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.

Foods · Dietary Supplements · Cosmetics · Veterinary · Medical Devices · Drugs · Tobacco · Cannabis

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December 2018

From the Desk of the Chairman

Cannabis – Federal Pathways to Regulation Explored

 

Dear Reader,

Ed Steele Chairman

Ed Steele, Chairman
and CEO

Welcome to the December 2018 edition of EAS-e-News, our free newsletter dedicated to companies regulated by FDA. I am sure you will agree it has been an interesting year thus far– particularly for food companies as FSMA compliance dates continue to arrive, food and dietary supplement labeling regulations continue to evolve, and the determination of what is and is not considered “fiber” raised questions. In addition, the tobacco industry is anxiously waiting on their own version of GMPs and the OTC industry is waiting on a Monograph reform. All of these and more are covered in our annual Year in Review, including, for those who attended the AdvaMed MedTech conference, a reintroduction to my granddaughter Ryan, who spoke on center stage.

Ryan Steele

Our Ask the Expert is answered by Jerry Dennis and concerns how FDA regulates lasers and radiation emitting devices. From lightbulbs to tanning beds to CT equipment, any radiation emitting device requires certification of compliance with pertinent regulations for their products. Jerry covers some of the basics here.

A special addition to this newsletter comes from one of our cannabis regulatory experts, Charlotte Peyton, who recently attended FDLI’s first annual cannabis conference. She provides her thoughts on the industry as the FDA and DEA grapple with how federal regulations might look in the future for this controversial industry.

Charles Breen’s FSMA Perspective discusses a recently released report on the sources of foodborne illnesses which highlights the urgency of FSMA compliance. Four “priority pathogens”, Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter together cause 1.9 million foodborne illnesses each year.

Upcoming EAS Seminars
Upcoming EAS Webinars
Upcoming Presentations and Conferences

Speaking of Charles, he presented a webinar for the National Customs Brokers and Forwarders Association (NCBFAA) recently on FSVP and how to protect your business where he showed an example of a worksheet on Supplier Evaluations. Requests for this worksheet have been much in demand. If you are interested in downloading, you may find it on the EAS website.

Registration for our spring seminars is underway. If you need Food Labeling and Dietary Supplement Labeling training, Gisela Leon and James Hoadley, Ph.D. will be instructing March 12-13 (food) and March 14-15, (dietary supplement) in Philadelphia. In addition, our Dietary Supplement GMP seminar will be April 2-3, 2019, also in Philadelphia and is instructed by attorney, Marc Ullman, Of Counsel with Rivkin Radler, Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D.; and Independent Advisor for Quality and Compliance, Robert Fish. We’d love to see you there!

Lastly, I’d like to welcome back consultant Greg Weilersbacher. Greg consulted with EAS some years back assisting our pharmaceutical clients with GMPs. We are pleased to that he has chosen to return!

Thank you for your interest in EAS. If we can be of assistance in your company’s regulatory endeavors, please don’t hesitate to reach out to me.

Sincerely,
Ed Steele Signature
Ed Steele
Chairman and CEO

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Issue of the Month

EAS’s 2018 Year in Review and Expectations for 2019 – Evolving FSMA, Anticipation for TPMPs

By Amy Scanlin, M.S.

As we reflect on 2018, we are again honored that so many look to EAS as their regulatory solution to a complicated world of FDA requirements. FDA’s continued focus on safety as well as the industry’s embrace of regulations that often challenge their old methods of doing business can only mean continued improvements and communications in the name of public health. In 2018, the Food Safety Modernization Act (FSMA) again dominated the news as numerous compliance dates arrived. ... [more]

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Who’s Who at EAS

Meet Issue of the Month Author Amy Scanlin, M.S.

Amy Scanlin

Amy Scanlin, M.S.

Amy Scanlin is a marketing coordinator and staff writer for EAS, providing technical support and coordination of EAS educational outreach seminars, webinars, and other communications. She has been with EAS since 2012 and prior had a career in the wellness industry, focusing on management and operations. She has a master’s degree in Health Promotion Management and has been a frequent contributor to industry publications on a variety of topics pertaining to regulations and research.

Meet New Consultant Greg Weilersbacher

Greg Weilersbacher

Greg Weilersbacher
(Pharmaceuticals)

With 25 years of industry experience, Greg Weilersbacher has successfully managed Quality Assurance, Quality Control, Analytical Development, Materials Management, GMP Manufacturing, GMP Facilities and Utilities Validation, and Facility Design and Construction Management in CMOs, biotechs and pharmaceutical companies. He has hosted FDA Pre-Approval Inspections and has led numerous European QP inspections of GMP facilities. Mr. Weilersbacher brings practical application of root causes analysis to Deviations and CAPAs and adds significant value to the execution of Supplier Qualifications, Regulatory Audit Preparation, Internal Audits, Training Systems and the evolution of a company’s Quality Systems.

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FSMA Perspective

New Report on the Sources of Foodborne Illnesses Highlights Urgency of FSMA Compliance

By Charles Breen, EAS Independent Advisor for FSMA Consulting Services

Charles Breen

Charles Breen

The Interagency Food Safety Analytics Collaboration (IFSAC) report, “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, highlights why FSMA is so important a tool in driving the food industry to do more to prevent foodborne outbreaks. Each year in the U.S., an estimated 9 million people get sick, 56,000 are ... [more]

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Drug and Device Corner

Recent FDA Drug / Medical Device Activity

Guidance Document updates on the FDA website:
All centers:

  • Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry

    On December 3, 2018, the U.S. Food and Drug Administration (FDA) published the guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The final guidance provides recommendations to industry on post-complete response letter (CRL) meetings between the FDA and abbreviated new drug application (ANDA) applicants to clarify deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

CDER:

CDER & CBER:

CDRH & CBER:

CBER:

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Ask the Expert

Laser Products and 510(k) Requirements

Each month EAS’ Ask the Expert answers questions sent in by readers on a variety of FDA regulatory topics. This month’s question on FDA’s regulation of lasers and 510(k) applications is answered by Jerry Dennis. Jerry is a former member of CDRH where he was responsible for radiation safety standards for laser products, (21 CFR 1040). He also developed regulatory policies and guided CDRH in report review criteria and regulatory policy pursuant to the Radiation Control Act and its regulation on radiation physics and biological effects. Prior to CDRH, he was a manager of high energy laser products for Hadron, Inc. If you would like to ask a question of our experts, click here.

Question: Is the FDA laser standard and product report in addition to the requirement for premarket notification (510k) or premarket approval?

Answer: Yes! And, FDA has additional regulatory requirements not only for laser products that are medical devices but also for other medical devices that generate radiation of any kind, ... [more]

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FDLI Cannabis Conference Covers Possible Pathways to Regulation

The first annual FLDI Cannabis Conference was held in Washington D.C. on November 2nd. What made this cannabis conference unique for me was not the content or the speakers but the audience attending. I have been part of the cannabis industry for the past four years, from the start of recreational sales in Colorado in 2014, and I have attended many cannabis conferences. They are normally attended by science researchers and cannabis industry people.

However, the FDLI Cannabis ... [more]

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What’s New on FDA’s Website

November Updates

FDA Logo

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

Latest FDA Updates →

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EAS in Action

Last Chance to Register for the EAS and FDA Presentation on New Dietary Fiber Regulations for IFT

IFT

We are just days away from the webinar that EAS is co-presenting with FDA for IFT. Declaring Dietary Fiber in Nutrition Information will be presented by Independent Consultant and labeling expert, James Hoadley, Ph.D., Douglas Balentine, Ph.D., Director at FDA’s CFSAN Office of Nutrition and Food Labeling, and Sarah Gebauer, Ph.D., Nutritionist at CFAN. The webinar will take place December 6, 2018, at 9:00 am EST. Registrations are accepted by the IFT. FDA and EAS will join forces to discuss the policy on labeling dietary fiber and unravel challenges facing the food industry as it considers the path forward.


Overcoming Seafood Fraud – a Free EAS Webinar Presented by Tim Hansen

Webinar

Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted to protect product identity and integrity. Join EAS Independent Consultant and former Director of the Seafood Inspection Program at NOAA, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.

Join Tim on December 18, 2018, at 1:00 pm Eastern for his discussion on Overcoming Seafood Fraud in a complimentary webinar hosted by EAS. Reserve your seat today!


EAS Schedules Five Part Webinar Series on OTC Monograph Regulations

Webinar

EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, will explore the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in a five-part complimentary webinar series.

Part 1 (January 16, 2019) will cover OTC Drug Monographs, Past, Present and Future and will discuss what a Monograph is, how it is used and how to interpret the different sections of the monograph.

Part 2 (February 27, 2019) will cover OTC Labeling requirements and Drug listings responsibilities.


Appendix T Storm is Hitting the Grade A Dairy Industry

Dairy Foods Magazine

Senior Director for Food Consulting Services, Allen Sayler, published an article in Dairy Foods Magazine on FDA’s PMO (Produce Milk Ordinance) new Appendix T, which mirrors FSMA in many ways in that it requires preventive controls for those hazards not already covered in the PMO. This new requirement may well be the dairy industry’s most significant new regulatory challenge for 2019. “One of the major challenges many firms face is the establishment of acceptable written food safety programs and maintenance of required records that demonstrate compliance with Appendix T. The failure of a Grade “A” dairy plant to meet any of these requirements will result in either loss of its Grade “A” designation or a request for the state to remove its Grade “A” designation.”

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Order Publications and Regulatory Tools

 

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Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

A 4″x6″ bound copy of 21 CFR Parts 11, 16, 117, is designed to fit in shirt pockets of management and plant personnel. Bulk discounts available.

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