EAS Consulting Group, LLC — EAS-e-NEWS — Current FDA Issues of Interest
A free monthly electronic newsletter published by EAS Consulting Group, LLC for the industries regulated by FDA.
Pharmaceuticals · Medical Devices · Foods · Dietary Supplements · Cosmetics · Tobacco Products
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 July 2010
In this Issue
Upcoming EAS Events
  • Institute of Food Technologists Annual Meeting and Food Expo [more]
  • Dietary Supplement GMP Seminar [more]
  • Dietary Supplement Compliance Review Seminar [more]

From the Desk of the President
GMPs, the Oil Spill and Hot Weather

Ed Steele, President

Dear Reader,

Now that the June 25, 2010 phase-in deadline for small firms in implementing FDA’s final rule for dietary supplement GMPs has passed, many firms remain uncertain of what to expect from the agency as it goes ahead with inspections. EAS Vice President Dean Cirotta said, in a June 28 report in The Tan Sheet, that the agency’s Compliance Program Guidance Manual offers a window into what inspectors look for and what GMP deviations likely will draw a warning letter. The manual, titled Compliance Program: Dietary Supplements -Imports and Domestic (7321.008), is available through our new EAS-e-Docs service (see details below).

This month, we feature the oil spill in the Gulf of Mexico and include the observations of EAS Senior Consultant Robert Becker, a seafood and a HACCP expert, and an advisor for the National Sea Grant program. As a resident of Mobile, Ala., he has first-hand knowledge of the situation.

Our Who’s Who at EAS section this month features a key member of our international consulting team, Senior Consultant Freddy Vaede, Ph.D., who is based in Paris, France. We also welcome aboard a new Senior Consultant, Kim Rice, who joins EAS after a 30-year FDA career.

Although the hot days of summer tend to bring a slowdown in business activity, we have yet to experience this at EAS. Recent activities by our senior staff included participation at the Natural MarketPlace 2010 show in Las Vegas, at the Standardized Information on Dietary Supplement Ingredients (SIDI) Working Group meeting in Washington, D.C., and in a Food and Drug Law Institute webinar on new menu labeling requirements, among numerous other activities. Our upcoming activities include exhibiting at the Institute of Food Technologists’ annual meeting and food expo in Chicago. If you plan to attend the expo, I invite you to stop by and see us at exhibit booth 3530.

As always, I hope you find our window into the world of FDA helpful in your work. Please feel free to share our insights with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Food Safety and the Oil Spill

As summer storms threaten to push oil-contaminated water in unpredictable directions in the Gulf of Mexico, federal and state food safety authorities continue to refine how they will protect seafood consumers into the future. Extended closures of fishing areas remain the first line of defense. Besides the closures, the authorities have increased seafood testing and they have developed a protocol for re-opening the closed areas.

Representatives from FDA, EPA and the National Marine Fisheries Service met in New Orleans last month with state health officers and state fisheries directors from Alabama, Florida, Louisiana, Mississippi and Texas to coordinate implementation of a joint protocol for sampling and reopening that will apply to state and federal waters.

State authorities in Louisiana are applying the protocol to consider reopening two areas and NOAA is applying the protocol to consider reopening two closed areas off the coasts of Louisiana and Florida. In addition, NOAA and FDA are monitoring fish caught just outside of closed areas, and testing them for petroleum compounds, to ensure that the closed areas are sufficiently large so as to prevent the harvest of contaminated fish. So far, fish flesh tested from outside the closure areas have tested well below any level of concern for oil-based contamination.

“Our goal, collectively, is to make sure that fish that have become contaminated or might become contaminated are kept off the market so they don’t get to the consumer,” says Don Kraemer, who recently became acting deputy director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Kraemer is leading FDA’s inspection program for seafood from the Gulf. The agency has set up a webpage for Gulf Oil Spill updates.

EAS Senior Consultant Bob Becker, a resident of Mobile, AL, has first-hand experience of the oil spill’s impact on Gulf coast residents and businesses. As an advisor with the National Sea Grant program, he has sat in on recent town meetings at which fishermen sought advice about what they should do when their fishing areas are closed.

“They are out of business because they can’t take out their boats. There is no quick fix for this,” Becker says.

In a June 14 letter to the fish and fishery products industry, CFSAN’s Acting Director, Michael Landa, urged them to reassess their HACCP plans to take account of the hazard of polycyclic aromatic hydrocarbons (PAHs) in crude oil. PAHs bio-accumulate in fish and shellfish at levels that can cause illness.

Landa did not mention the risk of the dispersants being used in unprecedented amounts in the Gulf. FDA says the dispersants do not accumulate in seafood and that there is no public health concern from them due to seafood consumption. But expert panels convened to assess the impact of the dispersants could only conclude that they were less harmful than the oil and that their long-term impacts were unknown.

Source Control

The Gulf seafood industry is adopting new safety measures or enhancing existing measures. Source control is a key measure and is already a regulatory requirement for molluscan shellfish processors. They must specify in their HACCP plans that they process shellfish harvested from growing waters approved for harvest by a shellfish control authority or from waters that have not been closed to harvesting by an agency of the Federal government. They may only accept shellstock tagged with the date and place of harvest (by State and site), the type and quantity of shellfish harvested, and an identification of the harvester or the harvester’s vessel. Bulk shellstock shipments may be accompanied by a shipping document that lists the same information.

Although source control is not a regulatory requirement for other fish and fishery product processors, FDA includes source control among its suggested strategies for dealing with environmental contaminants. Processors should set a critical limit in their HACCP plan of "No fish may be harvested from an area that is closed to commercial fishing by foreign, federal, state, or local authorities,” the agency says.

NOAA is sampling fish products at the dockside, to verify that the catch came from outside the closed area, using information from vessel monitoring systems that track the location of a vessel or information from on-board observers. If tainted fish are found in the dockside sampling, NOAA officials notify FDA and state health officials.

FDA, meanwhile, is focusing on the first step in the distribution chain and is targeting oysters, crab, and shrimp for additional sampling.

Who's Who at EAS
Meet EAS Senior Consultant Freddy Vaede

Freddy Vaede

Based in Paris, France, Freddy Vaede, Ph.D. specializes in supporting manufacturers of active pharmaceutical ingredients and dosage forms and assisting GMP manufacturing sites in Europe and Asia in their preparation for FDA and European inspections, and in managing the inspections. Dr. Vaede joined EAS in June 2008 as a senior consultant.

An expert in good manufacturing practices and an analytical chemist with 35 years of experience with multinational pharmaceutical companies, Dr. Vaede is fluent in English and French. He is a former head of quality at ICI-Pharma (now Astra-Zeneca), and at Rhône-Poulenc (now Sanofi-Aventis).

Dr. Vaede took part in the preparation of corporate quality and GMP guidelines/standards for Rhône-Poulenc Rorer, Aventis, and Sanofi-Aventis. He was in charge of many of the audits performed in manufacturing sites worldwide. In addition, he was responsible for managing quality risks for APIs from biological sources.

A frequent traveler, Dr. Vaede has conducted audits, assessments and training on GMP and quality matters at locations in Italy, France, Ireland, Finland, Spain, Germany, Switzerland, China, Japan, India, Russia and Israel.

“Dr. Vaede is a key member of our international consulting team, especially for GMP and quality matters for audits, assessments, and support for APIs and dosage form issues,” says EAS President Ed Steele.

What's New on FDA's Website
June Updates

Listed below are links to new additions to the FDA website for the month of June, 2010. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

FDA Press Announcements
Recalls and Safety Alerts
Congressional Testimony
Enforcement Reports
What's New by Topic

EAS in Action
EAS Showed Off Its Stuff at Natural MarketPlace 2010

EAS President Ed Steele and Vice President Dean Cirotta staffed the EAS Consulting Group exhibit booth at Natural MarketPlace 2010 at the Las Vegas Convention Center in Las Vegas, Nev., June 10-12.

The event, the 73rd official trade show of the Natural Products Association, drew 5,000 participants.

“This was a very worthwhile meeting for EAS,” says Steele. “The natural products industry has great energy and it continues to grow despite the weakened economy.”

According to an estimate from Natural Foods Merchandiser, natural products grew 3.4% in the past year to $33.85 billion. Natural MarketPlace 2010 was co-located with the World Tea Expo and the first-ever NutriCosmetic Summit.

Natural MarketPlace 2011 will be held in the same venue.

Steele and Cirotta Attend SIDI Working Group Meeting

EAS President Ed Steele and Vice President Dean Cirotta attended a meeting of the Joint Standardized Information on Dietary Supplement Ingredients (SIDI) Working Group in Washington, D.C., June 22.

“We are very pleased to contribute to the SIDI Working Group, which is helping to make the supply chain safer,” says Steele.

The group recently released a new Certificate of Analysis (CoA) Guideline to assist finished product manufacturers with the complex process of qualifying their ingredient suppliers. The voluntary CoA Guideline outlines the type and scope of information that should appear on a CoA provided by an ingredient supplier to its finished product manufacturer for a component or ingredient used in a dietary supplement. By standardizing the information on CoAs, the voluntary guideline helps both ingredient suppliers and dietary supplement manufacturers.

The SIDI Working Group is a cooperative effort of dietary supplement industry trade associations including the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA). The voluntary CoA guideline, along with sample CoA templates for botanical and non-botanical ingredients, is available on the five trade associations’ websites, along with the original SIDI protocol materials.

Visit the EAS Booth at IFT Expo in Chicago

IFT annual meeting and expo

If you are planning to attend the Institute of Food Technologists’ annual meeting and expo at the McCormick Place Convention Center in Chicago, Ill., July 17-20, we invite you to visit with our EAS Consulting Group representatives at booth 3530. Leave your business card and you may be the lucky winner of an iPod Nano.

Campbell to Serve on Editorial Advisory Board of Nutritional Outlook

Nutritional Outlook Cover

EAS Vice President Elizabeth (Betty) Campbell has joined the advisory board of Nutritional Outlook magazine, whose readers include manufacturers of dietary supplements and natural foods as well as contract manufacturers.

Before joining EAS in October 2006, Ms. Campbell spent 35 years at the FDA in various capacities, including Acting Director in the Office of Food Labeling at the Center for Food Safety and Applied Nutrition. She played a leading role in writing the regulations implementing the Nutrition Labeling and Education Act (NLEA) in the 1990s.

“I look forward to contributing to Nutritional Outlook in this advisory role,” says Campbell.

EAS Participates in Webinar on New Menu Labeling Requirements

EAS Vice President Elizabeth Campbell was one of two featured speakers in a June 29 Food and Drug Law Institute webinar titled Mandatory Federal Calorie Disclosure for Foods and Beverages in Restaurants, Vending Machines, and Other Places: What You Need to Know.

The new requirements were imposed by Congress when it passed the healthcare reform legislation that President Obama signed into law on March 23. The law modifies the Federal Food, Drug, and Cosmetic Act to require that, for each standard menu item offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name, the menu or menu board must provide a clear and conspicuous disclosure of the number of calories in the item, plus a statement concerning suggested daily caloric intake to enable consumers to understand the significance of the calorie disclosure. Similar requirements apply to items sold from vending machines. FDA must develop regulations to implement the requirements imposed by the law.

The other speaker was prominent food attorney John Bode, Principal of Olsson Frank Weeda Terman Bode Matz PC. The webinar was moderated by John Packman, senior counsel for food law for The Coca-Cola Company.

New EAS Senior Consultant Kim Rice

Kim A. Rice

Kim A. Rice has joined EAS after 30-years of investigative experience with the Food and Drug Administration involving pharmaceuticals, medical devices, foods and biologics.

After an early career as an inspector and then a supervisory investigator, Mr. Kim joined the agency’s headquarters in Rockville, Md, in 1993 as operations supervisor in the Office of Criminal Investigations. In 1996, he became Assistant Special Agent in Charge of special prosecution staff in Beltsville, Md. And in 2002, he became Special Agent in Charge of the Washington Field Office, where he had responsibility for investigations including product tampering, counterfeit pharmaceuticals, prescription drug diversion, distribution of unapproved products, Internet crimes, health fraud and product application fraud.

He worked closely with both product review and compliance staff in the various FDA centers to obtain expertise and support for investigations.

“Kim Rice brings a wealth of agency experience that will be very helpful for our clients,” says EAS President Ed Steele. “I am very pleased to welcome him to our senior consulting team.

EAS-e-Docs
New Additions to EAS-e-Docs

EAS-e-Docs

Our newly launched EAS-e-Docs service appears to be an instant hit, with hundreds of downloads in recent weeks. This free service makes available selected documents that we believe will help industry to comply with FDA’s laws and regulations. Among the latest additions to EAS-e-Docs are:

Cosmetics

Compliance Program Guidance Manual 7329.001 – Cosmetics Program; Import and Domestic. The objective of this compliance program is to help ensure that import and domestic cosmetics meet regulatory requirements through inspection, sample collection and analysis. The CPG provides detailed instructions for FDA officers on items that should address when inspecting both import and domestic cosmetic products.

Drugs

Guidance for Industry: CMC Postapproval Manufacturing Changes Reportable in Annual Reports. FDA is issuing this guidance to provide recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes that may be reported in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) post-approval manufacturing changes that FDA has determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report.

Foods

Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety; Draft Guidance. FDA issued this draft guidance to assist industry in transmitting regulatory submissions to the Office of Food Additive Safety (OFAS) in CFSAN at FDA.

Dietary Supplements

Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This document provides guidance to the dietary supplement industry for complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The guidance covers the following topics:

  • What "domestic address" means for purposes of the dietary supplement labeling requirements in section 403(y) of the Federal Food, Drug, and Cosmetic Act (FD&C Act);
  • FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 403(y);
  • When FDA intends to begin enforcing the labeling requirements of section 403(y).

Medical Devices

Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions. FDA is issuing this guidance to assist manufacturers in developing and conducting studies for IVD devices, particularly those exempt from most of the Investigational Device Exemption (IDE) regulations. The guidance explains data considerations that ultimately will affect the quality of the premarket submission.

Tobacco

Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. This draft guidance provides written guidance to industry and FDA staff on certain provisions of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

A free copy of these and other valuable documents will be sent to you by email upon request from the EAS-e-Docs page of the EAS website. Click here for a full list of available documents.

Upcoming Events

Institute of Food Technologists Annual Meeting and Food Expo
July 17-20, 2010
Chicago, Ill.
Booth 3530

Dietary Supplement GMP Seminar
September 14-15, 2010
EAS Headquarters
Alexandria, VA.
(Contact EAS for details).

Dietary Supplement Compliance Review Seminar
November 16-17, 2010
EAS Headquarters
Alexandria, VA.
(Contact EAS for details).

Order Publications and Regulatory Tools

EAS Labeling Type Size Guide 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
Code of Federal Regulations, A pocket Guide

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
Dietary Supplement Labeling Compliance Review, 3rd edition 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 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
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