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

Marc Ullman, Of Counsel, Rivkin Radler LLP

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

Maury Bandurraga, EAS Independent Consultant

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

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