Issue of the Month
Park Doctrine Prosecutions: Crime and Punishment, FDA Style

By EAS Senior Consultant, Jeffrey B. Springer

The Food and Drug Administration has many tools at its disposal to enforce compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. These sanctions can be used to punish businesses and individuals for illegal behavior and conduct involving the marketing of consumer and medical products regulated by the agency. These sanctions are imposed by the federal courts (judicial) and by the agency itself (administrative).

Judicial sanctions include confiscating contraband (seizure); orders to stop or prevent prohibited conduct (injunction); monetary fines (civil and criminal); consumer refunds (restitution); and imprisonment (criminal).

Administrative sanctions include notices of violations (Warning Letters); import restrictions (detention); revoking marketing approvals (revocation proceedings); prohibiting participation in FDA-regulated activities (debarment and disqualification); monetary fines (civil money penalties); and market removals (recalls).

According to recent communications and reports, it appears that one sanction that has been infrequently utilized by FDA for many years may be making a comeback. That sanction is known as Park doctrine prosecutions because it is named after a Supreme Court decision in 1975. In that case, the Court upheld the conviction of the president of a large national retail food store chain who had been charged by FDA and the Department of Justice with causing food to become adulterated by insanitary conditions.

A Park doctrine prosecution is described in the FDA Regulatory Procedures Manual, a reference manual for agency employees, as follows:

• The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act . . . without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.

• Misdemeanor prosecution under the Act can be a valuable enforcement tool . . . Once a person has been convicted of a misdemeanor under the Act, any subsequent violation of the Act is a felony, even without proof that the defendant acted with the intent to defraud or mislead. Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities.

Park doctrine prosecutions can be brought involving any of the products regulated by FDA: foods, dietary supplements, drugs, medical devices, cosmetics, and tobacco products. These prosecutions are indeed a powerful weapon for FDA because a business official can be held criminally accountable - even if the official was not aware of the violation - if the official was in a position of authority and responsibility to prevent or correct the violation and did not do so. A person who is convicted under the Park doctrine can be imprisoned for not more than one year, fined not more than $100,000 per count ($250,000 if death occurs), or both.

Corporate leadership must recognize that a more aggressive FDA enforcement program could have devastating personal consequences as well as jeopardize their business. The violation of any of the more than three dozen prohibited acts enumerated in the statute (e.g., sanitation conditions; manufacturing practices; labeling; unsafe or new ingredients; unapproved products; registration; adverse events) may result in strict criminal liability. As stated by the Chief Justice of the United States:

The requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntarily assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them.

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What FDA’s Draft Guidance on NDIs Tells Us

By EAS Senior Consultant, James E. Hoadley, Ph.D.

One month ago, FDA published a Federal Register notice on a Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications and Related Issues. This draft guidance came about because of a provision in the 2011 Food Safety Modernization Act in which Congress instructed FDA to issue, within 180 days after the enactment of the Act, guidance to clarify the agency’s policies regarding new dietary ingredients (NDIs). The fact that FDA issued this 50+ page draft guidance on time suggests the importance with which the agency views compliance with Section 413 of the Food Drug & Cosmetic Act.

So what comes next? FDA is obligated to follow its Good Guidance Practices (GGP) (OMB Bulletin for Agency Good Guidance Practices, and 21 CFR 10.115). At this step, FDA has only announced that the draft guidance is available for public comment; the draft guidance has not been implemented. FDA proposed a 90 day period for public comment. After reviewing comments received, the agency must prepare a robust response-to-comments document and make it publicly available. The OMB GGP Bulletin notes that the agency should (emphasis added) incorporate changes suggested in comments, when appropriate, into the final version of the guidance document. FDA may decide after reviewing comments that it is appropriate to issue another draft of the guidance document rather than a final guidance. FDA is not likely to make any changes in NDI notification compliance enforcement until after the final guidance is issued.

Although there are marked differences of opinion between the dietary supplement industry and the FDA on the policies discussed in the draft guidance, all parties should recognize the need for clear guidance from FDA on how the statutory requirement for NDI safety determinations and notifications are to be enforced. A lack of clear guidelines for NDI safety notifications, FDA’s stringent review of the notifications and the agency’s low “no objection” rate, and lax enforcement of the premarket NDI notification requirement, has resulted in a situation where a substantial portion of NDIs are marketed without submission of a NDI safety notification. Responsible firms who commit the resources to conduct thorough safety evaluations and submit a NDI safety evaluation are put at a disadvantage by a system that allows others to ignore the rules. The current system has allowed too many dietary ingredients that have been introduced in the U.S. since DSHEA to avoid submitting NDI safety notification and thus avoid any oversight that these dietary ingredients will indeed be reasonably be expected to be safe.

FDA has a good track record with a successful, voluntary GRAS premarket notification program for conventional food ingredients that works well for both the industry and the agency. It is possible for FDA to also create a fair premarket notification program for dietary supplement NDIs. The Good Guidance Practices are there to ensure transparency and public input in development of significant guidance documents. Your comments on the draft guidance are an important factor in FDA developing fair and effective NDI safety notification policies. Comments on the draft guidance may be submitted electronically to http://www.regulations.gov, or in writing to the Division of Dockets Management (HFA_305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md 20852, by October 3, 2011. Comments should reference Docket No. FDA-2011-D-0379.

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FDA’s Four New Directorates

By EAS Consulting Group Editor Declan Conroy

Commissioner Margaret Hamburg has created four directorates to oversee Food and Drug Administration centers and operations, with a deputy associate commissioner at the helm of each directorate now reporting directly to the Commissioner (See the new organizational chart).

The directorates tie together programs that share regulatory and scientific foundations, Hamburg told agency staff. Of the four directorates, one has existed for two years: The Office of Foods headed by Michael Taylor. The others are:

• Medical Products and Tobacco, headed by Dr. Steven Spielberg, former Dean of Dartmouth Medical School and Director of the Center for Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital in Kansas City.
• Global Regulatory Operations and Policy, headed by attorney Deborah Autor, director of the Center for Drug Evaluation and Research, and
• Operations, headed by a yet-to-be-named Chief Operating Officer.

The restructuring essentially replicates what was already done for foods, so the other centers now have someone to report to in the Commissioner’s office. Some observers believe the change places an unnecessary layer between career staff in the centers and the Commissioner, ending their traditional direct contact. Others question how the role of the Deputy Associate Commissioner for Global Regulatory Operations will mesh with Taylor’s increased focus on import activities.

Taylor has provided a role model in leadership and in representing the Office of Foods before lawmakers. To a large extent, the success of the new management arrangement will depend on those individuals who hold the key directorate positions.

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FSMA Perspective
Tight FSMA Schedule Keeps FDA on Task

By EAS Consulting Group Editor Declan Conroy

The Food and Drug Administration logged significant progress in its implementation of the Food Safety Modernization Act as it passed the six-month milestone on July 3. It now faces a new set of FSMA deadlines. More than a dozen additional tasks must be accomplished by Jan 4, 2012—one year from enactment of the new law.

For example, the agency must issue regulations to introduce the Foreign Supplier Verification Program, as well as guidance for importers. Also by Jan 4, the agency must designate the high-risk foods that will require additional record keeping. It has until Jan. 4, 2013 to develop a proposed rule on high-risk foods.

The agency has some even tighter deadlines to meet: By Oct. 1, for example, it is tasked with establishing at least two pilot projects with the food industry to evaluate ways to quickly identify recipients of contaminated food—at least one pilot each for processed foods and fresh produce.

By Oct. 1, the agency must submit a report to the Congress on the basis for selecting foreign countries in which the agency establishes offices. The report must describe the progress in helping the governments of those countries to provide safe foods, as well as for other FDA-regulated products destined for export to the U.S.

By Oct. 4, the agency must issue a proposed rule for the safety of food packed or held by a farm when it is not grown, raised or consumed on the farm or another farm under the same ownership.

Also by Jan. 4, the agency must issue guidance on the protection against intentional adulteration of foods.

Through the Centers for Disease Controls and Prevention, the agency must designate five Centers of Excellence to serve as resources for public health professionals in responding to food borne illness outbreaks.

In collaboration with USDA and the Department of Homeland Security, the agency is tasked with developing a National Agriculture and Food Defense Strategy, to be posted on the internet.

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Many Food Regulation Changes in India

By EAS Consultant, Parth Dave

India’s regulatory requirements for foods are evolving rapidly as the country tries to accomplish in a few years what took decades in the United States. The rapid changes reflect a growing interest in processed foods among India’s burgeoning middle class; McKinsey and Company says India will overtake China next year as the world’s fastest-growing economy.

As part of a major initiative to revamp food regulations, Indian lawmakers established the Food Safety and Standards Authority of India (FSSAI) in 2006. The FSSAI is broadly what would result from combining FDA’s Center for Food Safety and Applied Nutrition and USDA’s Food Safety and Inspection Service. It has regulatory authority for “primary” foods, processed foods, meat, poultry, and milk and fruit products.

In the latest development, new legislation introducing the Food Safety and Standards Rules, 2011, went into effect on August 1. The new law replaced the Prevention of Food Adulteration Act which was enacted fifty years ago. The aim is to develop an integrated food law with uniform standards across the country, to be implemented by states, municipalities and panchayats (local village councils).

So, as is the case in the U.S. with the Food Safety Modernization Act, the new law emphasizes that the manufacturer is responsible for food safety. Also, the regulatory focus will be on prevention and food inspectors will now be called food safety officers. The new rules will require a risk-based approach to imported food.

For many years, India has been an active participant in international standards development organizations such as the Codex Alimentarius Commission. But it has a long way to go to reach the standards of more developed countries. With a population of 1.2 billion—and a rapidly increasing middle class now estimated at 50 million—it has only 2,000 food inspectors for the entire country. It is very short of laboratories for testing, with about 75 public labs and 100 private labs. And only a few of the private labs are up to international standards.

Although the general shape of regulatory policy is becoming more like that of the United States and the European Union, with an emphasis on prevention and science-based decision-making, there are still many cultural differences. For example, India has a large vegetarian population, with particular labeling requirements for vegetarian and non-vegetarian products.

EAS will be monitoring the regulatory changes as the FSSAI implements the new Food Safety and Standards Rules and we will be available to assist clients with any questions. In addition, for those shipping packaged foods to India, EAS is now equipped to review labels for compliance with their labeling requirements.

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Who's Who at EAS

Meet EAS Senior Consultant Jeffrey B. Springer

After 33 years as an attorney in FDA’s Office of the Chief Counsel—including 20 years as Deputy Chief Counsel--Jeff Springer joined EAS as a senior consultant in 2006. He provides a wide range of regulatory consulting services, especially for product compliance and general strategy.

He joined the agency as a trial attorney in 1968 after he received his law degree from the Georgetown University Law Center. He represented the agency in civil and criminal enforcement cases as well as in defensive and appellate litigation in court. He went on to become Special Assistant to the Chief Counsel.

In 1975 he became the Deputy for Regulations and Hearings. In this role, his responsibilities included managing the legal review and clearance of agency regulations, the program review services, and administrative hearings. He became the Deputy Chief Counsel in 1979, a position he held for 20 years. In that position, he provided legal service and advice to high-ranking FDA officials, and represented the FDA for activities involving other federal agencies.

His final role at the FDA was as a Senior Advisor to the Chief Counsel. He was responsible for the redesign and reorganization of the agency’s law office and also managed the attorney recruitment and selection program.

“We are very fortunate to have someone with Jeff’s broad legal experience and his thorough understanding of how things are done inside the FDA,” says EAS President Ed Steele.

EAS Welcomes Joseph McCallion as Senior Consultant

Former FDA staffer Joseph McCallion is the latest addition to the EAS consulting team. He has more than 30 years’ experience in the agency, beginning as an analyst/chemist in the Brooklyn, N.Y. laboratory in 1977. Subsequently, he moved to the Import Operation Branch (later the Division of Import Operations – DIOP) where he was part of the team that developed FDA’s automated import processing system.

He retired from the agency in 2007, but returned in 2008 to serve as a consultant to FDA management regarding import operations and procedures.

In 1994, he became FDA’s Liaison Officer to US Customs – a role he held throughout his agency career. In 1998 he was promoted to Deputy Division Director of DIOP. In this role, he initiated, drafted, and reviewed Import Alerts and Bulletins, set criteria for imposition of Detention Without Physical Analysis, and reviewed petitions for removal of firms from DWPE. He reviewed the Import Chapter (9) of FDA’s Regulatory Procedures Manual, and drafted procedures on Import-for-Export, Warehouse Entries, Foreign Trade Zones, Personal Importation and other topics.

After the events of September 11, 2001 he was appointed the Special Assistant for Bioterrorism Issues and served as the ORA representative to the joint FDA/Customs task force charged with drafting and implementing regulations pursuant to the Bioterrorism Act of 2002. This work resulting in the establishment of FDA’s Prior Notice Center in December 2004 – FDA’s first (and only) 24/7 operational center, to screen imported products for potential terrorist activity.

Mr. McCallion received numerous FDA and U.S. Customs Awards, including the FDA Award of Merit, FDA Commendable Service Award, and the Commissioner of Customs’ Exceptional Service Award. He holds a B.A. in chemistry from the Catholic University of America in Washington, DC.

“I am delighted to welcome Joe to EAS,” says EAS President Ed Steele. “His vast knowledge of import issues will be particularly helpful to many of our clients. It is particularly good to have joe available as the FSMA takes hold and importing food products become more difficult. ”

EAS Welcomes Intern Wasim Kabir

It has become an EAS summer tradition to offer valuable work experience to promising young interns. This summer we welcome Wasim Kabir, a rising senior at Duke University, whose academic background includes chemistry and neuroscience. Wasim has explored various health-related careers through the Pipeline Program at the University of Michigan and as a lab assistant at the Duke University Medical Center. He is interested in our consulting work and enjoys challenges that require analytical and critical thinking. A native of Alexandria, VA, from an Ethiopian family, he is vice president of the Duke Ethiopian Student Transnational Association and treasurer of Duke’s Adopt-a-Grandparent program (a community service by students who volunteer with the elderly at a public nursing home and rehabilitation center) for the upcoming school year. He is also a member of the Muslim Student Association.

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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 July, 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 to seek public comment on IOM recommendations July 29, 2011


• Unapproved emergency birth control medicine possibly in U.S. distribution may be ineffective and unsafe July 28, 2011


• FDA issues draft guidance on device changes that warrant new premarket review July 26, 2011


• Foodborne outbreak potentially associated with papaya distributed by Agromod Produce, Inc. July 25, 2011


• FDA Center for Drug Evaluation and Research develops strategic science and research agenda July 25, 2011


• FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes July 20, 2011


• FDA, federal partners develop tools for food-emergency readiness July 20, 2011


• FDA outlines oversight of mobile medical applications July 19, 2011


• FDA approves vaccines for the 2011-2012 influenza season July 18, 2011


• Foodborne outbreak associated with raw milk from Tucker Adkins Dairy of York S.C. July 16, 2011


• FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks July 13, 2011


• FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies July 12, 2011


• FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people July 08, 2011


• FDA proposes new policy for some diagnostic and radiology devices July 07, 2011


• FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements July 05, 2011


• FDA issues anti-smuggling strategy and draft guidance on new dietary ingredients July 05, 2011


• FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease July 01, 2011


• FDA, Justice Department take action against California calf hauler July 01, 2011

• Ridley Block Operations Announces Voluntary Recall in Oklahoma and Texas July 30, 2011


• Nestlé Purina Recalls Limited Number of Purina ONE Vibrant Maturity 7+ Dry Cat Food Bags Due to a Potential Health Risk July 30, 2011


• Precautionary Recall Issued For H-E-B Brand Dairy Products July 30, 2011


• GHSW, LLC Voluntarily Recalls Fresh Cut Fruit Products Containing Papaya Due To Potential Salmonella Risk Associated With The Agromod Produce, Inc Papaya Recall July 30, 2011


• Finemost Corporation DBA Qualiherb Issues Voluntary Recall of Specific Lots of the Dietary Supplements containing Ephedrine Alkaloids. July 28, 2011


• Shata Trading Inc Issues Alert On Undeclared Sulfites In Three Rivers Brand Golden Raisins July 28, 2011


• Flying Food Group Recalls Additional Sandwiches, Parfaits, Wraps, Plates, Salads Because of Possible Health Risk July 28, 2011


• GHSW, LLC Voluntarily Recalls Fresh Cut Fruit Products Containing Papaya Due To Potential Salmonella Risk Associated With The Agromod Produce, Inc Papaya Recall July 27, 2011


• Intercharm Inc. Issues A Nationwide Voluntary Recall Of Slim Forte Slimming Capsules Lot 20100604 And Lot 20100928, Slim Forte Slimming Coffee Lot 20100903, And Meizitang Botanical Slimming Softgel Exp. 12.23.2011 Weight Loss Capsules Found To Contain Sibutramine July 27, 2011


• Agromod Produce, Inc. Recalls Papaya Because Of Possible Health Risk July 23, 2011


• Euphoria Fancy Food Inc. Issues An Alert On Uneviscerated Fish July 21, 2011


• American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates July 20, 2011


• Arizona Canning Company Issues Allergy Alert On Undeclared Soy Protein In Sun VIsta Brand Red Enchilada Sauce July 19, 2011


• Global Focus Marketing & Distribution, Ltd. Recalls The Silencer S2200 Centrifuge July 19, 2011


• American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates July 19, 2011


• Willamette Valley Fruit Co. issues allergy alert on undeclared butter in 8” Apple, Cherry & Marionberry Pies July 15, 2011


• Expanded Recall: Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men Recall July 15, 2011


• Bruce Foods Corporation Recalls Food Club Red Enchilada Sauce Because Of Possible Health Risk July 14, 2011


• Posh Bakery Issues Allergy Alert on Undeclared Eggs in Butter Mini Croissants and Chocolate Mini-Croissants July 08, 2011


• Evergreen Fresh Sprouts, LLC Voluntarily Recalls Alfalfa Sprouts and Spicy Sprouts Because Of Possible Health Risk July 1, 2011

• July 28, 2011 FDA User Fees: Advancing Public Health
  Margaret A. Hamburg, M.D., before the Senate Committee on Health, Education, Labor, and Pensions
• July 20, 2011 Regulatory Reform Series #5 - FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs
  Jeff Shuren, M.D., J.D., before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations
• July 07, 2011 PDUFA V: Medical Innovation, Jobs, and Patients
  Janet Woodcock, M.D., before the House Committee on Energy and Commerce, Subcommittee on Health

• July 27, 2011
• July 20, 2011
• July 13, 2011
• July 06, 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 Senior Consultant Joe Baca Bikes Across Iowa

EAS Senior Consultant Joe Baca—former director of the Office of Compliance at FDA’s Center for Food Safety and Applied Nutrition—joined thousands of other avid cyclists July 24-30 for a week-long trek across Iowa.

The event, called RAGBRAI (the Des Moines Register’s Annual Great Bicycle Ride Across Iowa) has been held every year since 1973. The organizers claim it is the “longest, largest and oldest bicycle touring event in the world.”

Participants in RAGBRAI XXXIX came from all 50 states and from 13 other countries, including Albania, Australia, Canada, Denmark, Finland, France, Germany, Ireland, Japan, Malaysia, Peru, United Arab Emirates and the United Kingdom.

Norma Skolnik Reviews FDA Regulations at CRS Annual Meeting

EAS Senior Consultant Norma Skolnik reviews FDA’s regulation of OTC drugs, dietary supplements and cosmetics, in a presentation at the Controlled Release Society’s annual meeting and expo, National Harbor, Md, July 30–August 3. Participants will learn about requirements for U.S. marketing of products in these categories, including registration, GMPs, labeling, and product claims. The presentation focuses on what makes a product a drug vs. a dietary supplement or a cosmetic.

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Upcoming Events

CHPA Partners with EAS for GMP Seminar on OTC Drugs

The Consumer Health Products Association (CHPA), in partnership with EAS Consulting Group, LLC, is presenting a custom-designed, training seminar on Good Manufacturing Practices on August 10-11, 2011, at the CHPA training facility, located at 900 19th Street, NW, Suite 700, Washington, D.C. This seminar is limited to 40 participants and is offered on a first-come first-serve basis.

The one and one-half day, intensive program will discuss FDA’s current Good Manufacturing Practice requirements and recent inspection findings for human OTC drug products. The course will cover the FDA regulations Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century, Quality Risk-and Science-Based Approaches, Pharmaceutical Development and Pharmaceutical Quality Systems. Participants will gain an understanding of cGMP requirements and FDA’s enforcement of the regulations. FDA issues of concern will be highlighted throughout the seminar with emphasis placed on recent FDA regulatory and administrative actions. FDA investigator observations as well as problems in dealing with FDA inspections will be illustrated in case studies.

Instructors for this in-depth seminar are Dean Cirotta, EAS Vice President, Anthony Celeste, EAS Senior Advisor, and Charles “Chris” Celeste, EAS Director, Regulatory Information and Submissions.

The seminar is designed for individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of Over-the-Counter drug products. It is also popular among consultants, auditors, attorneys and others interested in learning about the requirements of the drug GMPs and how they should be applied.

For registration, please visit: http://www.easconsultinggroup.com/seminars/seminar-081011.php. For more details, contact EAS Consulting Group: Cathryn Sacra at 703-684-4438, or CHPA Contact: Mary McDonald at 202-429-3531, or mary.mcdonald@chpa-info.org

Upcoming Events

Controlled Release Society (CRS) Annual Meeting and Expo
July 30–August 3, 2011
National Harbor, Maryland
(Presentation given by EAS Senior Consultant Norma Skolnik)

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)

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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