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

March 13, 2019, 1:00 PM Eastern

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?

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About the Presenters

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

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

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.

Dietary Supplements and FSMA Compliance – Fallacy or Fact?

April 16, 2019, 1:00 PM Eastern

Presented by: EAS Independent Consultants Heather Fairman & Maury Bandurraga

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of foods, 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 requires, among other things, that a Preventive Controls Qualified Individual (PCQI) develop a food safety plan. Another FSMA requirement is the need for a Foreign Supplier Verification Program (FSVP) when materials are sourced internationally which has been estimated to be more than half of all dietary supplement ingredients. Unfortunately, the dietary supplement industry is plagued by lack of compliance with these critical FSMA requirements and the FDA is beginning to crack down on firms with increased enforcement actions.

How does the dietary supplement industry including raw material manufacturers and suppliers, dietary supplement manufacturers, and dietary supplement brand owners referred to as Own Label Distributors (OLDs) avoid these enforcement actions? What aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply? What about other FSMA responsibilities like FSVP?

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. Learn the crucial steps to compliance, including what must be included in a food safety plan and what qualifications the PCQI must have in order to be qualified to create and oversee the program, and what is needed to develop an FSVP.

Dietary Supplement OLDs, manufacturers and raw material suppliers all have an obligation to protect public safety and ensure compliance with all the applicable regulations. Understanding these FSMA requirements and their role in the supply-chain are key to ensuring compliance.

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About the Presenters

Heather Fairman, EAS Independent Consultant

Heather Fairman brings 30 years of experience in QA/QC and regulatory compliance from her leadership roles in FDA regulated industries. She was formerly director of Corporate QA and regulatory compliance and the chief safety officer at Natural Organics, Inc., a New York based dietary supplement manufacturer. She has vast experience in establishing, reviewing and executing thorough SOPs, and in handling FDA audits, issues and responses. In addition to consulting, Ms. Fairman is a technical advisor to SIDS DOCK IWON herbal/raw material ingredient supply chain portfolio projects. SIDS (Small Island Development States) DOCK Island Women Open Network (IWON), is a Sustainable Energy and Climate Resilience Organization, that is the only small island intergovernmental organization vested with the full powers of the United Nations (UN), comprising almost 40 sovereign countries or one-fifth of the UN membership. Heather is a PCQI and was trained in FSMA-PCHF (Preventive Controls for Human Food) through the FDA accredited FSPCA program. She helps both dietary ingredient suppliers and finished product manufacturers meet compliance.

Maury Bandurraga, EAS Independent Consultant

Maury Bandurraga has in-depth expertise in quality assurance in a variety of FDA regulated product categories including packaging, food safety and quality, supply chain, labeling and claims. Prior to consulting she was the Food Safety and Quality Assurance Principal Scientist at Kelloggs and Food Supply Chain Food Safety and Quality Assurance Section Head at Procter & Gamble. Maury is both an FSMA and FSVP lead instructor through the FDA accredited FSPCA program and helps food and dietary supplement companies and their supply chains maintain vigilance of safety and compliance with Federal regulations.

Regulatory, Technical and Formulations for New Infant Formula Notifications – Challenges and Opportunities

April 2, 2019, at 1:00 PM Eastern

Presented by EAS Independent Consultants Robbie Burns, Ph.D. and Timothy Morck, Ph.D. and Independent Advisor for Food and Color Additive Safety, Robert Martin, Ph.D.

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.

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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.

About the Presenters

Robert Martin, Ph.D., Independent Advisor, Food and Color Additive Safety

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 Burns, Ph.D., Independent Consultant

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, Ph.D., Independent Consultant

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.

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

April 3, 2019 at 1:00 PM Eastern

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. Reserve your seat today!

About the Presenters

Charles Breen, Independent Advisor, FSMA Consulting Services

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.

Domenic Veneziano, Independent Advisor, Import Operations

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.

OTC Monograph Regulations a Five Part Webinar Series

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores 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 the future in a five-part series starting January 16, 2019.

Later sessions will include topics such as:

  • What makes a drug an OTC and the Monographs Compliance System
  • Understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic products, Homeopathic products in the OTC market
  • OTC Drugs and Your GMP Obligations – Understanding how the GMPs are Applied and Preparation for FDA Inspection.

Part 1

OTC Drug Monographs, Past, Present, and Future

January 16, 2019

Part 1 of the series, OTC Drug Monographs, Past, Present, and Future will discuss what a Monograph is and how it is used. She’ll dive into reading and interpreting the different sections of the monograph and discuss what the future might hold as Congress considers changes to the system. Join Susan on January 16, 2019, at 1:00 pm Eastern for part 1.

Part 2

OTC Labeling Requirements and Drug Listings Responsibilities

February 27, 2019 at 1:00 PM EST

Part 3

Cosmetics Labeling and Claims Regulations

March 27, 2019 at 1:00 PM EST