April 30, 2019
April 30, 2019
Dennis Gaalswykassists clients with food safety compliance requirements through development and implementation of FSMA and FSVP protocols. He is an expert in sanitation practices and sanitary equipment, SQF, HACCP and HARPC. Prior to consulting he was a consumer safety officer with CFSAN where he served on working groups responsible for developing regulations, guidance and implementation of the FSMA rules and accreditation of Third-Party Auditors. Additionally, he was a member of the Cadre Advisory Group that developed trainings for the Preventive Controls for Grade “A” Dairy Plant Regulators Course.
Natural Products Insider
Apr 22, 2019
Natural Products Insider
April 22, 2019
Natural Products Insider
April 18, 2019
Tara Lin Couch, Ph.D.
Mehrdad Tajkarimi, D.V.M., M.P.V.M., Ph.D.
Food Safety Magazine
April 16, 2019
Natural Products Insider
April 11, 2019
April 11, 2019
Natural Product Insider
April 5, 2019
Ronald J. Levine
The Food Safety Modernization Act, signed into law in 2011, includes an important provision for food importers under the Foreign Supplier Verification Program (FSVP) Final Rule. Namely, Part 1 Subpart L, Section §1.503 requires that importers of human and animal food enlist a Qualified Individual (QI) who has responsibility for developing a program and performing each activity under the program to ensure that the products that they are importing are not adulterated or misbranded (in regards to allergens) and have been produced in accordance with the preventive control regulations for human or animal food (CFR §117 & 507 respectfully), or the Produce Safety Rule (CFR §112).
Companies importing finished food and food ingredients for further processing into the U.S. must have a QI, either an employee or someone contracted to perform QI duties. This FSVP QI looks at each supplier closely and determines whether the foods or food ingredients they produce meet FDA’s strict safety requirements by assessing the supplier’s food safety plans and determining whether adequate controls are in place that would reduce or minimize harm due to biological, chemical and physical hazards. The QI would also have to identify verification activities that would ensure that the hazards are being addressed. Based on the type of activity identified, the importer may also have to enlist a Qualified Auditor (QA) to perform this function.
Everyone with a role in the importation of foreign sourced foods should be familiar with applicable FSVP requirements including brokers ,exporting shippers, foreign suppliers, and others. This comprehensive approach can help better protect food safety.
Join EAS Independent Advisor for FSMA and former FDA Seattle District Officer, Charles Breen and EAS Independent Advisor for Import Operations and former Director of the FDA’s Division of Import Operations, Domenic Veneziano, for an informative and fast-paced webinar on understanding the requirements of an FDA Qualified Individual and Auditor.
Mr. Breen became available to EAS Consulting Group after a distinguished career at the FDA working in areas such as HACCP and LACF and BSE prohibited materials in the dairy. Mr. Breen has worked with the industry on compliance issues related to the Bioterrorism Act of 2003 and led the field and HQ professionals in developing and implementing surveillance and compliance programs, and initial FSMA training implementation. His attention to detail has garnered him an FDA Award of Merit, Outstanding Achievement and five Commissioner Special Citations.
Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience. He served as director of the FDA’s Division of Import Operations for more than ten years. In that role, he was responsible for oversight of FDA’s import operations program and provided leadership, guidance, and direction to approximately 1,000 field investigators in more than 320 U.S. ports of entry. He also served as co-lead in the development of the FSMA import regulations and was the senior advisor on the implementation of FSMA and the FDA Safety and Innovation Act. Mr. Veneziano began his FDA career in 1992 as a field investigator in the New England District specializing in medical device inspections. In 1998 he became a supervisory investigator in New England overseeing the medical device and import programs.
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.
Just some of the roadblocks Infant Formulas face is that all ingredients must be GRAS specifically for Infant Formula use, Approved Food Additives, or have a history of safe use in U.S. formulas. The submissions which demonstrate this must also show that their formulations deliver on nutrient label declarations throughout shelf-life with nutrient levels within FDA-established ranges. Some examples of required studies include Protein Efficiency Ratio test for protein quality, nutritional shelf life stability studies and infant growth monitoring studies, all which must demonstrate the product is produced under processing conditions that assure safe and consistent formulas. Finally, when all the data is available it is assembled into a well-designed New Infant Formula Notification (NIFN) which is submitted to and reviewed by FDA. 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, scientists, and leaders in their fields at FDA and industry 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. for an informative and technical overview of one of FDA’s most challenging applications.
Learn more about EAS services with New Infant Formula Notifications as Allen Sayler and Robbie Burns, Ph.D. share critical information on FDA expectations for safety and submissions of NFINs.
Dr. Robert Martin is a former deputy director of FDA’s Division of Biotechnology and GRAS Notice Review. His 38-year career at the agency included service as a research chemist and as a consumer safety officer in the Division of Food and Color Additives. He became a supervisor and team leader after that division was renamed the Division of Petition Control. Dr. Martin holds a Ph.D. in chemistry from Georgetown University.
Robert, “Robbie” Burns retired from the Grocery Manufacturers Association as former Vice President of Health and Nutrition Policy. Previously, he was the Global Nutrition and Scientific Affairs Director at Cadbury Schweppes where he worked to establish consistent global standards and strategies for the improvement of product pipelines. Prior to Cadbury, he was at Mead Johnson Nutritionals where he worked on the scientific and regulatory aspects of new and reformulated infant formulas, Medical Foods and other nutritional products. Robbie has a Ph.D. in Nutritional Biochemistry from Queens University in Belfast, Ireland with Postdoctoral Research Fellowships at the Universities of Nottingham and Illinois, Urbana-Champaign. He is the author of nearly 50 papers and articles and has been an invited speaker at dozens of international symposiums and conferences.
Timothy Morck provides expertise in nutrition-related research, product development, regulatory and public policy and global scientific affairs. Dr. Morck’s career includes clinical nutrition practice, research, and medical school faculty appointments, scientific association management, entrepreneurial personalized nutrition start-ups, and executive and senior management positions at several global food, nutrition and pharmaceutical companies including The Dannon Company, Mead Johnson Nutritionals, Abbott Nutrition, Nestle Health Science and Nestle Corporate Affairs. The interplay between the legal, scientific, and regulatory framework surrounding medical foods has been a particularly sharp focus for him. He received a B.S. in animal science from Penn State University, followed by MS and Ph.D. degrees in nutrition (biochemistry & physiology minors) from Cornell University.
Tablets and Capsules
April 1, 2019
Drug Development and Delivery
EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, published a blog discussing the future of Homeopathy on the International Society of Pharmaceutical Engineering (ISPE) blog page iSpeak. FDA and FTC are taking a more proactive approach to homeopathic drugs indicating that they will be held to the same standard as other products with regard to claims.
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 through 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 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 50 independent consultants who can act in an expert witness capacity.
We welcome a number of new consultants this month: Robert Post, Heidi Stuttz, Jan Janson, William Scopa and Joel Martinez. I 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.
Chairman and CEO
Charlotte Peyton, a noted expert in cannabis, has published an article in a recent Cannabis Industry Journal. She discusses FDA’s stance with Hemp, CBD versus Isolates, and good manufacturing practice considerations. You may also wish to view the recent 2018 Farm Bill and the Cannabis Industry webinar presented by Attorney Marc Ullman, Of Counsel with Rivkin Radler and Tara Lin Couch, PhD, Senior Director of Dietary Supplement and Tobacco Services. This webinar is available on-demand on the EAS website.
By 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.
Steve Armstrong, EAS Independent Advisor for Food Law and Regulation, is co-author of an article published in the March 2019 Food Drug Law Institute Update Magazine covering FDA’s recent decision to delist six synthetic ingredients as required by the Delaney Clause, a 60-year-old provision of the Food, Drug, and Cosmetic Act (FDCA) which states, in plain language that FDA may not approve any food additive—even one that is safe—if it is “found to induce cancer” in laboratory animals. Steve hypothesizes as to whether it is time to repeal the Delaney Clause.
Independent Consultant, Joe Famiglietti, provides guidance to clients regarding FDA compliance matters. He has performed onsite audits at food manufacturing facilities and evaluated production and quality control operations for compliance with FDA regulations. Joe has experience in inspections of food manufacturing areas including low acid canned foods, acidified foods, infant formula and seafood HACCP. He assists in facility sanitation issues, provides in-house training to employees on food GMP issues and procedures for handling FDA inspections. Prior to consulting, Joe was a Compliance Officer at the FDA New York District, Import Operations Branch in Buffalo.
By Timothy Hansen
Each month, EAS answers one question sent in by our readers. This month’s Ask the Expert is answered by Independent Consultant and former head of the NOAA Seafood Inspection Program and Division Director in FDA’s Office of Seafood, Timothy Hansen. Tim has extensive experience in seafood regulatory affairs, certification, and advises the seafood industry on science and technological matters. If you would like to ask a question of one of our experts, click here.
Question: As a seafood importer how can I protect myself from fraudulent suppliers?
Hansen: The seafood industry is mostly comprised of smart, hardworking, honest professionals that take regulatory compliance seriously, and a few unscrupulous operators who aim to misrepresent their products for financial gain or enhanced competitive advantage. It would be wise for all firms and particularly importers of seafood to be aware of some of the more common fraudulent practices so that you can protect your firm, your customers and ward off FDA enforcement action by perpetuating fraud to your customers. Some types of fraudulent activities to be aware of:
Species substitution, usually representing a lower cost but similar species as a higher cost or higher quality species such as Chum Salmon for Coho Salmon. When this occurs, not only is the fish fraudulent but so too is the labeling including PDP, weight declaration and nutritional information.
In other cases, suppliers may provide a fraudulent shipment weight due to overglazing of ice, overbreading that exceeds USDC, NIST or AOAC standards, or even what is called “rat packing” where the superior product is on top, hiding the inferior product underneath.
According to the NOAA Fisheries Seafood Inspection Program, as of 2014 around 30% of seafood in the U.S. is considered fraudulent. This can be attributed to intentional fraud where the seafood operator is looking to gain an unearned profit, “best” the competition, or they commit fraud due to pressures stemming from the inability to fill customer orders. In other cases, unintentional fraud may also be committed, attributed to honest mistakes such as the misinterpretation of regulations or miscommunications and messaging errors due to poor process controls which lead to unknowingly receiving and accepting a fraudulent product from a supplier.
There are a number of ways the seafood industry can protect themselves, the most obvious of which is to develop relationships with reputable suppliers and to regularly inspect incoming shipments. In addition, if your firm does not already have fully developed product specifications guidelines consider creating these as part of your business operations plan. You will also want to have a Quality plan in addition to your HACCP plan and enhance your labeling controls beyond the minimum HACCP requirements. Consider also utilizing process control techniques such as statistical weight control charts and Quality Assurance software.
Protocols for all Quality, HACCP and other SOPs must be developed by a competent person, either within your organization or created by an outside entity, such as EAS, with expertise specific to the seafood industry. Ensuring compliant process control techniques can significantly increase your company’s integrity, leading to a satisfied customer, and reduce your risk of regulatory action.
EAS has a team of experts with career histories in FDA inspections and the seafood industry. If we can help your company to create or improve your compliance programs, please give us a call. We invite you to view our many industry services facts sheets on the EAS website, or more specifically that which pertains to our seafood services.
Dr. Robert Post is a former food industry executive, White House and regulatory agency executive, and university instructor with expertise in food science and nutrition. His roles in the food industry have included leading nutrition and regulatory affairs; corporate health and wellness programs; and food and health communications to support marketing and customers/sales. He has also directed legislative affairs, food ingredient specifications and approvals, food product design and innovation, food labeling and nutrition labeling strategies, design, and compliance; and brand communications strategies for customers, consumers, and health professionals. In the Federal sector, Rob directed the agencies that set the Dietary Guidelines for Americans, created MyPlate(.gov), and the national nutrition evidence library, supporting the White House as a key nutrition advisor. All roles involved expert mining of food and nutrition research and setting research pipelines for product design and product and process claims substantiation. Prior to consulting Rob was the Senior Director for Chobani Health and Wellness and Regulatory Affairs. He also served as the Executive Director for Center for Nutrition Policy and Promotion in the U.S. Department of Agriculture.
Heidi Stuttz is an expert in biotech and medical device oversight. She assists clients with a variety of projects including R&D programs, FDA submissions, EMEA dossiers, compliance enhancements and quality improvement initiatives. Assisting with product development processes from clinical trials to commercialization, Heidi demonstrates proven success with facilitating product development and moving regulatory programs forward. Heidi is experienced with auditing cGMPs for continuous process improvements, FDA ISO9000, records management as well as laboratory compliance/controls and validation and facilities and utility validation and remediation. She has worked as a Senior Project/Program Manager with Solution Systems and as a Quality Assurance Specialist at Wyeth Vaccines Division. Heidi has a M.S. from Johns Hopkins University, with degree in Biotechnology, Enterprise and Entrepreneurship, and concentration in Legal/Regulatory.
Mr. Scopa has over 30 years at Customs and Border Protection (CBP) at both ports of entry and Headquarters. During 15 years at the ports, he processed both the import and export clearance of cargo and passengers. At Headquarters, as a Branch Chief, he led the development of policies and procedures. These policies and procedures addressed such areas as, Intellectual Property Rights, Anti-Dumping and Countervailing Duties, and revenue collections. He spent several years leading CBP’s trade enforcement efforts in targeting evasion such as misclassification and undervaluation. His last position was CBP’s liaison to other government agencies and he worked with the other agencies to develop CBP import processing of the other agency imports for such agencies as EPA, FDA, and DEA. These processes included clearing other agency cargo under the Automated Commercial Environment (ACE).
Jan Janson is a quality consultant who provides assessments and recommendations on QMS development, Quality and Supplier Management. He conducts internal and supplier audits, develops product quality initiatives, supports CAPA and complaint analysis and more. In addition, Jan has extensive experience with audits against GMPs, Process Validation Reviews including process, software and methods and helps firms develop protocols for FDA 820, ISO 3485 compliance. Prior to consulting Jan was a Quality Manager at Biomet and Senior Quality Supplier Engineer at Medtronic.
As a former certified ORA BIMO FDA Investigator, Joel Martinez has completed 20-25 BIMO inspections in all therapeutic areas, interacting with CDER’s Office of Scientific Investigations (OSI) medical reviewers and BIMO Office of Compliance personnel for CBER, CDRH and CVM. He has significant experience in recognizing and understanding significant inspectional observations which would warrant further regulatory action and assists clients with understanding critical areas for a Sponsor/CRO in terms of being compliance with applicable 21 CFR regulations. Joel also conducts GLP audits domestically and internationally gaining inspectional experience of non-clinical laboratories.
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 50 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.
Drug Development & Delivery
Kaiser J. Aziz
In order to create a smart and quick-moving infrastructure that can adapt to the needs of future organizational, regulatory and scientific requirements, the Center for Devices and Radiological Health (CDRH) is beginning the implementation of a reorganization.
The reorganization will integrate CDRH’s premarket and post-market program functions along product lines, allowing their experts to leverage their knowledge to optimize decision-making across the product life cycle. This type of approach blends many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach. With the implementation of reorganization, the FDA aims to enhance information-sharing across the Center, increase collective decision-making, improve work-life balance and increase professional opportunities for employees.
The implementation is set to begin March 2019 and is expected to be completed by September 2019. FDA says the implementation will take place in a phased approach, and timelines for implementation will vary by office. Each office within the current CDRH structure is undergoing some change in order to better support and advance CDRH’s public health mission and vision.
More information can be found here.