|
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
|
December 2008 |
|
In this Issue:
|
|
Upcoming EAS Events |
- Dietary Supplement Labeling Seminar [more]
- New 2009 Seminars [more]
- Food Labeling Seminar and Update
- Dietary Supplement GMP Seminar
- Dietary Supplement Laboratories Seminar
- OTC Drug and Cosmetics Labeling Seminar
- “GMP Challenge” and Webinar [more]
|
|
|
From the Desk of the President:
A Look Ahead to 2009
Dear Reader:
Welcome to the December issue of EAS-e-News, our free, monthly newsletter for industries regulated by the Food and Drug Administration. EAS-e-News is designed to supply easy access to new information on FDA’s website along with a quick summary of the latest activities at EAS Consulting Group.
In this final issue of 2008, EAS Senior Consultant Norma Skolnik looks at what we might expect from the incoming administration. Ms. Skolnik, who is the subject of our “Who’s Who at EAS” section, has routinely produced such transition analysis in the course of her career.
Even before the Obama administration steps in, we are seeing signs of increased enforcement action at FDA. On October 28, for example, the agency sent a warning to Bayer concerning the marketing of aspirin products in combination with Health Advantage, a cholesterol-lowering dietary supplement. A week later, the agency sent federal marshals to Celsus Laboratories in Cincinnati, where they seized contaminated heparin from China. On November 10, the agency issued an import alert that requires melamine testing of all milk products and processed foods containing milk solids from China. We expect this increased level of activity to continue in 2009.
At EAS, meanwhile, we were pleased to receive a “no objection” letter from FDA in response to a Generally Recognized as Safe Notice submission for alkyl polyglycosides products used in the cleaning of foods. This adds to the number of successful GRAS submissions by EAS (formerly a division of AAC/Kendle) on behalf of our clients. See the “EAS in Action” section below for more detail.
In other EAS news, I am pleased to welcome GMP-expert James H. Knight to our team of pharmaceutical product consultants. His arrival is part of an ongoing expansion of our services to the pharmaceutical sector. Jim’s career to date has included prominent roles at Baxter-Travenol and Schering-Plough. Watch this space for more news of our expanded pharmaceuticals services.
Finally, despite the current economic uncertainties, it is good to acknowledge that there are things for which we can be thankful. With this in mind, I would like to wish you and your family a peaceful holiday season and a prosperous New Year!
Sincerely,
Ed Steele,
President
|
|
Who's Who at EAS:
Meet EAS Senior Consultant Norma Skolnik
Norma Skolnik joined EAS in January 2008, strengthening the EAS consulting team with her 30 years of regulatory experience in the food, dietary supplement and OTC drug industries.
Over the previous decade, Ms. Skolnik was director of regulatory affairs for Cadbury Adams USA (formerly Pfizer’s Adams Division). Prior to that role, she served as associate director of regulatory affairs at Wyeth Consumer Healthcare and at the Lederle Consumer Health division of American Cyanamid.
Ms. Skolnik has considerable experience in providing regulatory guidance for new and marketed OTC drugs including claims development and advertising reviews. She helped launch numerous products in the dietary supplement, OTC drug and functional food area. She has advised on strategies for gaining regulatory approvals when needed and has implemented adverse event reporting programs for dietary supplements and OTC drug products.
In addition to her expertise in U.S. requirements, Ms. Skolnik has broad experience in Canadian and Latin American regulatory issues. She has been involved in implementing recent FDA food safety and import safety programs and has experience resolving regulatory import issues. She can also advise clients on compliance with U.S. requirements for food imports and bioterrorism measures.
|
Issue of the Month
What to Expect from the New Administration
By Norma Skolnik, Senior Consultant
What changes might we expect to see at HHS/FDA and other federal regulatory agencies after the inauguration of President-elect Obama?
A Democratic President and a Democratic majority in the House and Senate could lead to a stronger HHS/FDA and more regulation. However, since Democrats failed to win enough seats to stop a Senate filibuster, the new President will need support from Republicans to enact his agenda.
Given the huge financial problems that the U.S. faces, Obama must first tackle the troubled economy as well as major challenges such as wars in Iraq and Afghanistan. He has acknowledged that the economy may force him to recalibrate his program, but he insists that he will not back off from campaign commitments.
“We can’t afford to wait on moving forward on key priorities identified during the campaign, including clean energy, healthcare, education and tax relief for middle class families,” he said, four days after the election. Other priorities likely to get immediate attention include job losses, education, and the environment.
The President-elect moved swiftly in selecting former Democratic Senate Leader Tom Daschle to replace HHS Secretary Michael Leavitt. Daschle is expected to be an able champion of the new administration’s healthcare reform goals. House Speaker Nancy Pelosi says the House will push for legislation long stalled by the Bush administration, such as healthcare for children and stem cell research.
As is customary, we can expect FDA Commissioner Andrew von Eschenbach to resign and the agency to be headed by an Acting Commissioner for at least some months. David Kessler is the only Commissioner in recent memory to be held over from one administration to another.
Food safety, particularly for food imports, is likely to continue as a top HHS/FDA priority. This issue will have strong ongoing support on Capitol Hill and from industry, as well as at the agency.
Given Senator Obama’s commitment to environmental issues, the EPA may be among the first agencies to be impacted. The grapevine says that Robert Kennedy Jr., an environmental activist, or Lisa Jackson, head of New Jersey’s EPA, may be appointed head of that federal agency.
Among the possible candidates mentioned to lead FDA are:
- Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research.
- Dr. Joshua Sharfstein, Commissioner of the Baltimore City Health Department. Sharfstein is a health policy advisor to the Democratic members of the House Government Reform Committee.
- Susan Wood, former FDA Assistant Commissioner for Women’s Health, who is currently a research professor at George Washington University’s Department of Environmental and Occupational Health.
President-elect Obama’s top choice to lead USDA is widely rumored to be Tom Vilsack, former Governor of Iowa, who is currently a Resident Fellow at Harvard’s Institute of Politics.
|
What's New on FDA's Website:
Listed below are links to new additions to the FDA website for the month of November, 2008. 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
- Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient November 24, 2008
- Stop & Shop Recalls Butternut Squash in Prepared Turkey and Ham Dinner November 24, 2008
- Fashion Sanctuary Issues a Voluntary Nationwide Recall of All Lots of Zhen De Shou Fat Loss Capsules Found to Contain an Undeclared Drug Ingredient November 23, 2008
- PANOS Brands Recalls Vegan Rella Cheddar Block November 20, 2008
- Wegmans Food Markets, Inc. Issues Voluntary Recall on Wegmans Italian Classics Seasoned Tomato Sauce November 20, 2008
- Seattle's Favorite Gourmet Cookies & Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops November 14, 2008
- CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream November 13, 2008
- Nestlé USA Voluntarily Recalls Two Production Codes of Nestlé Nesquik Strawberry Powder November 7, 2008
- ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets November 7, 2008
- Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments November 7, 2008
- Amy’s Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to Possible Undeclared Milk in Tofu Scramble in a Pocket Sandwich; Lot Code H148 November 7, 2008
- FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer November 6, 2008
- FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes November 5, 2008
- Nestlé Withdraws Nestlé Farinha Lactea Cereal in the United States November 3, 2008
October Archive of The FDA this Week: Andy's Take Enforcement Reports
What's New by Topic
|
EAS in Action:
EAS Reminds Industry of New Certification Requirement for Child-Resistant Packaging of Iron-Containing Dietary Supplements
The Consumer Products Safety Commission bypassed normal notice-and-comment rulemaking last month to issue an “immediate” final rule, effective November 12, to clarify new certification requirements for child-resistant packaging. The Commission has been swamped with questions about the changes, introduced by the Consumer Products Safety Implementation Act of 2008, which was enacted in August.
The law requires iron-containing dietary supplements subject to the Poison Prevention Packaging Act to comply with the new certification requirements. Child-resistant packaging certification is now required for all iron-containing products that contain 250 mg or more of elemental iron.
In the final rule, the Commission clarified that the importer of foreign products or the manufacturer of domestic products are responsible for the certification, which can be submitted electronically and can be based on a test of each product or on a reasonable testing program.
The Commission plans further rulemaking concerning a requirement for third party certification of children’s products, which will be phased in as it compiles a list of accredited testing labs.
The Council for Responsible Nutrition has called for a six-month delay in enforcing the CPSIA to allow its members time to “thoroughly and accurately” implement the certification requirement.
The final rule is available at www.cpsc.gov/businfo/cfr111008.pdf.
James Knight Adds to EAS’s Pharmaceutical Services
In the latest addition to the EAS team — part of an ongoing expansion of the group’s services to the pharmaceuticals sector — James H. Knight recently joined as a senior consultant on a contract basis.
An expert in the creation and implementation of Good Manufacturing Practice programs, Mr. Knight began his career at Baxter-Travenol, where he established the first GMP-compliant microbial limits testing laboratory in the company’s Kingstree, South Carolina facility. Subsequently, he spent 14 years with Schering-Plough HealthCare Products, where he established the first quality program for the division’s pilot production facility.
He became an independent consultant in 1999. In the following year, while continuing to work as an independent consultant, he became quality assurance director for the production of biologics used in clinical trials at St. Jude Children’s Research Hospital in Memphis, Tenn.
“I am delighted to welcome Jim to our team of pharmaceutical consultants,” said EAS President Ed Steele. “His addition brings an industry perspective to augment the strong FDA credentials of our current staff” he said.
EAS Consulting Group’s fast-growing team of consultants to the pharmaceuticals industry offers a depth and breadth of expertise from former FDA regulators and industry executives. The team currently includes Robert Fish, William Schwemer, William Ment, Robert Snell, Norma Skolnik, Linda Yang, Ph.D. and Freddy Vaede, Ph.D. Eduardo March, Bob Mazzaferro, and Roger Rand specialize in medical devices.
FDA Responds with No Objection to GRAS Submission
The Food and Drug Administration issued a “no objection” letter in response to a Generally Recognized as Safe notice submitted by EAS Consulting on behalf of Cognis Corporation.
The GRAS notice, submitted November 28, 2007, was for alkyl polyglycosides products for use in the cleaning of foods, including fruits, vegetables, meat and poultry products.
“Based on the information provided by Cognis, as well as other information available to FDA, the agency has no questions at this time regarding Cognis’ conclusion that alkyl polyglycosides are GRAS under the intended conditions of use,” said Laura Tarantino, director for the Office of Food Additive Safety in FDA’s Center for Food Safety and Applied Nutrition, in an October 14 letter.
This adds to the list of GRAS notices successfully submitted by EAS (formerly a division of AAC/Kendle) on behalf of our clients. Among the other submissions were notices for:
- epsilon-Polylysine, an antimicrobial agent;
- Sodium iron EDTA, a source of dietary iron for food fortification;
- Bacteriophage P100, for use as an antimicrobial in cheese;
- Triglycerides enriched in omega-3 fatty acids from fish oil, for use as a food ingredient;
- Polyoxyethanyl-alpha-tocopheryl sebacate (PTS), a solubilizer for the dietary ingredient coenzyme Q10 used in dietary supplements;
- Bacteriophage P100, for use as an antimicrobial to control L. monocytogenes in foods, including meat and poultry products;
- Phosphatidylserine, for use as a food ingredient; and
- Lecithin derived from krill.
|
Upcoming Events
Supplement Labeling Seminar in Salt Lake City
It’s not too late to register for the EAS Dietary Supplement Labeling Seminar, which will be held in Salt Lake City, Utah, December 9-10.
The intensive two-day training program will include workgroups in which participants will gain “hands on” understanding of how to comply with labeling regulations. The EAS instructors will explain how to prepare compliant labels, including mandatory elements and allowable claims.
The program supplies the “need-to-know” information for anyone responsible for preparing or reviewing dietary supplement labels, including industry personnel, consultants, auditors, attorneys and others interested in dietary supplement labeling compliance.
Act now to reserve a seat in this popular seminar before it is too late.
EAS has scheduled the following labeling seminars from January through early April 2009:
- Food Labeling Compliance Review Seminar
February 24-25, 2009
Alexandria, Va.
- Food Labeling Update
February 26, 2009
Alexandria, Va.
- Dietary Supplement GMP Seminar
March 17-18
Alexandria, Va.
- Ensuring Regulatory Compliance of Dietary Supplement Laboratories Seminar
March 19-20
Alexandria, Va.
- OTC Drug and Cosmetics Labeling Compliance Review Seminar
April 1-2, 2009
Alexandria, Va.
Registration details will be posted on the EAS website soon.
“GMP Challenge” and Webinar
EAS has scheduled a special webinar on Good Manufacturing Practices for dietary supplements February 5. In advance of the seminar, we will be inviting participants to take an online “GMP Challenge,” a quiz that will allow participants to confidentially assess their understanding of the new GMP requirements that will go into effect in June for firms with 20 – 500 employees.
Based on the results of the confidential “GMP Challenge,” the webinar will concentrate on elements of the rule that are least understood in an effort to help the industry achieve compliance before FDA begins its enforcement.
In addition to these initiatives in the lead-up to the June implementation deadline, EAS has scheduled public GMP and lab seminars March 17-19, and our experts are available to conduct in-house seminars and to assess readiness by conducting assessment audits.
Watch for further details of the GMP Challenge and webinar in the January issue of EAS-e-News.
|
Order Publications and Regulatory Tools
 |
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
|
 |
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
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
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  |
|
Share EAS-e-News with a colleague by email. Note the newsletter is copyright protected.
Contact EAS Consulting Group for permission to reuse any contents.
© EAS Consulting Group, LLC, 2008
|
|
|
