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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August 2018

From the Desk of the Chairman

Dietary Supplement GMP Compliance Includes Application to the Cannabis Industry

Dear Reader,

Ed Steele Chairman

Ed Steele, Chairman
and CEO

First, for those whom we had a chance to meet at the recent Institute for Food Technologists Annual Meeting held in Chicago, I am sure you will agree with me that this year’s event was one of the best. With so many changes at FDA with the implementation of FSMA, many timely topics on Food Defense and more, I am sure everyone in attendance returned to their firms with good ideas worth implementing. The two sessions that EAS moderated, PCHF - Successes and Challenges for FDA and the Food Industry and Food Importing: Green Light Strategies for Compliance with Game-Changing FSVP Requirements were both well attended with lively discussions. We’d like to thank the panelists who joined us – JoAnn Givens from FDA , Jeff Acker from DFA who participated in the PCHF session, Bob Brackett from IIT and EAS Independent Consultant, Susan Moyers, who participated in both PCHF and FSVP sessions and Erika Daniel from our Italian partner Almater who participated in our FSVP session.

I am pleased that EAS is presenting the next Dietary Supplement Good Manufacturing Practices seminar in cooperation with the American Herbal Products Association (AHPA). It will include an updated content section on how GMPs have application to the cannabis industry. The early bird rate runs through August 5, 2018, and this rate is extended to members of AHPA for the duration of the registration period. We hope you’ll join us in Dallas, TX on September 26-27, 2018 for this informative and updated seminar!

We welcome new consultant Beth Ann Crozier-Dodson, Ph.D., and re-welcome Tamika Cathey and Cindy Beehner, two consultants who have been a part of the EAS family previously and who are increasingly available to EAS clients. Dr. Dodson is an international consultant for food safety issues and an invited speaker and trainer on the topics of rapid methods for testing and bacterial identification and food safety. Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements and Cindy Beehner specializes in GMP requirements for food, dietary ingredient, dietary supplements and pharmaceuticals. Cindy is also the author of this month’s Issue of the Month on how to appropriately respond to FDA 483s.

We hope that you enjoy this edition of EAS-e-News! As always feel free to reach out if you have any questions and thank you for your interest in EAS.

Sincerely,
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

  • Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar
    Dallas, TX
    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

  • Are Industry-Initiated Environmental Swab-a-Thons a Benefit?
    Kathy Knutson, Ph.D.
    September 17, 2018

Upcoming Presentations and Conferences

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Issue of the Month

FDA 483 Responses – Missing the Mark?

By Cindy Beehner, Independent Consultant

In recent months, it appears more companies are having difficulties meeting the requirements of FDA Form 483, List of Observations, response. The inspection situation is very stressful and if it ends with the dreaded “483”, it can be positively overwhelming. However, when the initial reaction is over, it’s time to rally the staff and prepare the corrective and preventative action strategy that will be presented in the response within the allotted time frame. It is also ... [more]

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Who’s Who at EAS

Meet Issue of the Month Author and New Independent Consultant, Cindy Beehner

Cindy Beehner

Cindy Beehner
(Dietary Supplements)

Cindy Beehner has worked as a consultant since 1997, specializing in GMP requirements for food, dietary ingredients, dietary supplements and pharmaceuticals. Ms. Beehner performs due diligence assessments as well as procedures and documentation required for certifications for groups such as Therapeutic Goods Administration (TGA), World Health Organization (WHO), United States Pharmacopeia (USP) and National Food Producers Association (NFPA). She has a Bachelor of Science, Chemistry and Clinical Psychology from Moravian College, Bethlehem, PA.

Meet New EAS Consultants

Tamika Cathey

Tamika Cathey
(Dietary Supplements, Foods, Pharmaceuticals)

Tamika Cathey

Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness, executes mock GMP/FDA audits, performs risk assessments and gap analyses per FDA regulations and creates improvement programs based on findings. Cathey consulted with EAS from 2012-2016 and we are very pleased that she is again able to offer her expertise to our clients.

Beth Ann Crozier-Dodson

Beth Ann Crozier-Dodson, Ph.D.
(Foods)

Beth Ann Crozier-Dodson, Ph.D.

Dr. Dodson is an international consultant for food safety issues and an invited speaker and trainer on the topics of rapid methods for testing and bacterial identification and food safety. 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 teaching and training in microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.

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Standards of Identity

Are Plant-Based Proteins Milking Dairy?

By Allen Sayler, Senior Director for Food Consulting Services

When FDA announced recently that the agency is seeking public comment for standards of identity overhaul that will focus in part on plant-based products that are marketed as “milk” substitutes, manufacturers of those products as well as the consumers who enjoy them were left wondering how this review and any future changes would affect them. Consumers of soy, almond, rice, coconut and other plant-based “milk” enjoy these dairy alternative products for any number of reasons, ... [more]

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Drug and Device Corner

Recent FDA Drug / Medical Device Activity

EAS would like to bring to your attention the Draft Guidance released by the FDA for ANDA Submissions - Amendments to Abbreviated New Drug Applications Under GDUFA. This guidance describes the significant difference between GDUFA I and GDUFA II Amendments and the timelines associated with their review. The FDA considers all submissions to an ANDA to be an amendment, they will be classified based on the content and issued a goal date consistent with that classification. Please ... [more]

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What’s New on FDA’s Website

July Updates

FDA logoListed below are links to new additions to the FDA website for the month of July, 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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EAS in Action

Dietary Supplement GMP Seminar to Take Place in Dallas, TX

EAS Consulting Group will offer its two-day intensive Dietary Supplement GMP seminar September 26-27, 2018 in Dallas. Instructed by EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D., EAS Independent Advisor for Quality and Compliance, Robert Fish and back by popular demand, Marc Ullman, Of Counsel at Rivkin Radler, LLP, this next GMP course will include a new section on how quality and compliance applies to the emerging cannabis industry. Early-bird registration rates are in effect through August 5, 2018. In addition, we are pleased to offer members of the American Herbal Products Association (AHPA) an extended early-bird rate of $1,000.00. For more information or to reserve your seat, click here.


EAS Offers Official FSPCA Preventive Controls for Human Foods and FSVP Seminars

EAS Independent Consultant and FSPCA recognized lead instructor, Jenifer Kane, will co-instruct two FSPCA courses with Independent Consultant and trainer Susan Moyers, Ph.D. on the intricacies of Preventive Controls for Human Food as well as the Foreign Supplier Verification Program. Both courses will take place in early October in Alexandria, VA.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food Regulation) is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the U.S. and requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”. This course meets FDA’s requirement. Join EAS October 1-3, 2018 in Alexandria for this 2.5 intensive training. Earlybird discounts are available through August 14, 2018.

Next, the Foreign Supplier Verification Program (FSVP) requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FSMA and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. EAS’ two-day intensive FSVP Compliance Seminar will explain in detail FSVP rules, risk exposure by importers as well as US-based food processors using foreign sources of foods, food ingredients and food additives. Join us October 3-4, 2018 for this 1.5-day training. Earlybird rates are in effect through August 14, 2018.


New Webinar on Environmental Monitoring Added to EAS’ Summer Compliance Line-Up

Are Industry-Initiated Environmental Swab-a-Thons a Benefit?
September 17, 2018, 1:00pm Eastern

The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in the industry is that of pathogen contamination. It is generally understood that contamination in the processing environment will eventually make its way into the product. Even with the best of safety controls, it is imperative that companies have a robust environmental monitoring program that includes vigilant and regular testing. After all, finished product testing gives limited data and is a small snapshot of the entire lot manufactured. FDA can take hundreds of swabs during inspections, does your environmental monitoring meet that level of testing?

EAS Independent Consultant, Kathy Knutson, Ph.D. will host a complimentary webinar on the importance of Environmental Monitoring. Don’t wait for FDA, conduct your own swab-a-thon! Join us September 17, 2018, at 1:00 pm Eastern to learn important ways your company can stay ahead of the curve. Register by clicking here.


EAS Offers Complimentary Webinars on Cannabis, Foreign FDA Inspections, Temporary Marketing Permits and More

Quality Systems for the Cannabis Industry – Preparing for State GMPs
August 6, 2018, 1:00pm Eastern

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). 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. Reserve your seat by clicking here.

Preparing for Foreign FDA Inspections
August 14, 2018, 1:00pm Eastern

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. His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks. Join us for this webinar by clicking here.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application
August 21, 2018, 1:00pm Eastern

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). Learn more when EAS Independent Consultant, April Kates, discusses this unique marketing option in a webinar on the opportunities and Pitfalls of Temporary Marketing Permits and learn best practices for a successful TMP application. Reserve your seat by clicking here.


Crane Returns as a Presenter at CHPA’s OTC Academy

OTC Drugs

Susan Crane, Independent Advisor for OTC Drugs and Labeling will be presenting a session at the upcoming Consumer Healthcare Products Association OTC Academy on OTC drug labeling requirements, to include Drug Facts format and content, translating an OTC monograph into a compliant label, as well as covering other regulations that impact OTC drugs, such as child-resistant packaging requirements and Made in USA claims. This year’s OTC Academy will take place in Wilmington, DE October 9-10, 2018.


Yablunosky and Knutson to Speak at Upcoming Food Safety Consortium

Food Safety Consortium

EAS Independent Consultants, Andrea Yablunosky and Kathy Knutson are invited speakers at the upcoming Food Safety Consortium. Yablunosky will speak on food recalls, discussing the USDA/FSIS recall committee, as well as roles district offices play in a recall. She’ll then move on to the steps in a recall and important to-dos such as the drafting of a recall press release. Yablunosky is a former Director of Government Affairs at ConAgra Foods where she advised the company business units on implications of FDA and USDA policy objectives. With a background in food science and nutrition she is well-versed in policy development, product reformulations and promotions, recall preparedness and effective recall management.

Kathy Knutson, Ph.D. will speak on Lessons Learned in Food Safety and Applied to Cannabis-infused Edibles. She will discuss GMPs as the foundation of food safety and how HACCP builds on GMPs. Dr. Knutson is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry and she educates on issues surrounding cannabis-infused food products for sale in states with medical and recreational use legislation.

Food Safety Consortium will take place November 13-15, 2018 in Schaumburg, IL.


EAS Consultants Invited Speakers at Two FDLI Conferences

FDLI

EAS is pleased to be invited speakers at two upcoming Food Drug Law Institute (FDLI) Events. Andrea Yablunosky will speak at an in-house event held at FDA CFSAN on Food Labeling: Nutrient Content, Health, and Other Claims on August 7th. Bruce Silverglade will speak on the same subject as part of the Intro to Food Law conference which will be held in Washington, D.C. September 24-25, 2018. For more information on the Intro to Food Law event, click here.


EAS Co-Authors Article for FDLI Update on the Benefits of Consultants as Part of a Legal Team

FDLI

EAS joined forces with Ronald J. Levine, co-chair on Herrick, Feinstein LLP’s Litigation Department to author an article published in the Food Drug Law Institute Update Magazine on how the use of consultants can benefit a legal team. Consultants provide unique insights, given their detailed expertise in a particular subject matter, offering context and in-depth understanding of FDA regulations and intent of guidance documents. Consultants are frequently engaged, particularly during the discovery and trial stages for the planning and execution of a legal strategy. While the benefits they provide cannot be underestimated, the same due diligence for choosing the right consultant for the particular project must also not be taken lightly. Read more here.

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Order Publications and Regulatory Tools

 

VQIP – An Expedited FDA Food Import Release Program

EAS Independent Advisor for Import Operations and Former Director of Import Operations at the Food and Drug Administration, Domenic Veneziano presents an on-demand webinar offering a detailed overview on the requirements of VQIP, how to determine if your firm might qualify and benefit as well as insights into how to properly complete and file VQIP applications with FDA. Cost is $99.00.

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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