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 2010
In this Issue:
Upcoming EAS Events
  • Food Safety Summit [more]
  • Dietary Supplement GMP Seminar [more]
  • Natural Marketplace 2010 [more]

From the Desk of the President:
Will Lawmakers Support the Administration's Commitment to FDA?

Ed Steele, President Dear Reader,

Welcome to the March issue of EAS-e-News, our free newsletter for industries regulated by FDA.

As the nation struggles to emerge from a deep recession, the Administration's request for a 23 percent boost in FDA's fiscal year 2011 budget represents an especially big commitment--even though much of the increase would be in the form of user fees rather than direct budget authority. If approved by the lawmakers, this would give the agency more than $4 billion with which to focus food safety efforts on prevention, to invest in medical product safety and to improve regulatory science.

In anticipation of a good result on Capitol Hill, the agency is moving ahead on numerous fronts. Just last week, HHS Secretary Kathleen Sibelius announced an "unprecedented" cooperative effort between FDA and the National Institutes of Health that will help identify key questions in regulatory science – and then answer them.

We can expect great things to come from this joint effort. NIH is under the able leadership of physician and geneticist Francis S. Collins, who led the highly successful Human Genome Project. As part of the collaboration, the agencies will establish a Joint NIH-FDA Leadership Council to help ensure that regulatory considerations are taken into account when planning biomedical research, and that the latest science is integrated into the regulatory review process.

At EAS, meanwhile, we have a significant new initiative to highlight: Dean Cirotta is now EAS vice president with responsibility for pharmaceutical, dietary supplement and tobacco product services and he will play a lead role in expanding our presence in those product areas (See details below). I am delighted that we are now able to offer expanded services to both the Rx and OTC drug industries. This is in addition to the GMP, labeling and toxicology support we have provided to the supplement industry for years and the new services we are offering to the tobacco industry as they come under FDA regulation. Dean's quality experience will be invaluable as he assumes his leadership role at EAS.

In other EAS news, I am very pleased to welcome the newest member of our senior consulting team--Karin Ricker, who brings a wealth of experience as a regulatory scientist.

Our Issue of the Month article asks if your records can withstand the scrutiny of FDA inspectors. The author of this timely article is EAS Senior Consultant Leslie Bluhm, a former director of the Office of Field Programs in FDA's Center for Food Safety and Applied Nutrition. Given the agency's new focus on prevention, its expected budget increase and the possibility of new enforcement tools, this may be an appropriate time to take a close look at your records and documentation.

In addition, we take a look at the Federal Trade Commission's latest actions with regard to product packaging and labeling claims for Omega-3 on vitamin supplement products for children. In a move that should be ringing alarm bells in the industry, along with issuing warning letters the agency is actively encouraging consumers to file complaints if they see baseless claims on such products.

I hope you continue to find our "easy" updates useful and I encourage you to share them with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Can Your Records Withstand an FDA Review?
By EAS Senior Consultant Leslie Bluhm
Are your records an asset or a liability? Does your documentation substantiate what you do? Or do your plant's written procedures and processes just sit on a shelf and collect dust?

If you lack adequate records, you won't be able to demonstrate to an FDA inspector—or to anyone—that your plant is under control from receipt of ingredients through to the finished product in commerce.

Records and documentation are significant assets, but only if they are done correctly. The main idea is to create a proper record and verification that a specific operation was performed.

One key step is to create a Prerequisite Program (PRP) specific for the manufacturing plant. The PRP should include Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs), and Sanitation Standard Operating Procedures (SSOPs).

The GMP documentation will include sections dealing with construction and layout of buildings, layout of premises, utilities, waste disposal, equipment suitability and maintenance, prevention of cross contamination, personnel practices and policies, water supply and waste disposal, toilet and hand washing facilities, among other topics. In addition, it is good to document the receipt of ingredients, noting inspection, proper storage, and assigned lot numbers.

To establish SOPs, you need to document what you do and how you do it. Make sure to explain the scope of the process or procedure and to say who is responsible for the operation. As an added benefit, when you clearly state how to perform an operation, the instructions can be used for training new personnel.

It is useful to establish a record form that the operator can initial or sign and date. The form should include a space for noting any deviations. The immediate supervisor should review the records to corroborate that the operation was performed correctly or that the out of spec product was segregated or quarantined. You should also document who is to be informed about a deviation and who will make a decision on what should be done with the product that deviates from the established criteria.

The SOPs should include a "Revision Log" that has to be signed and dated. This will indicate to a reviewer that the documentation is not just collecting dust, and that you take it out and look at it with some frequency--and adjust it to fit any changes in your operations.

SOPs should include secure storage and segregation of sanitizing chemicals, food grade lubricants, and other chemicals in the plant. These records should include quantities, amounts taken and the date and signature of the employee authorized to access the materials. SOP documentation should also include pest control records, records of temperature indicating or recording devices for refrigerators, freezers and in-process control, and calibration of instruments. The records should document the control and critical control points in your operations and processes, as well as the assessment and disposition of any rework. SSOPs document the sanitizing process and procedures that are used to clean and sanitize the equipment and surrounding areas to reduce or eliminate the potential for contamination in the product. The corroboration by the sanitation supervisor that the SSOPs were performed correctly is integral to producing a safe product.

When you have comprehensive, up-to-date records in place at your plant, you will be well-prepared for that FDA review.

Who's Who at EAS:
Meet EAS Senior Consultant Leslie Bluhm

Leslie Bluhm Leslie Bluhm Ph.D. is a former director of the field programs division at the Center for Food Safety and Applied Nutrition. In addition to his work at FDA, he has served in various private sector roles, including management of technical research and development activities. He is an expert in HACCP, food GMPs, SSOPs and other food regulatory issues.

Dr. Bluhm began his career in industry as a research scientist with Miles Laboratories Inc., a Bayer subsidiary, advancing to become director of food science research. He later joined Joseph E. Seagram & Sons, where he served in various capacities, including vice president and director of technical affairs.

He held several senior positions at FDA, including director of the Division of HACCP Programs, which was renamed the Division of Field Programs. In this role, he managed a pilot program to introduce voluntary HACCP across the food industry. In addition, he managed the Low Acid and Acidified Canned Foods firm registration, and oversaw the Laboratory Quality Assurance Branch functions in accrediting state laboratories in the analysis of milk products and shellfish. He also served as deputy director of food chemistry and technology for the National Center for Food Safety and Technology in Chicago.

He is a HACCP certified instructor who leads "Train the Trainer" courses dealing with U.S. Seafood HACCP and with requirements for exporting seafood products to the U.S.

He has a B.Sc. degree in food science and technology from the University of Massachusetts, Amherst. He holds M.S. and Ph.D. degrees in food science and technology from the University of Illinois, Urbana.

"We are very fortunate to have Les Bluhm on our senior consulting team," says EAS President Ed Steele. "His extensive knowledge and expertise in HACCP, food GMPs, SSOPs and other food -safety related areas are valuable assets for our clients."

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of February, 2010. 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 Announcements
Recalls and Safety Alerts
Enforcement Reports
What's New by Topic
EAS in Action:
Dean Cirotta Named EAS Vice President

Dean Cirotta In a significant new development in the expansion of EAS Consulting Group's services, Dean Cirotta has been named vice president with responsibility for pharmaceutical, dietary supplement and tobacco product services.

Mr. Cirotta has more than 20 years of experience in the pharma sector, having served in senior management roles with responsibility for regulatory affairs, compliance and quality assurance. Immediately prior to joining EAS, he was president and chief operating officer of UPM Pharmaceuticals in Baltimore, Md, a subsidiary of SJ Strategic Investments, Bristol, Tenn.

Mr. Cirotta will divide his time between Bristol and the newly opened EAS offices in Rockville, Md.

"I am very pleased that Dean Cirotta has joined our senior management team," says EAS President Ed Steele. "With his practical experience and knowledge of the industry, he is well-qualified for this role."

EAS offers a range of pharmaceutical regulatory consulting and auditing services including application management, U.S. agent services, establishment registration and product listing, and cGMP quality system and pre-approval audits of manufacturers and vendors. To see a full list of services, click here.

New Addition to the EAS Network

Karin Ricker Ph.D. Karin Ricker Ph.D., is the latest addition to the fast-growing EAS team of senior consultants. A former consumer safety officer in FDA's Office of Food Additive Safety, Ms. Ricker reviewed industry submissions to evaluate the safety of food ingredients, including GRAS ingredients and biotechnology notifications for plant pesticides. Most recently, she worked as a toxicologist with the California Environmental Protection Agency's Office of Environment Health Hazard Assessment, where she evaluated chemicals for their potential to cause cancer in humans—and for a possible listing under the state's Proposition 65.

"I am delighted to welcome Karen to our growing team," says EAS President Ed Steele. "She brings the valuable perspective of a regulator who is also an accomplished scientist."

FTC Issues Warning Letters for Omega-3 Claims

The Federal Trade Commission recently sent letters to 11 companies warning that labeling claims about the benefits of Omega-3 fatty acid supplements in products targeted at children may be deceptive. The agency is closely monitoring claims relating to omega-3 fatty acids, probiotics, fiber products, antioxidants, and products marketed for use by children.

In a January 26 letter, the Commission urged the companies to review their product packaging and labeling to make sure they do not violate federal law by making unsupported claims about how the supplements benefit children's brain and vision function and development.

"Please be advised that if you make health-related claims for products without competent and reliable scientific evidence to support such claims, the FTC may take action to enforce and seek redress for any violations of the FTC Act as the public interest may require," said Mary K. Engle, associate director of the agency's Division of Advertising Practices.

She warned that product packaging and advertising might be in violation of the FTC Act unless manufacturers have scientific evidence to support claims that their products boost, improve, enhance, or support brain and vision function and development in children. Claims relating to intelligence, cognitive function, learning ability, focus, mood, memory, attention, concentration, visual acuity, and eye health may also be deceptive, she said.

The letters gave the companies the customary two weeks to respond and explain the steps they have taken, or intend to take, to ensure they are complying with the law. The agency threatened legal action for unsubstantiated claims. To see a sample letter, click here.

In the letter, the agency cited a recent investigation it conducted into similar claims made by Northwest Natural Products, Inc., marketer of L'il Critters Omega-3 Gummy Fish, a vitamin product for children. The company quickly modified its marketing materials for Gummy Fish, including product packaging and labeling.

The Commission has invited consumers to file complaints against any company they believe may be deceptively advertising dietary supplements for children.
Upcoming Events

Food Safety Summit
April 13-14, 2010
Convention Center
Washington, D.C.
Booth 520

Dietary Supplement GMP Seminar
April 27-28, 2010
EAS Headquarters
Alexandria, VA

Natural Marketplace 2010
June 10-12, 2010
Las Vegas, Nev.
Booth 1130
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
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, 2010