who is currently an affiliate professor with the Joint Institute for Food Safety and Applied Nutrition at the University of Maryland. He discussed the “intersection of science and policy at FDA.”

Former FDA Deputy Commissioner for Policy, Michael Taylor, who is now a research professor at George Washington University, explored what lies ahead for food additive regulation.

Jerome Heckman of the law firm Keller & Heckman, shared his thoughts on how the regulatory environment has unfolded over the past 50 years.

Even consumer advocates participated in the anniversary. Michael Jacobson, executive director of the Center for Science in the Public Interest, looked at the food additive laws with “50 years of hindsight.” Early in his career, Jacobson wrote a book titled Eater's Digest: The Consumer's Fact-Book of Food Additives.

Says Pauli: "As one who has always tried to understand food additive regulation by learning how we got to where we are, I particularly enjoyed Ms. Junod's discussion of earlier issues, Mr. Degnan's anecdotes on trying to convince a southern judge about what GRAS means, and Mr. Heckman's experience lobbying the legislators in 1958."

HBA Expo Explores New Product Directions

Ed Steele greets guests at HBA booth Congratulations to Barry W. Sanel of Packaging Advisors, Carmel, N.Y., who won a free ipod at the EAS exhibit during the HBA Global Exposition and Educational Conference, in New York, September 9-11.

The event and the booth were well-attended, with some of the attention focused on the development by cosmetics manufacturers of nutritional products with claims that they enhance beauty from the inside.

“This is a new product area for many of the manufacturers, but we have the expertise needed to help them work through any regulatory issues that may arise,” said EAS President Ed Steele.

Two EAS senior consultants—both former FDA officials—made presentations at the HBA Safety, Regulatory and Certification Summit, which took place during the expo. James Hoadley, former senior regulatory scientist in FDA’s Office of Nutritional Products, Labeling and Dietary Supplements, discussed the labeling of “beauty from the inside” products. And William Schwemer, former Special Assistant to the Deputy FDA Commissioner for Policy, reviewed the regulatory implications of transfers between pharma and the personal care industry. His presentation emphasized the importance of low-risk product manufacturers complying with requirements for Current Good Manufacturing Practices which pharma pioneered.

“We were very pleased with the level of interest in EAS at the HBA show,” Steele said.

EAS Consultant Takes a Hike

EAS Consultant Takes a Hike EAS Senior Consultant James E. Hoadley puts his creativity and leadership abilities to good use even when he is not working on behalf of clients. Last month, he led a Boy Scout troop on a hike into the Monongahela National Forest in West Virginia.

While camping in the Seneca Creek Backcountry Area, he showed the scouts how to make shelters from Tyvek-type house wrap. The material costs only a few dollars and can be turned into shelters that are roomier and lighter than standard tents. He also showed them how to make their own backpacking stoves out of aluminum cans. These take up less weight than equipment bought in stores—and best of all, they are free.

“I stress the philosophy of light weight and do-it-yourself,” he says.

His troop camped along Seneca Creek—one of the few remaining East Coast streams with native (not stocked) brook trout. They also made the climb from the creek to the summit of Spruce Knob—the highest point in West Virginia.

Jim brings the same “can do” attitude and enthusiasm to his consulting work for EAS.

Upcoming Events

Seminars

EAS Supplement Seminars Includes Case Studies
  • Dietary Supplement GMP Seminar
    September 30 - October 1, 2008
    Alexandria, VA
  • Ensuring Regulatory Compliance of Dietary Supplement Laboratories
    October 2-3, 2008
    Alexandria, VA
Participants in our September 30-October 1 seminar in Alexandria, VA, on good manufacturing practices for dietary supplement, learned how to apply FDA’s new GMP rule using specific case studies. The intensive two-day training by former FDA compliance officers William Ment and Robert Fish—who are now EAS Senior Consultants—detailed the responsibilities of firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with testing, quality control and distribution. Among other key insights, participants learned how to deal with returned dietary supplements, product complaints and recordkeeping.

Our separate two-day seminar “Ensuring Regulatory Compliance of Dietary supplement Laboratories,” in Alexandria, VA, October 2-3—also being presented by Mr. Ment and Mr. Fish—will explore key control elements, including testing, the physical lab facility and CGMPs, lab personnel issues and sampling plans, among others. Day two will address documentation, contracting of lab services, analytical methods, reference standards, material reviews and managing FDA inspections. Participants will learn how to deal with CGMP gaps and to implement the 15 key laboratory quality systems. They will see examples of lab CGMP deficiencies from FDA-483 drug citations and will get advice on how to demonstrate CGMP compliance.

Mr. Ment is a former director of FDA’s Baltimore District Laboratory. Mr. Fish is a former director of FDA’s Division of Field Operations.

In response to growing demand, we have scheduled an additional supplement labeling seminar December 9-10, 2008 in Salt Lake City, Utah. Visit www.easconsultinggroup.com for more information on this intensive training program.
Useful 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, 2008