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 · Tobacco Products
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 April 2010
In this Issue
Upcoming EAS Events
  • Food Safety Summit [more]
  • Food and Drug Law Institute Annual Conference [more]
  • Dietary Supplement GMP Seminar [more]
  • Food Labeling Compliance Review Seminar [more]
  • Natural Marketplace 2010 [more]

From the Desk of the President
The Health Care Bill and Labeling

Ed Steele, President

Dear Reader,

Welcome to the April issue of EAS-e-News, our quick summary of what’s new at the Food and Drug Administration and the latest developments at EAS.

In this issue, we focus on the implications for the regulated community of nutrition labeling provisions in the health care reform bill passed last month. Our Issue of the Month article on the topic is by EAS Vice President Elizabeth Campbell, former acting director in the Office of Labeling at the Center for Food Safety and Applied Nutrition.

Also in this issue, we take a quick look at FDA’s early steps as it gets to grips with the regulation of tobacco products. On March 19, the agency issued a final rule restricting access by children and adolescents to cigarettes and smokeless tobacco products. The rule will go into effect on June 22.

I was pleased to attend an FDA Alumni Association (FDAAA) luncheon last month at the agency’s White Oaks headquarters campus, to celebrate Commissioner Margaret Hamburg’s first year in that role. It was quite an event (Commissioner Hamburg is pictured here with FDAAA President Alan Andersen). More than one hundred FDA alumni and agency top management attended. The alumni association has a very close working relationship with the agency. Alumni members support CFSAN in responding to invitations from foreign governments to share the agency’s views on various policy matters, for example.

I also participated in another well-attended event last month, the GMA Science Forum in Washington, D.C., at which First Lady Michelle Obama gave the keynote address on her new “Let’s Move“ campaign aimed at reducing childhood obesity. The administration is strongly committed to tackling the obesity issue, and we can expect this to be reflected in FDA’s regulatory activities.

On the EAS front, we continue the expansion of our network of senior consultants. This month I would like to welcome aboard the three newest additions--Leah Andrews, Steven Huntoon and Kristi Musgrave (see details below).

As we have seen, food labels are receiving closer FDA scrutiny. In an open letter to the food industry March 3, Commissioner Hamburg identified food labeling as one of her top priorities. The agency will soon issue draft guidelines for front-of-pack calorie and nutrient labeling. We have scheduled an in-depth, two-day seminar of food labeling compliance for May 26-27 at our Alexandria, VA training center. In addition, FDA's final GMP rule goes into effect for all dietary supplement firms, regardless of size, in June. We have scheduled a seminar April 27-28 that will detail 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 (see details below).

As always, I hope you find EAS-e-News useful and I invite you to share it with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
New Health Care Law Requires Nutrition Labeling in Restaurants
By EAS Vice President Elizabeth Campbell

Deep inside the 2,700-page health care reform bill is a requirement for nutrition labeling in restaurants. But the change will not only affect foods sold in restaurants. It also applies to ready-to-eat foods sold in retail grocery stores, convenience stores, etc. Essentially, the foods exempted from mandatory nutrition labeling by Nutrition Labeling and Education Act regulations (21 CFR 101.9(j)(2) and (3)) are now required to carry nutrition labels.

Section 4205 of the Patient Protection and Affordable Care Act (H.R. 3590) requires declaration of calories and certain other nutrients for foods sold by restaurants, similar retail food establishments and vending machines. The requirement applies to companies with 20 or more stores. Specifically, the provision requires calories to be declared on the menu or menu board so that this information accompanies the name of the food. The firm must also have available to the consumer on request, information on the nutrients other than vitamins and minerals required to be declared in the Nutrition Facts on packaged foods.

One important feature of the provision is federal preemption for the labeling. In 1990 the NLEA exempted all restaurant foods and foods sold in similar circumstances (carry-out, etc.) from the mandatory nutrition labeling that was being instituted for packaged foods. In the absence of federal requirements for nutrition labeling in restaurants, several state and local jurisdictions have required or are considering requiring such labeling, adding significant complexity to the interstate sale of similar foods.

The federal preemption provision applies immediately for the 20-plus unit companies but not to the smaller companies that are not required to have nutrition labeling. The smaller companies that wish to obtain preemption can do so by voluntarily declaring the required information and registering with FDA every two years as a participant in a voluntary labeling program.

The new law requires FDA to publish, in one year, proposed regulations for declaration of the mandatory information. Although there is no deadline for the final regulations, FDA is required to report to Congress quarterly on progress on the final regulations. In addition, the law requires FDA to publish within 120 days a Federal Register notice specifying terms and conditions for firms to register for the voluntary program.

In the 1993 NLEA regulations, FDA encouraged voluntary nutrition labeling for restaurant foods and required nutrient information when nutrition claims were made for these foods. FDA provided that nutrient amounts declared for restaurant foods could be determined using a “reasonable basis” instead of direct chemical analysis of the food (21 CFR 101.10). The new requirement for nutrition labeling in restaurants includes this reasonable basis provision.

In establishing this reasonable basis for restaurant foods in the early 1990’s, the agency recognized the greater variation in preparation of restaurant foods and stated that it did not have data with which to make more specific requirements. It is likely that in establishing regulations for these new requirements, FDA will consider the experiences of those jurisdictions that have established nutrition labeling requirements. The agency may also access data from the industry or other sources. It would be advisable for companies that currently use nutrition labeling in their restaurants to evaluate their labeling programs and consider providing data to FDA during the comment period for the proposed regulations.

EAS will be happy to provide details on the provisions of the new law on request. We will follow the developments on the new requirements and keep clients informed. In addition, EAS intends to develop training (probably a new labeling seminar) in the provisions of the new regulations as soon as they are available.

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

Elizabeth (Betty) Campbell

Elizabeth (Betty) Campbell, former head of the Office of Food Labeling at the Center for Food Safety and Applied Nutrition, played a significant role in writing the regulations implementing the Nutrition Labeling and Education Act (NLEA).

Ms. Campbell’s agency career began as a chemist in the FDA’s New Orleans and Atlanta district offices. Subsequently, she transferred to Washington, D.C., where she served in increasingly responsible roles, finally becoming Acting Director in the Office of Food Labeling. She helped develop FDA’s policies on claims under the Dietary Supplement Health and Education Act, and the FDA Modernization Act of 1997. And she was responsible for implementing key NLEA elements, including training industry personnel and regulatory officials, developing an enforcement strategy, and guiding policy decisions.

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

After leaving the agency in 1999, she joined AAC/Kendle as a senior consultant, where she provided expert advice on a range of regulatory issues and reviewed food labels for compliance with FDA regulations. She joined EAS Consulting Group as Vice President in October 2006.

“Having someone of Betty’s labeling and claims expertise on our staff has enabled EAS to become the place to go for authoritative regulatory advice,” says EAS President Ed Steele.

What's New on FDA's Website

FDA Website Expands Coverage of Tobacco Products

FDA has established a special section on its web site for updates on the final rule issued last month that restricts the sale, distribution, and promotion of cigarettes and smokeless tobacco products make them less accessible and less attractive to children. Among other measures, the rule prohibits the sale of cigarettes or smokeless tobacco to people younger than 18, prohibits the sale of cigarette packages with less than 20 cigarettes, prohibits distribution of free samples of cigarettes, restricts distribution of free samples of smokeless tobacco, and prohibits tobacco brand name sponsorship of any athletic, musical or other social or cultural events. On June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTC Act) giving FDA the authority to regulate tobacco products. The agency has since been gathering information from stakeholders in order to work out how best to proceed with the implementation of its new authority.

Listed below are links to new additions to the FDA website for the month of March, 2010. 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 Announcements
Recalls and Safety Alerts
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action
EAS Continues to Expand Its Consulting Team

Leah Andrews, Steven Huntoon and Kristi Musgrave, are the three most recent additions to the EAS team of consultants.

Leah Andrews

Ms. Andrews is also a former FDA staffer, who began her career as an investigator in the agency’s Detroit District office and advanced to become pre-approval manager in the Atlanta District Office. Since leaving the agency in 2005, she has been a compliance consultant for pharma, biopharma and medical device companies.

Steven Huntoon

Mr. Huntoon is a food safety and quality professional with 35 years of experience in food service and consumer product R&D, manufacturing, and food safety and quality system management. He has worked with a range of foods including fresh and cultured dairy products, baked goods, frozen pizza and deli salads, fresh and processed meat, confections, and partially processed produce and nuts. He has served in senior food safety and quality roles with Fresh Express, Philip Morris and Kraft Foods. As quality director for Fresh Express of Salinas, Calif., he developed the company’s quality management system. More recently, as a consultant with Nobius Food Safety Management, he has worked on assignment with Nabisco, Kellogg, Kraft and other leading companies.

Kristi Musgrave

Ms. Musgrave has more than 13 years of experience in GMP-regulated environments. She began her career with Immuno U.S., Inc. as a microbiologist and advanced to take on responsibility for the quality control microbiology testing program. Ms. Musgrave became the Quality Operations Manager at Baxter in 2000. For the past six years, she has worked as a contract consultant with the Validation and Compliance Institute.

“I am very pleased to welcome three such experienced individuals to our growing network of consultants,” says EAS President Ed Steele. “Their expertise will be of great benefit to our clients.”

EAS Conducts Additional Training Seminars

Dietary Supplement GMP Seminar

FDA's final GMP rule goes into effect for all dietary supplement firms, regardless of size, in June, 2010. EAS will hold a dietary supplement GMP seminar April 27-28 that will to detail 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.

Instructors for this event will be EAS Senior Consultant William Ment, a former FDA staffer with wide experience in auditing QA programs at pharmaceutical and dietary supplement firms and laboratories, and EAS Vice President Dean Cirotta, who has 22 years of pharmaceutical experience, including serving in senior management roles with responsibility for regulatory affairs, compliance, quality assurance and overall corporate management.

Click here for more details.

Food Labeling Compliance Review Seminar

EAS will hold an in-depth, two-day seminar on food labeling compliance May 26-27 at its Alexandria, VA training center. Here is a chance to learn FDA food labeling requirements from labeling experts who helped to develop and implement the current regulations. Instructors for this event will include Elizabeth (Betty) Campbell, who served as head of FDA’s Office of Food Labeling before becoming a labeling consultant in 1999. Ms. Campbell played a key role in writing and implementing the Nutrition Labeling and Education Act (NLEA) regulations. Other trainers for this event are James E. Hoadley, Ph.D., another former FDA official who participated in the development of NLEA-implementing nutrition labeling and health claim regulations, and Gisela Leon, who has more than 20 years of experience in international labeling of food.

Click here for more details.

EAS Sponsors FDLI Annual Conference

FDLI Annual Conference

EAS Consulting Group will be both a sponsor and an exhibitor at the Food and Drug Law Institute’s 53rd Annual Conference in Washington. D.C, April 22-23. This event traditionally brings together participants interested in food and drug law and high ranking FDA officials, including the Commissioner, the Chief Counsel and the Center directors. We are expecting a very lively meeting this year.

Upcoming Events

Food Safety Summit
April 13-14, 2010
Convention Center
Washington, D.C.
Booth 520

Food and Drug Law Institute Annual Conference
April 22-23, 2010
Washington, D.C.
Silver Sponsor & Exhibitor

Dietary Supplement GMP Seminar
April 27-28, 2010
EAS Headquarters
Alexandria, VA

Food Labeling Compliance Review Seminar
May 26-27, 2010
EAS Headquarters
Alexandria, VA.

Natural Marketplace 2010
June 10-12, 2010
Las Vegas, Nev.
Booth 1130
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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