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 September 2008
In this Issue:
Upcoming EAS Events
  • Dietary Supplement GMP Seminar [more]
  • Ensuring Regulatory Compliance of Dietary Supplement Laboratories [more]
  • Dietary Supplement Labeling Compliance Review Seminar [more]
  • HBA Global Expo and Educational Conference [more]

From the Desk of the President:
Focus on Food Additives

Dear Reader:

Ed Steele, President EAS-e-News (pronounced “Easy” news) aims to provide a convenient window on the Food and Drug Administration’s activities, along with insights from our consultants on regulatory issues in the news. In addition, the publication outlines what our experts can do to help you in your interactions with the agency.

In this issue, we focus on food additives, and specifically on how the agency may respond to two GRAS notifications for stevia-derived ingredients. Senior Consultant Dr. Madhu Soni explores the long-running stevia saga and says that the agency may soon approve certain stevia-derived sweeteners as food ingredients, based on the latest toxicological safety data.

In another food additive initiative, the agency issued a final rule August 22 allowing irradiation, up to a maximum absorbed dose of 4.0 kilogray, of fresh iceberg lettuce and fresh spinach, for control of pathogens and for extension of shelf-life. Notwithstanding the industry’s desperate need for safe, new interventions to control pathogens in those products, the 30-day comment period is likely to draw protests from long-time opponents of the technology.

Our “Who’s Who at EAS” section for this month features George H. Pauli Ph.D., who is a leading expert in food additive regulation. He played a leading role in FDA’s shift from a GRAS petition process to a notification process.

In EAS-related news, I am delighted to report that the group is growing rapidly and is on track to significantly increase its 2007 revenues this year. See the “EAS in Action” section below for details. In addition, I am pleased to announce this month that I have agreed to chair the Communications Committee for the FDA Alumni Association. FDAAA is a very active non-lobbying group that—among its other important activities—plays a key role in maintaining agency access to the institutional memory of former FDA staffers.

In other EAS news, with the increased attention to dietary supplement claims, we have scheduled a Dietary Supplement Labeling seminar, to be held December 9-10 in Salt Lake City, Utah, conveniently located near many of the industry’s major manufacturers. I invite you to consider attending this popular seminar as well as the dietary supplement GMP and lab seminars previously announced.

Once again, I welcome you to our free, monthly publication and I hope you will continue to find it an informative and useful tool. Please feel free to share it with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Who's Who at EAS:
Meet EAS Senior Consultant George H. Pauli, Ph.D.

George H. Pauli EAS Senior Consultant George Pauli is a leading expert in food additive regulations, with nearly 29 years of FDA experience.

Dr. Pauli began his FDA career in 1977, retiring from the agency’s Center for Food Safety and Applied Nutrition in March 2006, where he was associate director for science and policy in the Office of Food Additive Safety. In 2004 he served as acting director of that office.

Dr. Pauli started his agency career as a consumer safety officer in the Petition Control Branch of the Division of Food and Color Additives, working mainly on indirect additive petitions, food irradiation, and the cyclic review of food additives. In 1981 he was named a supervisor and oversaw decisions on several color additive regulations, as well as indirect additive regulations and irradiated food regulations. At that time he directed development of the first decisions implementing FDA’s carcinogenic constituents policy.

In 1985, Dr. Pauli was named head of the Food Additive Policy Staff, a group created to work on difficult or unprecedented issues. In 1990 he was named chief of the newly created Novel Ingredients and Biotechnology Branch where he recruited new consumer safety officers for the Division of Food and Color Additives, and oversaw development of documents on emerging issues such as genetically engineered plants and novel ingredients, including olestra.

Following the major CFSAN reorganization in 1992, he became director of the center’s Division of Product Policy, the organization responsible for genetically engineered foods and other issues where policy had not yet been established. In this role, he headed efforts at reinventing government by replacing the GRAS petition and regulation process with a notification process and by establishing a formal collaborative process with USDA’s Food Safety and Inspection Service, to coordinate decisions on food ingredients added to meat and poultry products.

Dr. Pauli received numerous awards during his career including the FDA Award of Merit, the agency’s highest honor. He has served on expert panels for the World Health Organization and the International Atomic Energy Agency regarding irradiation of foods.

He joined AAC/Kendle as a contract consultant in 2006 and is now available to share his knowledge and experience with EAS Consulting Group clients.

Issue of the Month
The Long Race to Market a Non-Calorie Sweetener
By Madhu Soni, Ph.D., Senior Consultant
The Food and Drug Administration is currently reviewing two Generally Recognized as Safe notifications for a purified form of a non-calorie ingredient sweetener derived from stevia. New scientific data supporting its safe use may finally open the door for the marketing of this product as a food ingredient in the United States.

The race to market stevia or its derivatives as a sweetener in the U.S. began in the 1970s, driven by consumer demand for low-calorie food alternatives. The FDA challenged the legality of its use as a food additive in the 1980s, citing a lack of toxicological safety data. In 1995, the agency said that its use in dietary supplements is legal, as part of the implementation of the Dietary Supplement Health and Education Act of 1994.

The intense sweetener is prepared from the leaves of Stevia rebaudiana Bertoni, a plant grown in South and Central America. Extracts prepared from the leaves are 30-40 times sweeter than sucrose. Glycosides from the plant are up to 300 times sweeter than sugar.

Although not yet approved as a food additive in Europe and the United States, stevia is approved for marketing as a food ingredient in many countries, including Japan, Korea, Brazil and China.

In May of this year, Cargill Inc., and Whole Earth LLC submitted separate GRAS notifications for Rebaudioside A purified from stevia. The notifications cited new data on Rebaudioside A and also addressed unresolved questions from earlier studies with crude stevia extracts. Cargill published a series of articles on the safety of Rebaudioside A (Rebiana) for general use in sweetening foods and beverages. These publications, which included data from multi-generational safety and human clinical trials, appear to support the GRAS determination.

Some marketers have tried to work around the regulations by sweetening beverages with stevia and labeling them as dietary supplements. In such cases, the regulators look at the intended use of the product. Last year, FDA sent a warning letter to one company suggesting that its beverages containing stevia were adulterated, because they were conventional foods marketed as dietary supplements.

Self-affirmed GRAS

To secure FDA regulatory approval for marketing an ingredient, such as a derivative of stevia, as a sweetener one must submit a successful food additive petition, although such a petition and FDA approval are not required if one can demonstrate that use is generally recognized by qualified scientists to be safe. The self-affirmed GRAS notification process requires the same quantity and quality of scientific evidence as for approval of the substance as a food additive. But many companies are unwilling to risk marketing an ingredient based on their GRAS determination without first notifying FDA of the basis for their GRAS conclusion and receiving a “no question asked” letter from FDA to ensure that the agency has no objection.

The agency's goal is to respond to GRAS notifications within 180 days, although complicated issues can take longer. Watch upcoming issues of EAS-e-News for analysis of FDA’s response.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of August, 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
August Archive of The FDA this Week: Andy's Take
Congressional Testimony
  • July 31, 2008
    David Acheson, M.D., F.R.C.P.
    Associate Commissioner for Foods Subject: Salmonella Saintpaul Outbreak Investigation
    Before: Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, United States House of Representatives
Enforcement Reports
What's New by Topic
EAS in Action:
EAS Anticipates Strong Growth in 2008

EAS is growing rapidly EAS Consulting Group is growing rapidly and is on track to significantly increase its 2007 revenues this year. Much of the growth in earnings can be attributed to the company’s international activities.

“I am very pleased with the strong growth in our food, dietary supplement, drug, medical device and cosmetic business and expect that trend to continue,” says EAS President Ed Steele.

The company currently has more than 450 clients in 40 countries, including some of the largest corporations in the world, as well as many small and medium sized firms.

EAS now supplies services in: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cypress, Dominican Republic, Egypt, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kenya, Korea, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Singapore, South Africa, Switzerland, Thailand, Trinidad & Tobago, Turkey, the United Kingdom, and the U.S.A..

Because of the dramatic increase in demand for its services, EAS is entering partnership arrangements with knowledgeable consultants in other regions of the world, to provide clients with assistance in complying with foreign regulatory requirements.

In addition to its consulting, training and auditing activities, EAS also acts as the U.S. Agent for purposes of food facility registration for more than 120 foreign companies as required by the Bioterrorism Act of 2002.

HBA Show Approaching Soon (9/9-11)

HBA Global Exposition and Education Conference With just a few days left before the HBA Global Expo, EAS Consulting Group is pleased to extend an invitation for a Complimentary Guest Pass (valued at $25) for the show if you register online at www.hbaexpo.com!
  • HBA Global Expo
    September 9-11, 2008
    Jacob K. Javits Convention Center, New York City
To register online for a FREE Exhibit Hall Pass Compliments of EAS Consulting Group follow these simple instructions:
  • Click thru to www.hbaexpo.com “Register Now” and complete registration details.
  • Enter PRIORITY CODE EXH295 while registering.
  • Submit your registration and print a copy of the confirmation.
    • (An e-mail confirmation will follow within 24 hours.)
EAS Senior Consultant James Hoadley, Ph.D. will offer regulatory insights on the labeling of so-called “beauty from the inside” products at the HBA Safety, Regulatory and Certification Summit, in New York, September 10. The one-day symposium is part of the HBA expo.

Dr. Hoadley is stepping in for EAS Vice President Elizabeth Campbell. As scheduled, EAS Senior Consultant William Schwemer will discuss regulatory transfer between pharmaceuticals and personal care industries.

Hoadley and Schwemer will be joining EAS President Ed Steele at the EAS exhibit booth at the HBA expo, so please drop by and see them at booth 1149.

For more details, see www.hbaexpo.com.

Steele to Assume Communications Role for FDA Alumni

FDA Alumni Association EAS President Ed Steele has agreed to chair the Communications Committee for the Food and Drug Administration Alumni Association (FDAAA).

Founded in 2001, FDAAA is a non-profit, non-lobbying group that offers numerous educational programs and helps former FDAers keep in touch with each other and with the agency.

“FDAAA makes a major contribution, both to the former FDA staffers and by making their institutional memory available to the agency,” Mr. Steele says.

The group’s goals include enabling former colleagues to stay up-to-date on scientific and regulatory issues facing FDA. In addition, the group aims to educate the public about FDA’s work and to promote interest in public health careers. It also helps the agency in recruiting alumni with specialized expertise and institutional knowledge during critical situations. FDAAA also consults with foreign governments on the establishment and operation of their regulatory programs.

Other FDAAA activities include honoring exceptional contributions to public health by former FDA employees and other individuals. The association entered into a formal Memorandum of Understanding with FDA in 2003, which authorizes joint efforts.

Mr. Steele had a 30-year career with the agency, starting as an FDA analytical chemist in the New York District in 1964. He later moved to FDA Headquarters in Washington, D.C., where he held various positions of increasing responsibility at the Center for Food Safety and Applied Nutrition. In addition to managing FDA’s compliance and industry programs, he provided support to the center’s director on all science policy matters. He also served as a Division Director in the Office of Seafood, coordinated international affairs, and managed CFSAN’s education and technical assistance programs.

Mr. Steele joined AAC/Kendle in 1994 as vice president of the Food, Dietary Supplement and Cosmetic Consulting Division. He later served as president of AAC/Kendle in Rockville, MD. In October 2006 he formed EAS Consulting Group.

“I consider it a privilege to be asked by Tony Celeste, FDAAA President, to head the association’s communications activities,” he says. Steele’s appointment is expected to become official at the next meeting of the Board in October.

For more information on FDAAA activities, see www.fdaaa.org.
Upcoming Events

Seminars

Three Upcoming Dietary Supplements Seminars
  • Dietary Supplement Labeling Compliance Review Seminar
    December 9-10
    Salt Lake City, UT
In response to the increasing attention to dietary supplement claims, we have just added a new supplement labeling seminar to our schedule, to be held December 9-10, 2008 in Salt Lake City, Utah. The details will be posted on the EAS website.

There are still seats available in the dietary supplement GMP and lab seminars being held at our training facility in Alexandria, VA. Don’t delay – register today before it is too late.

Now that the final regulations on good manufacturing practices (GMPs) for dietary supplements are in effect for large firms and will become effective for medium sized firms in June 2009, EAS is conducting seminars to train the industry on the new rule. The dietary supplement GMP seminar will be held at the EAS headquarters in Alexandria, VA, September 30-October 1.

This intensive training program is given by former FDA compliance officials, and covers the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

The next upcoming seminar is titled Ensuring Regulatory Compliance of Dietary Supplement Laboratories, October 2-3.

FDA’s CGMP rule places significant emphasis and responsibilities on the dietary supplement laboratory and QC personnel. FDA focuses on laboratory controls during inspections to ensure that analytical results are credible and the laboratory is CGMP compliant. FDA trend data over the past several years shows that deficiencies in laboratory controls are among the most frequently cited observations during inspections of pharmaceutical companies.

The two day course will provide the knowledge and skills for evaluating, auditing, managing, and improving the CGMP compliance of your in-house and/or contract laboratory. You will gain knowledge for identifying and closing CGMP gaps and implementing the 15 key laboratory quality systems. You will be provided with examples of lab CGMP deficiencies from FDA-483 drug citations and recommendations for practices and procedures to ensure and demonstrate CGMP compliance.

The instructors for both seminars will be EAS Senior Consultant Robert Fish, former director of FDA’s Division of Field Operations, and EAS Senior Consultant William Ment, a former director of FDA’s Baltimore District Laboratory.

For more details, visit www.easconsultinggroup.com.

Tradeshows

Visit the EAS Consulting Group exhibit at the following tradeshow:
Hear EAS speakers at the HBA Summit:
Presentations on “beauty from the inside” product labeling by EAS Senior Consultant Dr. James Hoadley and on regulatory transfer between the pharma and personal care industries, by EAS Senior Consultant William Schwemer.
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