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.
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EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 April 2009
In this Issue:
Upcoming EAS Events
  • EAS Dietary Supplement GMP Seminar [more]
  • 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:
Recent Events Signal a Change for the Food Industry

Dear Reader:

Ed Steele, President Welcome to the April issue of EAS-e-News, our free, monthly e-publication for regulatory professionals interested in keeping current with issues at FDA and in learning what is happening at EAS Consulting Group.

The ongoing outbreak of Salmonella typhimurium linked to peanut products from Peanut Corporation of America is proof that the food supply chain is only as strong as its weakest link. Lawmakers on Capitol Hill identified PCA as a “bad actor” that deliberately failed to do the right thing to protect the food supply. But they also identified the failure of third-party audits to improve safety controls at PCA’s plant in Blakely, Georgia.

EAS is a consulting, training and auditing company whose clients include food manufacturers, and I feel very strongly that an effective audit generally takes more than one day-- as was the case at the PCA plant. An effective food audit requires time and the selection of auditors who have real food safety backgrounds. It is no longer sufficient to hire auditors that have just been trained to follow a checklist and to report on whether a firm is following their procedures. Hopefully, this incident will be a wake up call to the food industry to select third party auditors that have the knowledge and experience to help identify food safety hazards rather than to shop for those that are willing to hand out excellent ratings while not being allowed sufficient time to find problems.

During President Obama’s weekly radio address and video address on March 14 he announced his nomination of Dr. Margaret Hamburg, as the new FDA Commissioner, and his appointment of Dr. Joshua Sharfstein, as her deputy. Obama said the food safety system is too spread out, making it difficult to share information and solve problems. He also blamed recent underfunding and understaffing at FDA that has left the agency unable to conduct annual inspections of more than a fraction of the 150,000 food processing plants and warehouses in the country. "That is a hazard to public health. It is unacceptable. And it will change under the leadership of Dr. Margaret Hamburg," Obama pledged. EAS Senior Consultant Norma Skolnik supplies a quick introduction to Dr. Margaret Hamburg and Dr. Joshua Sharfstein in this month's issue of our newsletter.

Our Issue of the Month for April is by EAS Senior Consultant Jeannette Lyon, who explores what FDA’s 2005 model Food Code says about requirements for refrigeration at the retail food store or in a food service facility. Ms. Lyon is a leading expert in retail food sector regulations and she was one of the main writers of the Code.

Our EAS In Action section is very busy this month, but I would like to draw your attention to one item. Booz Allen Hamilton, in cooperation with the Produce Safety Project at Georgetown University and the Woodrow Wilson International Center for Scholars, recently held an invitation-only summit to explore the possible implications of introducing mandatory standards for produce. I attended and found the exercise very instructive. Such simulated scenarios offer a very compelling way to explore possible changes in food safety policy.

I would like EAS-e-News to facilitate interaction with our readers, so please feel free to contact me directly with any comments or follow-up questions.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Manufacturers: Should Your Food Be Refrigerated?
By EAS Senior Consultant Jeannette B. Lyon
Do you know if your food will be required by state regulators to be stored under refrigeration at the retail food store or in a food service facility?

Although many retailers and the food service industry are familiar with the provisions of the FDA Food Code, some manufacturers and processors may not be aware that state regulators who are responsible for inspecting grocery stores and restaurants follow the recommendations made in this document. Of particular interest is a relatively new provision that specifies which foods must be temperature-controlled for safety, something not found in the Code of Federal Regulations or in the Good Manufacturing Practices. In the 2005 FDA Food Code, “potentially hazardous food (time/temperature control for safety food)” (PHF/TCS food) is defined in terms of whether or not a food product requires time/temperature control for safety to limit pathogen growth or toxin formation. The progressive growth of all foodborne pathogens is considered, whether slow or rapid.

Hurdle Technology
The definition of PHF/TCS food takes into consideration pH, water activity (Aw), pH and Aw interaction, heat treatment, and packaging for a relatively simple determination of whether the food requires time/temperature control for safety. If the food is heat-treated to eliminate vegetative cells, it needs to be addressed differently than a raw product with no, or inadequate, heat treatment. In addition, if the food is packaged after heat treatment to destroy vegetative cells and subsequently packaged to prevent re-contamination, higher ranges of pH and/or Aw can be tolerated because remaining spore-forming bacteria are the only microbial hazards of concern. In some foods, it is possible that neither the pH value nor the Aw value is low enough by itself to control or eliminate pathogen growth; however, the interaction of pH and Aw may be able to accomplish it. Known as “Hurdle Technology,” this approach involves several inhibitory factors being used together to control or eliminate pathogen growth, when they would be ineffective if used alone.

Tables A or B, found in Chapter 1 of the 2005 Food Code, should be used to determine if a food is deemed to be PHF/TCS or not. If a product assessment is required, the food is considered PHF/TCS until inoculation studies or some other acceptable evidence shows that the food is a PHF/TCS food or not.

More information on this issue can be found in the Institute of Food Technologists (IFT) Report, Evaluation and Definition of Potentially Hazardous Foods. The 2005 Food Code can be found at http://www.cfsan.fda.gov/~dms/fc05-toc.html and the Supplement to the 2005 Food Code is available at http://www.cfsan.fda.gov/~dms/fc05-sup.html#a3health.

Who's Who at EAS:
Meet EAS Senior Consultant Jeanette B. Lyon

Jeanette B. Lyon EAS Senior Consultant Jeannette Lyon is a leading expert in retail food sector regulations. A former chief of food inspection for the State of Maryland, she spent ten years with the Food and Drug Administration, where she was one of the lead writers of the agency’s model Food Code until 2006.

During her time as chief of Maryland’s food inspection program, she pioneered the use of HACCP principles by inspectors when conducting inspections in retail stores and food service establishments. In addition, she wrote groundbreaking statewide regulations that introduced risk-based inspection, prioritizing inspection frequency based on each establishment’s risk.

Ms. Lyon joined FDA in 1996. After a brief stint in the Office of Seafood dealing with raw molluscan shellfish issues, she returned to the retail food store and food service sector. Her work included the training of FDA personnel in writing language that complies with the conventions of the Food Code. She was recognized as a National Standard in the interpretation and application of the Food Code. In addition, she wrote and presented numerous training sessions to state and local agencies on food safety and the Food Code.

Ms. Lyon joined EAS in October 2006 as a senior consultant, following two years as a consultant for AAC/Kendle International. She has a master’s degree in Health Science from Johns Hopkins University and is a Registered Sanitarian. Her special focus at EAS is on evaluating food systems for risk factors that may contribute to foodborne disease. She also provides training in retail food safety.

Hamburg and Sharfstein Bring Change to FDA
By Norma Skolnik, Senior Consultant
Margaret A. Hamburg, M.D. Margaret A. Hamburg, M.D., slated to head the Food and Drug Administration, is drawing unprecedented praise from constituents and her nomination has brought hope for better things to come at the beleaguered agency. Also boosting the spirits of FDA stakeholders is the President’s nomination of Joshua Sharfstein, M.D., to be Principal Deputy Commissioner.

Dr. Hamburg, 53, who was assistant health secretary under President Bill Clinton, helped to lay the groundwork for the government’s bioterrorism and flu pandemic preparations. As New York City’s health commissioner for most of the 1990’s—the youngest person to hold that position—she created a program that cut the high rates of drug-resistant tuberculosis.

When he announced the nomination on March 14, President Obama said food safety will be a top FDA priority. Currently the agency only has resources to conduct inspections at a small fraction of the 150,000 food processing plants and warehouses in the country. “That is a hazard to public health that is unacceptable and it will change under the leadership of Dr. Margaret Hamburg,” he said.

Sharfstein, a Baltimore pediatrician, challenged the FDA on the safety of OTC cold medicines for young children and he served as health policy aide to Senator Henry Waxman (D-Calif.) who plays a leading role in overseeing the drug industry.

The naming of two prominent public health professionals is "a clear signal that this administration has placed a priority on bolstering FDA’s food safety role" commented Pamela Bailey, president and CEO of the Grocery Manufacturers Association.”

Hamburg and Sharfstein are both outsiders to the agency and will face a major challenge in trying to turn it around. Hamburg’s appointment as FDA Commissioner requires Senate confirmation. Sharfstein’s appointment does not.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of March, 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
  • March 26, 2009
    Joanne R. Less, Ph.D.
    Director, Good Clinical Practice Program
    Subject: FDA's Role in Overseeing Institutional Review Boards
    Before: Subcommittee on Oversight and Investigations
    Committee on Energy and Commerce
    House of Representatives
  • March 11, 2009
    Steven M. Solomon, D.V.M., M.P.H.
    Assistant Commissioner for Compliance Policy
    Subject: Recall of FDA-Regulated Products
    Before: Subcommittee on Regulations and Healthcare
    Committee on Small Business
    House of Representatives
Enforcement Reports
What's New by Topic
EAS in Action:
Produce Summit Simulates New Standards

EAS President Ed Steele took part in an interesting invitation-only produce safety summit in Washington, D.C., March 5, hosted by the Woodrow Wilson International Center for Scholars and presented by Booz Allen Hamilton. The day-long event, which focused on the implications of mandatory safety standards for produce, included simulations along the lines of those used in recent years for counterterrorism measures. The objective of the simulation was to; “assess the implications of mandatory produce standards, and identify insights on how standards could be best shaped today as a result of exploring these implications.” The 45 participants were grouped into five stakeholder teams, representing producers, customers, federal departments and agencies, consumer protection groups, and state and local governments.

In the first hypothetical scenario, FDA introduced mandatory safety standards for fresh leafy green produce, similar to the voluntary guidelines that are currently being used in the produce sector. Each team explored the hurdles involved in implementing the new safety standards, which included various record-keeping requirements. For example, producers were required to test the water for microbial contaminants and to keep irrigation records.

In the second scenario, FDA added new requirements to the standards, including testing of samples from each lot packaged at the farm or packing area, for generic E. coli, Salmonella spp. and E. coli O157:H7. In addition, it has required retraining in hygiene for farm workers every six months, and the reporting of illness and the reassignment of ill workers. The agency has also required that produce should not be harvested within 30 feet of flooding, that planting must not begin until 60 days have passed to allow soil to dry, or that the soil be tested to shorten that period to 30 days.

“I found it fascinating as a member of the state and local government team to see the obstacles to implementing such changes and to realize how little oversight of produce growers there is at this time,” Steele said. Industry is concerned that mandatory standards will lack flexibility and will not be sufficiently commodity-specific.

A final report for the summit will be posted on the EAS website when it becomes available. Keep an eye out for it. The lessons learned from this exercise will be insightful.

Steele Joins Industry Leaders on Panel at FDLI and FDA Annual Conference

FDLI and FDA Conference EAS President Ed Steele will join industry leaders for a special breakout session on FDA’s Center for Food Safety and Applied Nutrition, at the upcoming Food and Drug Law Institute and Food and Drug Association Annual Conference in Washington, D.C., April 22-23. The conference includes separate breakout sessions for each FDA center, with Center directors discussing their biggest challenges and presenting their understanding of the priorities of the new Administration. CFSAN Director Stephen Sundlof, who has been extremely busy since his appointment just over one year ago, will have much to discuss with the panel.

Christopher L. Hagenbush, a partner in Patton Boggs LLP will serve as the panel moderator. Tony Corbo, senior lobbyist, Food and Water Watch and Daniel F. Shaw, vice president and deputy general counsel, H.J. Heinz Company, will join Steele on the panel.

EAS Joins Consumer Healthcare Products Association (CHPA)

CHPA EAS Consulting Group was among 13 new members elected by the Consumer Healthcare Products Association’s board of directors at their March 12 meeting.

CHPA is a not-for-profit association representing the makers of over-the-counter medicines and nutritional supplements, and the consumers who rely on these healthcare products. EAS’s membership in CHPA should help CHPA's members with their regulatory needs.

“We look forward to working closely with CHPA and its members at this challenging time for the industry,” says EAS President Ed Steele.

Dr. Soni Leads Sweetener Workshop at SOT

EAS Senior Consultant Dr. Madhu Soni was session chair for a workshop on high-intensity sweeteners at the Society of Toxicology’s annual meeting, held in Baltimore, Md., March 15-19.

Dr. Soni explained that the quest for the perfect high-intensity sweetener with a clean, sweet taste, no off-flavor, non-caloric, and no adverse health effects continues. To date, the U.S. Food and Drug Administration has approved five artificial sweeteners: aspartame, acesulfame-K, neotame, and sucralose, in addition to saccharine. Currently, cyclamate is pending FDA approval/re-approval. The session looked at lessons learned from previously approved sweeteners, concerns related to obesity, and some possible future sweetener developments.

Alan Rulis, former director of FDA’s Office of Food Additive Safety, who is now senior managing scientist for the Center for Chemical Regulation and Food Safety at Exponent, Inc., explained that time and again the agency’s original judgments have successfully withstood challenges over the years.

Free EAS GMP Challenge Webinar

For those who missed the live EAS GMP Challenge webinar, held February 5, a recording of this free session is now available on demand.

Topics covered in the webinar include:
  • The most often misunderstood dietary supplement GMP compliance issues, such as setting specifications, establishing material review processes and the roles and responsibilities of quality control personnel.
  • The steps you should be taking right now.
  • The significance of the lab portion of GMPs.
Brad Williams, manager of FDA’s Division of Dietary Supplement Programs joined Carl Reynolds, EAS vice president, and Ed Steele, EAS president for this 75 minute webinar.

The GMP Challenge Quiz Now Available on EAS Website

For those who were not able to take the EAS GMP Challenge Quiz when it was first made available in conjunction with the EAS GMP Challenge Webinar, it can be now be taken directly on the EAS website. This free, 10-question quiz is designed to test your current knowledge of the dietary supplement GMP rule. After you take the quiz you can contact EAS for the correct answers.

The current quiz is the same one that was successfully used in advance of the February 5th webinar. It will be revised with new questions monthly so you can take the GMP Challenge periodically. It can be taken individually or in groups. It is an excellent training tool for companies that wish to test how well managers and staff know the GMP requirements.

Click on the EAS GMP Challenge Quiz to see how you do!
Upcoming Events
Seminars/Workshops

EAS Dietary Supplement GMP Seminar
  • May 14-15, 2009
    Evening Star Building
    Washington, D.C. 20004
    EAS Instructors: Robert Fish & William Ment
FDA’s new dietary supplement GMP Rule goes into effect on June 25, 2009 for firms of 20 to 500 employees. Are you prepared? Our final Dietary Supplement GMP Seminar before the deadline will be presented May 14-15 in Washington, D.C.

This program, presented by former FDA compliance officials, will provide all the information needed to comply with the agency’s final rule. It will also address the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved in testing, quality control and distribution of supplements.

EAS instructors Robert Fish and William Ment will present the seminar. Mr. Fish, a former agency investigator, has wide expertise in compliance matters and current GMPs as they relate to dietary supplements, pharmaceuticals, devices, and biologics manufacture. Mr. Ment, a former director in FDA’s Baltimore District Laboratory, has broad experience in auditing of QA programs for pharmaceutical and dietary supplement firms. He has been active in the training of industry personnel in FDA’s dietary supplement GMP regulations.

The deadline for registering is April 30th and space is limited. Don’t delay if you are interested in attending this seminar.

Click here for more details of this seminar.

Food Labeling in Four Easy Pieces - The Basics & Beyond
  • May 20, 2009
    Marriott Airport Hotel
    Newark, New Jersey
    Dr. James Hoadley and Beatrice Greenberg
EAS Senior Consultants Dr. James Hoadley and Beatrice Greenberg will be among the presenters at a Food Institute labeling workshop titled Food Labeling in Four Easy Pieces: The Basics & Beyond, at the Marriott Airport Hotel, Newark, N.J., May 20.

Ms. Greenberg will join Robert Post of USDA’s Center for Nutrition Policy and Promotion in a session on labeling “tough spots,” including allergens, flavors, country of origin, and state issues. Dr. Hoadley will present a session on label claims. Other instructors for the event will include attorney Robert Hahn, principal of Olsson Frank and Weeda, and Regina Hildwine, senior director for science policy, labeling and standards at the Grocery Manufacturers Association.

Click here for more details.

Tradeshows EAS will be among the exhibitors at the 11th annual Food Safety Summit in Washington, D.C, April 27-29. The summit has become a prominent event in the food safety calendar, where industry experts, academics and regulators gather to discuss the latest food safety issues--such as what industry can learn from the outbreak of Salmonella Typhimurium linked to peanut ingredients. Come see us at booth 423.
EAS will also be among the exhibitors at the annual Society of Cosmetic Chemists Suppliers’ Day in Edison New Jersey on May 12-13. This two-day event sponsored by the New York Chapter, showcases the newest cosmetic 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 booth 933 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
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