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
 June 2010
In this Issue
Upcoming EAS Events
  • Natural Marketplace 2010 [more]
  • 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
A Portal to the Future

Ed Steele, President

Dear Reader,

Just last week, FDA and the National Institutes of Health unveiled a new, online Safety Reporting Portal that I predict will become one of the main points of contact between consumers and the federal food and drug regulatory agency. Although currently limited to reports relating to human and animal food, animals drugs and adverse event reports relating to human gene transfer trials (through NIH), the portal will eventually extend to human drugs and medical devices. I predict that the Safety Reporting Portal will have a significant impact on FDA's Adverse Event Reports program and on the way the industry and the agency interact.

Because of "technology limitations," reports already submitted through FDA's Reportable Food Registry will not be accessible to the new system, the agency says. So any amendments to a previously submitted safety report will require re-entering the original material. But despite the glitches, the portal is already an impressive initiative.

Here at EAS, we have just launched a new service of our own--EAS-e-Docs (pronounced "EZ Docs") —which will make available selected documents that we believe will help industry comply with FDA's laws and regulations. Our first free document is FDA's field instructions for its Dietary Supplement Compliance Program. The response to this new service has been outstanding (See below). This month's Issue of the Month article looks at some of the items detailed in that document.

Our Who's Who at EAS section this month features Richard Debo, a microbiologist and a leading HACCP expert who spent much of his FDA career at the agency's New Orleans and Atlanta District offices. In addition, I am very pleased to welcome the two newest additions to the EAS consulting team, Dr. Richard Schwen and Dr. Shrikant Dighe.

FDA staffers were among the trainees at the latest EAS Food Labeling Compliance Review Seminar, held May 26-27 in our Alexandria, VA training center. Participants said they found the seminar "invaluable," which is gratifying but not surprising. The seminar instructors included Gisela Leon, an EAS Consultant with vast international labeling experience, along with EAS Vice President Elizabeth Campbell and EAS Senior Consultant James Hoadley, two former FDA officials with the "institutional memory" that trainees tend to find most useful.

As always, I hope you find our EAS-e-News updates—and now our new EAS-e-Docs service—helpful in your work.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
What FDA Inspectors Will Target as they Inspect, Sample and Review Labels for Dietary Supplements

The Food and Drug Administration has just issued its Dietary Supplement Compliance Program to its field offices. This new directive offers valuable insights into what the agency will be looking for in cGMP inspections at both domestic and foreign dietary supplement firms, and into how inspectors will approach the selection and analysis of samples and label reviews.

"This is a very useful document," says EAS President Ed Steele. "Although written for FDA field inspectors, it is also an excellent reference for the industry. These are all issues we routinely emphasize in our dietary supplement GMP and labeling training programs."

Among other details, the directive lists 70 items on which inspectors should focus their attention. In initial interviews with firms, for example, FDA inspectors are instructed to ask about the types of products a firm handles and to select a minimum of two products to inspect, including at least one product containing a botanical ingredient. They are also to place attention on matters related to personnel, the physical plant, equipment, utensils, production and process controls, components, packaging and labeling, returned dietary supplements, and product complaints, among others.

The directive calls on inspectors to review labels of two or three products, focusing on:

  • products that fail to bear nutrition labeling,
  • products that fail to bear an appropriate statement of identity on the principal display panel, and
  • products that bear (a) a health claim or a nutrient content claim that has not been authorized by FDA; (b) a health claim that is not the subject of a letter granting enforcement discretion; (c) a nutrient content claim that is not based on an authoritative statement; (d) or any health claim that appears to be based on an authoritative statement under the Food and Drug Administration Modernization Act (FDAMA).

Other areas of emphasis for label reviews include products that bear authorized health claims or nutrient content claims that do not qualify for making the claims; products that bear nutrition ("Supplement Facts" panel) labeling with significant format deviations; products in solid dosage form with added iron or iron salts that fail to bear the required warning statement; products that use the term "ginseng" but are ineligible to do so; products that fail to disclose a required major food allergen; products that fail to bear other mandatory label information; failure to maintain adequate records by firms that manufacture dietary supplement containing cattle derived material; and products that appear to contain a source of ephedrine alkaloids.

Under nutrient analysis, the directive states that inspectors should select for analysis only nutrients that are declared as being present at or above 25 percent of the RDI or DRV, and should select a maximum of four nutrients per product, giving priority to Vitamin A/Beta Carotene, Selenium, Folic Acid, Pantothenic Acid, or Vitamin C. For any remaining analysis, they should select those nutrients declared at the highest percentages of the RDI or DRV at or above 25 percent.

The directive also includes instructions to the field force relating to adverse event reporting. It directs inspectors to review labels for up to five different dietary supplement products manufactured, packed, or distributed by the firm being inspected, to assure that the labels bear a domestic address or domestic phone number. The information should include either a complete address within the United States to include firm name, street address (or P.O. Box), city, state and zip code or complete telephone number, including the area code, through which the person responsible for submitting reports of serious adverse events to the agency can receive the reports. Labels lacking this information are misbranded, the agency says.

The directive includes specific instructions to the field force relating to ephedrine alkaloid analysis, and for products containing edible ruminant tissue or tissue-derived ingredients from BSE-affected or at-risk countries.

A free copy of the Dietary Supplement—Import and Domestic Compliance Program document (7321.008), is available through the new EAS-e-Docs service.

Who's Who at EAS
Meet EAS Senior Consultant Richard Debo

Richard Debo

Microbiologist and former FDA official Richard Debo has been a member of the EAS team as a senior consultant for several years. His 37-year federal career included roles as an investigator, a compliance officer, a trainer and a director of field operations.

A leading expert in HACCP, he was the agency's very first HACCP-trained investigator in the early 1970's and he participated in the drafting of the Seafood HACCP regulation that went into effect in December 1997. He served in the agency's Atlanta District Office and the New Orleans District agency where he became the director of field operations.

Mr. Debo served as the training and professional development monitor for the Atlanta District office. In this role, he provided training in microbiological analytical methodology and inspection of food processing plants. He developed a seafood inspection training course that was given to all the agency's investigators in the southeast region.

"Like many of our senior consultants, Richard has an insider's grasp of how the FDA approaches its oversight role," says EAS President Ed Steele. "We are very fortunate to have him on the EAS consulting team."

GAO Testifies on Herbal Dietary Supplements/Hatch Takes Issue

The Government Accountability Office has prepared a report on deceptive or "questionable" marketing practices for herbal dietary supplements. Gregory Kutz, GAO's managing director for forensic audits and special investigations, introduced the document in May 26 testimony before the Special Committee on Aging in the U.S. Senate.

According to Kutz, GAO investigators found that certain supplements commonly used by the elderly included claims that the products can treat, prevent, or cure conditions such as diabetes, cancer, or cardiovascular disease.

Posing as elderly customers, the GAO investigators were "often told by sales staff that a supplement would prevent or cure conditions such as high cholesterol or Alzheimer's disease," the report says. They were also given potentially harmful medical advice. One seller said it was not a problem to take ginkgo biloba with aspirin to improve memory, although FDA warns that combining aspirin and ginkgo biloba can increase a person's risk of bleeding.

Senator Orrin Hatch (R-Utah), longtime supporter of the dietary supplement industry responded in a press release dated May 27 saying that the government's conclusion is overly broad and misleading. "We don't need new and entirely unnecessary enforcement laws and bureaucracies, which would restrict the ability of over 150 million Americans to use dietary supplements. What we need is to ensure that the Food and Drug Administration is properly implementing and enforcing existing dietary supplement laws," Sen. Hatch said.

The full GAO report, titled Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice (GAO-10-662), and the Hatch press release titled, "Hatch Takes Issue with GAO's Report on Dietary Supplements," are available through our new EAS-e-Docs Service.

What's New on FDA's Website

Listed below are links to new additions to the FDA website for the month of May, 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
Introducing EAS-e-Docs

EAS-e-Docs

EAS Consulting Group has introduced a new service called EAS-e-Docs, which will make available selected documents that we believe will help industry in complying with FDA's laws and regulations. For example, we are now offering a free copy of FDA's field instructions for its Dietary Supplement Compliance Program.

The field instructions document details those issues FDA's field offices should address when they make GMP inspections of both domestic and foreign dietary supplement firms and what they should look for as import shipments are offered for entry into the United States.

"The response so far has been outstanding," says EAS President Ed Steele. "I think the regulated community will really appreciate getting easy access to such useful information. We will send you an e-mail that contains a link to the document you need at no cost."

The Dietary Supplement Compliance Program's objectives are to:

  • Conduct inspections of domestic and foreign dietary supplement firms, using appropriate Current Good Manufacturing Practice regulations
  • Collect and analyze domestic, domestic-import, and import samples of dietary supplements of vitamins, minerals, and proteins to compare label declarations to the nutritional composition of the product.
  • Collect information to determine the extent to which dietary supplements are being labeled in accordance with the nutrition labeling ("Supplement Facts" panel) and other labeling requirements.

Knowing what FDA inspectors will be concentrating on will be invaluable to you as you get ready for FDA inspection. Click here for a copy of the Dietary Supplement—Import and Domestic Compliance Program (7321.008). Other useful documents will be periodically added to the EAS website (www.easconsultinggroup.com). Check it often for updates.

Two New Consultants Add to EAS Scientific Credentials

EAS is pleased to announce the addition of two seasoned scientists to the EAS consulting team: Richard "Rick" Schwen, a toxicologist and regulatory affairs expert, and Shrikant Dighe, a former FDA research chemist and review scientist.

Rick Schwen

Dr. Schwen spent 23 years with Procter and Gamble's drug research organization where he gained hands-on experience with drug discovery, toxicology and regulatory affairs. Subsequently, he held senior regulatory affairs positions with Kendle International and Parexel International. More recently he has been serving as vice president of safety and regulatory affairs for Cincinnati-based Strategic Regulatory Consulting.

Dr. Dighe, a chemist, has more than 30 years of experience as a research scientist, review scientist and science manager, including 20 years with FDA. He joined the agency in 1973 as a review chemist and progressed to become chief of the biopharmaceutics review branch from 1980 to 1985. He went on to establish and direct the agency's division of bioequivalence from 1985 to 1994. Since leaving the agency in 1994, he has been a consultant to the pharmaceutical industry in pharmacokinetics, bioavailability, bioequivalence, analytical method validation, dissolution testing, and FDA regulation of pharmaceuticals.

"I am delighted to welcome Rick and Shrikant to our consulting team. Their extensive scientific and regulatory knowledge will be a significant asset for our pharma clients," says EAS President Ed Steele.

Dean Cirotta Supports Healthcare Outreach

Dean Cirotta with Crossroads Medical Mission

In addition to his demanding role as vice president of EAS Consulting Group, Dean Cirotta makes time to serve as chairman of a non-profit organization, Crossroads Medical Mission, which provides free healthcare and medication to the underprivileged and uninsured in southwest Virginia and northeast Tennessee. Once a year, the group's volunteers travel to Grundy, Va. to provide physicals for more than 200 underprivileged children. Dean joined nearly three dozen volunteers May 20 as they caravanned to the Mountain Mission School in Grundy with a mobile medical unit and "doctor's office on wheels."

"Before Crossroads Medical Mission, we had to load six students at a time into a van and take them to town for their physicals," says Mark Hood, principal of the Mountain Mission School. "This could take six hours per trip!"

The Crossroads Medical Mission works in partnership with outreach organizations such as homeless shelters, food pantries, community centers, and Christian churches of various denominations.

"It is very satisfying to be able to assist CMM through my work as Chair," Cirotta says.

EAS Sponsors Tobacco Merchants Association Annual Meeting

Tobacco Merchants Association

EAS President Ed Steele and Vice President of Pharmaceutical, Dietary Supplement and Tobacco Services Dean Cirotta attended the Tobacco Merchants Association's 95th annual meeting and conference in Williamsburg, VA, May 23-25. As sponsors of this annual event, EAS had the opportunity to meet tobacco industry executives and share thoughts on how FDA may regulate this industry now that tobacco has come under its responsibility.

Because of FDA's new regulatory authority under the Family Smoking Prevention and Tobacco Control Act, companies manufacturing or importing tobacco products are required to provide a listing to the agency of all ingredients in their tobacco products. The FSPTCA also gives FDA authority to set standards for nicotine yields and for the reduction or elimination of other harmful substances in tobacco products. In addition, the agency will review products to determine whether they meet certain standards before they can be marketed as "light," "mild" or "low." Premarket review is also required for tobacco products that were not commercially marketed as of February 15, 2007, or were modified after that date.

EAS can to offer assistance to the tobacco industry on FDA compliance and other regulatory matters. For details, contact EAS Vice President Dean Cirotta.

IFT Recognizes Two Lawmakers with Science Award

EAS President Ed Steele was among the participants at a reception held by the Institute of Food Technologists to present the 10th annual Congressional Support for Science Award, which went this year to Rep. Allen Boyd Jr. (D-Fla.), and Sen. Richard Burr (R-N.C.). The award presentation was held at the US Capitol Building in Washington, D.C., on May 25.

Among other initiatives, Rep. Boyd supported H.R.1398 to amend nutrition labeling of food offered for sale in foodservice establishments within the Federal Food, Drug, and Cosmetic Act. He serves on the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee of the House Appropriations Committee where he is influential in funding a safe food supply and a healthy agricultural economy.

Sen. Burr has been a leading co-sponsor of Sen. Richard Durbin's (D-Ill.) bill S.510 to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. He sponsored a bipartisan amendment to this bill to ensure FDA consultation, education, and outreach to farms, businesses, and farmers to help them understand and comply with produce safety requirements. Burr has supported S.456 to develop guidelines to manage the risk of food allergy and anaphylaxis in schools/early childhood education programs, and S.558 to amend nutrition labeling of food offered for sale in foodservice establishments within the Federal Food, Drug, and Cosmetic Act.

EAS Labeling Seminar Draws Industry and FDA Trainees

Participants at the EAS Food Labeling Compliance Review Seminar, held May 26-27 at our Alexandria, VA training facility, included both representatives of the regulated industry and new FDA staffers--a sign of the agency's confidence in the EAS program.

This in-depth, two-day seminar covered how foods should be labeled to comply with labeling rules, as well as the latest in food labeling issues that are receiving FDA's attention.

Instructors for the seminar included Elizabeth (Betty) Campbell, who served as head of FDA's Office of Food Labeling before leaving the agency to become a labeling consultant, and James Hoadley, a former senior regulatory scientist in the Office of Nutritional Products, Labeling and Dietary Supplements. Both participated in the development of the Nutrition Labeling and Education Act regulations. The third instructor was international labeling expert Gisela Leon, who has more than 21 years of international labeling experience in additional to her expertise in U.S. labeling issues.

Seminar participants received the EAS Food Labeling Compliance Review, 4th. Edition (hardback book and CD), a Participant's Manual, and an EAS Type Size Guide.

Upcoming Events
Learn How to Comply With Dietary Supplement Labeling Regulations

EAS will hold is next Dietary Supplement Labeling Seminar at the EAS training facility in Alexandria, VA., November 16-17, 2010, at which participants will learn how to prepare supplement labels that comply with FDA requirements.

Instructors for this seminar are EAS Senior Consultant James Hoadley, Ph.D., and EAS Consultant Gisela Leon. Dr. Hoadley is a former senior regulatory scientist in FDA's Office of Nutritional Products, Labeling and Dietary Supplements. Prior to joining EAS, he was involved in the scientific review and drafting of authorizing regulation, or denials, of nearly all health claim petitions received by FDA's Center for food Safety and Applied Nutrition over the previous decade. Ms. Leon, a former director of quality management for Schöller Lebensmittel GmbH in Germany, is knowledgeable about labeling laws throughout the world, in addition to being an expert in U.S. regulations.

The seminar is designed for individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of dietary supplements, including those responsible for preparing or reviewing labels. Participants get an opportunity to apply learning in practical work sessions to facilitate their understanding of the regulations. They also receive the popular hardback labeling reference, Dietary Supplement Labeling Compliance Review, authored by EAS Senior Consultant, James Summers with contributions by EAS Vice President, Elizabeth Campbell.

Visit the EAS web site for more details.

Upcoming Events

Natural Marketplace 2010
June 10-12, 2010
Las Vegas, Nev.
Booth 1130

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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