Issue of the Month
FSMA’s ‘Terrible Beauty’ and the New Role of Food Importers

by EAS Senior Consultant, Joseph McCallion

All changed, changed utterly:
A terrible beauty is born.

In writing these words, W.B.Yeats was not only describing the turmoil and chaos that accompanied Ireland’s 1916 Easter Rising that led to its eventual freedom from British rule, but also presaging the subsequent bloody Irish Civil War.

In many ways the business landscape for food importers – including importers of dietary supplements and dietary ingredients –after passage of the Food Safety Modernization Act (FSMA) represents a similar upheaval in existing business practices and the potential for significant civil and criminal penalties if adequate precautions are not taken.

Prior to FSMA, food importers were free to import food based solely on price and availability – leaving it to FDA to determine if the food was safe, sanitary, and compliant with all applicable requirements. Since FDA was able to sample and examine only a miniscule amount of imported food the actual risk of FDA detecting a non-compliant shipment was minimal. Finally, even if FDA identified such a shipment, the importer could contest FDA’s decision, request permission to bring the shipment into compliance (“reconditioning”) or, as a last resort, re-export the product, either to the original supplier or to an alternate market. As a result, importers had little incentive to institute pre-emptive controls to ensure that the products they introduced were in full compliance.

FSMA changed this on several levels.

Importers are now required to verify that their foreign suppliers operate in such a manner so as to ensure that their food products are not adulterated and are produced in compliance with FDA’s preventative controls program. FDA-identified “high risk” foods will need to be certified by independent third party auditors (who in turn must be accredited by FDA-recognized authorities.) Beyond the mandatory foreign supplier verification and certification requirements, importers who wish to take advantage of expedited entry procedures may enroll in the Voluntary Qualified Importer Program (VQIP) by agreeing to import only food from facilities that have a certification from an accredited third party auditor. Finally, before any food is imported into the U.S., the importer must inform FDA if the food has previously been refused admission by any other country, and, if so, by which country.

Importers also face new fees for FDA re-inspection of their shipments if FDA’s initial inspection found it non-compliant. These re-inspections include review of documents submitted to contest FDA’s initial decision, review of private laboratory analyses, request for (and supervision of) reconditioning, and FDA supervision of destruction of refused shipments.

Failure to comply with many of the requirements of FSMA has been codified as “Prohibited Acts” under section 301 of the Federal Food, Drug, and Cosmetic Act (21USC331). As was pointed out in Jeffrey Springer’s article last month (Park Doctrine Prosecutions: Crime and Punishment, FDA Style), even inadvertent or unintentional commission of one of these acts can lead to a misdemeanor prosecution – and a subsequent commission can lead to a felony.

Truly a “terrible beauty”.

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FSMA Perspective
On FDA’s Re-inspection User Fees

By EAS Consulting Group Editor Declan Conroy

As part of its implementation of the Food Safety Modernization Act, the FDA plans to charge fees of $325 per hour for foreign facility reinspections. If no foreign travel is involved, the rate will be $224 per hour.

The user fees may result in a significant change in the relationship between foreign facilities and their U.S. agents. The agency plans to bill and collect fees from the responsible party for each domestic facility and from the U.S. agent for each foreign facility subject to a rein spection. This will mean that U.S. agents, whose role in most cases has been limited to a registration function, may now be liable for thousands of dollars in user fees.

The fees may also be imposed for failure to comply with a recall order, and for importer re-inspections. The charges will be in place for fiscal year 2012, which begins October 1, 2011.

In an August 1 Federal Register notice (76 FR 45820), the agency explained that it is required to assess the fees based on an estimate of 100 percent of its cost for each activity. The notice included a lengthy explanation of how the agency arrived at the hourly fees and said reinspections that involved foreign travel would be $335 per hour. In a subsequent notice (76 FR 53478), this was corrected to $325 per hour.

In a separate August 1 notice (76 FR 45818), the agency called for comments on proposed guidelines for small businesses relating to the fees, which could include reduced fees. But any adjustment to the fee schedule for small business must be done through notice and comment rule making, the agency says. It is also seeking comments by October 17, 2011 (Docket No. FDA–2011–N–0529) on how small businesses should be defined.

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Who's Who at EAS

Tony Zesimopoulos Joins EAS

Tony Zesimopoulos is the latest addition to the EAS Consulting Group’s cadre of senior consultants. With more than 28 years in pharmaceutical research and development, quality assurance and compliance — including more than a decade in key positions at Barr Laboratories — he brings valuable experience to the EAS team.

In 1992, he was responsible for the defense of analytical methodology at Barr Laboratories in a legal challenge by FDA. He worked with expert witnesses, legal counsel and FDA to develop a framework for various cGMP guidelines for the industry. He assembled a team to respond to court and agency requests and to update methods and validations. Barr succeeded in keeping more than 50 of its most important products in the marketplace while achieving full cGMP compliance for its facilities. In 1996, he became director of analytical research and development. Since 2004, he has been a senior consultant in his own consulting firm, PharmacoAnalytics, LLC.

He has worked with the USP since 1985 as a contributing member for numerous monographs and on the development of general chapters. In 2003, he served on the USP Biopharmaceutics Expert Committee Working group on Liquid Filled Capsules, which developed guidelines for this dosage form, including QC/QA testing requirements.

“I am delighted to welcome Tony to EAS,” says EAS President Ed Steele. “His experience in interacting with FDA to resolve compliance issues will be most useful to our clients.”

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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 August, 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 Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards August 31, 2011


• FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer August 26, 2011


• FDA hurricane preparedness checklist August 26, 2011


• FDA: U.S. Marshals seize food products held at North Carolina warehouse August 25, 2011


• FDA requests seizure of adulterated seafood at California company August 25, 2011


• La FDA trabaja con México para proteger la inocuidad de las papayas importadas August 25, 2011


• FDA approves Firazyr to treat acute attacks of hereditary angioedema August 25, 2011


• FDA working with Mexico to protect safety of imported papayas August 25, 2011


• FDA approves Botox to treat specific form of urinary incontinence August 24, 2011


• FDA approves Adcetris to treat two types of lymphoma August 19, 2011


• FDA: Regulatory science plan positions agency to foster innovation through better science August 17, 2011


• FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer August 17, 2011


• FDA seeks comment on proposed guidelines for high-quality clinical studies August 15, 2011


• FDA proposes guidelines that clarify benefit-risk determinations for medical devices August 15, 2011


• FDA, state of Arkansas sign agreement to advance regulatory science August 12, 2011


• FDA approves the first specific treatment for scorpion stings August 3, 2011


• FDA, international counterparts report progress on drug inspection collaboration August 2, 2011


• FDA reopens comment period on proposed ‘gluten-free’ food labeling rule August 2, 2011

• King International Recalls the Shoulderflex Massager August 31, 2011


• Pure Encapsulations, Inc. Issues Allergy Alert On Undeclared Egg Allergen In Prenatal Nutrients August 31, 2011


• Vita Food Products Issues Voluntary Recall of 4 oz. Vita Classic Premium Sliced Smoked Atlantic Nova Salmon Packages with "SELL BY DEC 15 2011 01961" Purchased on July 25 or After August 26, 2011


• H&P Industries, Inc. Issues a Voluntary Recall of All Lots of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel August 25, 2011


• Ajinotmo Frozen Foods Issues Allergy Alert On Undeclared Shrimp And Fish In Vegetable Gyoza Dumplings August 24, 2011


• Precautionary Recall Issued for Pretzel Logic Cookies Sold at Central Market August 24, 2011


• YoCream International, Inc. Issues Allergy Alert On Undeclared Egg In Nonfat NY Cheesecake Frozen Yogurt Mix August 24, 2011


• Paleteria La Super Issues Allergy Alert on Undeclared Walnuts, Milk and Coconut in Their Nut, Esquimal , and Pina Colada Ice Cream Bars August 22, 2011


• The Christie Cookie Company Issues Allergy Alert On Undeclared Eggs, Soy Lecithin, Wheat and Milk On The Labels Of the Following Gift Tins August 19, 2011


• Atlanta Oriental Food Recalls Cut Napa Kimchi Because Of Possible Listeria Monocytogenes August 19, 2011


• Winn-Dixie Issues Voluntary Recall On 'Winn-Dixie Choco Charm Chocolate Drink' Due To Mislabeling And Undeclared Allergen August 17, 2011


• Whole Foods Market announces recall for marinades in six Mid-Atlantic states and Washington, D.C. because of undeclared allergens August 13, 2011


• FRESH FOOD CONCEPTS, INC. RECALLS LAYER DIP PRODUCTS CONTAINING GUACAMOLE BECAUSE OF POSSIBLE HEALTH RISK August 12, 2011


• Miss Bonnie's Gourmet Recalls Classic Cheddar Cheese Spread August 12, 2011


• Unilever United States, Inc. Issues Allergy Alert for Mislabeled 24-Count Boxes of Popsicle® Sugar Free Orange,Cherry and Grape Flavor Due to Undeclared Milk August 11, 2011


• Fresh Strawberries From Washington County Farm Implicated In E. coli O157 Outbreak In NW Oregon August 11, 2011


• XYMOGEN® ISSUES ALLERGY ALERT ON UNDECLARED Peanut Protein IN 3 Varieties of OrganiX Bars: Omega-3, Spice and Greens August 9, 2011


• Merrick Pet Care Recalls Doggie Wishbone (Item #29050, Lot 11031 Best by 30 Jan 2013) Because of Possible Salmonella Health Risk August 8, 2011


• Fresh & Easy Neighborhood Market Voluntarily Recalls One Date Code Of f&eâ„¢ Brand Organic Baby Spinach Because Of Possible Health Risk August 8, 2011


• Winn-Dixie Issues Voluntary Recall On Specific In-Store Bakery Items Due To Mislabeling And Undeclared Allergens August 8, 2011


• Transpecos Foods, LP Issues Allergy Alert on Undeclared Soy Allergen in Cheddar Cheese Jalapeno Bites and Cream Cheese Jalapeno Bites August 6, 2011


• American Regent, Inc. Initiates Voluntary Recall of Seventeen Lots of Vasopressin Injection, USP, Multiple Dose Vials Due to Sub-Potency August 3, 2011

• August 31, 2011
• August 24, 2011
• August 17, 2011
• August 10, 2011
• August 3, 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

Joe Baca to Speak at China-US Conference on Food Safety Governance

EAS Senior Consultant Joe Baca will give a presentation on U.S. federal-state relations at the China-U.S. Conference on Food Safety Governance in Beijing, September 10.

Baca brings a wealth of experience to the event. He served in FDA for more than 37 years, both in the field and at the agency’s headquarters. He worked on the regulatory aspects of all of commodities regulated by the agency and managed nearly all of the regulatory tools available to FDA including administrative, civil and criminal actions. He was the Director of the Office of Compliance, Center for Food Safety and Applied Nutrition from 1999 to 2008.

Participants at the Beijing event will also hear from food safety expert Dr. Michael Osterholm of the University of Minnesota.

Steele and Kabir Attend “Promoting U.S.-China Cooperation with Food Safety Activities” Event

EAS President Ed Steele and intern Wasim Kabir attended the “Promoting U.S.-China Cooperation with Food Safety Activities” Conference in Washington, DC on August 5, 2011.

The event was hosted by the China Chamber of Commerce of Foodstuffs and Native Produce (CFNA), and was co-hosted by the Food and Drug Law Institute (FDLI).

The event aimed to promote U.S.- China cooperation in food quarantine, agricultural product regulation, import and export administration, and to consolidate and develop trade links in food and agricultural products between the two countries. It was a great opportunity to make meaningful links with some of China’s top food safety experts from government and business.

Senior representatives from the Ministry of Commerce of the People's Republic of China (MOFCOM), Shandong Province, industry organizations and food produce companies were present. Delegates enjoyed speeches and presentations about the current situation of China's food and agricultural industry and had the opportunity to participate in discussions that could further promote Sino-U.S. cooperation in agricultural products and food trade.

Dr. Robert Brackett, VP and Director, Institute of Food Safety and Health at Illinois Institute of Technology and Director, FDLI Board presented the welcoming address on behalf of the FDLI.

EAS is Available to Assist the Tobacco Industry to Prepare for FDA Initial Inspections

EAS experts are available to help tobacco companies to prepare for the recently-announced initial inspections by the Food and Drug Administration.

In an August 16 letter to registered tobacco establishments, the agency said it will begin facility inspections on October 1, 2011. Because the agency has not yet established good manufacturing practice regulations for tobacco products, the inspections will assess compliance with the regulations that are currently in effect. These include, but are not limited to, establishment registration and product listing, ingredient listing; packaging, labeling, and advertising requirements; and marketing authorization for new and modified risk tobacco products.

The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain authorization before they market their products. On January 5, 2011 the FDA issued Substantial Equivalence Guidance requiring that certain tobacco products introduced or changed between February 15, 2007 and March 22, 2011 be reviewed and approved by the agency in order to remain on the market. The deadline for submitting the substantial equivalence applications under section 905(j) of the Act was March 22, 2011. Because of the limited time manufacturers had to submit the 905(j) reports, the FDA is allowing manufacturers who acted in good faith to meet the March 22, 2011 deadline a reasonable time to supplement their initial submissions. The agency said it would define a reasonable time for each manufacturer on a case-by-case basis.

For more information, contact EAS Vice President Dean Cirotta.

EAS Consulting Group Editor Races in Leukemia Cup Regatta

EAS Consulting Group Editor Declan Conroy is a member of the Five Skippers crew that will race in the 18^th Annual Leukemia Cup Regatta on the Potomac River in Washington, D.C., September 9-10. The skippers combine their joy of sailing with fundraising to fight blood cancers. Over a decade, they have raised more than $160,000 for the Leukemia and Lymphoma Society, which is the world's largest voluntary health organization dedicated to funding blood cancer research.

The Five Skippers, pictured from lower left clockwise, include Mike Geissinger, Dan McClafferty, Tom Hannan, George Umberger, Declan Conroy, and Patrick Derry. Yes, there are actually six members of the crew at present.

EAS Conducts OTC GMP Training Seminar in Cooperation with CHPA

EAS Consulting Group conducted a training seminar on OTC Drug Good Manufacturing Practices at the Consumer Health Products Association (CHPA) training facility in Washington, D.C., August 10-11. EAS Vice President Dean Cirotta, EAS Senior Advisor Anthony Celeste, and EAS Director of Regulatory Information and Submissions, Charles “Chris” Celeste, were the instructors for this custom-designed event in which participants gained an understanding of the cGMP regulations and FDA’s enforcement. The seminar included a number of case studies that involved the active participation of the attendees.

Participants found remarks by Milva Melendez, CSO and Compliance Officer from FDA’s OMPQ, CDER to be particularly helpful. She responded to questions to help students understand how FDA goes about enforcement of the regulations.

CHPA plans to offer this seminar to member companies every six months. The next session is being planned for February, 2012.

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Upcoming Events

Hoadley Participates in Webinar on FDA’s NDI Guidance Document

EAS Senior Consultant James Hoadley, Ph.D. will participate in a timely webinar on FDA’s NDI guidance document and its impact on the dietary supplement industry, scheduled for September 14, 2011 from 2-4 p.m. ET.

Other speakers will include Douglas "Duffy" MacKay, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition; Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs; Dan Levy, a supervisor of the NDI Review Team in FDA’s Division of Dietary Supplement Programs; and Ashish Talati, a partner in the law firm Amin Talati, LLC.

The goal of this webinar is to provide an overview of FDA’s process for reviewing New Dietary Ingredient Notifications (NDIN’s), to examine the current FDA thinking regarding the draft guidance, to offer a legal perspective on the NDIN guidance, and to offer tips and best practices for successful NDINs. Dr. Hoadley, a former FDA staffer, will offer his perspective on NDIN best practices.

The webinar is being co-sponsored by the Council for Responsible Nutrition and Virgo Publishing LLC.

Click here for more details.

EAS Schedules Dietary Supplement Labeling Compliance Review Seminar

EAS will offer its Dietary Supplement Labeling Compliance Review Seminar at the EAS Training Facility, in Alexandria, VA., December 6-7, 2011

This in-depth seminar will provide participants with all they need 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.

Presenters for this event will be EAS Senior Consultant James Hoadley, Ph.D., a former senior regulatory scientist at FDA, and Gisela Leon, who has an extensive background in both U.S. and European labeling requirements.

Visit the EAS web site for more details.

Food Labeling Compliance Review Seminar and Update

EAS is presenting the Food Labeling Compliance Review Seminar at the EAS training facility in Alexandria, Va., November 8-9, 2011. This timely session will provide answers the your most challenging questions about how foods must be labeled to comply with complex labeling rules, including differences between FDA and USDA requirements.

Seminar participants may also sign up for a separate Food Labeling Update, scheduled for November 10, 2011. Most participants who attend the two-day seminar stay for this popular update, in which EAS experts address other emerging issues.

Lead instructor for the seminar and update will be EAS Vice President Elizabeth (Betty) Campbell, a 35-year veteran of FDA who served as head of FDA's Office of Food Labeling. Joining her for the seminar will be EAS consultants James Hoadley, Ph.D., and Gisela Leon. Dr. Hoadley is a former FDA research scientist who spent ten of his 20-year agency career in the Office of Nutritional Products, Labeling and Dietary Supplements with primary responsibilities in food label claim regulations. Ms. Leon is experienced in European food laws, multi-language labeling, and the legal clearance of package labeling of food and dietary supplements.

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.

EAS Exhibits at PDA/FDA Joint Regulatory Conference and EXPO East

EAS will be exhibiting at the PDA/FDA Joint Regulatory Conference sponsored by the Parenteral Drug Association and the FDA in Washington, D.C., September 19-21, 2011. This annual meeting and expo brings together agency officials for face to face discussion with industry exerts.

In one especially popular session, Compliance Directors from CBER, CDER, CDRH and CVM, as well as the Office of Regulatory Affairs, will give their perspective on current compliance issues affecting the manufacture, testing and distribution of biopharmaceutical products, active drug substances and drug products and medical devices and combination products. After their brief presentations, the presenters will respond to questions from the floor.

Visit EAS representatives Tony and Chris Celeste at Table 44.

Also this month, EAS will be exhibiting once again at EXPO East, which is returning to Baltimore, Md., September 21-24, 2011, after being in Boston for the past three years.

Visit EAS representatives Ed Steele, Chris Celeste and Parth Dave at booth 5134.

Upcoming Events

FDA's NDI Guidance Document - Webinar
September 14, 2011
Online
(EAS Participating)

PDA/FDA Joint Regulatory Conference
September 19–20, 2011
Washington, DC
(EAS Exhibiting)

EXPO East
Sept. 21–24, 2011
Baltimore, Maryland
(EAS Exhibiting)

Supply Side West
October 12–13, 2011
Las Vegas, Nevada
(EAS Exhibiting)

Regulatory Affairs Professional Society
October 22–26, 2011
Indianapolis, Indiana
(EAS Exhibiting)

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

Food Labeling Update
November 10, 2011,
Alexandria, Virginia
(EAS Training)

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

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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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