Issue of the Month
FDA: The Year in Review

by EAS Director of Regulatory Information and Submissions, Charles "Chris" Celeste,
and EAS Consultant Parth Dave

The Food and Drug Administration may consider 2011 to have been a pretty good year when all is said and done. For example, the agency faced a possible cut of $285 million in appropriated funding for fiscal year 2012—which began October 1, 2011—but finally emerged with a modest increase of $50 million and an FY 2012 budget of $2.5 billion, making it one of the few federal agencies to receive an increase for FY 2012 from a Congress searching desperately for ways to reduce the huge budget deficit.

The signing by President Obama of the Food Safety Modernization Act on January 4, 2011 got the agency’s food-related activities off to a good start for the calendar year. Since then, FSMA implementation has been a key driver of regulatory activity in those agency centers involved in food-related work. We should note here that Section 103 of FSMA specifically excludes dietary supplements from the Act’s hazard analysis and prevention control requirements.

Foods

Enactment of FSMA marked a major shift in the agency’s food safety focus, from responding to contamination to prevention-based controls. This has been reflected in an increase in inspections as well as in changes in how the agency plans to pay for its inspection program. Take reinspection fees, for example. In the event of a reinspection after a previous inspection of a foreign facility or import reinspection/reexamination or recall activities, fees for the hours spent by FDA inspectors will now be collected directly from the U.S Agent or Importer. It remains to be seen how this arrangement will work in practice. For domestic food facilities, the fees will be collected from the responsible domestic party.

In 2011, the agency published its long-awaited draft guidance on New Dietary Ingredients (NDI). The document provides guidance on filing premarket NDI notifications for dietary ingredients not sold in the U.S prior to 1994. Increased enforcement is expected in this area as the guidance becomes final, with firms required to go through the NDI process and to submit safety notifications to the agency. The agency has been working on new requirements that will impact nutrition labeling, menu labeling in chain restaurants and vending machines, and its front-of-pack labeling policy.

Drugs

The agency approved 35 novel medicines in FY 2011, including two major drugs for late-stage metastatic melanoma. Yervoy is the first drug ever shown to be effective in extending the lives of patients with that late-stage cancer. A second drug, Zelabrof, was approved along with a first-of-its-kind companion diagnostic test—BRAF V600E—which will determine if a particular patient will respond to the new medication. In addition, the agency approved the first drug to treat Hodgkins lymphoma in 30 years, as well as new drugs for late-stage prostate cancer; thyroid cancer; metastatic breast cancer; and late stage lung cancer.

In other agency activity, the Center for Drug Evaluation issued a series of documents in June effecting Over-the-Counter (OTC) Sunscreen Drug Products including: a Final Rule for Labeling and Effectiveness Testing; a Draft guidance ‘‘Enforcement Policy— OTC Sunscreen Drug Products Marketed Without an Approved Application’’; a proposed rule to limit the maximum labeled SPF value to ‘‘50+.’; and an ANPR requesting data on certain dosage forms.

A revised CPG 440.100 for Marketed Unapproved Drugs was issued in September providing additional clarification on how FDA is going to exercise its enforcement discretion regarding unapproved drugs and how illegally marketed drug products must get FDA approval. Also, to further the goals of the current Good Manufacturing Practices (CGMPs) for the 21st Century Initiatives, FDA issued a new Guidance on Process Validation: General Principles and Practices.

Looking ahead to 2012, we can expect to see increased FDA enforcement actions in the areas addressed in these guidance documents.

On the international level, FDA increased its activities, with more joint inspections with foreign authorities. The agency also launched a program in which it will share regulatory/inspectional information with selected foreign regulatory authorities.

Medical Devices

The Center for Devices and Radiological Health issued numerous guidance documents in 2011. But two in particular have drawn significant industry attention. On July 27, CDRH issued the guidance on 510(k) Device Modification: Deciding When to Submit a 510(k) for a Change to an Existing Device. This document provides guidance on when a new 510(k) should be submitted for a change or modification to a legally marketed device. On August 15, the center issued guidance entitled Design Considerations for Pivotal Clinical Investigations for Medical Devices. This guidance is intended to describe different study designs relevant to the development of clinical studies to be used to fulfill premarket clinical data requirements.

Tobacco

FDA’s Center for Tobacco Products announced on January 5, that the agency will require substantial equivalence submissions for new tobacco products. This requires that certain tobacco products introduced or changed after February 15, 2007 must be shown to be “substantially equivalent” to products commercially available on February 15, 2007.

On June 21, the agency released nine graphic health warning images that will be required to appear on every package of cigarettes. The graphic images are expected to help prevent children from smoking and to encourage adults to quit. However, in a November 7 setback, a Federal Judge granted a preliminary injunction preventing the agency from requiring graphic warning labels on cigarettes.

In August, the agency announced that formal regulatory inspections of all registered tobacco facilities will begin on October 1, 2011. The FDA sent a letter to each registered establishment stating that even though there are no tobacco GMPs in place, inspections will be conducted according to the Tobacco Act and will involve assessment of compliance with the current regulations and requirements of the Act. This may include establishment registrations, product listings, ingredient listings, packaging, labeling, advertising and the marketing authorization for new and modified risk tobacco products.

With four weeks left in calendar 2011, there may still be time for an unexpected crisis to derail the agency. But, all things considered, it has been a year of significant activity and some progress on key regulatory issues.

Return to the Top of the Newsletter

FSMA Perspective
Prevention Tops FDA’s Agenda

by EAS Consulting Group Editor Declan Conroy

As FDA officials diligently prepare proposed regulations on Preventive Controls for Registered Human Food and Animal Food/Feed Facilities for end of year or early 2012 release, the agency has extended through December 20 the public comment period on the relevant docket, opened May 23, 2011 (see Federal Register, Vol. 76, No. 211).)

Deputy Commissioner for Foods, Michael Taylor, emphasized the agency’s focus on prevention in implementing the Food Safety Modernization Act, in an address at the China International Food Safety and Quality Conference and Expo in Beijing, November 2.

Although the agency has many rulemaking mandates in the new law, it is prioritizing preventive control standards for food and feed facilities, produce safety standards, foreign supplier verification, and accredited third-party certification, he said.

“I want to emphasize that, even after we issue final rules over the next year or so, we will be allowing additional time for firms to come into compliance. We are committed to devising a compliance schedule that ensures as much as possible an orderly, feasible transition to the new system,” Taylor said.

FSMA Section 103 introduces new hazard analysis and preventative control requirements for FDA-regulated human food and animal feed facilities, similar to those already in place for seafood and juices. Most of the section 103 provisions are added to the Food Drug and Cosmetic Act as Section 418, while some provisions amend several other FDCA sections.

Here are just some ways in which the new preventive control requirements will differ from existing HACCP regulations:

• There is a new requirement under FSMA for a written hazard analysis, which must address radiological hazards, unintentionally introduced hazards, and intentionally introduced hazards. Under existing HACCP regulations, only the preventive control plan is required to be committed to writing so it can be made available to FDA inspectors.
• Under Section 418 (c), preventive controls must be applied for adulteration and misbranding as well as for safety issues. Formerly, only safety issues triggered preventive controls.
• Under Section 418 (f), records of verification efforts will be required to be made available to FDA inspectors. This is not currently required under HACCP regulations.
• FSMA requires the regulated facilities to identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism. This is not explicit in existing FDA or USDA HACCP regulations.

In its November 1 request for comments, the agency lists two contacts for further information. One is Jenny Scott, former vice president of food safety programs for the Grocery Manufacturers Association, who is now a senior advisor in the Center for Food Safety and Applied Nutrition and is leading the agency's work group on guidance for preventive controls. The second contact is Kim Young of the Center for Veterinary Medicine.

Here is a link to docket FDA-2011-N-0238.

Return to the Top of the Newsletter

Who's Who at EAS

Meet the EAS Director of Regulatory Information and Submissions

Charles "Chris" Celeste joined EAS Consulting Group in 2009 as Director of Regulatory Information and Submissions. Chris was a former colleague: Prior to joining EAS, he was the Director of Regulatory Operations and Intelligence at Kendle Regulatory Affairs (formerly AAC Consulting Group).

As Director of Regulatory Operations and Intelligence at Kendle, Chris was responsible for preparing and coordinating the submission of various sponsor applications (INDs, ANDAs NDAs, DMFs, and VMFs in non-CTD, CTD, and eCTD formats) to FDA. He has assisted sponsors with the preparation and submission of electronic Drug Establishment Registration and Drug Product Listings, import issues and general regulatory questions.

Chris began his career at AAC in 1990 as a Freedom of Information Act Coordinator. In that role, he was responsible for coordinating all of the activities of the Information Services Division, including supervising the research associates and the weekly publication of the FDA News & Information.

He has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.

Chris inherited his interest in regulatory matters from his father Tony Celeste, who was President of AAC Consulting Group and is a leading food and drug regulatory authority. Tony is currently the principal advisor to EAS President Ed Steele, with primary responsibility for expanding the company's consulting, auditing and training services to the pharmaceutical and related industries.

"Chris has helped us greatly with the expansion of our services to the pharmaceuticals sector," says EAS President Ed Steele. "His understanding of the submission process for INDs, NDAs, ANDAs, and DMFs, is especially valuable for our clients.”

EAS Adds Two Consultant to Its Expert Network

EAS welcomes two new consultants, Pamela Wojtowicz and Rebeca Lopez-Garcia, to its growing network of consultants.

Ms. Wojtowicz has extensive experience in FDA drug and device regulatory operations focusing on Current Good Manufacturing Practices for Drugs and Quality Systems Regulations for Medical Devices.

Ms. Wojtowicz was Director of the International Relations and External Affairs Staff in the Office of Standards and Regulations, Center for Devices and Radiological Health, from 1990 to 1995. For 14 years, she was a consumer safety officer at CDRH. She directed more than 100 investigations to obtain evidence supporting FDA regulatory actions to correct QSR, labeling, premarket and other violations.

From 2000 to 2004, she was a senior consultant with AAC Consulting Group. She has conducted audits of international and domestic medical device and pharmaceutical manufacturers. In addition, she has provided customized on site training on GMP and Designed and presented more than 400 QSR training programs to internal FDA and External Manufacturers’ organizations.

Ms. Wojtowicz holds a BS degree in education, chemistry and math and an MS degree in education and chemistry, from the State University College at Buffalo, N.Y. She was the Regulatory Affairs Professional Society’s Regulatory Affairs Professional of the Year 1994.

Based in Mexico City, Dr. Lopez-Garcia (right) has been an independent consultant with Logre International Food Science Consulting since 2000. She has worked with some of the largest international food companies, including H.J. Heinz, Tate & Lyle, Cargill, and the Coca Cola Company.

She is an experienced trainer in both Spanish and English in a range of food safety subjects including sampling methods, risk management of naturally-occurring toxins, sanitation, risk management of chemical hazards, food regulations, GMPs, and HACCP. Dr. Lopez-Garcia is an expert in Mexican/Latin American food laws and regulations.

She holds a Ph.D. in food science from Louisiana State University, a Certificate in International Food Law from Michigan State University, and a B.S. degree in chemistry and food science from Universidad La Salle, Mexico.

Return to the Top of the Newsletter

What's New on FDA's Website

Listed below are links to new additions to the FDA website for the month of November, 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 approves first generic version of cholesterol-lowering drug Lipitor November 30, 2011


• FDA takes enforcement action against Pennsylvania dietary supplement maker November 23, 2011


• FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep November 23, 2011


• FDA permits marketing of a system to repair failed, problematic fix for aortic aneurysms November 21, 2011


• FDA warns consumers not to eat one batch of Loyd Grossman Korma Sauce November 18, 2011


• FDA approves Eylea for eye disorder in older people November 18, 2011


• FDA approves first supplemental test for Chagas disease November 18, 2011


• FDA Commissioner announces Avastin decision November 18, 2011


• FDA approves Erwinaze to treat a form of leukemia November 18, 2011


• FDA Statement on the International Tobacco Regulators' Conference November 16, 2011


• FDA approves first drug to treat a rare bone marrow disease November 16, 2011


• FDA approves first cord blood product November 10, 2011


• FDA issues two draft guidance documents to facilitate investigational medical device studies in humans November 10, 2011


• FDA acts to protect children from illegal tobacco sales November 10, 2011


• FDA Statement on Makena November 8, 2011


• FDA launches website on safe disposal of used needles and other “sharps” November 8, 2011


• FDA approves Erbitux to treat late-stage head and neck cancer November 7, 2011


• FDA warns consumers not to eat Bio Gaudiano brand Organic Olives Stuffed with Almonds November 4, 2011


• FDA warns consumers not to eat certain ASSI Brand frozen oysters November 4, 2011


• FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm November 4, 2011


• FDA: 35 innovative new drugs approved in fiscal year 2011 November 3, 2011


• FDA approves first artificial aortic heart valve placed without open-heart surgery November 2, 2011


• FDA approves system to repair abdominal aneurysms in people with small arteries November 2, 2011


• FDA Enters Consent Decree of Permanent Injunction in NY Tissue Residue Case November 1, 2011

• Front Row Produce Recalls Grape Tomatoes Because Of Possible Health Risk November 30, 2011


• Ocean Spray Voluntarily Recalls Limited Quantity of Original Flavor Craisins® Dried Cranberries and Bulk Dried Cranberries Sales November 25, 2011


• Giant Eagle Canned Pumpkin Media Statement November 23, 2011


• Caribbean Rum Balls Issues Allergy Alert On Undeclared Allergens In "Rum Balls" November 23, 2011


• Four Star Import & Distribution Inc Issues An Alert On Uneviscerated Fish November 23, 2011


• King And Prince Seafood Corp. Issues Voluntary Recall Notice On Nova Style Cold Smoked Salmon And Sable Fish Lox, Salmon Sushi Fillets, And Salmon Trim Because Of Possible Health Risk November 23, 2011


• Maxipan Bakery Corp Issues Allergy Alert On Undeclared Milk Allergens In "Semita De Pina" (Sweet Pineapple Cake) November 23, 2011


• Four Star Import & Distribution Inc. Issues An Alert On Uneviscerated Fish November 23, 2011


• Trans-Ocean Products Recalls "transOCEAN Wild Alaska Sockeye Smoked Salmon" Lot No 1280W & 1293W Because of Possible Health Risks November 22, 2011


• Rio Grande Imports Inc. Issues Allergy Alert on Undeclared Dairy in Semita de Piña (Pineapple Jam Filled Pastry) November 21, 2011


• Maumee Valley Vending Company Issues Allergy Alert on Undeclared Milk in Buffalo Chicken Wedge Sandwiches Containing Cheese November 18, 2011


• Diamond Crystal Brands Inc. Announces a Nationwide Recall for GFS® Sugar Canisters Due to Undeclared Milk November 18, 2011


• United Natural Foods, Inc. Announces Updated Information For Recall Related to Gentes Foods Gordita Black Bean Tortillas Due to Possible Health Risk November 17, 2011


• The J.M. Smucker Company Announces a Limited Voluntary Recall on Two Specific Best-If-Used-By Dates of 16 oz. Smucker’s® Natural Peanut Butter Chunky Due to Possible Health Risk November 16, 2011


• CooperVision Announces Expanded Recall of Avaira Line of Contact Lenses Expanded Recall Involves Limited Number of Lots of Avaira Sphere Lenses November 16, 2011


• Ready Pac Foods, Inc. Announces Voluntary Product Recall Because Of Possible Health Risk November 16, 2011


• United Natural Foods, Inc. Expands Recall Of Foodmatch Inc. Divina Olives Due To Possible Health Risk November 14, 2011


• United Natural Foods, Inc. Recalls Gentes Foods Gordita Black Bean Tortillas Due To Possible Health Risk November 10, 2011


• Keime Inc dba Barry's Vitamins Conducts a Nationwide Voluntary Recall of Virility Max Dietary Supplement: Lot Number 10090571 November 10, 2011


• United Natural Foods, Inc. Recalls Tabatchnick Fine Foods Yankee Bean Soup & Foodmatch Inc. Divina Olives Due to Possible Health Risk November 9, 2011


• Kimberly-Clark Recalls Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency from a Limited Number of Retail Stores Within the United States November 9, 2011


• Golden Glen Creamery Issues Voluntary Recall of Raw Cheddar Because of Possible Health Risk November 8, 2011


• Rice-A-Roni Issues Voluntary Recall on a Small Quantity of Specific Family Size Rice-A-Roni Rice Pilaf Flavor Product Due to Undeclared Milk Allergen November 4, 2011


• FDA Warns Consumers Not to Eat Bio Gaudiano Brand Organic Olives Stuffed with Almonds November 4, 2011


• FDA Warns Consumers Not to Eat Certain ASSI Brand Frozen Oysters November 4, 2011


• Badia Spices Recalls Pinenuts Because of Possible Health Risk November 4, 2011


• Quirch Foods Co. Issues a Voluntary Alert on Uneviscerated Salted Smoked Split Herring Packed in 18lb Wooden Boxes, Due to a Possible Clostridium Botulinum health risk. November 4, 2011


• FDA Confirms Salmonella on Sunrise Commodities’ Turkish Pine Nuts November 4, 2011


• Foremost Foods International, Inc. Issues Recall On Certain Pangasinan Smoked Seafood Products Due To Possible Health Risk November 3, 2011


• Pure Italian, LLC Recalls Bio Gaudiano Brand Stuffed Olives With Almonds Because Of Possible Health Risk November 1, 2011

• November 15, 2011 Medical Devices: Protecting Patients and Promoting Innovation
  Jeffrey Shuren, M.D., J.D., before the Senate Committee on Health, Education, Labor and Pensions

• November 23, 2011
• November 16, 2011
• November 9, 2011
• November 2, 2011

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

Return to the Top of the Newsletter

EAS in Action

Dr. James Hoadley Authors Book Chapter for Functional Foods: Concept to Product

EAS Senior Consultant James Hoadley, PhD has contributed a chapter on U.S. Regulation of Functional Foods for the second edition of a book titled Functional Foods, Concept to Product, published by Woodhead Publishing, Cambridge, U.K.

The chapter addresses health claims, structure/function claims, nutrient content claims, medical food and food for special dietary use, and ingredient safety.

Dr. Hoadley joined the EAS consulting team in October 2007 after a 20-year FDA career, where he was involved in reviewing almost all health claim petitions received by FDA’s Center for Food Safety and Applied Nutrition over the previous decade. He spent ten years as a senior regulatory scientist in CFSAN’s Office of Nutritional Products, Labeling and Dietary Supplements with primary responsibility for food label claim regulations.

Dean Cirotta Writes on Tobacco GMPs in New FDLI Book

EAS Vice President Dean Cirotta has contributed a chapter on Good Manufacturing Practices for tobacco products in a new Food and Drug Law Institute book titled Tobacco Regulation and Compliance: An Essential Resource, scheduled for release December 5 at the FDLI Tobacco Regulation and Litigation Conference in Washington, D.C.. It is the first FDLI book devoted exclusively to tobacco products. The book’s editor is food and drug attorney Azim Chowdhury of Keller & Heckman, who has also contributed a chapter on criminal liability and the Park doctrine.

EAS Congratulates FDLI Leadership Award Recipients

EAS Consulting Group is sponsoring the FDLI 2011 Annual Holiday and Leadership Awards Reception and will also be showcasing EAS regulatory services at the FDLI Enforcement, Litigation and Compliance Conference at the Westin Georgetown in Washington, D.C., December 6-7, 2011. Each year, the institute recognizes up to four individuals from various areas of the food and drug law community for their distinguished service and leadership. The reception will be held on the evening of December 6 from 5:30 to 7:00 p.m.

This year’s winner are:

Return to the Top of the Newsletter

Upcoming Events

Next Food Labeling Compliance Seminar is Scheduled for Early June 2012

If your resolutions for the New Year include learning more about compliance with the Food and Drug Administration’s food labeling regulations, now is the time to plan on attending our next Food Labeling Compliance Review Seminar, which will be held at the EAS training facility in Alexandria, Va., in early June, 2012.

This popular, 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 in the Center for Food Safety and Applied Nutrition, and EAS consultants James Hoadley, and Gisela Leon.

The details will be posted on the EAS web site when the dates are firmed up.

Sign Up for the Upcoming Dietary Supplement GMP Seminar

EAS Consulting Group is offering another opportunity to learn how to comply with FDA’s GMP rule for dietary supplements. Our next Dietary Supplement GMP Seminar will be held at the EAS Training Facility, in Alexandria, VA., January 17-18, 2012. 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.

Upcoming Events

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)

Dietary Supplement GMP Seminar
January 17-18, 2012
Alexandria, Virginia
(EAS Training)

Food Labeling Compliance Review Seminar
Early June, 2012 (dates to be announced)
Alexandria, Virginia
(EAS Training)

Return to the Top of the Newsletter

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	$ 200.00
	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	$ 240.00 / set
To purchase any items listed above download our

Return to the Top of the Newsletter