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
 July 2009
In this Issue:
Upcoming EAS Events
  • Dietary Supplement GMP Seminar [more]
  • Ensuring Regulatory Compliance of Dietary Supplement Laboratories [more]

From the Desk of the President:
FDA Promises More Transparency

Dear Reader:

Ed Steele, President Welcome to the July issue of EAS-e-News, our free e-newsletter for companies regulated by the Food and Drug Administration. These are exciting times for the agency, with an influx of new energy and the prospect of increased funding, and with the Congress expected to require some of the most sweeping changes the agency has seen in 50 years. Among numerous proposals, the Food Safety Enhancement Act of 2009 includes mandatory recall authority and a new revenue source for FDA from annual registration fees for food facilities.

The agency held a June 24 public meeting on “transparency” in Washington, D.C., as part of a new effort to make information on FDA activities and decision-making “useful, understandable, and more accessible.” It was the first public meeting by the agency’s Transparency Task Force, which is chaired by Principal Deputy Commissioner Joshua Sharfstein, former Commissioner of the Baltimore City Health Department.

In a move related to transparency, the agency unveiled a newly redesigned website, which Commissioner Margaret Hamburg said was updated in response to feedback that the site could be hard to use. She described the new design as the result of an “unprecedented collaboration” by hundreds of individuals. But she admitted that it is still a work in progress.

In part, the lack of consistency and the uneven look of the site was an accurate reflection of the agency’s structure, with separate centers operating with varying degrees of independence. This is a structural problem shared by many large organizations and is not easy to fix.

Many of you are aware that the deadline for implementation by medium-sized dietary supplement producers of the agency’s new GMP final rule has come and gone. Brad Williams, manager of FDA’s Division of Dietary Supplement Programs, says that between 200 and 300 medium-sized producers are likely to be inspected by FDA within one year of the June 25 deadline. This would account for a significant percentage of firms in that category in the United States. If you would like to check your understanding of the rule, you may take our free GMP Challenge Quiz. I also invite you to view the free EAS GMP Challenge webinar, which includes useful insights on compliance.

Our Issue of the Month for July is by EAS Senior Consultant David K. Park, a vulnerability assessment expert who believes that industry erred after September 11, 2001 in separating defense and safety issues. He argues that vulnerability assessments, in order to be effective, need to include both defense and traditional safety concerns.

Our EAS In Action section features the arrival of validation expert Rik Atkinson on our consulting team. Rik brings a unique set of skills and broad experience.

I greatly appreciate the positive feedback we have received on EAS-e-News and I invite you to continue to ask questions or to submit comments on what you read here. Also, please feel free to share the newsletter with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Hitting the Food Defense Target with a Vulnerability Assessment
By EAS Senior Consultant David K. Park
Immediately after September 11, 2001, the predominant message conveyed to the food sector by industry spokespersons was that food security (a.k.a. food defense) is not food safety. Industry was advised to separate food safety and food defense activities into two risk management components. I believe this “divide and conquer” approach is fundamentally flawed.

Food defense should never be addressed using an independent risk assessment and management approach, because this actually heightens the probability of a large-scale “system failure” occurring within our food supply.

Food industry professionals have inadvertently complicated the development of better solutions by listening to the opinions of third-party auditors who often lack the combined food safety and food defense expertise required to properly assess true vulnerabilities and by relying on commercial software to mass-produce food defense plans for businesses based on “one-shoe-fits all” solutions.

Widely used food defense audits employ standard checklists to the prerequisite HACCP-style food safety audits that, from my personal experience, often overestimate the effectiveness of mitigations in place. A recent example of a “checklist-style” audit failure was offered in congressional testimony on March 9, 2009, by Rep. Henry Waxman (D-Calif.) during the House Energy and Commerce Subcommittee on Oversight and Investigations in Food Safety Hearings related to the salmonellosis outbreak linked to Peanut Corporation of America. A third-party auditing firm was accused of failing to detect critical food safety hazards in an inspection, and of issuing a misleading “superior” inspectional rating at one PCA facility.

In my opinion, a thorough food defense vulnerability assessment must precede an audit. Unfortunately, many businesses only conduct an audit, or conduct an audit first. A food defense audit is performed against an already established set of standard or documented processes previously developed using the results of a vulnerability assessment. Because the purposes of audits and vulnerability assessments are not the same, very different outcomes can result from them.

I believe we have to think about prevention and response in a different way. The most effective responses to complex events are not those that identify a perpetrator (intentional or not) to bring about public punishment. It is far better to deter, detect, and prevent threats.

EAS Consulting Group has adopted this new way of thinking and offers new tools and an innovative vulnerability assessment approach. Addressing problems pro-actively can make the difference in saving your business and brand.”

Who's Who at EAS:
Meet EAS Senior Consultant David K. Park

David K. Park Senior Consultant David K. Park joined the EAS team in April 2008. Mr. Park is an internationally recognized expert in thermal processing. He is also an expert in food safety and defense, specializing in improving processes, procedures and policies in order to defend a company’s brand and business.

Early in his career, he was head of the process engineering section of the National Canners Association, which has since evolved into the Grocery Manufacturers Association. After eight years with the canning group, he joined TechniCAL, Inc., a thermal process consulting firm in New Orleans, La., as Technical Director. He later served as Technical Fellow at the FMC FoodTech, Food Processing Systems Division in Madera, Calif.

Mr. Park left FMC FoodTech in 2001 to become an independent food safety and food defense consultant. He still serves as a vice-president of TechniCAL, where he directs their thermal processing authority program.

Mr. Park has served as an Institute of Food Technologists Distinguished Lecturer and he currently lectures on thermal processing certification subjects at FDA/USDA Better Process Control Schools. He also holds a special-term appointment with Argonne National Laboratory in Argonne, IL. as an infrastructure assurance analyst helping to support government and industry preparedness in food defense. He holds a DOE Top Secret security clearance.

“We are very fortunate to have someone with Dave’s unique background and expertise as a member of our consulting team,” says EAS President Ed Steele.

Tougher USDA Enforcement to Impact Some FDA-Regulated Imports

USDA’s Food Safety and Inspection Service plans to require a source certification process for meat, poultry or egg products used in small amounts in imported foods. The change could impact a large number of FDA-regulated foods that contain small amounts of processed egg products, including egg noodles, cake mixes, sauces and baked goods.

The change is primarily aimed at certifying the source of meat and poultry ingredients. Pending a rulemaking, the agency says it will allow “alternative mechanisms” to show that egg products were produced under acceptable conditions.

Current regulations do not define what constitutes a “small amount” of egg products, but the agency usually refers to the definitions of less than two percent for cooked meat or poultry and less than three percent for raw meat or poultry.

FSIS defines egg products as eggs that are removed from their shells for processing. The processing of egg products includes breaking eggs, filtering, mixing, stabilizing, blending, pasteurizing, cooling, freezing or drying, and packaging. This is done at USDA-inspected plants. Egg products include whole eggs, whites, yolks and various blends with or without non-egg ingredients that are processed and pasteurized and may be available in liquid, frozen, and dried forms.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of June, 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
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action:
Rik Atkinson Joins EAS Consulting Team

Rik Atkinson Walter (Rik) H. Atkinson III is the latest addition to the growing EAS team of senior consultants. He is an expert in validation of pharmaceutical products, with more than 25 years of experience in current Good Manufacturing Practices. Rik began his career as a process manager for a vitamin and antibiotic manufacturer. He later added to this experience by becoming a process manager for liquid vitamin blends, formulating more than 200 blends for the food, health care, and infant formula industry. His broad experience led him to become Technical Team Leader for numerous products, including antibiotics and vitamins. He joined AAC Consulting LLC (Kendle International Inc.) in 2002 as a consultant, where he helped pharmaceutical companies with their active pharmaceutical ingredients, process equipment, utility and analytical instrument validation efforts and validation protocol review and approval. As a member of the EAS team, he is now available to help our clients with their validation needs. He can also supply valuable expertise for re-engineering, outsourcing, safety redesign, asset verification, activity-based management/costing, process expansion, process start-up, relocation, cost reduction and/or vendor-managed inventory.

“I am delighted to welcome Rik to our team of senior consultants,” says EAS President Ed Steele. “Our clients will benefit greatly from his knowledge and experience.”

Campbell Reviews Health Claims at FDLI Webinar

EAS Vice President Elizabeth (Betty) Campbell reviewed FDA’s latest approach to health claims for foods and dietary supplements, in a June 30 webinar titled Health Benefit Claims for Food and Dietary Supplements: Defining the Boundaries, hosted by Food and Drug Law Institute.

The boundaries appear to be shifting, at least in terms of FDA compliance efforts. In the agency’s first such action against a major food manufacturer in almost a decade, General Mills drew a May 5 warning letter over a cholesterol-lowering and heart health claim on Cheerios boxes. The cholesterol claim had been in place for two years, the heart health claim for twelve years. The agency charged that the labeling was in violation of federal law. The Federal Trade Commission has also been getting tough on claims. It recently settled a complaint with Kellogg Co. over claims that Frosted Mini-Wheats could improve attentiveness in children.

The agency allows a health claim linking soluble fiber from whole grain oats to a reduced risk of heart disease by means of lowering cholesterol, Cheerios boxes have cholesterol as a prominent, stand-alone claim, FDA said.

Ms. Campbell headed the Office of Food Labeling in FDA’s Center for Food Safety and Applied Nutrition. She helped develop current FDA policies on claims under the Dietary Supplement Health and Education Act, and the FDA Modernization Act of 1997.

The other featured presenter at the Food and Drug Law Institute event was Barbara O. Schneeman, director of FDA’s Office of Nutrition, Labeling and Dietary Supplements, who offered an agency perspective on its health claims policies. The webinar was moderated by Christopher L. Hagenbush, a Partner in the law firm of Patton Boggs LLP.

IFT Expo a Success, Despite Downturn

Food Safety Summit The Institute of Food Technologists annual meeting and expo, held this year in Anaheim, Calif., June 7-9, was a successful event, despite the economic downturn. In a June 7 keynote presentation titled “What’s Next? The Current Economy and the Future of Food,” Todd Buchholz, a Harvard professor and a former White House Economic Policy Advisor, predicted that the beginnings of an economic recovery will emerge in the United States this fall. Our representatives at the event, senior consultants James E. Hoadley, Ph.D., and Madhu Soni, Ph.D., reported strong interest from attendees who visited the EAS exhibit booth.

Congratulations to Christopher Wada, vice president of Technical Services, Discover Foods, the lucky winner of our free iPod.

Upcoming Events
EAS Announces Plans for New Fall Seminars

EAS is pleased to announce the following seminars:

Oct. 6-7 Dietary Supplement GMP Seminar
Oct. 8-9 Ensuring Regulatory Compliance of Dietary Supplement Laboratories

Both seminars will be held at the EAS training facility in Alexandria, VA.

We are also planning other seminars in the coming months, including sessions on Food Labeling and Dietary Supplement Labeling. The details for all the fall seminars will be posted soon on our web site.
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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