Issue of the Month
On the IOM’s New Front-of-Package Nutrition Report

by EAS Senior Consultant James Hoadley

The newly released Front-of Package Nutrition Rating System and Symbols Phase II report from the Institute of Medicine (IOM) proposes changes that would be hard for industry to swallow and that would involve significant regulatory challenges for FDA and USDA.

The IOM recommended FDA and USDA implement a single, standard Front-of-Package (FOP) nutrition information system for all packaged food, replacing any existing system. The IOM-recommended FOP system has two parts: (1) calories per serving, and (2) a three-point scale nutrition ‘points,’ with saturated plus trans fats, sodium, and added sugars each getting one point when their amounts are below a qualifying level. Foods in which the amount any of the ‘point’ scoring nutrients is above a disqualifying level would automatically have zero nutrition points.

Congress had directed the Centers for Disease Control and Prevention and IOM to undertake this examination of FOP nutrition rating systems and nutrition-related symbols. IOM’s 2010 FOP Phase I report examined the strength and weaknesses of currently used FOP systems and made some initial conclusions. The conclusions were that (1) the most useful FOP information is calories expressed per serving size in a familiar household measure, and (2) additional displayed FOP information should be limited to those nutrients most closely related to prominent health conditions (i.e., saturated fat, trans fat and sodium).

Following the IOM’s FOP Phase I report, the Grocery Manufacturers’ Association (GMA) and the Food Marketing Institute (FMI) introduced the Nutrition Keys FOP, offered as a voluntary, simple, uniform FOP nutrition information system for US food and beverage manufacturers to follow. The Nutrition Keys FOP system consists of four icons, presented together as a set, showing amounts per serving of calories, saturated fat, sodium and sugars. An exception is made for small size packages which can display the calories icon alone. The set of four icons may be accompanied by up to two additional ‘nutrients to encourage’ icons (i.e., vitamins, minerals, dietary fiber) present in amounts greater than 10% DV per serving. GMA changed their system name to Facts Up Front just before the Phase II report.

There are two basic types of FOP systems now in use: (1) nutrient specific systems that display amounts of specific nutrients (such as the Facts Up Front system), and (2) summary systems that use a single icon to score the nutrient content of a food (such as the Hannaford Guiding Stars system). The new IOM FOP report concludes that it is time to move away from the FOP systems that provide mostly nutrition information. The IOM conclusions note that there should be a single standardized FOP system; the FOP system should motivate food and beverage companies to reformulate their products to be healthier; and encourage retailers to prominently display products that meet this standard.

FDA is in the process of revising nutrition labeling rules; their proposal to update nutrition labeling regulations is expected before end of this calendar year. Whether the agency uses this rulemaking activity as an opportunity to follow the IOM recommendation that a single, mandatory FOP point system replace existing industry developed FOP nutrition information systems remains to be seen. However, an indication that this may not be the case is in the recently issued FDA five-year Strategic Plan for foods whose key initiatives include issuing regulations updating the Nutrition Facts label and serving sizes, but to only ‘explore’ FOP labeling opportunities.

An "uncorrected copy" of the 250-page IOM report, titled Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices, is available for free PDF download from National Academies Press. The final version will be offered for sale in PDF and printed formats.

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FSMA Perspective
FDA Issues Administrative Detention Guidance for Industry

by EAS Consulting Group Editor Declan Conroy

FDA’s authority under Section 207 of the Food Safety Modernization Act includes the power to order administrative detention of food if there is simply "reason to believe" a product is adulterated or misbranded. Formerly, under authority introduced by the Bioterrorism Act 2002, the agency needed "credible evidence or information." In an October 24 update on its website, the agency issued new guidance for industry to explain its current thinking about how detentions will be handled.

The agency may detain an article of food for up to 20 days after a detention order is issued and the food may be detained for ten calendar days if more time is needed for a seizure or injunction. So, the total detention period may be up to 30 calendar days.

Requests for modification of a detention order must be submitted in writing to the FDA representative who approved the original detention order. In most cases, this will be the director of the relevant FDA District Office.

FDA defines perishable food as food that is not heat-treated, not frozen, and not otherwise preserved so as to prevent the quality of the food from being adversely affected if held longer than seven calendar days under normal shipping and storage conditions. For perishable food, an appeal must be filed with the FDA District Director whose district detained the article of food, within two calendar days of receipt of the administrative detention order. For non-perishable food, a notice of intent to file an appeal and to request a hearing must be filed within four calendar days of receipt of the administrative detention order.

If FDA initiates a seizure against a perishable food that is subject to an administrative detention order, the agency will send the seizure recommendation to the Department of Justice within four calendar days after the administrative detention order is issued, unless there are extenuating circumstances.

Administrative detention authority applies to both foods offered for import and food in domestic commerce. FDA’s authority to administratively detain food is separate from the agency’s authority to refuse admission of imported food.

Appeals of a detention order must be filed within ten calendar days of the receipt of the order. And FDA must confirm, modify or terminate the order within five calendar days after an appeal is filed, after providing an opportunity for an informal hearing, according to the guidance.

It remains to be seen how often the agency will invoke its expanded authority under the FSMA.

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Who's Who at EAS

Meet EAS Expert Consultant Robert Martin

Robert Martin, a former deputy director of FDA’s Division of Biotechnology and GRAS Notice Review, joined the EAS team of consultants in June of this year. His 38-year career at the agency included service as a research chemist and as a consumer safety office in the Division of Food and Color Additives. He later advanced to become a supervisor and team leader after that division was renamed the Division of Petition Control.

While in that division, he was CFSAN’s contact for antimicrobial chemicals used directly in food. And he was responsible for all petitions submitted for antimicrobial chemicals for direct use in food that were eligible for "expedited review." His efforts led to nine final rules in the Federal Register based on expedited review petitions.

Prior to joining the agency, he spent three years as a research chemist for the DuPont Company, from June 1965 to June 1968.

Dr. Martin holds a Ph.D. in chemistry from Georgetown University. He is an experienced instructor and has taught numerous courses and has written many articles for peer-reviewed publications. From 1974 to 2002, he was an Adjunct Professor of Chemistry at the University of the District of Columbia, where he taught a course in organic chemistry. He also counseled students and advised them on careers. Active in local community organizations, he served for several seasons as a youth football and basketball coach. On numerous occasions, he visited schools in the Washington, D.C. area to participate in career programs and to talk about science. He also served as a judge for many local science fairs.

"Robert is proving to be a invaluable resource and I am delighted to welcome him to our team of consultants," says EAS President Ed Steele. "He is a real asset for our clients."

EAS Welcomes New Consultant - Brad Douglass

Seattle-based Brad Douglass is the latest addition to the EAS consulting team. He has a Ph.D. in chemistry from the University of Southern California as well as a Master’s degree in regulatory science from USC. Since his graduation in 2006, he has worked in various capacities with the dietary supplement company Jarrow Formulas Inc., including that of technical specialist, education manager and regulatory/science consultant. He has also served with two pharma companies-- at KinetiChem Inc., as a senior scientist, and at C5Rx Pharmaceuticals, as a research/innovation consultant.

"Brad’s strong academic background and his industry experience make him a valuable addition to our consulting team," says EAS President Ed Steele.

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What's New on FDA's Website

Listed below are links to new additions to the FDA website for the month of October, 2011. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

• FDA warns consumers not to eat Wegmans’ bulk Turkish pine nuts October 28, 2011


• FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation October 26, 2011


• FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder October 24, 2011


• FDA approves Onfi to treat severe type of seizures October 24, 2011


• FDA: U.S. Marshals seize food products at Illinois warehouse October 18, 2011


• FDA proposes lower risk classification, special controls for external pacemakers October 17, 2011


• FDA approves Ferriprox to treat patients with excess iron in the body October 14, 2011


• FDA: U.S. Marshals seize foods stored at Washington State facility October 11, 2011


• FDA approves combination therapy Juvisync October 7, 2011


• FDA, CMS launch pilot program for voluntary parallel review of innovative devices October 7, 2011


• FDA approves Cialis to treat benign prostatic hyperplasia October 6, 2011


• FDA and NIH announce joint study on tobacco use and risk perceptions October 6, 2011


• FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans October 5, 2011


• FDA approves gel to stop blood flow during blood vessel surgery October 4, 2011


• FDA Outlines Plans for an Outside Network of Scientific Experts October 4, 2011


• FDA awards three grants to stimulate development of pediatric medical devices October 3, 2011


• FDA works to improve science used to approve medical devices October 3, 2011


• FDA: New transparency report outlines proposals for enforcement data, for public comment October 3, 2011

• Rite Aid Voluntarily Recalls 12 oz. Tins of Rich Fields Butter Cookies October 29, 2011


• Pacific Oyster Company Issues Allergy Alert On Undeclared Sulfites In Nate's Spiced Prawns October 29, 2011


• Eating Right Soy Protein Burgers Allergy Alert And Voluntary Recall Due to Undeclared Milk October 29, 2011


• Rhythm Superfoods Announces Allergy Alert and Voluntary Recall of Kool Ranch Kale Chips October 28, 2011


• Wegmans Food Markets, Inc. Announces Recall of Bulk Turkish Pine Nuts Due to Possible Salmonella Contamination October 26, 2011


• Nike All-American and Nike Super Poor Boy Recalled by Landshire, Inc Because of Possible Health Risk October 26, 2011


• Emporium Packaging & Spice Co. Issues Allergy Alert On Undeclared Milk And Soy In Ponchatrain Sauce Mix October 26, 2011


• American Egg Products Recalls Frozen Egg Product Because Of Possible Health Risk October 25, 2011


• Fresh & Easy Neighborhood Market Voluntary Recalls One Date Code Of f&e Brand Washed Spinach Because Of Possible Health Risk October 24, 2011


• Salmonella Illnesses Linked To Organic Eggs Consumers, Food Preparers Reminded to Cook Eggs Thoroughly October 21, 2011


• Yamaya USA, Inc. Recalls Masago (Capelin Roe) Because Of Possible Health Risk October 21, 2011


• Nike All-American Recalled by Landshire, Inc Because of Possible Health Risk October 21, 2011


• Consumer Alert - Undeclared Sulfites In Dried Dates October 21, 2011


• General Mills Issues Voluntary Class One Recall of One Day’s Production of Chocolate Flavor Fiber One 90-Calorie Chewy Bars October 20, 2011


• Insight Pharmaceuticals Issues A Voluntary Nationwide Recall Of "Nostrilla Nasal Decongestant" Due To Bacterial Contamination October 20, 2011


• Carefusion Initiates Class I Recall Of EnVe Ventilators October 20, 2011


• Murray Biscuit Company, LLC Issues Allergy Alert And Voluntary Recall Of Small Quantity Of Murray Sugar Free Chocolate Chip Cookies Due To Undeclared Pecans October 20, 2011


• Product Recall: Fair Oaks Dairy Issues Voluntary Recall For Fair Oak Royal Blue Cheese Because Of Possible Health Risk To Listeria Monocytogenes Contamination October 20, 2011


• Taylor Farms Retail Inc. Initiates A Precautionary Recall Because Of Possible Health Risk October 19, 2011


• NASSAU CANDY CONDUCTS NATIONWIDE RECALL ON SELECT BOXES OF NANCY ADAMS CLASSIC MINI S‘MORES FOR POSSIBLE UNDECLARED PEANUT ALLERGEN October 19, 2011


• Kroger Recalls Select Containers of Private Selection Extreme Moose Tracks Ice Cream for Undeclared Allergen October 17, 2011


• River Ranch Recalls Products Because of Possible Health Risk October 14, 2011


• CooperVision Continues the Voluntary Recall of Avaira™ Toric Contact Lenses October 14, 2011


• Osamu Corporation Recalls Frozen Ground Tuna October 13, 2011


• Media Statement on Voluntarily Recall of Giant Eagle Farmer's Market Shredded Iceberg Lettuce October 13, 2011


• NOW Foods Issues Voluntary Recall of Brewer’s Yeast Tablets October 13, 2011


• CFE International Fish Exporters Issues Alert on Uneviscerated Salted, Smoked, Split Herring Lot Code: 1171, Plant Registration #2406 October 12, 2011


• Nestlé Prepared Foods Company Announces Allergy Alert and Voluntary Recall of LEAN CUISINE® Dinnertime Selects™ Chicken Fettuccini Recall Due to Package Mislabeling October 11, 2011


• Whole Milk With An Expiration Date Of 10/22/11 From Farmers All Natural Creamery Voluntarily Recalled Due To Possible Health Concerns October 7, 2011


• Fruit Fresh Up, Inc. Recalls Fresh Cut Cantaloupe and Cut Mixed Fruit Containing Cantaloupe Distributed in New York State Because of Possible Health Risk October 6, 2011


• Prolab Proactively Recalls Some Protein Products in Order to Correct Labeling for Items That May Have Undeclared Milk and/or Wheat and Gluten Allergens October 6, 2011


• Flowers Foods Issues Allergy Alert And Voluntary Recall On Mrs. Freshley's Canadian Labeled Cereal Bars October 5, 2011


• Superior Metabolic Technologies Inc Recalls Uprizing 2.0 Because the Product Contains Superdrol, Which is a Synthetic Steroid, Making it an Unapproved New Drug October 5, 2011


• Thumb Oilseed Recalls Soy Flour (Utilized To Manufacture Human and Animal Food) Due To Salmonella Contamination October 4, 2011


• Thorntons Recalls Garden Salad and Chef Salad Because of Possible Health Risk October 1, 2011


• Kraft Foods Voluntarily Recalls Three Varieties of Velveeta Shells & Cheese Microwaveable Cups With Limited "Best When Used By" Dates October 1, 2011

• October 26, 2011
• October 19, 2011
• October 12, 2011
• October 5, 2011

• Food
• Drugs
• Medical Devices
• Tobacco Products
• Biologics
• Animal Feed and Drugs
• Radiation Protection
• Cosmetic
• Toxicological Research
• Regulatory Affairs

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EAS in Action

EAS to Sponsor FDLI Enforcement, Litigation & Compliance Conference

EAS is sponsoring the FDLI Enforcement, Litigation & Compliance Conference and Annual Holiday and Leadership Awards reception, which will be held at the Westin Georgetown in Washington, D.C., December 6-7, 2011. The Leadership Awards reception will be held on the evening of the first day from 5:30 to 7:00 p.m.

In one session, compliance directors from FDA's product centers will discuss their respective compliance activities. The preliminary speaker list includes: Mary Ann Malarkey, director, Office of Compliance and Biologics Quality, CBER (invited); Ilisa Bernstein, acting director, Office of Compliance, CDER (invited); Steven Silverman, director, Office of Compliance, CDRH; Michael W. Roosevelt, acting director, Office of Compliance, CFSAN; Ann Simoneau, director, Office of Compliance and Enforcement, CTP; and Dan McChesney, director, Office of Surveillance and Compliance, CVM.

This popular meeting is designed for intermediate to advanced regulatory attorneys and litigators, regulators, compliance experts, consultants and academics in the drug, medical device, biologic, diagnostic, food and dietary supplement industries. It includes topics of interest to tobacco, veterinary medicine and cosmetics professionals. Here is a link to the full agenda.

EAS Supports IFT’s First Food Policy Impact Conference

EAS is sponsoring a new Institute of Food Technologists event, titled Food Policy Impact, which will be held in the Sheraton Crystal City, Arlington, VA, December 1, 2011.

The speaker line-up for this event is very strong: It includes Mike Taylor, FDA Deputy Commissioner for Foods, and prominent food attorneys John Bode, of John Bode LLC (formerly of Olssen, Frank and Weeda), and Peter Barton Hutt of Convington and Burling, as well as other well known names in the food regulatory arena.

The conference will include two tracks, one on food safety, and the other on food labeling and marketing. In the labeling track, for example, Barbara Schneeman, director of FDA’s Office of Nutrition, Labeling and Dietary Supplements, will discuss the policy rationale for food labeling in the U.S., and representatives from Canada and the European Union will do the same for their jurisdictions.

The new event has grown out of the mid-year meeting of IFT’s Washington D.C. Section and the Food Law and Regulations Division. It promises to provide attendees with "actionable" information on food safety, product tracing, food marketing and labeling, and regulatory procedures and compliance. Participants will include regulatory affairs and food policy professionals, as well as government officials. This event should be helpful for anyone engaged the legal, marketing, product development, supply chain management, and QA/QC areas.

EAS Senior Consultant Robert Becker Undergoes Surgery

Friends and colleagues of EAS Senior Consultant Robert Becker, who is currently convalescing after surgery, may read Bob’s journal and send their good wishes for his recovery using CaringBridge, a free web service.

A journal entry for October 30 reported that Bob was recovering well from October 28 surgery and that he was being released to go home earlier than expected.

We extend our very best wishes to Bob and his family. Here is the link to his web site.

EAS Exhibited at SupplySide West and Sponsored Lively NDI Workshop

EAS exhibited at a record-breaking SupplySide West show in Las Vegas, Nev., October 12-13 and sponsored a lively "town hall" meeting on New Dietary Ingredient Guidance during the show.

The15th anniversary event broke records for attendance and exhibits, with more than 9,700 dietary supplement, food/beverage and cosmeceutical executives from 64 countries and 1,340 booths—which represented a nine percent increase in exhibitors over the record set last year.

"SupplySide West is always an upbeat show and the energy of the town hall format was a great addition this year," says EAS Vice President Betty Campbell, who staffed an EAS information table for participants in the meeting.

The event included a video commentary from Sen. Orrin Hatch (R-Utah), chief sponsor of the Dietary Supplement Health and Education Act of 1994.

EAS Vice President Dean Cirotta and EAS Director of Regulatory Information and Submissions Chris Celeste were at the EAS exhibit booth on the show floor, where they responded to the regulatory compliance concerns of visitors to the booth.

"This was a useful meeting," Cirotta says. "It is always instructive to hear what is on the minds of your customers."

EAS Had a Successful Showing at RAPS

EAS Director of Regulatory Information and Submissions, Charles "Chris" Celeste, and EAS Consultant Parth Dave staffed the EAS exhibit at the Regulatory Affairs Professional Society (RAPS) annual meeting, held at the Indiana Convention Center in Indianapolis, October 22–26, 2011.

This year’s event was titled "2011 RAPS: The Regulatory Convergence," and many participants did converge on the EAS booth.

"We were very pleased with level of interest," Celeste says.

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Upcoming Events

Food Labeling Seminar

EAS labeling experts are preparing for the Food Labeling Compliance Review Seminar to be held at the EAS training facility in Alexandria, Va., November 8-9, 2011.

Participants will learn food labeling from former FDA labeling officials who helped shape current labeling regulations and from experienced food labeling consultants. This hands-on, two-day seminar covers the basics of how foods need to be labeled to comply with the complex set of labeling rules, covers the latest in food labeling issues that have drawn FDA’s attention, and provides answers to your most challenging questions. This seminar also includes an opportunity to discuss your specific labeling issues with our expert instructors.

This in-depth seminar is designed for individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of foods, as well as those responsible for preparing or reviewing food labels. It is also helpful for consultants, auditors, attorneys and others interested in food labeling compliance.

Instructors for this event will include EAS Vice President Elizabeth (Betty) Campbell, a former acting head of the FDA Office of Food Labeling n the Center for Food Safety and Applied Nutrition, and EAS consultants James Hoadley, Ph.D., and Gisela Leon. The seminar and update are designed for individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of foods, as well as those responsible for preparing or reviewing food labels. The two sessions are also very popular with consultants, auditors, attorneys and others interested in food labeling compliance.

Visit the EAS web site for more details. Late registrations are still being accepted.

Dietary Supplement GMP Seminar

Here is a chance to learn what you need to know to comply with FDA’s GMP rule for dietary supplements. The Dietary Supplement GMP Seminar will be held at the EAS Training Facility, in Alexandria, VA., November 15-16, 2011. This popular seminar addresses 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.

Instructors for this event will be EAS Vice President Dean Cirotta and EAS Senior Consultant William Ment.

Visit the EAS web site for more details.

Dietary Supplement Labeling Compliance Review Seminar

Do you need to learn how to comply with FDA’s labeling requirements for dietary supplements? If so, the EAS Dietary Supplement Labeling Compliance Review Seminar is designed for you. The seminar will be at the EAS Training Facility, in Alexandria, VA., December 6-7, 2011. It is designed to provide participants with everything needed to prepare labels that comply with FDA requirements. Participants will have the opportunity to ask EAS experts about regulatory requirements for mandatory labeling elements and allowable dietary supplement claims for their specific products. And they will take part in a workgroup exercise to facilitate their understanding of the regulations.

The instructors for this event will be EAS Senior Consultant James Hoadley, Ph.D., and Gisela Leon.

Visit the EAS web site for more details.

Upcoming Events

Food Labeling Compliance Review Seminar
November 8-9, 2011
Alexandria, Virginia
(EAS Training)

Dietary Supplement GMP Seminar
November 15-16, 2011,
Alexandria, Virginia
(EAS Training)

IFT Food Policy Impact
December 1, 2011
Arlington, Virginia.
(EAS Sponsoring)

Dietary Supplement Labeling Compliance Review Seminar
December 6-7, 2011
Alexandria, Virginia
(EAS Training)

FDLI Enforcement, Litigation & Compliance Conference
December 6-7, 2011
Washington, D.C.
(EAS Sponsoring)

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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
	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
	No Margin for Error – GMP Training Video A 1967 video produced by FDA demonstrating the consequences of not following GMPs. An excellent training tool to motivate employees to follow drug GMPs. 25 minute video in DVD format	$ 99.00
	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 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
To purchase any items listed above download our

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