A Successful Expert Witness is One Who can Demonstrate Expertise While Connecting with a Jury

An effective Expert Witness is more than one who can write expert opinions, be deposed or provide testimony in court. Experts must represent your company accurately, independently and objectively in matters of legal proceedings and do so in a manner that enables them to communicate to, connect with, and convince the decision maker, whether that decision will be made by a jury or mediator. Agencies, judges and juries, want to hear from well-respected and knowledgeable expert witnesses. Whether the issue is recalls, labeling claims, safety audits, or almost any other challenge to a facility or a product having a competent expert by your side can make all the difference.

EAS independent advisors and consultants are routinely called to serve as an expert witness in a variety of cases. Our team of over 70 former high-level FDA officials and industry executives who act in an expert witness capacity average over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. These experts have the knowledge, qualifications, and experience necessary to explain and clarify issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.

If EAS can be of assistance as you prepare for your next litigation or mediation challenge, please reach out to Dean Cirotta, President and COO directly. EAS will assure that the specific needs and requirements of your case will be matched with an expert whose knowledge and experience enhances your client’s legal standing.

Preparing For a FDA Preventive Controls Inspection

Joe Famiglietti

The new rule on Preventative Controls for Human Food is mandated by the 2011 FDA Food Safety Modernization Act. Preventive Controls (PC) are steps that a food facility must take to reduce or eliminate food safety hazards. The rule also includes updates to the Current Good Manufacturing Practice (CGMP) requirements such as mandatory training and procedures to control allergen cross-contact. In general, the new rule applies to you if you are required to register with FDA and if you manufacture, process, pack or hold foods. By now, all firms meeting the activities in the prior sentence have to be in compliance with the PC rule unless they are exempt or subject to modified requirements. 

Firms covered by the new rule must have and implement a written food safety plan (FSP) and are further required to conduct a hazard analysis in order to identify food safety hazards requiring controls including preventive controls. The new rule requires an appropriate control be developed and implemented that could include process, allergen, sanitation or other controls. When preventive controls are required, the FSP must also include written procedures for monitoring, corrective actions, verification (including validation as deemed necessary) and supporting records, as well as a written recall plan and a supply chain program. The FSP must be prepared or its preparation overseen by a preventive controls qualified individual (PCQI).           

If your company is using an existing HACCP program, changes are required in developing a FSP because control need not always be at a CCP (critical control point), but can be handled by a prerequisite program or a preventative control program. For example, allergen cross-contact can be controlled by a written sanitation preventative control program that requires proper cleaning methods be implemented rather than establishing critical limits at a CCP.

The preparation of a proper FSP is crucial, since this is one of the first documents FDA will likely request to see during a PC inspection. There is no standardized or required format for the FSP, but all of the elements as required in 21 CFR 117.126(b) must be in the written document. FDA has published guidance regarding the preparation of a FSP and hazard analysis. See https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UC517391.pdf.

You can expect FDA to arrive unannounced to conduct a PC inspection unless you are located outside of the US, in which case FDA will provide written notice prior to arriving. During the inspection you can expect FDA to carefully review your company’s written food safety programs and to review all required records, such as monitoring and verification records. If deemed necessary, FDA may collect extensive environmental monitoring microbiological samples throughout your facility to determine if pathogens are in the plant environment. If there are positive sample results for pathogens, FDA can require products to be recalled. FDA can also compare the DNA fingerprints of any pathogens found to isolates in the CDC’s database and then require recalls if any matches are identified. If FDA deems your facility as not being compliant, you can expect the agency to take regulatory actions against your firm if voluntary compliance is not taken

You can properly prepare for an FDA PC inspection by considering the following:

Have a written plan covering how your company will handle an FDA inspection that includes a working area for the FDA and that assigns responsibilities for your employees who will be involved in the inspection. You need to have a policy on how to handle any objectionable conditions FDA may bring to your attention and make an attempt to correct any of these conditions while FDA is on-site.

Be sure your FSP is in final form and is signed by your firm’s owner, operator or agent in charge and be sure there is at least one person who is familiar with the overall food safety program who can explain it to the FDA.

Have training records readily available including PCQI training / qualifications, employee sanitation training and records documenting the qualifications all employees including supervisors.

Be sure record keeping is in order and is easily accessible including monitoring and verification records. 

If operational or FSP deviations have occurred, be sure appropriate corrective actions have been taken supported by records that must be made available for FDA review.

Be sure your allergen control procedures are in order. All ingredient labels should be reviewed to assure they are accurate and contain all required allergen labeling. Be sure all CGMPs are being followed to prevent unintentional allergen cross-contact issues during ingredient receipt, storage, process, packaging and labeling operations.

Conduct your own environmental monitoring. FDA will likely swab for microbes if you are producing ready-to-eat (RTE) foods that are exposed to the environment prior to packaging. You need to be sure you are conducting an appropriate monitoring program before FDA arrives. If problem areas are identified, corrective actions need to be implemented.

If product testing is used to verify a control, be sure the test is scientifically valid and have corrective action procedures in the event of positive results.

You must conduct reanalysis of the FSP at least once every three years or whenever there is a significant change that effects food safety.

Be sure you have information and records regarding where raw materials are sourced and documentation that the materials are being purchased from approved vendors. It is no longer an option to purchase raw materials from just any source. The new rule requires there must be a supply chain program which includes documentation demonstrating that either suppliers provide safe raw materials, or that another party will apply controls for the hazard.

For food with a hazard requiring a PC, there is now a requirement to have a written recall procedure that includes descriptions of the steps to be taken as well as assigning responsibility for taking those steps.

Conduct or hire an experienced consultant to perform a mock FDA inspection that includes a thorough sanitation audit and review of your programs and records. Conducting a gap analysis audit of your operation will assist in identifying areas that require improvement before FDA finds them.

Be sure all labels being used have been reviewed and approved by a food label expert.In summary, FDA is in full enforcement mode related to the FSMA Preventive Controls regulation. The food manufacturing industry needs to have its food safety program updated to incorporate the Preventive Control provisions. Your PCQI and entire QA staff as well as plant supervisors should be prepared to answer FDA’s questions and demonstrate that you conduct your business in a preventive mode of operation. With proper planning you can have a positive experience from an FDA PC-based inspection and continue to provide consumers with safe foods.

Crossing T’s and Dotting I’s – Preparing for a FDA Preventive Controls Inspection

Dear Reader,

Welcome to the April 2019 edition of EASeNews, the free newsletter for industries regulated by FDA.

We are pleased to announce our latest short video describing the many services that EAS provides. This month our regulatory specialist, Victoria Pankovich, shares the various FDA requirements for company registrations and product listings. As you may know, the complexities of registrations differ by product category, and not all commodities are required to list their products. EAS helps you to sort though what is required and what information is needed to comply with FDA regulations in this regard. Should you wish to outsource this annual or biannual requirement, EAS is available to help.

If we missed you at our recent food and dietary supplement labeling compliance seminars in Philadelphia, it is not too late to purchase the companion handbook for the seminar. The Food Labeling Handbook and the Dietary Supplement Labeling Handbook were written by instructor Gisela Leon and share points on how to ensure label accuracy, from what and how information must be covered to more detailed specifics of FDA compliance. To purchase your copy please visit the EAS store.

If you haven’t registered for our one-day seminar Ensuring Regulatory Compliance of GMP Laboratories seminar which will be taught by Senior Director Tara Lin Couch, Ph.D. in Denver on April 23, there is still time. This This one-day intensive program will discuss FDA’s current GMP requirements for Research and Development and Quality Control Laboratories and will highlight FDA issues of concern with emphasis placed on recent FDA regulatory or administrative actions. All of this will allow participants to gain an understanding of the importance of laboratory GMPs and how to meet FDA’s requirements. Please join us in Denver!

Our issue of the month author is Joe Famiglietti who discusses preparing for a FDA Preventive Controls inspection. Our Ask the Expert is answered by Tim Hansen and discusses how seafood importers can protect themselves from unscrupulous suppliers. Lastly our new section, Did you Know? covers EAS expert witness considerations, an area in which EAS is proud to have deep roots with our over 70 independent consultants who can act in an expert witness capacity.

We welcome a number of new consultants this month: Heidi Stuttz, Jan Janson, William Scopa, Dennis Gaalswyk and Joel Martinez. In invite you to learn more about their backgrounds in Who’s Who.

Thank you as always for your interest in EAS and please feel free to forward this newsletter onto a colleague or link with us on LinkedIn.

Sincerely,

What Does the 2018 Farm Bill Mean for the Cannabis Industry?

Presented by: Marc Ullman, Of Counsel, Rivkin Radler LLP and Tara Lin Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services

The 2018 Farm Bill answered many questions for the cannabis industry, but its message has also been largely misunderstood. Misinterpretations as to the legality of including cannabis as an ingredient in foods, herbal products, and dietary supplements have erroneously lead firms to begin planning and production of illegal products, and, in the case of those which legally include (by state) CBD ingredients there is often little regard or understanding of how to manage the quality, including product specifications for the production of a consistent and safe product.

Join EAS Senior Tara Lin Couch, Ph.D. and special guest, Marc Ullman with Rivkin Radler for a dynamic and informative discussion on what the Farm Bill really means for the cannabis industry. What is FDA’s position on cannabis and how are the states managing the patchwork of federal regulations that make this burgeoning industry so confusing? Finally, in those cases where companies are legally producing cannabis products, what steps should be taken to implement and improve upon sound quality systems?

About the Presenters

Tara Lin Couch, Ph.D., Senior Director, Dietary Supplements and Tobacco Services

Tara Couch

Dr. Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25-years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap- analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory trainings via seminar, webinar, and on-site presentations.

Marc Ullman, Of Counsel, Rivkin Radler LLP

Marc Ullman

Attorney Marc Ullman represents clients in matters relating to all aspects of the firm’s practice, including Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.

Will Pathogens Cause FDA to Suspend Your Food Facility Registrations?

Dear Reader,

Welcome to the March 2019 issue of EASeNews, the free newsletter for industries regulated by FDA. It is hard to believe it is already March and with spring right around the corner, if you haven’t already signed up for your “spring training” I invite you to join EAS at one of our upcoming regulatory compliance seminars. Food and Dietary Supplement Labeling will be held in Philadelphia beginning March 12, 2019; the Dietary Supplement GMP two-day seminar will be held April 2-3, 2019 also in Philly; the Compliance with GMP Requirements for Dietary Supplement Laboratories seminar will take place April 23, 2019 in Denver and May 7 begins our four Dietary Supplement GMP One-day Refresher Series. The first Refresher takes place in Denton, TX, just outside of Dallas on May 7th, and the second takes place in Riverside, CA on May 14th. We invite you to join us!

In addition to seminars, we have a number of complimentary webinars this spring, with two new topics recently added. What Does the 2018 Farm Bill Mean for the Cannabis Industry? will take place on March 13, 2019, and Dietary Supplements and FSMA Compliance – Fallacy or Fact? will take place April 16, 2019. As you know, we take great pride in bringing you important regulatory information which can help you develop and improve practices to meet FDA requirements. To learn more about these two newest webinars or to see our entire line up of spring EAS webinars, please visit the webinars page of the EAS website. From OTCs, to Cosmetics, to Cannabis to Dietary Supplements, we have something for you.

I am very pleased to welcome a number of esteemed colleagues who are new EAS Independent Consultants. This month we welcome Janet Collins, Sophia Lily, Jay Mansour, Jeffrey Roberts, and George Yanulis. You may read more in the Who’s Who section of this issue. 

Our issue of the month is written by Kathy Knutson, Ph.D. and concerns a very real problem for the industry – that of the identification and storage of pathogen genomic information in database trackers which can years later reemerge as a problem for a facility, even when the pathogen is not isolated in a finished product. Dr. Knutson raises interesting questions and I encourage everyone to use this article as a starting point to renew your commitment to sanitary facilities and hypervigilance against contaminations.

Our Ask the Expert is answered by Ronald J. Levine, who is both an EAS Independent Consultant and General Counsel at the firm Herrick, Feinstein LLP and discusses the importance of finding an expert witness that will well represent your firm in litigation, mediation matters, the preparation of expert opinion papers and more. EAS has nearly 70 consultants who we recognize as experts who can act as an extension of legal teams. To learn more about our services, please view our industry services sheet which explains some of our capabilities in more detail. You may have also seen our recent press release discussing EAS capabilities acting in the capacity of an expert witness. If you missed it, I invite you to view it on our LinkedIn Page.

Lastly, I am very pleased to announce the release of our new short video discussing FSVP and Qualified Individual Requirementsplaced on the Food industry by FDA. We had a lot of fun putting this together and hope that you find it enjoyable as well as informative. Please, as always let me know if you have any questions on this service or any other that EAS provides.

Thank you,

Ed Steele, Chairman and CEO

Steve Armstrong to Present at Two Upcoming FDLI Events

Join EAS Independent Advisor for Food Law and Regulation, Steve Armstrong, at the upcoming FDLI Intro to Food Law and Regulation taking place in Washington, D.C., March 19-20, 2019. Steve will be part of an esteemed group of presenters and will discuss Food Safety and Unintended Components and Contaminants of Food. Click here to hear more. In addition, Steve will be speaking again at the FDLI Food Enforcement conference on March 21, 2019. He will be part of a panel discussion on FDA’s FSMA enforcement.

How Do Legal Teams Find and Identify Good Expert Witnesses?

Each month EAS answers one question sent in by a reader. This month’s question on how to choose an expert witness for FDA legal proceedings is answered by Independent Consultant, Ronald J. Levine. Ron has had a successful career history as a litigator at one of the top New York law firms and is available to EAS clients for assistance with compliance questions and risk assessments. We were interested in hearing Ron’s thoughts since EAS provides consultants who can become a part of a legal team, by writing expert opinions, participating in depositions or being called to the stand as an expert witness. You can view EAS’ Expert Witness Services Sheet to learn more. If you would like to ask a question of our independent consultants, please contact us.

How Do Legal Teams Find and Identify Good Expert Witnesses?

Thank you for an excellent question. As a litigator who has retained many expert witnesses during my 40- year career as a lawyer, I have found that finding the right expert for a case can make all the difference in the world.

In almost any investigation or litigation involving regulated products, an expert can help explain your position to the fact-finder and render opinions which an average person would not have the knowledge or experience to offer. The FDA expert’s ability to offer a deep understanding of complex regulations and production protocols, such as Good Manufacturing Practices (GMP); and assistance with developing strategy in responding to the FDA; can make the expert a valuable extension of the legal team.

Where are the Legal Teams Looking?

Once the legal team has identified the subject area and credentials of the expert required for the task, they will begin the search.

The team may well begin with publications, articles and websites in the practice area and will be most interested in the positions the expert has taken in the past on the topic at issue – to see whether the opinion aligns with the legal team’s stance.

Experts who have testified previously, with names appearing in published court opinions, may be found by attorneys who are researching the legal authority in the area. Also, legal teams may send out queries via bar groups and industry associations.

How can I find a “Good” Expert?

There are at least three qualities of a “good” expert witness.

First and foremost, experts should be able to articulate what makes them an expert. Expertise could be based upon academic and professional credentials​ and on the job experience. In some cases, experience as an academic provides extra credibility, particularly those who have published in peer-reviewed journals.

Secondly, a “good” expert is one who is able to articulate his or her opinions in a manner which lay people will understand and accept. The expert will not be addressing peers who talk the same language. They will be trying to convince a jury, who may have limited educational credentials​ and no experience in the field. Legal teams will also be looking for experts who are poised and make others feel comfortable. They are going to avoid those who arrogant or not willing to listen.

Finally, legal teams are looking for experts who are able to handle themselves under intense cross-examination. They need to be able to listen to questions. The expert must be on the alert for trick questions, and know how to answer questions posed by experienced trial lawyers. Legal teams want to work with a seasoned expert who are familiar with the courtroom.

February 2019 Drug and Device Corner

Sunscreen Innovation Act to Enhance Product Safety Requirements

On February 21, 2019 FDA issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States. Aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science, the provisions address sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

Per FDA, the agency is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act. OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. Over the last twenty years, new scientific evidence has helped to shape the FDA’s perspective on the conditions, including active ingredients and dosage forms, under which sunscreens could be considered GRASE. For more information, please visit: Sunscreen Proposed Rule

You may also be interested in EAS complimentary webinar series on OTCs which includes a discussion of monograph reform expectations, labeling, registrations and lists and more. For more information please visit the upcoming webinars page on the EAS website or view our many on-demand webinars on a variety of topics pertinent to the industry.

Federal court enters consent decree against compound manufacturer

The FDA is continuing to see concerning activity when it comes to some compounded drugs, including problems related to the conditions under which compounded sterile medicines are made. As a result, the FDA continues intense focus in this area. The FDA will take enforcement actions against compounders who fail to produce sterile drugs in compliance with FDA regulations.

A consent decree of permanent injunction was filed against a company and its owner. The consent decree prohibits the company and its owner from, among other things, manufacturing, holding, or distributing human or animal sterile drugs compounded at their facility until they comply with the Federal FD&C Act and FDA regulations.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA. Further information can be found on the FDA website.

Medical Device Classification Procedures

The FDA issued a final rule on the classification procedures for medical devices on 17th December, 2018 entitled “Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures”. The rule will be effective from March 18th, 2019.

The purpose of this final rule is to incorporate the amendments by Food and Drug Administration Safety and Innovation Act (FDASIA) to the FD&C Act which governs the classification and reclassification of medical devices. Also, additional changes have been made by the FDA independent of the FDASIA in efforts to update its regulations governing classification and reclassification of medical devices. The rule will enhance consistency and uniformity across reclassification processes and will also help to reduce regulatory and economic burden.

Summary of the major provisions of the final rule include the provisions for reclassification of devices and for requiring PMA applications for preamendments class III devices to change from a rulemaking proceeding to an administrative order process. Prior to publication of a final order reclassifying a device or requiring a PMA application for a preamendments class III device, FDA must publish a proposed order in the Federal Register, consider any comments submitted on the proposed order, and hold a device classification panel meeting. This final rule also clarifies the process where reclassification of a postamendments device or a transitional device is initiated by FDA, rather than in response to a petition. The final rule also removes the requirement for a hearing under part 16 (21 CFR part 16) for reclassifying transitional devices.

More information can be found at regulations.gov

Guidance Document updates on the FDA website

Guidance Document highlight

In order to improve communications regarding corrective actions in response to inspectional observations with medical device companies, the FDA issued a draft guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The document was issued on February 19th, 2019.

Earlier, companies could ask for a feedback on proposed corrective actions but there was no standardized process in place for provision of nonbinding feedback. The draft guidance proposes to standardize the process of communicating and submitting nonbinding feedback for companies on certain kinds of documented inspectional observations that are issued on a Form 483, during either premarket or postmarket inspections of device establishments. It also describes how the FDA evaluates and responds to such requests.

The proposed guidance has outlined steps on the process of requesting a nonbinding feedback.

These include timely submission of request, eligibility criteria, justification of request, proposed responsive actions and how the FDA will respond with a nonbinding feedback. More detailed description can be found here.

CDER

Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry Draft guidance document for sponsors who are developing drugs and therapeutic biologics for Eosinophilic Esophagitis (EoE) stating FDA’s current recommendations regarding clinical trials for EoE drugs.

Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment Guidance on FDA’s current thinking about drug product development and designing of trials relevant to study of depot buprenorphine products for Opioid Use Disorder treatment through 505(b)2 pathway for a new drug application (NDA) submission

Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry Draft guidance document intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under section 505(c) and 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(c) and (j)), respectively with identifying required contents for marketing status notification and format to submit these notifications required under section 506I of the FD&C Act (21 U.S.C. 356i)

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Product This guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities.

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. CDER is issuing this draft guidance to obtain public comments on the proposed program.

Competitive Generic Therapies This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. This guidance also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs. This guidance also provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products The purpose of this guidance is to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended to help cigarette smokers stop smoking. This guidance reflects the FDA’s current recommendations regarding overall development programs to support NRT drug products for smoking cessation and related chronic indications.

CDER & CBER

Safety and Performance Based Pathway – Guidance for Industry and Food and Drug Administration This guidance provides FDA’s current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equivalence for premarket notification (510(k)) submissions

The Least Burdensome Provisions: Concept and Principles – Guidance for Industry and FDA Staff

Rare Diseases: Common Issues in Drug Development Guidance for Industry Rev. 1 Draft guidance is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in conducting more efficient and successful drug development programs.

Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) The PMA regulation (21 CFR 814.42(e)) identifies the criteria that, if not met, may serve as a basis for refusing to file a PMA. This guidance is intended to be used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process.

CDRH & CBER

Evaluation of Devices Used with Regenerative Medicine Advanced Therapies This guidance provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with FDA’s current thinking regarding evaluation of devices used in the recovery, isolation, or delivery of regenerative medicine advanced therapies.

Refuse to Accept Policy for 510(k)s The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

CDRH & CDER

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Guidance for Industry and Food and Drug Administration Staff This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST).

CDRH

Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements † This guidance describes the Food and Drug Administration’s (FDA) intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(l), from premarket notification requirements.

CBER

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions This guidance addresses regenerative medicine therapies which are defined in section 506(g)(8) of the FD&C Act as including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271).

The 21st Century Cures Act (Cures), signed into law on December 13, 2016, amended several sections of the Federal Food, Drug, and Cosmetic Act. This guidance was developed and issued prior to the enactment of Cures, and certain sections of this guidance may no longer be current as a result. FDA is assessing how to revise this guidance to represent our current thinking on this topic. For more information please contact DICE@fda.hhs.gov.

EAS Welcomes New Consultants in March 2019

Janet Collins, Ph.D.

Dr. Janet Collins assists EAS clients with all matters of food regulatory compliance issues. Her expertise includes product development with an eye towards global agricultural advocacy, appreciation for diversity, and strong expertise in human health science, nutrition and food regulation, and systems for global food acceptance. Janet demonstrates strong global communications/advocacy and leadership with measurable and collaborative results. She recently retired from the position of Executive and Senior Vice President, Science and Regulatory Affairs at CropLife America and was the President of the Institute of Food Technologists from 2008-2015.

Janet Collins PhD

Sophia Lily

Sophia Lily has over 25 years of experience in the regulated pharmaceutical, nutraceutical and food industry Quality Control, Quality Assurance. She is based in India and is experienced in handling inspections, validations, vendor audits and training. She routinely works with, including training, personnel in a range of GMP topics including Data Integrity. With expertise including GMP compliance, gap analysis and remediation and development of roadmaps to compliance, she has successfully implemented effective quality management systems for many companies both small and large.

Sophia Lily

Jay Mansour

Jay Mansour is a seasoned Medical Device regulatory consultant with 20+ years of experience. He has successfully filed more than 100 510(k) clearances across many technologies and assists clients with QMS turnkey projects, including personnel training, and CE marking products as well as responding to FDA’s 483 and warning letters. He is an expert in Process Validations (software, sterilization and more).

Jay Mansour

Jeffrey Roberts

Jeffrey Roberts is an expert in software and systems auditing/validation including compliance with 21 CFR Part 11, 21 CFR Part 820 and ISO-13485. He writes Software Development Life Cycle (SDLC) documents including Validation Compliance Plan (VCP), Functional Requirements Specification (FRS), System Design Specification (SDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR).

Jeffrey Roberts

George Yanulis, Ph.D.

Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.

George Yanulis PhD

Will FDA Suspend Your Food Facility Registration Based on Environmental Results?

In October 2018 FDA suspended the registration of Working Cow Homemade, Inc., of Florida. Working Cow is an ice cream manufacturer, ceased operations, and has cooperated with FDA. As part of its decision to suspend their registration FDA determined: 

  • Insanitary conditions were observed during inspections in both 2017 and 2018.
  • Following a 2017 inspection, an environmental sample tested positive for Listeria monocytogenes. Per FDA protocol, the whole genome sequencing data for the pathogen was uploaded to the Genome Trakr database.
  • In 2017, Working Cow conducted a recall. According to FDA, Working Cow did not implement corrective actions after the 2017 findings and recall.
  • In September 2018, the CDC informed the Florida Department of Health of a genetic match between the 2017 environmental Listeriaand a 2018 patient plus two patients in 2013.
  • Working Cow has a Florida customer base that includes potentially immunocompromised adult consumers at nursing homes and assisted living facilities.
  • A 2018 Listeria monocytogenes environmental isolate matched the 2017 environmental isolate, making the pathogen a potential resident strain.

The pathogen was not isolated from the finished product.

If Listeria monocytogenes is found in the environment from an area after a kill step and before the packaging is sealed, there is the potential for the pathogen to be transferred from the environmental site to a food contact surface and then to the product. This concept is recognized in the scientific community and is the justification for environmental monitoring programs which verify the effectiveness of equipment and facility sanitation programs, employee hygiene, and employee training programs. A pathogen in zone 4 can go to zone 3, in zone 3 can go to zone 2, and in zone 2 can go to zone 1. While every facility is different and there is no single citation of what constitutes each zone, here is one description:

  • Zone 1 – Direct product contact & indirect product contact (surfaces from which contaminants can drip, drain or be drawn onto product contact surfaces), includes pressurized air
  • Zone 2 – Equipment non-product contact areas immediately adjacent to processing equipment
  • Zone 3 – Facility non-product contact areas within processing, packaging & ingredient/finished product cooler areas, i.e. floors; walls; ceilings; overhead piping, conduit & structural supports; drains; forklifts & pallet jacks that enter processing & packaging areas
  • Zone 4 – Facility and equipment non-product contact areas located outside of the processing, packaging & ingredient/finished product cooler areas, i.e. warehouses, dock areas, break rooms, hallways

I understand the thinking that the pathogen from the environment could get into the ice cream and as a consultant I have seen the certainty of a problem break down when the details and specifics are thoroughly evaluated. Questions to ask as sites evaluate their pathogen control programs are: What is the proximity of the finding to the finished product? Is there a history of environmental sample results related to detection of pathogens? What is the laboratory’s positive control culture to ensure the reported results are correct?

PulseNet was formed in 1996 enabling laboratories to use the genetic matching method of pulsed-field gel electrophoresis (PFGE). FDA started to transition from PFGE to whole genome sequencing (WGS) after investigating a 2012 Salmonella outbreak. Isolates have been added to the Genome Trakr database at an exponential rate, and laboratories have converted or are in the process of converting from PFGE to WGS.

WGS use and values are evolving in risk assessment and investigations. There are several different WGS equipment manufacturers. The laboratory method for WGS at FDA is not the same method used by CDC. One uses SNPs, and the other uses alleles. A “match” is not always a perfect match, and there is debate among FDA, CDC, academic, and commercial laboratories as to how close the specific genetic data must be for a “match.”

The analogy I use is calling twin babies “identical” where there may still be a few physical differences; identical twins are genetically identical and a “match.” Fraternal twins are not genetically identical and clearly not a match. When WGS is conducted on an environmental isolate and a patient isolate of a pathogen to see if they match, the data may show genetic differences. The scientific community has not agreed on how much of a difference can be measured and the isolates be labeled as genetically identical.

WGS data lives forever in Genome Trakr, so it is conceivable and perhaps likely that environmental samples taken in your facility this week could be matched to a pathogen from six years ago, but without an isolate from your finished product! Even though the concept is mind-boggling, this is where enforcement currently lies in and CDC today.

So to answer my question, Will FDA Suspend Your Food Facility Registration Based on Environmental Results?, based on recent history with FDA using the tool of WGS as the “Holy Grail” for proving microbiological contamination, the answer could be is “Yes.” When there is a match between an environmental pathogen with a finished product isolate or a patient isolate, FDA will be on your doorstep. Your work is to train employees, re-emphasize and enhance current Good Manufacturing Practices, build a strong and positive food safety culture, re-evaluate your current FDA-compliant food safety plan to ensure effectiveness, and keep records that prove your food safety and corrective action efforts are occurring daily.

In conclusion, the food manufacturing and retail food industry need to prepare themselves for the increased use of all types of genetic screening of environmental and finished product isolates by not only FDA or CDC, but by state food safety regulators, third-party auditors and their customers. One way to prepare is to learn as much as possible about whole genome sequencing (WGS), identify private laboratories that conduct WGS and learn about their methodology and equipment. This will allow you to get out ahead of this new regulatory tool that has the potential of improving the safety of the US food supply but with potential damaging consequences in cases where matches are found.

EAS Webinar: Dietary Supplements and FSMA, Fallacy or Fact?

Since the passage of the Food Safety Modernization Act (FSMA) in 2011, dietary supplements are now subject to many aspects of the seven major regulations that were issued by FDA to support enforcement of FSMA. One of the most important of these regulations being 21 CFR 117, Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF). Which aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply to dietary supplements? What about other FSMA responsibilities like FSVP? How does the dietary supplement industry including raw material manufacturers and suppliers, dietary supplement manufacturers, and dietary supplement brand owners avoid enforcement actions?

Join EAS Consulting Group’s FSMA and Dietary Supplement experts Heather Fairman and Maury Bandurraga for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Register now for our April 16, 2019 webinar at 1:00 pm Eastern.

Strategic Product Development a Key Component of Regulatory Compliance

Did You Know?

Product development is more than just labeling, it is a holistic approach from ideation through commercialization that strategically looks at the category in which the product is intended to be marketed and those regulatory requirements surrounding it. Are there claims being made which have legal definitions? Is the product competing against similar products but with a unique competitive advantage? Does the product contain a new ingredient for which a GRAS submission must be filed?

Once the product idea is born, the strategic and often difficult decisions begin. EAS Consulting Group’s product development team works with companies to best position new and relaunched products in the marketplace. We can review your labels, claims and marketing materials for regulatory compliance, and assure the study design, results and dossiers demonstrate safety of the ingredients and packaging. In addition, we can also assist GMP and Food Safety Modernization Act compliance during production.

If your company is thinking of a new product, product line extension or even repositioning an already existing product, contact EAS Consulting Group for a consultation about your project and how our product development capabilities can help you meet your business goals. EAS’ product development team consists of former attorneys, microbiologists and toxicologists, labeling and claims specialists and experts in packaging and food safety. For more information, contact Allen Sayler, Senior Director of Food Consulting Services at 571-447-5509 or asayler@easconsultinggroup.com.

Meet March 2019 Issue of the Month Author

Kathy Knutson, Ph.D.

Kathy Knutson, Ph.D. 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 as she educates on issues surrounding cannabis infused food products for sale in states with medical and recreational use legislation. Kathy has a Ph.D. in Food Science from the University of Minnesota and prior to consulting worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.

Kathy Knutson PhD

EAS Webinar – Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports

EAS Independent Advisor for Import Operations, Domenic Veneziano and EAS Independent Advisor for FSMA, Charles Breen are collaborating for a complimentary EAS webinar discussing the requirements of a Qualified Individual per FDA requirements. Join us on April 3, 2019, at 1 pm Eastern to learn about this important provision for food importers under the Foreign Supplier Verification Program (FSVP) Final Rule. Part 1 Subpart L, Section §1.503 requires that importers of human and animal food enlist a QI who has responsibility for developing a program and performing each activity to ensure the products they are importing are not adulterated or misbranded and have been produced in accordance with the preventive control regulations for human or animal food or the Produce Safety Rule. FDA has specific expectations of the QI. Does your company meet the mark? Join us for our webinar and learn more about FSVP and EAS services as a QI through this explainer video.

EAS Offers Hygienic “Best” Sanitation Practices for Delivering Safe Snack Foods at SNAXPO

EAS Independent Consultants David Blomquist and Jenifer Kane will present a one-day seminar at the upcoming SNAC International Annual Conference, SNAXPO, March 31-April 2, 2019 in Orlando, FL. The training which takes place on March 31 will provide practical information, “real-world” examples and tips on how to enhance daily operational practices related to improving existing food safety and quality programs for the snack food industry. Focusing on criteria for selecting, installing and maintaining processing equipment and utensils, how to effectively clean processing equipment and more. Participants will gain an appreciation of compliance requirements of the applicable FSMA regulations.

EAS Offers Webinar on Developing New Infant Formula Notification

The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies not well-prepared for the rigors of FDA review and assessment.

Learn the steps to NIFNs as well as the pitfalls and challenges companies face in leading up to the assembling of an Infant Formula dossier. EAS Consulting Group’s experts will walk you through challenges and pitfalls which delay or prevent final FDA approval of this most important nutrient for growing infants. Join Robert Martin, Ph.D., Robert Burns, Ph.D., and Timothy Morck, Ph.D. on April 2, 2019, at 1 pm Eastern for a technical overview of one of FDA’s most challenging applications. Register today and learn more about EAS services in infant formulas in this explainer video.

New EAS Webinar Announced – What Does the Farm Bill Mean for the Cannabis Industry?

The 2018 Farm Bill answered many questions for the cannabis industry, but its message has also been largely misunderstood. Misinterpretations as to the legality of including cannabis as an ingredient in foods, herbal products, and dietary supplements have erroneously lead firms to begin planning and production of illegal products, and, in the case of those which legally include (by state) CBD ingredients there is often little regard or understanding of how to manage the quality, including product specifications for the production of a consistent and safe product.

Join EAS Senior Tara Lin Couch, Ph.D., and special guest, Marc Ullman with Rivkin Radler, LLP on March 13, 2019, at 1 pm Eastern for a dynamic discussion on what the Farm Bill really means for the cannabis industry. What is FDA’s position on cannabis and how are the states managing the patchwork of federal regulations that make this burgeoning industry so confusing? In those cases where companies are legally producing cannabis products, what steps should be taken to implement and improve upon sound quality systems? Register here and learn more about EAS quality systems services for the cannabis industry here. You may also wish to view our CBD and Hemp Regulatory Fact Sheet here.