Issue of the Month
Dietary Supplement Warning Letters Focus on GMP Violations

by EAS Consultant Parth K. Dave

Under the FDA Final Rule 21 CFR 111, all domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPs). In our review of warning letters from the last six months we have found twelve dietary supplements warning letters that included GMP violations.

The table below lists the most frequently cited violations found during FDA facility inspections in the past six months (April 2011 to September 2011):

The most frequent area of non-compliance has been in establishing specifications and determining whether the specifications are being met. Companies need to establish specifications (21 CFR 111.70) for any point/step/stage in the manufacturing cycle for quality, for each component used in manufacturing, for in-process production, labels and packaging and final product.

Companies then need to determine if their specifications are being met (21 CFR 111.75) by establishing tests for verifying the identity of ingredients, monitoring in-process production, collecting samples from batches of finished product and testing them for such attributes as identity, purity, strength, composition, and visual examination. In addition, companies must maintain complete and accurate documentation demonstrating that the specifications are met.

It is important for companies to educate their personnel in all aspects of 21 CFR Part 111 and audit their internal processes to ensure compliance with the GMP requirements. EAS can assist companies with these activities and is here to provide any consulting services regarding the GMP regulation. We have consultants with decades of FDA and industry experience who can assist companies in performing facility inspections and in implementing quality systems.

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FSMA Perspective
FERN Labs and FDA’s Commitment to Partnerships

by EAS Consulting Group Editor Declan Conroy

Section 202 of the Food Safety Modernization Act, which deals with laboratory accreditation for analysis of foods, requires the Food and Drug Administration to submit updates to the Congress on the progress of the Federal Emergency Response Network, the secure laboratory network for federal, state, and local government agencies engaged in food safety and defense activities. The network is an example of FDA’s strategy of using partnerships as it moves ahead with implementation of its FSMA mandates.

According to the agency’s report submitted to the Congress last month, the number of FERN laboratories has increased from just eight in 2004 to 172 this year. Already, the FERN labs are playing a significant role in federal surveillance efforts. Since 2007, when FDA and USDA’s Food Safety and Inspection Service responded to the melamine contamination of pet foods, FERN state labs have participated in federal emergency response and surveillance efforts.

The network was activated for the 2006 E. coli O157:H7 outbreak linked to spinach and member labs helped developed a harmonized method of analysis that was approved within days for use by all FERN labs. The rapid method cut several days off of the time required to obtain sample results. In the melamine crisis, FERN labs developed a new screening method for melamine and cyanuric acid. FERN was not officially activated for the 2009 Salmonella Typhimurium outbreak linked to peanut butter, but member labs in Minnesota, Michigan, Ohio and Connecticut contributed to the investigation.

The network is involved in numerous FSMA-related activities. FERN is building laboratory capacity, which is required under Section 110. It is also contributing to enhanced foodborne illness surveillance, which is required under Section 205. In addition, FERN labs will be involved in the training of state and local food safety officials, which is required under Section 209.

In a new initiative aimed at increasing the agency’s use of partnerships, FDA’s Office of Regulatory Affairs is creating an Office of Partnerships and a new position of Senior Advisor for Federal-State Relations. Joe Reardon, a former director of the food and drug protection division of the North Carolina Department of Agriculture and Consumer Services, will fill the new role. He joined the agency in the summer of 2009 to serve as a liaison with the states.

In addition, FDA’s Office of Foods is creating a new senior position of Director of Intergovernmental Affairs and Partnerships. Jeff Farrar, associate Commissioner for food protection, will serve in that role. Farrar is a former director of the California Department of Public Health’s Food and Drug Branch.

In a related initiative, the agency is establishing an Integration Task Force to oversee the development of new strategies to achieve full partnership with state and local agencies. Members of the task force will include senior officials from ORA, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and state and local agencies involved in the Partnership for Food Protection. Reardon and Farrar will co-chair the task force.

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Who's Who at EAS

EAS Continues to Expand its Senior Consulting Team

Miguel Montalvo, Judah Duncan, Russ Rutledge and Sylvia Owens have joined the growing EAS network of senior consultants.

Miguel Montalvo has more than 27 years of experience in quality assurance and validation for the pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology and medical device industries. His early career included work with Baxter Healhtcare Corp., Briston Myers-Squibb Inc., MOVA Pharmaceutical Corp., Raytheon Engineers and Const. Corp., and Millipore Corp. From 1999 to 2006 he was vice president of validation compliance for AAC Consulting, LLC. He holds a B.Sc. degree in chemical engineering from Rensselaer Polytechnic Institute in Troy, N.Y., and an MBA in business administration from Universidad del Turabo in Puerto Rico.

Judah Duncan is a former FDA food investigator who spent 18 years with the agency before joining the Food Safety and Inspection Service in 2008. He holds a B. Sc. degree in biology from Manuel L. Quezon University in the Philippines.

Russ Rutledge spent 15 years with FDA in various roles, Starting as a chemist in the agency’s division of drug analysis, based in St. Louis, Mo., he went on to become a senior pharmaceutical analyst in the agency’s Puerto Rico District office. He subsequently joined the Center for Drug Evaluation and Research as a consumer safety officer. He joined AAC Consulting Group in 2001, where he conducted cGMP audits and training and reviewed responses to 483s. He holds a B. Sc. degree in chemistry from the University of New Mexico.

Sylvia Owens is another former FDA staffer, whose career has included work as a regulatory compliance officer at the Center for Biologics Evaluation and Research, as well experience at Celltech Pharmaceuticals, the Otsuka Maryland Research Institute, Kendle Regulatory Affairs, MedImmune, and Johnsons Immediate Solutions LLC. She is an expert in cGMPs, GCPs, and GLPs. She holds a B. Sc. degree in biology from the University of the District of Columbia, and a M. Sc. in technology management from the University of Maryland.

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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 September, 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 seeks comment on streamlined review of lower risk, new technology, devices September 30, 2011


• FDA participates in global efforts to protect consumers and patients from unsafe drugs on the internet September 29, 2011


• FDA enters consent decree of permanent injunction against Florida drug companies September 28, 2011


• FDA clears first single use face mask for children September 28, 2011


• FDA Warns Consumers Not to Eat Raw Oysters Harvested from Hood Canal Area 4 in Washington State September 26, 2011


• FDA approves Remicade to treat ulcerative colitis in children 6 years and older September 23, 2011


• FDA approves Soliris for rare pediatric blood disorder September 23, 2011


• FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011 September 21, 2011


• FDA confirms Listeria monocytogenes on Jensen Farms’ Rocky Ford-brand cantaloupes September 19, 2011


• FDA warns consumers not to eat Rocky Ford Cantaloupes shipped by Jensen Farms September 14, 2011


• FDA establishes foodborne illness outbreak response network September 14, 2011


• FDA: Minnesota companies agree to halt sale of amino-acid products with unapproved claims September 14, 2011


• FDA investigates multistate outbreak of listeriosis September 13, 2011


• FDA announces changes in drug center’s oncology office September 12, 2011


• FDA warns consumers of botulism risk in La Ruche tapenade, spreadable tomato paste September 10, 2011


• FDA: Pilot projects to explore ways to trace sources of foodborne illness September 7, 2011


• FDA announces new staff training for medical device reviewers September 6, 2011

• Jensen Farms Includes IN, LA, and WI in Cantaloupe Recall Notification September 30, 2011


• True Leaf Farms Expands Voluntary Recall of Bagged, Chopped Romaine September 30, 2011


• True Leaf Farms Announces Voluntary Recall of Bagged, Chopped Romaine September 29, 2011


• Andrew Williamson Fresh Produce Expands Possible Distribution Area of Voluntary Organic Grape Tomato Recall Recall Still Confined to Original Production Lot September 29, 2011


• Andrew Williamson Fresh Produce Announces Precautionary Recall of Organic Grape Tomatoes Due to Possible Health Risk September 29, 2011


• Publix Recalls Spinach Dip Due To Possible Health Risk September 27, 2011


• M & P Food Productions, Ltd. Issues Allergy Alert On Several Varieties Of Vareniki/ Dumplings Because Of Undeclared Milk And Wheat Allergens In Products September 26, 2011


• Rich Products Corporation Announces Nationwide Voluntary Recall of Seapak Breaded Butterfly Shrimp, Net Wt. 22 Oz., Due To Undeclared Milk Ingredient (Whey) September 26, 2011


• Carol’s Cuts recalls fresh cut cantaloupe and cut mixed fruit containing cantaloupe because of possible health risk Distributed in KS, Mo, and NE September 23, 2011


• Smoked Spilt Herring Uneviscerated September 23, 2011


• Pepperidge Farm Voluntarily Recalls Limited Quantity Of Baked Naturals Sesame Sticks September 23, 2011


• DEL BUENO RETIRA QUESO CON POSIBILIDAD DE RIESGO DE SALUD September 17, 2011


• Del Bueno Recalls Queso Fresco Casero Cheese Because of Possible Health Risk September 17, 2011


• Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives September 16, 2011


• Strong America Ltd Issues Alert on Undeclared Sulfites in Huipu Chinese Wolfberry September 15, 2011


• FDA warns consumers not to eat Rocky Ford Cantaloupes shipped by Jensen Farms September 15, 2011


• Jensen Farms Recalls Cantaloupe Due to Possible Health Risk September 14, 2011


• Sanith Ourn Farm Issues Voluntary Recall of Fresh Hot Basil Due to Potential Salmonella Risk September 14, 2011


• Fine Mexican Food Products, Inc. Recalls 2.2 lb. Frozen Avocado Pulp & 3 lb. IQF Avocado Halves From Peru Because of Possible Health Risk September 13, 2011


• Falcon Trading Company, Inc./SunRidge Farms Issues Allergy Alert on Undeclared Peanuts in Milk Chocolate Cranberries September 13, 2011


• Chocolate Decadence Issues Allergy Alert on Undeclared Milk in Multiple Lines of Chocolate Products September 12, 2011


• Watkins Incorporated Issues Allergy Alert On Undeclared Milk In Soynilla September 12, 2011


• BUI Natural Tofu Issues Allergy Alert on Undeclared Soy and Wheat in Their Shrimp Salad Roll and Vegetarian Salad Roll September 10, 2011


• Best Food Cash & Carry Issues Allergy Alert On Undeclared Sulfite In Deer Brand "Raisin Golden" September 8, 2011


• Quaker Oats Issues Voluntary Recall Of Specific 8-Count Quaker Chewy Smashbar Graham Pretzel Snack Bars Due To Undeclared Milk Allergen September 3, 2011

• August 14, 2011 Securing the Pharmaceutical Supply Chain
  Deborah M. Autor, Esq., Deputy Commissioner for Global Regulatory Operations and Policy, before the Senate Committee on Health, Education, Labor and Pensions
• August 13, 2011 Agro-Defense: Responding to Threats Against America's Agriculture and Food System
  Ted Elkin, Director, Office of Food Defense, before the Senate Committee on Homeland Security and Governmental Affairs, Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia

• September 28, 2011
• September 21, 2011
• September 14, 2011
• September 07, 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 Consultants in Demand as Expert Authors

EAS consultants are in demand these days as authors. Four EAS consultants are writing chapters for an upcoming Food and Drug Law Institute publication on the Food Safety Modernization Act. EAS President Ed Steele and EAS Senior Consultant Robert Becker will contribute a chapter on hazard analysis and preventive controls, while EAS Senior Consultant Michael Olson will contribute a chapter on lab certification and Senior Consultant Joseph McCallion will contribute to a section on imports. The book, which has the working title “The Food Safety Modernization Act: Raising the Bar,” is scheduled for release early next year.

In addition, EAS Vice President Dean Cirotta is preparing a chapter on future Tobacco GMPs for a separate FDLI book on Tobacco Regulation, which is scheduled for release at the end of this year.

EAS Sponsors NDI Town Hall Meeting at SupplySide West

EAS is sponsoring a “town hall” meeting on New Dietary Ingredient Guidance at the SupplySide West show in Las Vegas, Nev., October 12-13, 2011. The session will be held Oct. 12 from 2:00 p.m. to 5:00 p.m. Virgo Publishing is hosting this innovative event.

The town hall format offers participants an opportunity for open discussion with industry leaders and representatives of FDA. Senior executives from the American Herbal Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance will also provide their perspective on NDIs.

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

EAS Vice President Betty Campbell will be available to answer any questions you have at an information table at the town hall session, but EAS will also have an exhibit booth at the main show. We invite you to meet with EAS Vice President Dean Cirotta and EAS Director of Regulatory Information and Submissions Chris Celeste at the EAS exhibit booth #21116 on the show floor.

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

EAS representatives Ed Steele, Chris Celeste and Parth Dave were pleased to discuss the regulatory concerns of participants at Natural Products EXPO East, in Baltimore, Md., September 21-24, 2011. With more than 20,000 participants and approximately 1,450 exhibits, EXPO East was warmly welcomed back to Baltimore after three years in Boston. The natural products industry remains as robust as ever. According to the organizers, more that 350 companies exhibited at the show for the first time. Next year’s event will also be held at the Baltimore Convention Center.

EAS also exhibited at the PDA/FDA Joint Regulatory Conference sponsored by the Parenteral Drug Association and the FDA in Washington, D.C., September 19-21, 2011, where EAS representatives Tony and Chris Celeste met with visitors to the EAS booth. This annual meeting and expo brings together agency officials for face to face discussion with industry exerts.

Anthony Celeste Reviews Inspection Trends at CHPA Workshop

EAS Senior Advisor Anthony Celeste will review FDA’s findings during inspections as well as the latest inspection trends at the Consumer Health Products Association’s Product Quality and Operations Workshop in Bethesda, Md., October 6-7, 2011.

The presentation will focus on FDA warning letters and 483s from FDA inspections of drug manufacturers, with special attention to OTC drugs.

Mr. Celeste is a leading food and drug regulatory authority. He joined EAS in January 2011 after a distinguished career in senior FDA management roles and, subsequently, as president and CEO of AAC Consulting Group until its acquisition in February 2001 by Kendle International. He served as Kendle's senior vice president of regulatory affairs from 2001 to January 2010.

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Upcoming Events

Mark Your Calendars to Attend Upcoming EAS Seminars

EAS will be holding several seminars in the coming months on food labeling, dietary supplement labeling and Good Manufacturing Practices for dietary supplements.

The Food Labeling Compliance Review Seminar will be held at the EAS training facility in Alexandria, Va., November 8-9, 2011. Seminar participants may also sign up for a separate Food Labeling Update, scheduled for November 10, 2011, which will offer insights into emerging issues. Instructors for this seminar will be EAS Vice President Elizabeth (Betty) Campbell, 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.

The Dietary Supplement Labeling Compliance Review Seminar will be held 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., and Gisela Leon.

Visit the EAS web site for more details.

The Dietary Supplement GMP Seminar will be held at the EAS Training Facility, in Alexandria, VA., January 17-18, 2012. The seminar details the requirements in the GMP final rule along with and gives practical guidance on how to apply these requirements. You will also be coached in how to prepare for an FDA inspection and how to avoid getting a 483 form. 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

CHPA, Product Quality and Operations Workshop
October 6-7, 2011
Bethesda, Maryland
(Tony Celeste – Presenting)

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 Workshop
November 10, 2011,
Alexandria, Virginia
(EAS Training)

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

Dietary Supplement GMP Seminar
January 17-18, 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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