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
 March 2009
In this Issue:
Upcoming EAS Events
  • Food Institute Labeling Workshop: Food Labeling in Four Easy Pieces - The Basics & Beyond [more]
  • Food Safety Summit [more]
  • NYSCC 2009 Suppliers’ Day [more]

From the Desk of the President:
FDA Goes Multimedia

Dear Reader:

Ed Steele, President Welcome to the March issue of EAS-e-News, our free, monthly newsletter for industries regulated by the Food and Drug Administration.

Stung by charges that it acted too slowly in the ongoing Salmonella Typhimurium outbreak linked to peanut products, FDA launched its own multimedia effort to explain itself. The agency recently posted a video on its website, titled “Anatomy of an Outbreak,” which steps through the timeline of the latest outbreak and explains how quickly the agency acted at each step.

The five-and-half-minute video features Stephen Sundlof, director of the agency’s Center for Food Safety and Applied Nutrition, Michael Rogers, FDA’s head of field investigations, and Robert Tauxe, deputy director for science in CDC’s Foodborne, Bacterial, and Mycotic Disease Division. All three perform well. Recording videos must be a lot less stressful than answering reporters’ questions or testifying before lawmakers on Capitol Hill.

“I think the public should feel very confident that FDA is on the job and will continue to be,” says Sundlof, at the close of the video, which can be viewed at www.fda.gov.

FDA is not the only organization to enter the new multimedia world made possible by broadband internet access. I am pleased to report that EAS had a wonderful response to the February 5 EAS GMP Challenge webinar, which broke registration records for the webinar series hosted by Natural Products Insider.

Speakers for the free event included Brad Williams, manager of FDA’s Division of Dietary Supplement Programs, Carl Reynolds, EAS vice president—and myself. Click here to view a recording of the webinar and learn tips from the experts on how to comply with the new cGMP requirements. In addition, see our EAS In Action section for highlights of the very informative Q&A portion of the webinar.

Despite the ongoing economic turmoil, EAS continues to steadily expand its team of expert consultants. I am very pleased to welcome Beatrice Greenberg, former head of labeling regulation implementation at CFSAN, to our expert team (See details below).

Our “Who’s Who at EAS” section this month features EAS Consultant Gisela Leon, whose knowledge of global labeling issues is second to none.

I hope you continue to find EAS-e-News useful and that you will share it with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Who's Who at EAS:
Meet EAS Consultant Gisela Leon

Gisela Leon EAS Consultant Gisela Leon has more than 20 years of industry experience in quality management for food production. She spent much of her career with Schöller Lebensmittel in Germany, becoming a director of quality management.

Ms. Leon spent three years as a consultant with AAC/Kendle before joining EAS in October 2006. As an EAS consultant, she helps clients assure compliance with U.S. labeling requirements for food and dietary supplements. She is also expert in European food law and multi-language labeling for various countries throughout the world.

At Schöller Lebensmittel, she gained a wealth of experience, assuring the marketability of 900 ice cream and bakery products sold in 25 countries. She also streamlined the company’s multi-language labeling. Her experience included quality assurance work as technical supervisor for the company’s ice cream production plants, both inside and outside Germany.

In addition, she supervised quality assurance for externally purchased frozen foods and baked products, and established the company’s master test plans for raw material and ice cream products. She developed HACCP plans, evaluated raw materials, and ensured comparable methods in product evaluation. And she implemented the company’s ISO 9001 quality management system.

She speaks English, German, and French and can assist companies in ensuring that their products meet U.S., EU and other foreign labeling requirements. She has a Master’s degree in food technology engineering—the equivalent of food science in the U.S.—as well as a Master’s degree in business.

Ms. Leon brings valuable expertise to assist firms in complying with various labeling requirements throughout the world.

Issue of the Month
FDA Enforcement: What We Learn from Past Actions
By Gisela Leon, Consultant
One way to predict how the Food and Drug Administration will enforce compliance with the agency’s labeling regulations is to look at what it has done in the recent past. In 2008, the agency issued just nine warning letters for food labeling violations and 44 warnings for problems with dietary supplement labeling. Most of the supplement violations were identified by looking at the marketers’ websites.

For food products, FDA frequently targeted undeclared allergens, often along with a failure to declare sub-ingredients or a failure to list ingredient by their common name. So, for example, for products containing butter, manufacturers should check that milk is declared as an allergen. Or if products contain flour, manufacturers should be sure that wheat is declared as allergen. Some companies with spelt products fail to declare wheat as an allergen.

In addition, the agency looks for food products that fail to declare the correct nutrient amount and serving size. So manufacturers need to check labels to verify that the required nutrients are declared, and that the declarations comply with the rounding and formatting requirements for Nutrition Facts and that the appropriate format for package size and shape is used.

Nutrient content claims also drew the agency’s attention. Manufacturers need to check labels and verify that the conditions of claims, such as "more," “rich," or sugar-free" are met. Some manufacturers are unaware that "plus" in certain contexts is interpreted by the agency as a "more" claim.

The agency also targets "disease" claims, which cause the food product to be regulated as a drug. To avoid this problem, manufacturers need to check labels and verify that any structure/function claims are correctly phrased and will not be considered a "disease" claim.

Agency Targets Websites

Of the 44 warning letters issued to dietary supplement marketers last year, 41 of them were as a result of a review of the firms’ websites, according to a report in the January issue of NutraIngredients-USA. Only three letters were linked to facility inspections. The majority of problems cited related to cancer and heart disease claims.

FDA issued two warning letters over labeling claims that made the dietary supplements drugs. Another letter cited the unlawful use of the ingredient lovastatin in a red yeast rice product. One drug company received two warning letters, for combining aspirin with calcium in one product and with phytosterols in another. Both products were declared to be unapproved new drugs.

We can conclude that manufacturers need to carefully review their websites to make sure that the labeling does not render the product a drug in the eyes of the regulators. And it is especially important to know when website advertising becomes labeling for regulatory purposes.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of February, 2009. 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
Viewpoint: A Message from the Acting FDA Commissioner
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action:
What’s Missing from FDA’s GMP Final Rule?

Many questions that arise in the course of implementing FDA’s new GMP requirements for dietary supplements are not specifically addressed in the text of the agency’s final rule, according to speakers at the February 5 EAS GMP Challenge webinar.

There is no specific guidance, for example, for temperature and humidity controls for the warehousing of dietary supplements. But “if you set a specification to ensure the quality of a dietary supplement that includes temperature or humidity, you would be expected to monitor for that specification,” explained EAS Vice President Carl Reynolds.

Similarly, the rule does not define validation or verification methods or list specifications, but leaves it to companies to find appropriate methods for whatever specifications they set.

One participant in the webinar asked if the rule permits skip lot testing of dietary components and ingredients using specifications other than identity. This issue is not specifically addressed in the rule, explained Brad Williams, manager of FDA’s Division of Dietary Supplement Programs. He made a distinction between components such as excipients and active ingredients. “If you have a qualified vender, you can rely on a [Certificate of Analysis] from a component manufacturer, unless it’s for one of the dietary ingredients,” he said.

Participants in the webinar had earlier completed a quiz to assess their understanding of the rule. One question dealt with the need to report complaints to the agency. Actually, there is no mandatory requirement under this rule to report complaints to FDA. The agency requires reporting of adverse events, but not in the GMP rule, Reynolds explained.

Dietary supplement ingredient manufacturers are not covered by the new rule. Agency officials expect that ingredient manufacturers will continue to be required to comply with food GMPs, Williams said. Their ingredients “will have to meet GMP [requirements], but the responsibility is on the manufacturer of the finished product to do that,” he said.

Another participant asked how a manufacturer could confirm the identity testing on a supplier’s Certificate of Analysis? Again, that is not specifically addressed in the rule. One way would be to test a certain number of batches for the specifications that have been set for that particular component, Reynolds explained.

Participants in the EAS GMP Challenge also took part in a confidential quiz aimed at assessing their understanding of the GMP final rule. One question concerned the use of water that “may become a component of the dietary supplement.” Almost all respondents believed that the water must at a minimum comply with EPA’s National Primary Drinking Water regulations as well as any state and local government requirements. Actually, the final rule dropped the reference to EPA’s NPDW because some supplement firms have water supplies that are not compliant with EPA requirements. Now, the rule merely says that water that may become a component in the product must at a minimum comply with any federal, State and local government requirements.

Companies fall into three categories in terms of their preparation for compliance with the new GMP requirements, according to EAS President Ed Steele. One group has taken little action so far and is not at all prepared. A second group consists of companies that have made an effort to achieve compliance and believe they are in compliance, but are actually far from being compliant. In the third category are companies that have made a very conscientious effort to comply. However, despite these efforts “we have not found any firms in full compliance with the new rule in any EAS audit,” he said. He acknowledged that some firms are further ahead than others but said there is much room for improvement. And he urged firms that have not adequately prepared to delay no further.

Click here to view a recording of the webinar, which was hosted by Virgo Publishing.

Former FDA Official Strengthens EAS Labeling Capabilities

Beatrice (Bea) Greenberg Beatrice (Bea) Greenberg, former head of the labeling regulation implementation team in FDA’s Center for Food Safety and Applied Nutrition, agreed to provide assistance to EAS clients, further strengthening the EAS labeling consulting team.

Ms. Greenberg joined FDA as a field investigator in the Philadelphia District in 1977. During her career as an investigator, she conducted inspections in a variety of FDA-regulated industries. For several years, she served as recall co-coordinator for the Philadelphia District. Before moving to the Washington, D.C. area in 1997, she was selected for several details to CFSAN to help review comments on the proposed Nutritional Labeling and Education Act regulations. She also helped in training efforts arising from NLEA, as well as in the implementation and enforcement of the NLEA regulations.

When she relocated to Washington, D.C., she first served as a recall coordinator for the Center for Biologics Evaluations and Research. In March 2002, she joined CFSAN to work once again on food labeling issues. She retired from the agency in December 2008.

“I am delighted to welcome Bea Greenberg aboard,” said EAS President Ed Steele. “Her knowledge of labeling issues is second to none and her expertise will be of great benefit to our clients.” She joins other EAS labeling experts Betty Campbell, James Hoadley, Gisela Leon and James Summers.

EAS Consultant Speaks at FDLI’s Supplement Conference

EAS Vice President Carl Reynolds spoke at the January 29-30 Food and Drug Law Institute conference in Washington, D.C., titled “What You Need to Know about Emerging Dietary Supplements: Issues & Trends.” Reynolds, a former FDA Investigator with 37 years of FDA experience and over a decade of consulting experience, alerted conference attendees on what the dietary supplement industry should expect when FDA makes inspections for compliance with its new GMP regulations. He emphasized that inspections will be longer than usual and will focus on records review.

Steve Mister, president and CEO of the Council for Responsible Nutrition, also discussed emerging topics, and suggested that a broad interpretation of Section 912 of the FDA Amendments Act of 2007 could “turn food ingredients into drugs.” The section applies to all food, “maybe even dietary supplements,” he said.

EAS Hosts Food Labeling Seminar

Participants in the February 24-25 Food Labeling Compliance Review Seminar, held at the EAS headquarters in Alexandria, Va., learned the finer points of labeling requirements from EAS Senior Consultants Gisela Leon, James Hoadley and Beatrice Greenberg. They were joined by Robert Post, deputy director of USDA’s Center for Nutrition Policy and Promotion. Dr. Post reviewed USDA’s latest thinking on labeling compliance issues and explained the difference between FDA and USDA requirements. EAS Vice President Elizabeth Campbell provided commentary and answered questions based on her 35-year tenure at FDA. She was a prime author of the NLEA regulations that formed the basis of the current food labeling requirements in the U.S.
Upcoming Events
Seminars/Workshops
  • Food Institute Labeling Workshop:
    Food Labeling in Four Easy Pieces - The Basics & Beyond
    May 20, 2009
    Marriott Airport Hotel
    Newark, New Jersey
    EAS Instructors: Dr. James Hoadley & Beatrice Greenberg
The following EAS seminars scheduled for March and April are being rescheduled:
  • Dietary Supplement GMP Seminar
  • Ensuring Regulatory Compliance of Dietary Supplement Laboratories Seminar
  • OTC Drug and Cosmetics Labeling Compliance Review Seminar
Check www.easconsultinggoup.com for the latest schedules.

Tradeshows EAS will be among the exhibitors at the 11th annual Food Safety Summit, where industry experts, academics and regulators will gather to discuss the latest food safety issues and ideas--for example what industry can learn from the outbreak of Salmonella Typhimurium linked to peanut ingredients. Come see us at booth 423. EAS will be among the exhibitors at this key yearly event for the cosmetic industry. The annual Society of Cosmetic Chemists Suppliers’ Day is sponsored by the NY Chapter. This 2-day event showcases the newest products and the latest innovations from around the world. It is one of the largest events of its kind in the world! Visit us at our booth to learn how we can help with your U.S. regulatory requirements.
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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