EAS Consulting Group, LLC — EAS-e-NEWS — Current FDA Issues of Interest

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A free monthly newsletter published by EAS Consulting Group, LLC for the industries regulated by FDA.

Pharmaceuticals · Medical Devices · Biologics · Foods · Dietary Supplements · Cosmetics · Tobacco Products

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July 2018

From the Desk of the Chairman

FDA Releases Guidance Documents on Dietary Fiber Declarations

Dear Reader,

Ed Steele Chairman

Ed Steele, Chairman
and CEO

Welcome to EAS-e-News, a monthly newsletter produced by EAS Consulting Group and dedicated to FDA regulated industries.

We have sad news to share on the passing of Bill Ment who was a long-time friend and consultant to EAS. Please refer to the Who’s Who section of this issue for our tribute to Bill.

The Food Industry received a long-awaited answer to the question of how the agency will regulate dietary fiber when, on June 14, two guidance documents on how isolated or synthetic non-digestible carbohydrates relate to dietary fiber declarations were published. As you will read in this month’s Highlights of What’s New at FDA, written by Independent Advisor for Labeling and Claims, Betty Campbell and Independent Consultant and labeling expert, Gisela Leon, for almost two years industry has been in a state of uncertainty regarding at least 26 non-digestible carbohydrates under FDA’s review. Firms are encouraged to determine whether this new guidance affects the dietary fiber declarations of their products and revise labels as needed.

Our Issue of the Month article is written by Independent Consultant Charles Otto and discusses ten major updates in the 12th edition of FDA’s Food Code. This Code is the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world.

We welcome independent consultants Kristen Steel, Philip Scharago, and Beth Ann Crozier-Dodson, Ph.D. Kristen is a regulatory professional with a strong background in compliance and strategic partnerships within healthcare, CPG and foodservice environments. Philip is a pharmaceutical consultant with extensive knowledge of Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. Beth Ann is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Read more in our Who’s Who section.

We have added two new webinars as part of our summer webinar series – Preparing for Foreign FDA Inspections and Opportunities and Pitfalls of Temporary Marketing Permits. We invite you to reserve your seat today!

EAS is excited to be exhibiting and speaking at IFT this month – please stop by our booth S322 if you will be in attendance. In addition, EAS is also an invited speaker at the International Association of Food Protection conference. Read more about what’s happening at EAS in EAS-in-Action.

I hope you enjoy this issue of EAS-e-News. As always, please feel free to reach out to me with any questions and share this newsletter with your colleagues.

Ed Steele Signature
Ed Steele
Chairman and CEO

Upcoming EAS Seminars
  • Food Labeling Compliance Seminar
    Kansas City, MO
    September 24-25, 2018

  • Dietary Supplement Labeling Compliance Seminar
    Kanas City, MO
    September 26-27, 2018

  • FSPCA Preventive Controls for Human Food Course
    Alexandria, VA
    October 1-3, 2018, 2018

  • FSPCA Foreign Supplier Verification Programs (FSVP) Course
    Alexandria, VA
    October 3-4, 2018, 2018

Upcoming EAS Webinars
  • Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations
    Tara Lin Couch, Ph.D.
    August 6, 2018

  • Preparing for Foreign FDA Inspections
    Peter Saxon
    August 14, 2018

  • Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application
    April Kates
    August 21, 2018

Upcoming Presentations and Conferences

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Issue of the Month

FDA Food Code 12th Edition - What’s New?

By Charles S. Otto, III, Independent Consultant

The FDA Food Code is used as the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world. It is updated every two years through a collaborative process with the Conference for Food Protection where all stakeholders have a voice in what is included in the next edition published by FDA. Allen Sayler, Senior Director for Food Consulting Services, in his March column in the ... [more]

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Who’s Who at EAS

In Memoriam: Bill Ment

Bill Ment

Bill Ment

We have sad news to share on the passing of Bill Ment who was a long-time friend and consultant to EAS. Bill had a 34-year career at FDA, where in his last agency role he served as the Laboratory Director in Baltimore, MD, with responsibility for a full range of FDA field lab sample analyses and research studies for imported and domestic products. Following FDA retirement in 1999, he began consulting with AAC Consulting Group and Kendle Regulatory Affairs, from which EAS Consulting Group grew. Thanks to Bill’s expertise and outstanding reputation both at FDA and as a consultant, he was quickly asked to join the ranks of EAS Independent Advisors, overseeing GMP Auditing Services. Bill performed many pharmaceutical, laboratory and dietary supplement audits of API and finished product manufacturers, and helped companies improve their laboratory and QC/QA operations. He was also instrumental in the development of the EAS Dietary Supplement Good Manufacturing Practices seminar, which has become an EAS flagship training program. Most importantly, Bill was a great friend to many at EAS where he often mentored new consultants, helping them to make the transition from industry or FDA to the consulting world. He was an easy-going man of great integrity, with an unbelievable work ethic and he will be truly missed. Please keep Bill’s family in your prayers as they go through this difficult time. Should you wish to make a contribution in Bill’s memory, here is a list of charities with meaning to Bill and his family.

Meet Issue of the Month Author Charles Otto, III

Charles Otto III

Charles Otto, III

Charles Otto is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel programs, milk safety and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.

Meet New EAS Consultants

Philip Scharago

Philip Scharago

Philip Scharago

Philip Scharago is a pharmaceutical consultant with extensive knowledge of ISO 13485, 14971, QSR GMP 820, ICH, MDD/EU, ICH, CGMP, Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. He has more than twenty-five years working in the Medical Device and Pharmaceutical Industries in the areas of Quality Assurance and Regulatory Affairs and extensive experience developing and improving quality systems to meet FDA requirements and remediation of FDA-483 observations and Warning Letters.

Kristen Steel

Kristen Steel

Kristen Steel

Kristen Steel is a regulatory professional with strong background in healthcare marketing, compliance and strategic partnerships within healthcare, CPG, and foodservice environments. She works with project and database management, organizational management, FDA/USDA/DSHEA regulatory and labeling requirements, as well as an international framework as it relates to product labeling.

Beth Ann Crozier-Dodson PhD

Beth Ann Crozier-Dodson, Ph.D.

Beth Ann Crozier-Dodson, Ph.D.

Beth Ann Crozier-Dodson, Ph.D., is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Dr. Crozier-Dodson has spoken in, designed and taught customized microbiology/food safety workshops across the globe. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.

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FSMA Perspective

Produce Safety Rule’s July Compliance Dates

By Charles Breen, Independent Advisor for FSMA

Charles Breen

Charles Breen

Those closely watching FSMA compliance dates will note that July 26, 2018 marks a significant date for FSVP and the Produce Safety Rule. Specifically,

  • importers with Small Business Foreign Suppliers will now be required to comply with sprout requirements of Produce Safety Rule;
  • importers with Small Business Foreign Suppliers that are farms producing sprouts are eligible for a Qualified Exemption under the Produce Safety Rule; and importers with Large Foreign Suppliers ... [more]

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Drug and Device Corner

Recent FDA Drug / Medical Device Activity

Federal Register Notice Vol 83, No. 108

FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain ... [more]

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Ask the Expert

OTC Monograph System Gets an Update

Susan Crane

Susan Crane

This month’s Ask the Expert is answered by EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane. Susan specializes in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution of OTC drugs and dietary supplements.

Each month EAS chooses one question sent in by a reader of EAS-e-News. To submit your question, use the Contact Us link on our website.

Question: Why is FDA updating the OTC monograph system?

Crane: The current OTC monograph system has been in use since the 1970’s and has proven to be a lengthy and cumbersome rule-making process for finalizing, or making changes to the monographs. Several monographs have been in the “Tentative Final” stage ... [more]

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What’s New on FDA’s Website

June Updates

FDA logoListed below are links to new additions to the FDA website for the month of June, 2018. Use of this section of EAS-e-News is intended to provide an “easy” way to keep current with FDA news and information.

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Highlights of What’s New at FDA

Updated Guidance for Declaration of Dietary Fiber in Nutrition Labels

Elizabeth “Betty” Campbell, Independent Advisor for Labeling and Claims and Gisela Leon Independent Consultant and labeling expert

Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber: [1] non-digestible soluble and insoluble carbohydrates and lignin that are intrinsic and intact in plants; and [2] isolated or synthetic non-digestible carbohydrates determined by FDA to have acknowledged beneficial physiological effects. The FDA regulation listed 7 ingredients that had been found to have a beneficial physiological effect.

On June 14th, 2018, a little over 18 months before the compliance date for the new nutrition labeling, FDA issued two guidance documents regarding how isolated or synthetic non-digestible carbohydrates relate to the dietary fiber declaration. These guidance documents resolve nearly two years of uncertainty for at least 26 non-digestible carbohydrates under FDA review for their potential beneficial physiological effect.

FDA stated in one guidance document that the agency had found a beneficial physiological effect for 8 more ingredients and would use enforcement discretion to allow manufacturers to immediately reevaluate their fiber ingredients for inclusion in the dietary fiber declaration. The second document contained the scientific evaluation of data showing a beneficial physiological effect for those 8 ingredients.

The list of FDA-approved isolated or synthetic non-digestible carbohydrates with acknowledged beneficial physiological effects now include the following 15 substances:

  1. [beta]-glucan soluble fiber (as described in 101.81(c)(2)(ii)(A))
  2. psyllium husk (as described in 101.81(c)(2)(ii)(B))
  3. cellulose
  4. guar gum
  5. pectin
  6. locust bean gum
  7. hydroxypropyl-methylcellulose
  8. mixed plant cell wall fibers
  9. arabinoxylan
  10. alginate
  11. inulin and inulin-type fructans
  12. high amylose starch (resistant starch 2)
  13. galactooligosaccharide
  14. polydextrose
  15. resistant maltodextrin/dextrin.

The agency describes “Mixed plant cell wall fibers” as a large group of fibers that include cellulose, pectin, β-glucan, and/or arabinoxylan. FDA listed several examples of ingredients that include these fiber components, including apple fiber, citrus fiber, pea hull fiber and many others.

With the evaluation decisions in the new guidance, the list of 26 non-digestible carbohydrates under FDA evaluation as dietary fiber has now been shortened to 9. The ingredients where no determination has been reached include commonly used fibers such as gum acacia, carboxymethylcellulose, karaya gum, pullulan, xanthan gum and some other starches.

With the publication of these new documents, firms are encouraged to verify whether the updated guidance affects the dietary fiber declaration of their products. Nutrition information in recently created Nutrition Facts and Supplement Facts panels might need to be updated. EAS consultants are available to assist in evaluating ingredients in light of the new guidance and revising labels accordingly.

Food Safety Plan Builder Updates Released

FDA has released an updated version of the downloadable Food Safety Plan Builder tool designed to help owners and operators of food establishments with the development of a food safety plan that identified hazards requiring preventive controls to prevent foodborne illnesses specific to their facilities. All Food Safety Plans must contain those components that are needed to be in compliance with the 21 CFR part 117, or “CGMP & PC for Human Food rule” requirements in Subpart C – Hazard Analysis and Risk-Based Preventive Controls. A Food Safety Plan is a set of written documents that are based on food safety principles and incorporates hazard analysis and preventive controls, including supply-chain programs and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions, and verification. Those wishing to use the FSPB as their primary tool may wish to have a qualified third-party, such as EAS, review the plan for adequacy.

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EAS in Action

EAS Consultants to Present in Two Technical Sessions at the IFT 2018 Annual Meeting


EAS Independent Advisor Charles Breen is the panel moderator for two technical sessions at IFT – one on the Preventive Controls for Human Foods and another on the Foreign Supplier Verification Program. Esteemed panelists include for PCHF, Joann Givens, Director of the Office of Human and Animal Food Operations-West, Office of Regulatory Affairs at FDA, Robert Brackett, Director of Illinois Institute for Technology and Vice President of Institute for Food Safety and Health, Jeffrey Acker, Vice President of Food Safety and Compliance, Dairy Farmers of America and Susan Moyers, EAS Independent Consultant. Panelists for the FSVP include Susan Moyers, Robert Brackett and Erika Daniel with Almater, an Italian food technology and consulting firm with which EAS partners to assist European companies wishing to export food products to the U.S.

If you are attending IFT we invite you to stop by the EAS booth, S322 and attend these two sessions. PCHF - Successes and Challenges for FDA and the Food Industry will take place on Monday, July 16, 2018 at 10:30 am - 12:00 pm; and Food Importing: Green Light Strategies for Compliance with Game-Changing FSVP Requirements will take place Tuesday, July 17, 2018, at 10:30 am - 12:00 pm. Both will be held in room S502AB at the McCormick Place, the 2018 Annual Conference venue.

Please contact Allen Sayler at asayler@easconsultinggroup.com to set up an appointment to speak with EAS at the trade show.

EAS Presents Summer Webinar Series on Regulatory Topics Pertaining to Cannabis, Foreign FDA Inspections and Temporary Marketing Permits

Quality Systems for the Cannabis Industry – Preparing for State GMPs

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). Titled “Quality Systems for the Cannabis Industry, Preparing for State GMPs”, she will discuss how GMPs applications to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry. Join Tara on August 6, 2018, at 1:00 pm Eastern for this free webinar by clicking here.

Preparing for Foreign FDA Inspections

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks. Join us August 14, 2018, at 1:00 pm Eastern for a free webinar on Preparing for FDA Inspections where you will learn where most regulatory problems are found by the FDA, how OAI (Other Action Indicated) results are categorized by the FDA and what you can do to avoid these disappointing results.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit (TMP’s). With TMP’s companies with novel standardized food innovations may apply to market test a food product that deviates from the standard of identity for that particular food, providing FDA with data needed to consider a future petition to amend the standard. Join Independent Consultant April Kates, on August 21, 2018, at 1:00 pm for this informative webinar on Opportunities and Pitfalls of Temporary Marketing Permits where you’ll learn best practices for submitting a successful TMP application.

Rapid Testing Methods for the Dairy Industry to be Discussed at IAFP


Independent Consultant David Blomquist will discuss rapid testing methods for safety and spoilage in the dairy industry at the upcoming International Association of Food Protection’s annual meeting which will take place July 8-10, 2018 in Salt Lake City. IAFP provides an opportunity for professionals to discuss current and emerging food safety issues, the latest science and innovative solutions to new and recurring problems.

Probiotics Here to Stay Says DeMuri in Natural Products Insider

Natural Products Insider

EAS Independent Consultant Steve DeMuri authored an article in Natural Products Insider on Probiotic health benefits of natural foods and supplements. With many reported health benefits currently being studied, “Probiotics are here to stay and now is the time for companies to conduct new product development to incorporate probiotics into the “tinkering process” that is part of all food technology and product development efforts,” he says.

Couch Authors Tablets and Capsules Feature on the Importance of Quality Agreements

Tablets and Capsules magazine

Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. has published an article in Tablets and Capsules magazine on the importance of quality agreements for dietary supplement manufacturers. “The dietary supplement industry, like the pharmaceutical and food industries, relies heavily on contractors and subcontractors. However, no matter who does what along the supply chain, the product owner is ultimately responsible for GMP compliance,” she says.

Elizabeth Campbell and April Kates Discuss Clean Labels in Natural Products Insider

Natural Products Insider

EAS Independent Advisor Elizabeth “Betty” Campbell and Independent Consultant, April Kates have co-written an article on how to keep “clean label” claims legal for Natural Products Insider. “Marketing a clean label can be a great way to for brands to connect to consumers,” they say, “but they need to ensure their statements don’t run afoul of a legal claim.”

Schebella Offers Tips for Designing Cannabis Food Edibles in the State of California in Cannabis Industry Journal

Cannabis Industry Journal

Independent Consultant Celia Schebella discusses tips for designing a cannabis edible in the state of California that meets customer expectations and regulatory requirements in Cannabis Industry Journal. Designing a cannabis food product with GMPs, local regulations, ingredient sourcing and scalability in mind can help companies succeed, she says.

Dixon Helps Tobacco Firms Prepare for FDA Inspections in the Tobacco Reporter

Tobacco Reporter Cover

Karen Dixon discusses critical points for helping tobacco firms prepare for FDA Inspections in this month’s issue of the Tobacco Reporter, including FDA’s inspection authority and how companies should prepare internally, including a having a detailed inspection plan in place. It is important to note that FDA inspections are not always preannounced, so companies in all industries are encouraged to have written and detailed SOPs as well as ready access to critical information that would be pertinent and requested as part of FDA’s inspection.

Fairman Discusses the Potential Effects of Brexit on US-UK Food and Dietary Supplement Trade

Natural Products Insider

The U.K.’s departure from the EU sparks uncertainty in future trade agreements with the United States, which may not be finalized until after Brexit occurs, says Heather Fairman in a recent article for Natural Products Insider. “For U.S. supplement companies that currently are actively exporting/importing products to the U.K., a watchful eye should be kept on the Brexit transition.”

EAS Short Videos Describe Services to the Food Industry

YouTube Playlist

EAS offers a wealth of regulatory consulting capabilities in all FDA commodity areas, as well as USDA and some state regulatory services as they pertain to food and dietary supplement products. EAS is creating short clips that discuss our capabilities and is posting them on our website. We invite you to learn more about our Product Development and Labeling services, FSMA, food and dietary supplement labeling as well as food additive services through these videos. We’ll be adding additional so stay tuned.

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Order Publications and Regulatory Tools


Food Labeling Handbook: A Concise Guide for 21 CFR 101

This 115-page Food Label Handbook offers in-depth detail to assist companies in developing compliant food labels based on FDA’s final rule. Developed by EAS Independent Consultant, Gisela Leon, the guide discusses how changes to nutrient values are listed and how those changes impact claims. * Includes updated information on FDA dietary fiber declarations.

EAS has a wide array of products to aid in your company's regulatory compliance.

To view the products that EAS sells visit our products page.

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