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
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From the Desk of the President:
Welcome to the Second Issue of EAS-e-News

Dear Reader:

Ed Steele, President It is my pleasure once again to introduce you to EAS-e-News, our free, monthly newsletter for industries regulated by the Food and Drug Administration. I greatly appreciated the many positive comments on our first edition.

The goal of these updates is to offer insights into FDA’s activities, while letting you know what EAS is doing to help with your regulatory needs.

FDA shifted into crisis mode last month in response to the outbreak of Salmonella Saintpaul linked to raw tomatoes. Stung by complaints over its response to previous outbreaks, the agency struggled to warn consumers of the risks without shutting down an entire industry. It tried to limit the damage to growers by identifying those states and countries that were not believed to be sources of the contaminated produce.

Responding to outbreaks will always be a challenge for FDA, especially as most outbreaks are well advanced by the time the agency gets involved and most produce-related outbreaks are not traced to a source. Our “What’s New on FDA’s Website” section includes the “Andy’s Take” audio commentary on the tomato outbreak from FDA Commissioner Andrew von Eschenbach.

In this issue, we feature an analysis of FDA’s approach to allergens by EAS Vice President Elizabeth Campbell. She says the dietary supplement industry needs a better understanding of Food Allergy Labeling and Consumer Protection Act (FALCPA) requirements since EAS is finding that many supplement manufacturers do not realize that the law applies to them. Ms. Campbell is also featured in our “Who’s Who at EAS” section.

Elsewhere we report on a recent presentation by EAS Senior Consultant Dr. James Hoadley, a former senior regulatory scientist at FDA, who discussed the evolution of the agency’s thinking on health claims.

In addition to these insights from our experts, this e-publication is designed to cut through the increasing clutter of information from FDA and other sources. I do hope you like EAS-e-News and that you will share it with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
A Look at Current Activity in Implementing the Food Allergen Labeling Law
By EAS Vice President Elizabeth (Betty) Campbell
The dietary supplement industry needs a better understanding of Food Allergy Labeling and Consumer Protection Act (FALCPA) requirements. Many supplement manufacturers do not realize that the law applies to them and affects the labels of such common dietary ingredients as glucosamine (which need to identify the shellfish species) and fish oil (which need to identify the fish species).

Congress enacted the FALCPA in 2004, with an enforcement date of January 1, 2006. The law defined “major food allergens” and required label declaration of the plain language name of each major food allergen present as an ingredient in the food. The “big eight” allergens are milk, eggs, peanuts, tree nuts, fish, crustacean shellfish, and wheat. This set of eight foods and food categories are responsible for about 90 percent of food allergy reactions in the United States.

One provision of the law was that the presence of a major food allergen had to be declared, even for those ingredients exempt from declaration under the ingredient provisions (e.g., flavors and incidental additives). The name of the allergen had to be on the label. The food industry struggled to identify all the allergens that had been exempt from ingredient declaration prior to the law. Industry had to re-label much of their product.

Now, the market is changing and what was a burdensome requirement is becoming a new niche marketing approach. Foods that are “free from” an offending ingredient or substance are being developed and marketed in this fast-growing niche. The Washington Post reported, in a June 8 article (“Food Allergies Trigger Multibillion-Dollar Specialty Market,”), that “the market for food allergy and intolerance products is projected to reach $3.9 billion this year.” Large food companies and small companies, many of them new, are marketing foods on the basis that they are “free from” a particular allergen or other offending substance, the report said.

As required by FACLPA, FDA proposed a definition for “gluten free” claims. Previously, there had not been an FDA position on “gluten free.” It is likely that this proposed policy gave many food manufacturers the confidence to use the term. The market for “gluten free” foods is expected to increase from $700 million in 2006 to $1.3 billion in 2010, The Washington Post reported.

Even though we have provided advice and training since FALCPA was enacted in 2004, EAS consultants still find errors on clients’ labels and a need for clarification of the provisions.

As often happens with FDA labeling policies, even those with major food safety significance, it is taking longer than was hoped to inform all of industry of the policy and to get the correct information on all labels.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of June, 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
June Archive of The FDA this Week: Andy's Take
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action:
IFT Food Science Awards Go to Representatives DeLauro, Whitfield

The Institute of Food Technologists gave its 2008 Congressional Support for Science Award to representatives Rosa DeLauro (D-Conn.) and Ed Whitfield (R-Ky).

The annual award is for distinguished service by legislators or policy-makers in advancing the role of science and technology in food and agricultural policies. It is presented to two members of Congress as an acknowledgment of outstanding contributions to science-based food policies during the previous year.

EAS Consulting Group President Ed Steele (pictured here with Rep. DeLauro and IFT Executive Vice President Barbara Byrd Keenan) attended the June 4 award presentation in Washington, D.C.

Ed Steele with rep. Rosa DeLauro and Barbara Byrd Keenan Rep. DeLauro serves as chair of the Appropriations Committee’s subcommittee for agriculture, rural development, FDA and related agencies. She has worked hard this year to secure funding for a safe food supply. For the fiscal year 2009 appropriations bill, her subcommittee voted to fund FDA at $282 million above the Administration’s budget request and at $1.6 billion above the requested USDA budget.

Rep. DeLauro is a co-founder of the Congressional Food Safety Caucus.

“We are very proud to recognize Congresswoman DeLauro for her dedication to making the U.S. food supply safe and nutritious for consumers,” said IFT President John Floros.

Rep. Whitfield serves on the House Committee on Energy and Commerce and is the ranking member on its Commerce, Trade, and Consumer Protection Subcommittee. He offered strong support for a range of agriculture and food assistance programs in the Food and Energy Security Act of 2007, better known as the Farm Bill.

“Rep. Whitfield’s unique knowledge of farming operations has positioned him as an important voice on a range of food issues from farm-to-fork, and this award recognizes his dedication,” Floros said.

In a separate IFT-related activity, EAS was an exhibitor at the institute’s annual meeting and expo, held this year in New Orleans, June 28-July 1. The event drew an estimated 22,000 participants.

EAS Signs on Consultant in Paris, France

Freddy Vaede, Ph.D., joined EAS last month as a contract consultant based in Paris, France.

Dr. Vaede is an expert in good manufacturing practices and quality for active pharmaceutical ingredients and dosage forms. He specializes in supporting GMP manufacturing sites in Europe and Asia, helping them in their preparation for FDA and European inspections, and in managing the inspections, where needed.

“I am thrilled to welcome Dr. Vaede to our team,” said EAS President Ed Steele. “As an EAS Contract Consultant, he is now available as an expert in GMP and quality matters for audits, assessments, and support for APIs and Dosage Form sites worldwide.”

Dr. Vaede is an analytical chemist with 35 years of experience with multinational pharmaceutical companies. He is a former head of quality at ICI-Pharma (now Astra-Zeneca), and at Rhône-Poulenc (now Sanofi-Aventis).

Dr. Vaede took part in the preparation of corporate quality and GMP guidelines/standards for Rhône-Poulenc Rorer, Aventis, and Sanofi-Aventis. Among his other responsibilities, he was in charge of many of the audits performed in manufacturing sites worldwide. In addition, he was responsible for managing quality risks for APIs from biological sources.

EAS Consultant Discusses Label Elements, Claims

EAS Senior Consultant Dr. James Hoadley took part in a food labeling training seminar early last month in Newark, N.J., along with Robert Hahn of the Washington, D.C. law firm Olsson Frank Weeda Terman Bode Matz. The day-long seminar was presented by The Food Institute.

Dr. James Hoadley in a Training Seminar In a December 21, 2007 Federal Register notice, Hoadley explained, FDA announced a re-evaluation of the scientific evidence for two regulated “significant scientific agreement” health claims and two “qualified health claims.” These re-evaluations, he said, will follow an evidence-based review system rather than the original Nutrition Labeling and Education Act “totality of available scientific evidence” system.

“This puts people on notice that a couple of existing health claims may be revoked,” he said.

A toxicologist and nutritionist, Dr. Hoadley joined EAS in October 2007 after retiring from FDA, where he was directly involved in the scientific review of nearly all health claim petitions received by FDA’s Center for Food Safety and Applied Nutrition over the past decade.

In his Newark presentation, Dr. Hoadley focused on mandatory food label elements and label claims. He explained how the agency’s approach to health claims has evolved since the passage of the Nutrition Labeling and Education Act of 1990 and he predicted that the evolution will continue.

The FDA Modernization Act of 1997, for example, provided for health claims based on an authoritative statement from other U.S. government scientific bodies or the National Academy of Science, as opposed to FDA’s own determination of significant scientific agreement.

In his 20 years with the agency, Hoadley worked as a research scientist in the nutrition division of the Center for Food Safety and Applied Nutrition, and later as a toxicologist, performing food additive and GRAS petition safety reviews in the Office of Premarket Approval. In addition, he participated in the development of nutrition labeling and health claim regulations implementing the NLEA.

Over the past ten years, he was a senior regulatory scientist in the Office of Nutritional Products, Labeling and Dietary Supplements with primary responsibilities in food label claim regulations. He was involved in some of the most precedent-setting health claim regulatory problems, as CFSAN adapted to the FDA Modernization Act’s requirement for authorization of food label claims based on authoritative statements.

Who's Who at EAS:
Meet EAS Vice President, Elizabeth Campbell

Elizabeth (Betty) Campbell Elizabeth (Betty) Campbell brought formidable expertise in food product regulation to the EAS Consulting Group when she joined as Vice President in October 2006. Ms. Campbell spent 35 years working at the FDA in various capacities, including Acting Director in the Office of Food Labeling at the Center for Food Safety and Applied Nutrition.

After serving 10 years as a chemist in the FDA’s New Orleans and Atlanta district offices, Ms. Campbell transferred to Washington, D.C., where she joined the agency’s Guidelines and Compliance Research Branch. From there, she moved into other roles culminating in her role as Acting Director in the Office of Food Labeling. Much of her time at the FDA was spent in developing regulations for food. She played a leading role in writing the regulations implementing the Nutrition Labeling and Education Act (NLEA) in the 1990s.

Once the NLEA regulations were written, she was responsible for implementing key elements, including training industry personnel and regulatory officials, developing an enforcement strategy, and guiding policy decisions. She also helped develop current FDA policies on claims under the Dietary Supplement Health and Education Act, and the FDA Modernization Act of 1997.

Ms. Campbell participated in the NAFTA Technical Working Group on Packaging and Labeling as the head of the U.S. delegation, and in several Codex Alimentarius committees. She also served as a U.S. delegate to the Codex Committee on Food Labeling.

She joined AAC/Kendle in 1999 as a senior consultant, where she shared her extensive experience in food guidelines with clients throughout the world. Ms. Campbell can review food labels for compliance with FDA regulations and provide expert advice and strategies. Her knowledge also extends to regulations and guidance documents concerning chemical contaminants, filth in food, and other issues gleaned from her years at the FDA.

EAS Consulting Group is fortunate to have someone of Ms. Campbell’s experience to help clients in need of advice on food regulations and labels. She will be happy to share her expertise with your company.

Upcoming Events

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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 value labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell

Hardbound book and CD		 $ 199.99 / set
Food Labeling Compliance Review, 4th edition Food Labeling Compliance Review, 4th edition

A value labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell.

Hardbound book and CD		 $ 199.99 / set
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