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 2009
In this Issue:
Upcoming EAS Events
  • Schwemer Leads Bio/Pharma Risk Management Workshop [more]
  • Dietary Supplement GMP Seminar [more]
  • Ensuring Regulatory Compliance of Dietary Supplement Laboratories [more]
  • Food Labeling Seminar [more]
  • Food Labeling Update [more]
  • Dietary Supplement Labeling [more]

From the Desk of the President:
Commissioner Hamburg Gets Our Attention

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

"What we want to create is really a standard of practice that is a little bit different," said FDA Commissioner Dr. Margaret Hamburg, in response to a question following her remarks on enforcement at a Food and Drug Law Institute event in Washington, D.C., August 6. Although she may not have meant that to sound like a warning to industry, the Commissioner certainly succeeded in getting our attention.

Dr. Hamburg said the agency is committed to being "as transparent as possible" about expectations, and that industry should commit to working in "as responsive a way as possible to address our concerns." She went on to lay out some timeframes for action that will become the new standard.

For example, the agency will tighten its post-inspection deadlines, so industry will generally get no more than 15 days to respond to any significant inspection findings before the agency issues a warning letter or takes other enforcement action. In addition, the agency will speed up the warning letter process by only requiring that those letters presenting significant legal issues undergo a review by the agency's Office of Chief counsel.

Also, the agency will work quickly to follow up on corrective actions taken by industry after a warning letter is issued or a major product recall occurs, she said. And she warned that the agency is prepared to act even before a formal warning letter is issued, if there is an immediate public health risk.

Along with the various sticks, Dr. Hamburg offered a carrot to industry, in the form of a new "close-out" process in the event that violations are fully corrected. It remains to be seen how the agency will follow through on these initiatives, especially given that they will mean more work for FDA's already stretched workforce.

The FDA is not the only organization that is quickly evolving at this time. EAS continues to expand its team of expert consultants. I am delighted to welcome the two newest members of the team--Mike Shah and Hans Knapp (see details below).

Also, the fall series of EAS seminars begins next month with the Dietary Supplement GMP Seminar, October 6-7 followed by the lab seminar, "Ensuring Regulatory Compliance of Dietary Supplement Laboratories, October 8-9 at the EAS headquarters in Alexandria, VA. These events will include an assessment of FDA's new approach to enforcement.

As always, I hope you continue to find our quick round-up of FDA activities useful. Please feel free to share it with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
FSEA Includes New Requirements for Imported Foods
By EAS Consultant Gisela Leon
The recently passed House bill "Food Safety Enhancement Act of 2009" substantially strengthens the Food and Drug Administration's authority over foods under the agency's regulatory control--including imports. The next step for the bill is the Senate.

The bill authorizes the agency to establish a traceback system for imported as well as domestic food, a requirement for third party certification of imports, and safety and security guidelines for food imports. It also requires the agency to adopt a risk-based food facility inspection schedule – including more inspections than in previous years. The agency must establish an inspection frequency for high-risk and low-risk facilities and facilities that contain food. USDA-regulated food and alcohol-related facilities are exempt.

Both foreign and domestic producers will be required to register their facilities and pay fees. They will also be required to conduct a hazard analysis and to implement risk-based preventive controls, and to implement a written food safety plan. Importers will be required to use only accredited testing laboratories and will be required to register and pay annual fees. Certain imported foods–not yet defined–will have to be accompanied by a certification that the product complies with the Federal Food, Drug, and Cosmetic Act.

The FSEA requires the agency to introduce regulations to implement the act's requirements. Section 109, for example, deals with certification and accreditation. Certification must be by a "qualified certifying entity." This may be an agency or a representative of the government of the country from which the article originated, or an individual or entity recognized by the Secretary of Health and Human Services, or an accredited body recognized by the Secretary. The Secretary is also required to issue regulations to ensure that any qualified certifying entity and its auditors are free from conflicts of interest.

The bill allows three years for Section 109 to be implemented. But requirements for facility registration and the payment of an annual fee are likely to be in place by end of this year.

Who's Who at EAS:
Meet EAS Senior Consultant Donald F. Fernholz

Don Fernholz Don Fernholz joined EAS as a contract consultant in 2006. He has more than 41 years of inspection experience, including 32 years with the Food and Drug Administration and a further nine years conducting audits and serving as a consultant to FDA regulated industries.

Mr. Fernholz began his FDA career in 1964 as an investigator at FDA's St. Louis District Office. After a short time as a special investigator for the Minnesota State Health Department, he returned to the FDA to work as an investigator in the Minneapolis District Office. Later, he transferred to the FDA Chicago District Office where he worked as an investigator for seven years. He continued to develop his expertise in all areas of food manufacturing and warehousing, dietary supplements, cosmetics, convenience food manufacturing, and pharmaceutical manufacturing, including small volume injectables and other dosage forms.

His next role was as a senior resident post investigator in Fargo, North Dakota. After four years, he was selected as a supervisory investigator in charge of a new Field Resident Post in Akron, Ohio. During his management of that office he worked closely with state and local health officials, and assisted industry in bringing their operations into compliance with FDA requirements. He held the position of supervisory investigator for 20 years, during which time he was in charge of the FDA Resident Posts in Akron, Cleveland, Youngstown, Toledo, and Columbus, Ohio.

Mr. Fernholz joined AAC/Kendle as a contractor in 1997 as a senior consultant, where he provided expert advice on FDA requirements and regulations to clients and performed audits of manufacturing facilities throughout the United States. He conducted comprehensive audits of food manufacturing and warehousing facilities, dietary supplements manufacturers and Good Agricultural Practices for produce growers and distributors.

At EAS, he is available to conduct audits, and to provide expert regulatory advice and training.

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of August, 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
Enforcement Reports
What's New by Topic
EAS in Action:
Two More Pharmaceutical Consultants Join EAS

EAS Consulting Group is pleased to announce that Hans Knapp and Michael Shah have joined the growing EAS team of pharmaceutical consultants.

Hans Knapp Mr. Knapp's unique background includes 30 years of professional experience in preclinical toxicology and drug regulatory affairs. In the first sixteen years of his professional career, he worked as a research toxicologist in the agricultural chemical and pharmaceutical industries. He has supported projects in drug regulatory affairs since 1992, working with Bristol-Myers Products, and SmithKline Beecham Consumer Healthcare. In 1995, he joined Warner-Lambert Consumer Healthcare and remained with the organization through 13 years of acquisitions by Pfizer and Johnson & Johnson. He ended this phase of his career as a Director of Global Regulatory Affairs with McNeil Consumer Healthcare in December, 2008.

Michael Shah Michael Shah is a pharmaceutical industry veteran whose 33-year career has included quality assurance, quality control, regulatory affairs and manufacturing roles with such Fortune 500 companies as Bayer Corp., and Pfizer. He served with Bayer in Toronto, Ontario for 15 years, finally becoming QA/QC director of the facility. He has been an independent consultant since 2002.

"I am very pleased to welcome Hans and Mike as the newest members of our pharmaceuticals consulting team," says EAS President Ed Steele.

Steele Joins Joint Standardized Information on Dietary Ingredient Working Group

EAS President Ed Steele has joined the Joint Standardized Information on Dietary Ingredients (SIDI) Working Group, which is working to create a voluntary industry-wide ingredient supplier qualification program for the dietary supplement industry. The group held a day-long planning meeting in Washington, D.C., August 6.

Bill Frankos, director of FDA's Division of Dietary Supplement Programs, said the agency expects industry to be innovative in ensuring safety and quality of ingredients and that supplier qualification needs to go beyond questionnaires. Although FDA's dietary supplement final rule on Good Manufacturing Practices mentions supplier qualification, it does not include specifics on how ingredient suppliers are to be qualified.

The SIDI working group believes that the best-case scenario would be for guidelines to shift from voluntary status to mandatory as they become industry practice. The group is using the Certificate of Analysis guidelines for excipients as a template for the dietary ingredient version.

SIDI has established subcommittees to work on specific issues. Subcommittee Two, for example, is developing a self-assessment audit checklist for manufacturers and suppliers (and possibly retailers), as well as a dietary supplement component supplier GMP audit guideline. Draft documents are expected to be available early in 2010.

SIDI currently includes seven industry and regulatory organizations and 16 member companies. Member organizations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Counsel for Responsible Nutrition, the Natural Products Association, the Food and Drug Administration, the National Science Foundation, and the United States Pharmacopeia. The group's company members currently include Albion, A.M. Todd, BASF, Bayer, Beijing Ginkgo Group, Colorcon, DSM, EAS Consulting Group, Embria Health Sciences, GNC, Joy QM Systems, Kemin, Kyowa Hakko, NBTY, Nutramax, and Nutrilite.

Take the GMP Challenge Quiz
Upcoming Events
Schwemer Leads Bio/Pharma Risk Management Workshop

EAS Senior Consultant Bill Schwemer will lead a pre-conference workshop on risk management at the upcoming 5th Annual Bio/Pharmaceutical and Medical Device Product Recalls Summit in Alexandria, Va., September 24-29, hosted by the Center for Business Intelligence.

The September 24 workshop will explore the most effective risk management models for bio/pharma companies, with a focus on practical applications. It will also review why the Food and Drug Administration is overhauling its risk assessment thinking.

James Wood, a partner at Reed Smith LLC, will be co-leader for the session. He recently co-authored a book titled “Prescription Product Recalls – A Proactive Primer.”

For more details, visit www.cbinet.com.

Deadline for Dietary Supplement Seminars Approaches

EAS has two dietary supplement training events scheduled for early October at our training facility in Alexandria, VA, and now is the time to secure a place if you plan to attend.

The Dietary Supplement GMP Seminar, October 6-7, will review the current good manufacturing practice requirements for dietary supplements. This seminar will be presented by former FDA compliance officials, who will provide all the information needed to comply with the agency's new GMP rule, covering 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 second event, titled Ensuring Regulatory Compliance of Dietary Supplement Laboratories, October 8-9, will focus on requirements for laboratories under FDA's final rule, which places significant emphasis and responsibilities on laboratory and QC personnel. The agency focuses on laboratory controls during inspections to ensure that analytical results are credible and the laboratory is in compliance with current GMP requirements. FDA trend data over the past several years show that deficiencies in laboratory controls are consistently among the most frequently cited observations during inspections of pharmaceutical companies.

Other upcoming events include:

Food Labeling Seminar
October 20-21
Alexandria, VA

Food Labeling Update
October 22
Alexandria, VA

Dietary Supplement Labeling
December 2-3
Alexandria, VA

Check the EAS web site for details.
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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