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 · Tobacco Products
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
January 2011
In this Issue
Upcoming EAS Events
  • FDLI Food Labeling, Advertising and Marketing Conference [more]
  • FDLI Dietary Supplement 2011 Conference [more]
  • Food Labeling Compliance Review Seminar [more]
  • Supply Side East [more]

From the Desk of the President
As We Begin a New Year...

Ed Steele, President

Dear Reader,

Welcome to the January issue of EAS-e-News, our free news update for companies regulated by the Food and Drug Administration.

I hope you had a restful holiday season and that you have come back with renewed energy for the—often unpredictable—tasks ahead. If you are in the FDA-regulated food sector, for example, you now face uncertainties about how the agency will implement its new authority under the Food Safety Modernization Act. We will be closely tracking the agency’s implementation efforts and I promise to report back to you here about what we learn.

The first such report is our Issue of the Month article by EAS Senior Consultant Faye Feldstein, who was until recently acting director of FDA’s Office of Food Defense, Communications and Emergency Response. Ms. Felstein is also the subject of our Who’s Who at EAS section.

As I mentioned in a previous issue, EAS recently celebrated its fourth anniversary as an independent company. When I established EAS Consulting Group in October 2006, my goals were to provide the best regulatory advice to our clients, to find the best consultants, and to set up an operation that looked after the interests of the company, our staff and the clients that we serve. I am delighted to say that in four short years, EAS Consulting Group has established an international reputation for excellence in regulatory consulting, training, and auditing--and we continue to grow. We now have more than 650 clients in 40 countries.

In the context of continued growth, I am thrilled to announce that Anthony C. (Tony) Celeste, a prominent figure in the regulatory community, has recently joined us as Senior Advisor. In addition, I am pleased to welcome another former FDAer, Jerome “Jerry” Dennis, to our team of senior consultants.

I would like to draw your attention to an important article in this issue on increased FDA enforcement of antioxidant claims, by EAS Vice President Betty Campbell. The agency noticeably increased its enforcement of food and dietary supplement labeling violations in 2010. Ms. Campbell advises manufacturers to be more careful in the language they use on the label and in labeling.

Finally, look out for our new version of EAS-e-Docs. The first edition will arrive mid January.

EAS is looking forward to continued success in 2011 and beyond. As we begin the New Year, I take this opportunity to wish the same to you!

Sincerely,
Ed Steele Signature
Ed Steele,
President


Issue of the Month
FDA and the New Food Safety Legislation

By EAS Senior Consultant Faye Feldstein

With the passage of the Food Safety Modernization Act, Congress has provided the first major reform of FDA’s mandate since 1938, including both new food safety requirements and new food safety authorities.

As I review the bill’s provisions, it is clear to me that Congress has provided the tools for the agency to make a significant shift in the approach to food safety, from one of reaction to foodborne emergencies and hazards, to one of prevention. This shift in focus has been foreshadowed by public comments by the agency’s leadership and by the President’s Food Safety Working Group, which committed the agency to prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery.

Specifically, The Food Safety Modernization Act tasks the FDA with more than a dozen new rulemakings, and with the release of numerous guidance documents and reports.

Some provisions of the new act go into immediate effect, while others require new regulations or other agency action within specified timelines. Immediately, the agency will have mandatory recall authority for all FDA-regulated foods, when there is a “reasonable probability” that food from a facility will cause serious adverse health consequences or death for humans or animals. Also in effect immediately are new FDA powers to inspect company records, to increase the frequency of inspections and to require import certification of food, and an immediate requirement for firms to update the FDA registration biennially, rather than once.

So what does that mean for us?

In order to prepare for the implementation of the various provisions, let’s focus on those that are in effect immediately. FSMA requires some new information via the registration provision, including consent to permit inspection of the facility by the FDA, a valid e-mail address for the facilities representative or U.S. Agent, and a potentially expanded list of food product categories manufactured, processed, packed or held at the facility. So, a review of current registration information and operations may be useful at this time.

The FSMA expands the current records access authority to include broadened access to all records relating to an article of food, if the agency has a reasonable belief that a particular article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. And it further states that records may be required that are related to “any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner.” So it is useful at this time to conduct a thorough review of your recordkeeping processes and procedures, compartmentalization, content and scope and to ensure that you can provide rapid access to records that the agency may request.

Looking a bit ahead, the focus on a preventative approach includes future requirements for some industry preventive control plans and hazard analyses, both for internal operations and upstream and downstream distribution partners. Taking time to begin now to understand and evaluate (or re-evaluate) the hazards in your operation and those that may be inherent in your supply chain and distribution chain will give you a head start as these new requirements are developed.

As the FDA gears up for an increased focus on prevention and surveillance, using its new powers under the FSMA, I believe this is an opportune time for some preventive efforts by the regulated industry.


Who's Who at EAS
Meet EAS Senior Consultant Faye Feldstein

Faye Feldstein

Faye Feldstein recently joined EAS Consulting Group after ten years with the Food and Drug Administration--most recently as acting director of the Office of Food Defense, Communications and Emergency Response.

From January 2002 to June 2006, she was director of the Division of Cooperative Programs at the Center for Food Safety and Applied Nutrition. Prior to that role, she was a consumer safety officer in the Division of HACCP Programs.

Before joining the agency, she spent 12 years with the culinary manufacturing division of W. R. Grace and Co., beginning as director of quality control and advancing to become vice president and plant manager. During her 12-year tenure, the division never had an outbreak or a classified recall of any product.

A recipient of many agency awards, she received the FDA Outstanding Service award in June 2010. She holds a Bachelor of Science degree in microbiology and a Master of Science degree in food science from the University of Maryland.

“I am very pleased to have Faye Feldstein on our team,” says EAS President Ed Steele. “With her FDA food safety experience and her perspective as a former industry executive, she is a most valuable asset for our clients.”


Increased FDA Enforcement of Antioxidant Claims

By EAS Vice President Elizabeth Campbell

The Food and Drug Administration noticeably increased its enforcement of food and dietary supplement labeling violations in 2010. I believe the agency’s more strict approach to antioxidant claims, for example, indicates that manufacturers need to be more careful in the language they use on the label and in labeling, to avoid making unauthorized implied nutrient content claims.

The agency issued at least three Warning Letters last year criticizing antioxidant claims for tea products. Two of the Warning Letters featured violations based on claims in labeling (on websites) for effects of antioxidants on disease, with the nutrient content claims listed as the second violations (In Warning Letters, FDA generally lists violations in descending order of significance.). The third Warning Letter addressed only the nutrient content claims.

All three products made claims for antioxidants that used terms the agency had formally or informally designated as expressed or implied nutrient content claims. The claims included such terms as “enhanced with,” “packed with,” fortified with,” “abundantly found in,” and “rich source.” These terms clearly constituted claims that are not permitted for the flavonoid antioxidants in tea. Antioxidant claims are defined by regulation as available only to nutrients that have Daily Values and that exhibit antioxidant activity. The regulation lists vitamins C and E and beta carotene as the only antioxidants known to FDA. A claim for any other Daily Value nutrient would have to be based on documentation that the substance had antioxidant function.

EAS has advised clients who want to make antioxidant claims to avoid the types of terms cited in these Warning Letters. Except for “x mg (antioxidant)” claims, we have advised the avoidance of any terms that indicate the amount of the substance and the careful use of only phrasing that implies the antioxidant function of the substance. In one instance, in spite of efforts to avoid terms that implied amounts of antioxidants, FDA was of the opinion that the language on the label referring to “the all-natural goodness and healthful blend” of the tea, may be viewed as implying that the antioxidants were present in a significant amount when viewed in the context of the entire label. It is possible that FDA was influenced by the presence of “50% DV of vitamin C” in the list of antioxidants in the tea product, but even so, this is the strictest interpretation of what constitutes an implied nutrient content claim that we have seen from the agency.

The claims regulations have always included implied claims as well as express claims, and FDA has always stated that the overall impression of the label can be the basis for finding that there is an implied nutrient content claim. Because of the increased labeling enforcement activity, companies have already become more careful with language that could be implied disease claims. We believe they should also consider reviewing current labels for potential implied nutrient content claims.


What's New on FDA's Website
December Updates

Listed below are links to new additions to the FDA website for the month of December, 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

Tony Celeste Joins EAS as Senior Advisor

Anthony C. Celeste

Internationally recognized as a leading food and drug regulatory authority, Anthony C. Celeste will serve as the principal advisor to the EAS President and will have primary responsibility for expanding the company’s consulting, auditing and training services to the pharmaceutical and related industries. He will also be available to provide expert consulting advice to EAS clients on a broad range of food and drug topics.

“It is an honor to be reunited with Tony and to have him join EAS, says EAS President, Ed Steele. “He is a giant in the regulatory consulting industry and our clients will benefit by having access to his wealth of food and drug knowledge.”

Mr. Celeste joins EAS after a distinguished, 50-year career split between serving in senior-level management positions at the Food and Drug Administration and developing and managing one of the nation’s most reputable regulatory consulting firms. He served with FDA for 25 years after joining its New York District office in 1960 as a chemist. He held a series of positions of increasing responsibility during his tenure, finally serving as director of the Office of Regional Operations, the Washington, D.C. headquarters unit responsible for managing and directing the agency's field force of investigators, analysts, compliance officers, and administrative staff.

After leaving the agency in 1985, Mr. Celeste served as president and CEO of AAC Consulting Group, Inc., an independent FDA consulting firm, until its acquisition in February 2001 by Kendle International Inc., a global clinical research organization. He retired in January 2010 as Kendle’s senior vice president of regulatory affairs, a position he held since 2001. He is currently serving as the regulatory affairs advisor at the International Society for Pharmaceutical Engineering (ISPE) and is lead director on the Board of Directors of Sucampo Pharmaceuticals.

Jerome “Jerry” Dennis Added to EAS List of Consultants

Jerome E. (Jerry) Dennis

Jerome E. (Jerry) Dennis, who retired from FDA’s Center for Devices and Radiological Health in 2008 after 33 years with the agency, has joined EAS as a senior consultant on a contract basis.

At CDRH, he was the agency’s international expert in laser and optical radiation safety and safety standards. Prior to joining the center, he spent 15 years in industry. He was the manager of high-energy laser products for Hadron, Inc. in New York. Previously, he served with TRG, Inc. in New York. His early experience was with the Naval Material Laboratory in New York, as a researcher into the effects of optical radiation from nuclear weapons.

Mr. Dennis currently chairs the International Electrotechnical Commission’s international standards committee for optical radiation safety and laser equipment, and the U.S. committee of experts for that committee. In 2010 he received the highest level of recognition from the Commission, the Lord Kelvin Award.

“I am pleased to welcome Jerry Dennis to our team,” says EAS President Ed Steele. “His specialized experience at CDRH will be most helpful to clients with laser products regulated by that center.”

FDA Issues “No Objection” Letter to EAS GRAS Determination for Wheat Bran Extract

FDA’s Office of Food Additive Safety has issued a “no objection” letter in response to a Generally Recognized as Safe (GRAS) notice for wheat bran extract, submitted by EAS on behalf of Fugeia NV.

The notice, filed May 28, 2010, declared that wheat bran extract is GRAS for use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, frozen dairy desserts, gelatin and puddings, grain products and pastas, jams and jellies, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, and snack foods, at concentrations ranging from 2.4 to 3.2 grams of wheat bran extract per serving.

“Based on the information provided by Fugeia NV, as well as other information available to FDA, the agency has no questions at this time regarding Fugeia NV’s conclusion that wheat bran extract is GRAS under the intended conditions of use,” the agency said, in a November 22 letter. As is customary, the agency did not make its own determination regarding the GRAS status of the additive.

James Hoadley and Dean Cirotta to Speak at FDLI Food Week

FDLI Food Week 2011

EAS Senior Consultant Dr. James Hoadley and EAS Vice President Dean Cirotta are scheduled to speak at separate food labeling and dietary supplement conferences during FDLI’s Food Week 2011 in Washington, D.C., January 24-27.

Dr. Hoadley, a former senior regulatory scientist at FDA, will address labeling issues at the Food Labeling, Advertising and Marketing Conference, January 26. Mr. Cirotta, VP of Pharmaceutical, Dietary Supplement and Tobacco Services at EAS, will speak at the Dietary Supplement 2011 Conference, January 27.

EAS to Conduct Advanced OTC Drug GMP Training for CHPA Members

CHPA

EAS has entered into an arrangement with the Consumer Health Products Association to offer custom-designed advanced GMP training for manufacturers of over-the-counter drugs in a two-day seminar at the CHPA headquarters in Washington, D.C., February 17-18. The EAS presenters will include: Dean Cirotta, VP of pharmaceutical, dietary supplement and tobacco services; Tony Celeste, senior advisor; and Chris Celeste, director of regulatory information and submissions. The members-only event is limited to 40 participants. Contact CHPA for more details.

Increased Enforcement to Boost Participation in Labeling Seminars

In light of FDA’s increased enforcement of food labeling regulations, EAS anticipates increased attendance at the next Food Labeling Compliance Seminar, which will be held at the EAS headquarters in Alexandria, Va., March 29-30.

The instructors for this in-depth seminar will be EAS consultants James E. Hoadley, a former senior regulatory scientist at FDA, and Gisela Leon, who has an extensive background in U.S., European and other international labeling requirements.

The seminar offers a quick way to learn about the issues that triggered recent FDA warning letters and to get up to date on FDA food labeling requirements, through instruction from recognized labeling experts. The seminar includes interactive work sessions.

For details, contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com.


Upcoming Events

FDLI Food Labeling, Advertising and Marketing Conference
January 26, 2011
Washington, D.C.

FDLI Dietary Supplement 2011 Conference
January 27, 2011
Washington, D.C.

Food Labeling Compliance Review Seminar
March 29-30, 2011
Alexandria, Va.

Supply Side East
May 2-4, 2011
Secaucus, N.J.


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
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> 100 $ 7.00 each
Code of Federal Regulations Part 210 & 211, A pocket Guide

Pharmaceutical GMP Regulation -
A Pocket Guide


A 4"x6" bound copy of 21 CFR Part 210, 211 and 11 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
$ 194.99
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
$ 229.00 / set
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