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
 January 2009
In this Issue:
Upcoming EAS Events
  • The EAS GMP Challenge - FREE Webinar on GMP Final Rule [more]
  • Food Safety Summit and the NYSCC Suppliers’ Day [more]
  • 2009 Seminars [more]
    • Food Labeling Seminar and Update
    • Dietary Supplement GMP Seminar
    • Dietary Supplement Laboratories Seminar
    • OTC Drug and Cosmetics Labeling Seminar

From the Desk of the President:
Looking Forward to a Good New Year

Dear Reader:

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

As we enter the new year, I invite you mark your calendar for the February 5 EAS GMP Challenge --a free webinar--to hear FDA officials and our own experts discuss the most misunderstood GMP issues. Our GMP gap analysis audits of dietary supplement manufacturers have revealed that many companies have a lot of work to do to achieve compliance with FDA’s final GMP rule by the June 2009 deadline for companies with 20-500 employees. See below for webinar details.

In a significant move by FDA last month, the agency issued a “no questions” response to two Generally Recognized as Safe notifications for a Stevia-based intense sweetener Rebaudioside A. The agency made it clear in December 17 letters to Cargill and Whole Earth Sweetener Company that the “no question” response applies only to the uses listed in the notifications and does not automatically clear the way for other Stevia-based products. See details below.

Our “Who’s Who at EAS” section this month features Robert (Bob) Becker. Bob is an internationally recognized HACCP expert who played a key role in FDA’s introduction of mandatory HACCP for seafood processors. His “Issue of the Month” article offers an agency insider’s perspective on the evolution of HACCP.

In other EAS news, I am delighted to welcome two new senior consultants, Sal Pinella and Gloria Dunnavan, to the EAS team. Sal joins us from Kendle Regulatory Affairs – North America where he was a senior regulatory consultant for pharmaceuticals. Gloria is a former director of the Division of Compliance in FDA’s Center for Veterinary Medicine. See below for more details.

Despite the economic downturn, here at EAS we are anticipating a good new year. I hope you continue to find EAS-e-News useful and that you will share it with your colleagues.

I wish you a joyous and prosperous New Year!

Sincerely,
Ed Steele Signature
Ed Steele,
President

Who's Who at EAS:
Meet EAS Senior Consultant Robert E. Becker Jr.

Robert E. Becker Jr. EAS is fortunate to have an internationally recognized HACCP expert, Robert Becker, on its team of senior consultants.

Mr. Becker spent 35 years with the Food and Drug Administration, working as a consumer safety officer and a regional seafood specialist.

Soon after retiring from the agency, he joined AAC/Kendle as a contract consultant in January 2001 (EAS was formerly a division of AAC/Kendle). He joined EAS as a senior consultant in October 2006.

His FDA responsibilities included issuing credentials to seafood HACCP inspectors under the agency’s Seafood Certification Program. He was called upon to conduct the most complex seafood regulatory inspections in FDA’s Southeast Region. He also consulted with state and Sea Grant personnel on seafood issues, and trained more than 1,200 federal and state regulators via live satellite when the seafood HACCP regulations were finalized.

An AFDO Certified Seafood HACCP Trainer, Mr. Becker is available to conduct HACCP audits, write HACCP plans and conduct HACCP training courses for seafood warehouses and processing facilities, juice processors or other food facilities that use HACCP to control potential hazards.

Issue of the Month
HACCP Has Come a Long Way
By EAS Senior Consultant Robert (Bob) Becker
Over the 11 years since the seafood HACCP regulation became effective, I have seen a significant increase in management’s awareness and understanding of the regulation and of the benefits of controlling food safety hazards. Because of FDA’s HACCP requirements for seafood and juice processors, USDA’s meat and poultry HACCP rule, and the voluntary HACCP programs that are being introduced across the food sector, consumers are getting safer and higher-quality products.

I inspected seafood processors for more than 25 years before FDA introduced mandatory seafood HACCP in 1997. Before HACCP, sanitation ranged from fair to poor in many of the smaller firms --and in some of the larger ones. Well-run and well-controlled seafood firms were the exception rather than the rule. Many food safety hazards, like metal fragments and histamine production, were not being addressed or were inadequately controlled. And time/temperature abuse was very common. In short, before HACCP, many seafood firms did not have control of the food safety hazards in their facilities.

Take crabmeat, for example. I worked with about 25 crabmeat processors on the Gulf Coast of Alabama prior to the seafood HACCP regulation. It’s a unique industry where cooking of the crabs occurs at the beginning of processing and the crabs are extensively handled as the meat is extracted by hand and placed in finished product containers. The product is ready to eat with no further cooking. Before the introduction of HACCP, I was afraid to eat crabmeat produced by any of these firms. I might have considered eating products from one or two of the cleaner ones--if I saw the crabs being cooked. None of them kept any cooking records, sanitation records or processing records.

Now that they are operating under HACCP principles, I would have no problem eating crabmeat from most of these firms. I admit that I would still not eat crabmeat from one or two processors, even though all now have cooking records, sanitation records and time/temperature records. All the plants smell better and the crabmeat lasts longer on the shelf because the crabs and crabmeat are not subjected to excessive temperatures during processing, storage or shipping.

Training Needed
Effective training played a key role in the success of HACCP. A year or so before the seafood HACCP regulation went into effect, training courses were held to train industry and regulators together. The regulation requires that HACCP-trained individuals are present in each firm to take part in the hazard assessment step and to review processing records to assure compliance.

As the effective date of the seafood HACCP regulation drew near, FDA had to train its investigators to ensure that the regulation was enforced in a consistent and fair way. The agency opted to train state and FDA regulators through a live, two-day training course by satellite downlink. I was selected as part of that training cadre and was on closed circuit TV to about 1,300 regulators across the country. We made presentations and fielded questions live on the air. We also produced the training manual, which took months to write, edit and publish.

Later, as enforcement of the seafood HACCP regulation progressed, the agency felt that a certification program for seafood HACCP investigators was needed to standardize enforcement. I was one of the first investigators certified in this program and went on to audit other seafood investigators on a pass/fail basis.

The HACCP training program recognized by FDA is a three-day course certified by the Association of Food and Drug Officials. I have participated as a trainer in numerous certified HACCP courses and am currently responsible for an average of two of these courses per year.

In just over a decade, HACCP has achieved a solid track record among seafood, juice, meat and poultry processors, and is now being usefully applied elsewhere in the food sector. I am pleased to be involved in this continuing evolution as a member of the EAS team.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of December, 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
October Archive of The FDA this Week: Andy's Take
Enforcement Reports
What's New by Topic
Zero-Calorie Sweetener Clears Regulatory Hurdle

As anticipated in the September 2008 issue of EAS-e-News, FDA issued a “no questions” response to GRAS notifications from Cargill and Whole Earth Sweetener Company for the zero-calorie intense sweetener Rebaudioside A-- commonly called rebiana--which is purified from the stevia plant.

Cargill’s rebiana product, Truvia, is a general and table-top sweetener that will be used in some Coca Cola products. Whole Earth’s parent company, Merisant, produces a separate rebiana product, PureVia, which will be used in various foods, including some Pepsi products, and also as a table-top sweetener.

The Whole Earth GRAS notice listed a use level of 150 milligrams per kilo for cereals, including oatmeal, cold cereal and cereal bars. It also listed use levels of 150 mg/kg for energy drinks and flavored waters, 150-500 mg/kg for fruit juice drinks and diet soft drinks, and 90-450 mg/kg for ready-to-drink teas.

FDA stressed that it has not made its own determination regarding the GRAS status of Rebaudioside A and that the companies are responsible for ensuring that their food ingredients are safe and in compliance with legal and regulatory requirements.

The Joint FAO/WHO Expert Committee on Food Additives has established an acceptable daily intake for steviol glycosides of up to 4 milligrams per kilogram of bodyweight per day. FDA said the equivalent ADI for Reb A is 0-12 mg/kg of bodyweight per day, because rebiana’s molecular weight is more than three times that of steviol.
FDA Issues Warning over Nutrient Content Claim

EAS wants to draw our clients’ attention to a recent FDA warning letter in which the agency cited—for the first time ever to our knowledge—a violation of the requirement that, when a nutrient content claim is based on the addition of a nutrient, the added nutrient must be in compliance with the fortification policy in 21 CFR 104.20.

That policy states that FDA “does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.”

The December 10 warning targeted a Coca-Cola product, Diet Coke Plus, which includes the words "Diet Coke with Vitamins & Minerals" on the main display panel. The agency’s letter is online at http://www.fda.gov/foi/warning_letters/s7064c.htm.
EAS in Action:
Pharmaceuticals, Animal Drug Experts Join EAS Consulting Team

EAS Consulting Group is pleased to announce the addition of two new senior consultants-- Salvatore (Sal) J. Pinella and Gloria Dunnavan --to its team of regulatory specialists.

Mr. Pinella has more than 50 years of experience in pharmaceutical regulations, including almost 30 years with FDA, where his work included reviewing drug applications in the agency’s Center for Drug Evaluation and Review.

After retiring from the agency in 1986, he became a freelance consultant to the pharmaceutical industry until January 2003, when he joined Kendle Regulatory Affairs as a senior regulatory consultant. At Kendle, he conducted inspections of pharmaceutical companies to assess their compliance with cGMP regulations, and he prepared and edited drug applications.

Ms. Dunnavan joins EAS after a 35-year career with FDA, where she was a former director of the Division of Compliance at the Center for Veterinary Medicine. She brings valuable expertise in training and compliance to the EAS team.

“We are very fortunate to have these two new members on our consulting team,” says EAS President Ed Steele. “I know they will play an important role in expanding the human pharmaceutical and veterinary products part of our business,” he adds.
Upcoming Events
EAS Hosts FREE Webinar on GMP Final Rule

Take the GMP Challenge Don’t wait until FDA begins enforcement of its final Dietary Supplement GMP regulations. Sign up for our free February 5 webinar and take the EAS GMP Challenge!

This is an opportunity to check your understanding of the new rule and to ask questions of FDA regulatory experts, either in advance or during the live session. Speakers for the free, 60-minute webinar will include Brad Williams, Manager of FDA’s Division of Dietary Supplement Programs, Carl Reynolds, EAS Vice President, and Ed Steele, EAS President. The seminar will be moderated by Jon Benninger of Virgo Publishing.

Webinar participants will be invited to take a quick, confidential online quiz to assess their understanding of the new GMP requirements, and then to ask questions and learn about:
  • The most often misunderstood GMP compliance issues, such as complying with sub-lot testing requirements for finished products and establishing material review processes.
  • The steps they should be taking right now.
  • The significance of the lab portion of GMPs.
  • Much more.
A summary of the GMP challenge quiz results will be provided at the webinar.

In addition, EAS has scheduled GMP and lab seminars March 17-19. Our experts are also available to conduct in-house seminars for individual organizations and to assess readiness for conducting gap assessment audits.

Click here to sign up for the webinar and take the EAS GMP Challenge.

EAS Exhibits at Food Safety Summit and the NYSCC Suppliers’ Day

Food Safety SummitEAS Consulting Group will be exhibiting at the Food Safety Summit Conference and Expo at the Washington D.C. Convention Center, April 27-29. Now in its eleventh year, the summit has become one of the top food safety meetings of the year. If you plan to attend, please join members of the EAS consulting team in the exhibit hall. See www.foodsafetysummit.com for details.

Food Safety SummitEAS will also exhibit at the Society of Cosmetic Chemists “Suppliers’ Day” at the New Jersey Convention and Exposition Center in Edison, N.J., May 12-13. This popular annual event is hosted by the society’s New York chapter. See www.nyscc.org for details.

Register Now for these Upcoming Seminars

EAS has scheduled the following seminars through early April: Visit www.easconsultinggroup.com for details of these intensive training sessions.
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, 2008