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
 November 2009
In this Issue:
Upcoming EAS Events
  • Dietary Supplement Labeling [more]
  • Food Labeling Compliance Review and Update [more]

From the Desk of the President:
Seeking a Smart Choice

Ed Steele, President If the food industry does not voluntarily develop "a common, credible approach" to front-of-package (FOP) and shelf labeling, the Food and Drug Administration will consider using its regulatory tools, warned Barbara Schneeman, director of FDA's Office of Nutrition, Labeling and Dietary Supplements, in a letter to industry last month. FDA staffers are now scrutinizing FOP labels that appear to be misleading and are looking for symbols that either expressly or by implication are nutrient content claims.

In response to a September 21 letter from Rep. Rosa DeLauro (D-Conn.) concerning industry's Smart Choices program, which includes an FOP logo, FDA Commissioner Margaret Hamburg said the agency's concerns extend beyond any particular program. Consumers are less likely to check the Nutrition Facts label on the information panel at the back or side of the package on products that carry front-of-package labeling, the agency believes.

Commissioner Hamburg said the agency wants to work with the food retailers and manufacturers, as well as with nutrition and design experts and the Institute of Medicine, to develop "an optimal, common approach to nutrition-related FOP and shelf labeling." The Smart Choices program, which is administered by NSF International and the American Society for Nutrition, has been placed on hold pending the development of standardized criteria.

Our Issue of the Month article features another labeling issue: EAS Senior Consultant Beatrice Greenberg reviews what appears to be an unusual recall relating to the absence of a voluntary allergen warning. Ms. Greenberg, who retired last year as head of FDA's labeling regulation implementation team, is also featured in our Who's Who at EAS section.

These and other emerging issues will be among those addressed next month in the Food Labeling Compliance Review Seminar and Update and in the Dietary Supplement Labeling Compliance Review seminar (see details below).

Our EAS In Action section this month features EAS Senior Consultant Nancy Chew, who received an honorary fellowship from the Regulatory Affairs Professionals Society, an award issued for significant leadership within the profession.

On a personal note, I would like to offer my condolences to the family and friends of former FDA colleague, Paul Kuznesof, who died last month at age 68 (see details below).

Once again, I would like to remind you that the free EAS GMP Challenge webinar and GMP Challenge Quiz are still available on the EAS website, so please feel free to visit and share the free tools with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Rare Recall Raises Advisory Statement Issues
By EAS Senior Consultant Beatrice Greenberg
In what appears to be an unusual recall action early last month, Affy Tapple, LLC, of Niles, Illinois, recalled its "Limited Edition – Classic Candy Flavors" two-pack caramel apples, apparently because the product label did not include the allergen statement "manufactured on shared equipment with peanuts and tree nuts." The company had received a report of a peanut fragment on the topping of one apple. The unusual aspect of the recall is that there is no FDA law or regulation that requires such advisory statements, so the absence of such a statement should not prompt a recall.

In fact, the agency has long been concerned about the use of advisory statements. In 1996, it issued a notice to manufacturers advising that adherence to current good manufacturing practices (CGMPs) is essential for effective reduction of allergic reactions and that advisory labeling should not be used in lieu of adherence to CGMPs. On September 10, 2008, FDA held a public meeting to gather information to assist the agency in developing a long term strategy for dealing with advisory labeling that addresses unintentional cross-contact of foods with major food allergens. To date FDA has not issued any guidance regarding the use of advisory statements based on the input received at that meeting.

A recall is the voluntary removal from the market of a product that violates FDA's laws or regulations. The failure to declare the presence of a major food allergen would be classified as a recall because such a labeling error is a significant violation of the law. The presence of an unintentional allergen that is attributable to poor CGMPs is also a significant violation. Since the failure to provide an advisory statement does not violate any laws or regulations, the absence of such labeling has never been classified as a recall. On the other hand, the presence of an advisory statement may be false and misleading if adequate measures are not taken to prevent contamination with an undeclared allergen.

FDA often posts company press releases concerning recalls on the agency website prior to its review and the completion of an investigation. So the content of the company's press release may not reflect the final agency classification of the recall. The release can be found at http://www.fda.gov/Safety/Recalls/ucm185187.htm.

Will FDA view the reason for the recall as the failure to label the product with the advisory statement "manufactured on shared equipment with peanuts and tree nuts," as stated in the press release? Or will the agency view it as a GMP issue that led to the actual presence of peanut, a major food allergen, in a product that is not formulated with peanut? We will have to wait and see the Enforcement Report to find out. My prediction is that the action will be classified as a recall due to the presence of undeclared peanut.

Who's Who at EAS:
Meet EAS Senior Consultant Beatrice Greenberg

Beatrice (Bea) Greenberg Beatrice (Bea) Greenberg is a former head of the labeling regulation implementation team in FDA's Center for Food Safety and Applied Nutrition. Following her retirement from the agency in December 2008 she agreed to assist EAS clients on a consulting basis.

Ms. Greenberg began her FDA career as a field investigator in the Philadelphia District in 1977. During her career as an investigator, she conducted inspections in a variety of FDA regulated industries. For several years, she served as Philadelphia District's recall co-coordinator. Prior to moving to the Washington, D.C. area, she served as a Compliance Officer in the Philadelphia District office. While in that position, she participated in several details to CFSAN to assist staffers in reviewing comments received on the proposed Nutrition Labeling and Education Act regulations. She also assisted in FDA's NLEA training efforts and in the implementation and enforcement of the NLEA regulations.

When she relocated to Washington, D.C. in 1997, she first served as a recall coordinator for the Center for Biologics Evaluations and Research. In March 2002, she joined CFSAN to work once again on food labeling issues.

"I am very pleased to have someone with Bea Greenberg's unsurpassed experience of labeling on the EAS team," says EAS President Ed Steele.

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of October, 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
Enforcement Reports
What's New by Topic
EAS in Action:
Regulatory Affairs Group Honors Nancy Chew

Nancy Chew EAS Senior Consultant Nancy Chew was named an honorary fellow by the Regulatory Affairs Professionals Society (RAPS), an international organization of regulatory professionals in the medical device, pharmaceutical and biotechnology sectors. The RAPS Fellows program recognizes senior regulatory professionals for "significant contributions and leadership in the advancement of the profession." Ms. Chew received the honor at the group's recent annual meeting in Philadelphia, Pa.

Ms. Chew is a frequent lecturer on regulatory issues and teaches courses in drug development and pharmaceutical registration. The founder of a consulting consortium, Regulatory Affairs, North America LLC, she joined the EAS team of senior consultants this summer.

Dietary Supplement GMP Seminar Highlights Compliance

Participants in our Dietary Supplement GMP Seminar, October 6-7, learned how to achieve compliance with FDA's final regulations on good manufacturing practices (GMPs) for dietary supplements, which went into effect for companies with 20-500 employees as of June 25, 2009. Former FDA compliance officials Robert Fish and William Ment presented this intensive training program 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.

This seminar is also available for individual firms upon request. In-house seminars can be a cost-effective way to train your employees. They also allow the program to be tailored to your particular needs. Contact Cathryn Sacra or call (703) 684-4408 for details.

In Memory of Paul Kuznesof

Paul Kuznesof We regret the passing of a friend and former FDA colleague, Paul Kuznesof, age 68, who died peacefully in his sleep October 2 after a fight against lung cancer.

Paul's many areas of expertise included chemistry, Brazilian culture and the Japanese martial art, aikido, in which he held a second degree black belt. His love of Brazilian culture began in the early 1970s, when he was a professor of chemistry at the State University of Campinas in Brazil—the first of more than a dozen American and European professionals hired to start a graduate research program in chemistry at the university.

Paul's FDA career spanned 23 years. He retired from the agency on February 2007 after six years as chief chemist in the Office of Food Additive Safety. In that role, he was responsible for managing the pre-market review of a large number of food additives, color additives, GRAS substances, herbals and botanicals. From 1997 until his retirement, he was the agency's acknowledged expert on specifications of identity and purity for additives and ingredients intended for use in food. He also worked with several influential international organizations, including the Joint Expert Committee on Food Additives and the Codex Committee on Food Additives and Contaminants.

Paul joined EAS Consulting Group as a contract consultant in May 2007. We extend our condolences to his family and friends.
Upcoming Events

Dietary Supplement Labeling
December 2-3
Alexandria, VA

Food Labeling Compliance Review and Update
December 8-10
Alexandria, VA

Dietary Supplement Labeling Compliance Review Seminar

Labeling policies are getting priority attention at the Food and Drug Administration, so manufacturers can expect an increased focus on labeling compliance. Participants at the Dietary Supplement Labeling seminar, which will be held December 2-3 at the EAS training facility in Alexandria, VA., will learn how to prepare labels that comply with FDA requirements, including mandatory labeling elements and allowable dietary supplement claims. Participants will take part in a workgroup exercise to facilitate their understanding of the regulations. They will also receive the popular EAS Consulting Group hardback labeling reference, Dietary Supplement Labeling Compliance Review.

Instructors for this seminar are EAS Senior Consultant James Hoadley, Ph.D., and EAS Consultant Gisela Leon. Dr. Hoadley is a former FDA staffer who played an important role in implementing nutrition labeling and health claim regulations under the Nutrition Labeling and Education Act. Ms. Leon is an expert in U.S. labeling requirements and is knowledgeable about labeling laws throughout the world.

Check the EAS web site for details.

Food Labeling Compliance Review and Update

There is still time to sign up for the Food Labeling Compliance Review and Update, which will be held at the EAS training center in Alexandria. VA, December 8-10. The two-day seminar and optional one-day update gives participants an opportunity to apply what they learn in practical work sessions. The Update will explore issues that are not currently in the regulations but that may become requirements.

Participants in the December 10 update get a further opportunity to network with experienced label reviewers and to have their labeling questions addressed. EAS Senior Consultant Betty Campbell, who served as the head of FDA's Office of Food Labeling, will be on hand for the Update, along with other labeling experts. Ms. Campbell played a key role in writing and implementing the Nutrition Labeling and Education Act regulations.

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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