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

From the Desk of the President:
What’s Ahead for Health Claims?

Dear Reader:

Ed Steele, President Welcome to the November issue of EAS-e-News, our quick round-up of activities at the Food and Drug Administration and of what’s new at EAS. In this issue, we focus on FDA’s health claims policy and explore what the future may hold in terms of compliance with the agency’s requirements.

EAS Senior Consultant James Hoadley, who played a leading role in reviewing health claim submissions during the latter half of his 20-year FDA career, is the author of our “Issue of the Month” article, Evolution of Health Claim Regulation in the U.S. Dr. Hoadley has been in great demand as a presenter and author on this topic, most recently at the American College of Nutrition’s annual meeting, held in Arlington, Virginia. He also contributed a chapter on the subject to a new book on nutraceutical and functional food regulations, published by Elsevier’s Academic Press. See details in our “EAS in Action” section. Dr. Hoadley is also the featured consultant in our “Who’s Who at EAS” section this month.

In other EAS activities, I attended the SupplySide West show in Las Vegas last month, and found that, despite the current economic uncertainty, participants exhibited the high energy and optimism that is characteristic of the industry. The show’s educational program featured a presentation by EAS Vice President Carl Reynolds on Good Manufacturing Practices for dietary supplements. I also had the pleasure of attending a reception on October 20 at the U.S. Department of State to honor the 163 Fellows from 90 countries who are participating in the 2008-2009 Hubert H. Humphrey Fellowship Program. EAS hosted Humphrey Fellow, Denis Pesut from Croatia for a six month internship earlier this year (See EAS-e-News, June 2008 issue).

In the meantime, we have firmed up arrangements for our December 9-10 dietary supplement labeling seminar in Salt Lake City (See details below). This has been a busy year for training. By year’s end, we expect to have held 17 seminars, including in-house and public events. Plans are currently being made to conduct additional (food labeling; dietary supplement GMP/ lab; and, OTC drug) seminars in early 2009. Look for details in upcoming issues of EAS-e-News.

One item among the links to FDA’s various websites drew my attention as I prepared this introduction. FDA Deputy Commissioner for Policy, Randall Lutter, in a guest participation in the “Andy’s Take” audio message for October 3, described the agency’s implementation of the FDA Amendments Act of 2007, as “a bit like remodeling a kitchen while continuing to cook in it.” I think that’s a very good analogy for the challenge facing the agency.

I hope you enjoy this issue of EAS-e-News. Please feel free to forward it to your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Who's Who at EAS:
Meet EAS Senior Consultant James E. Hoadley, Ph.D.

James Hoadley James Hoadley joined the EAS consulting team in October 2007 after a 20-year career with the Food and Drug Administration. He brought an impressive track record, having been involved in reviewing almost all health claim petitions received by FDA’s Center for Food Safety and Applied Nutrition over the previous decade.

Dr. Hoadley spent those ten years as a senior regulatory scientist in CFSAN’s Office of Nutritional Products, Labeling and Dietary Supplements with primary responsibility for food label claim regulations. He was involved in some of the agency’s most precedent-setting health claim regulatory problems, as CFSAN evolved in response to the FDA Modernization Act provision for authorization of food label claims based on authoritative statements, as well as to the 1999 Pearson v. Shalala federal court decision that led to qualified health claims, and to Pearson-related lawsuits.

Dr. Hoadley’s work with the agency began in 1987 as a research scientist in CFSAN’s nutrition division. He later worked as a toxicologist, performing food additive and GRAS petition safety reviews in FDA’s Office of Premarket Approval. He took part in the development and implementation of the Nutrition Labeling and Education Act.

Dr. Hoadley earned his Ph.D. in toxicology at the University of Cincinnati College of Medicine, and did postdoctoral research in nutrition at the University of Florida. He received his Bachelor of Science degree from Ohio State University.

His energy and enthusiasm is apparent in his consulting work on behalf of EAS, as well as in his voluntary efforts as a Boy Scout troop leader (See EAS-e-News, October 2008 issue).

Issue of the Month
Evolution of Health Claim Regulation in the U.S.
By James E. Hoadley, Ph.D., Senior Consultant
FDA’s food label health claim policies have evolved from the original 1990 Nutrition Labeling and Education Act (NLEA) health claim provisions--and they continue to evolve. The act made the agency the sole gatekeeper of the health claim authorization process. Some of that gatekeeper authority has since been lost, but the agency may still deny claims if new scientific evidence does not support them.

NLEA required the agency to issue regulations authorizing health claims if there was significant scientific agreement that the claim was substantiated by scientific evidence. The act defined a health claim as a label statement characterizing a relationship between a nutrient and a disease or health related condition. FDA substituted the term “substance” for “nutrient” in the NLEA health claim definition to ensure that dietary supplement ingredients were covered by the agency’s regulation of health claims. A “substance” includes specific foods or components of foods, such as vitamins, minerals, herbs or other similar nutritional substances.

Some of FDA’s gatekeeper authority was lost with the 1997 FDA Modernization Act, which provided a bypass of FDA’s health claim regulation process. Under FDAMA, health claims based on authoritative statements of federal scientific bodies (other than FDA) would be authorized, without FDA issuing regulations, simply by notifying FDA, at least 180-days prior using the new claim. To date there are only five authoritative statement health claims.

The 1999 Pearson Federal Appeals Court decision brought the biggest change in FDA health claim policy. The Pearson decision said the First Amendment did not permit FDA to prohibit health claims for which the scientific evidence to support the claim fell short of the significant scientific agreement standard. Because the court instructed FDA to permit claims based on the existence of any credible evidence for the claim, FDA drafted formal guidance as to what constitutes “credible scientific evidence” (Evidence-Based Review System for the Scientific Evaluation of Health Claims, July 2007). Instead of issuing regulations, FDA permits the use of qualified health claims through “enforcement discretion” letters.

FDA still retains some of its gatekeeper role. The agency must permit a qualified health claim if there is any credible evidence to support the claim. But FDA determines what constitutes “credible evidence.” Also, the less credible evidence there is to support a claim, the more qualifying language FDA can require to explain to consumers the limitations of the supporting science, and FDA decides what the qualifying language will be. The qualifying language required of some of the more recent qualified health claims permitted by FDA has dampened interest in such claims.

FDA is now re-evaluating several authorized health claims under the “credible scientific evidence” standard. The claims under review include two significant scientific agreement claims (for lipids/cancer and soy protein/heart disease), and two qualified health claims (for antioxidant vitamins/cancer and selenium/cancer). Based on new evidence, the agency indicated that it is doubtful that these claims are still substantiated.

Whatever the outcome of the current re-evaluation, it is certain that the agency’s approach to health claims will continue to evolve.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of October, 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
October Archive of The FDA this Week: Andy's Take
Enforcement Reports
What's New by Topic
EAS in Action:
Reynolds Speaks at SupplySide West Seminar

SupplySide West 2008 EAS Vice President Carl Reynolds was among the featured speakers last month at an advanced course on dietary supplement GMPs, presented October 21-22 by the Natural Products Association as part of the educational program at SupplySide West, in Las Vegas, Nevada.

The seminar focused on the provisions of FDA’s final GMP rule, which established new mandatory requirements for dietary supplement manufacturers and dietary supplement distributors. The course was aimed at companies with a good understanding of current GMPs, but with a need for additional insights on how to implement the new rule.

The seminar included:
  • A comprehensive discussion of FDA’s GMP requirements including establishing and confirming specifications, QC personnel responsibilities, laboratory operations, scientifically valid analytical methods, raw materials and finished product testing requirements, and change control
  • Developing GMP-compliant SOPs, master manufacturing and batch production records, and other required documentation
  • Working with your suppliers and other vendors to ensure quality and consistency in meeting GMP compliance
  • Third-party certification
  • How to handle visits from the FDA
  • Tips on getting started incorporating new FDA GMP requirements within your company’s current GMP systems
  • An opportunity for technical question and answer discussion with industry GMP experts
  • Group activity regarding establishing regulatory specifications
Other presenters at the session included Cindy Beehner, President, Quality Design Systems, and Aaron Secrist, Director of Quality, Nature’s Way. Mr. Secrist offered an industry insider’s perspective on compliance with the new rule.

Steele Attends CRN Symposium on Dietary Supplements

Council for Responsible Nutrition Annual Symposium in New Mexico EAS President Ed Steele attended the Council for Responsible Nutrition’s annual symposium on dietary supplements in Santa Ana Pueblo, New Mexico, October 2-5.

At the event, CRN President and CEO Steve Mister—although strongly optimistic about the future of the industry—highlighted some of the challenges it will likely face next year.

Food safety legislation will most certainly be high on the agenda for the new Congress in 2009, he predicted. Agenda items will include country-of-origin labeling, border inspections, third party certification, and fees, including inspection fees, import fees, and facilities fees, he said.

In addition, a new report by the Government Accountability Office on dietary supplements, expected early in the New Year, will draw the attention of Congress to the industry, he said. At FDA, meanwhile, the agency’s widely anticipated guidance on new dietary ingredient notifications and further implementation of GMPs are just two items on the agenda, Mister said.

Other featured speakers at the event included: FDA Associate Commissioner for Foods, David Acheson; Director of the National Center for Complementary and Alternative Medicine, Dr. Josephine Briggs; and Dan Roam, author of The Back of the Napkin: Solving Problems and Selling Ideas with Pictures.

The CRN event coincided with the Albuquerque International Balloon Fiesta.

EAS Consultant Reviews Health Claim Regs at ACN Meeting

American College of Nutrition EAS Senior Consultant James Hoadley offered a Food and Drug Administration perspective on food label claims in a presentation at the 49th annual meeting of the American College of Nutrition, held in Arlington, Virginia, October 2-5.

Dr. Hoadley was among the featured presenters at a symposium on the regulation of nutraceuticals, functional foods and health claims. The session’s key goals were to assess regulations governing claims, to discuss the quality and safety of dietary supplements, and to summarize global food regulations.

Dr. Hoadley’s presentation drew on his book chapter titled “FDA Perspectives on Food Label Claims in the USA,” which appeared in the recently published "Nutraceutical and Functional Food Regulations in the United States and Around the World," published by Elsevier’s Academic Press.

The book’s editor, Debasis Bagchi, a professor of pharmacology and pharmaceutical sciences at the University of Houston, Texas, was a co-moderator of the ACN symposium, along with Sidney Stohs, senior vice president of research and development at Advocare International, Carrollton, Texas.
Upcoming Events

EAS Dietary Supplement Labeling Seminar

EAS is now accepting registrations for its upcoming Dietary Supplement Labeling Seminar, which will be held in Salt Lake City, Utah, December 9-10.

Now that FDA’s final GMP rule is in place, the agency is expected to give higher priority to the regulation of dietary supplements, along with an increased focus on labeling compliance. This intensive training seminar will explain how to prepare labels that comply with FDA requirements, and will address mandatory labeling elements and allowable dietary supplement claims.

Dietary Supplement Labeling Seminar Attendees will participate in work groups to boost their understanding of the regulations. Each participant will receive a copy of the popular labeling reference, Dietary Supplement Labeling Compliance Review, 3rd edition, an EAS Type Size Guide and copies of all seminar slides to use for reference purposes.

The instructors for the seminar will be EAS consultants James Hoadley and Gisela Leon. Dr. Hoadley spent the last decade of his 20-year FDA career as a senior scientist in the Office of Nutritional Products, Labeling and Dietary Supplements, with prime responsibilities in food label claim regulations. Ms. Leon worked for 20 years as the director of quality management of a large German food firm, where she became expert in Europe’s food labeling laws and regulations. She has since gained expertise in U.S. food labeling requirements.

Visit www.easconsultinggroup.com for more information.

Not including the upcoming Salt Lake City event, EAS has held 17 seminars so far this year. Twelve of those were held “in-house” for employees of individual companies, while the remaining five were public seminars open to all participants.

The breakdown of seminars by topic was:
  • Dietary Supplement GMPs (three in-house, two public),
  • Dietary Supplement GMP for Managers (one in-house),
  • Dietary Supplement Labeling Compliance, (four in-house),
  • Ensuring Regulatory Compliance of Dietary Supplement Laboratories (one in-house, two public),
  • Food Labeling (two in-house, one public), and
  • OTC Drug Labeling (one in-house).
By having EAS conduct training programs at your facility, the program can be tailored to your needs and can involve all those that need the training at one time. More and more companies are finding the “in-house” seminars to be a cost effective alternative to sending individual staff members to out-of-town seminars.

Contact Ed Steele at 703-684-4468 to discuss your training needs.
EAS Pocket Guide to Dietary Supplement GMPs

Do your employees need a quick reminder of the Food and Drug Administration’s final Good Manufacturing Practice rule for dietary supplements? Because the majority of firms in the industry must be in compliance with the new rule by June 2009, now is a good time to think about staff training.

EAS, easy-to-use pocket guide to 21 CFR Part 111 In addition to GMP training programs and gap assessments, EAS offers a reprint of 21 CFR Part 111 in a handy pocket guide format.

“This guide offers a simple way to become really familiar with the requirements,” says EAS President Ed Steele. “We suggest that each employee within the firm with a role to play in GMP compliance be given a copy.”

The four- by six-inch pocket guide is designed to fit into the shirt pockets of managers and plant personnel involved with the manufacturing, packaging, labeling or holding operations for dietary supplements.

The guide provides:
  • A reminder of the importance of GMP compliance.
  • A ready reference for the requirements.
  • A way to ensure that employees can not claim to be unaware of the GMP requirements.
The guide costs $7 to $10 dollars, depending on the quantity purchased.
To order pocket guides and other EAS publications and regulatury tools see below.
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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