EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
25 Years of DSHEA: A GMP Auditor’s Perspective – Podcast
Natural Products Insider April 18, 2019 https://www.naturalproductsinsider.com/contract-manufacturing/25-years-dshea-gmp-auditor-s-perspective-podcast Tara Lin Couch, Ph.D.
Updated Food Safety Training, Solution for Upcoming FSMA Challenges, Part 3
Mehrdad Tajkarimi, D.V.M., M.P.V.M., Ph.D. Food Safety Magazine https://www.foodsafetymagazine.com/enewsletter/updated-food-safety-training-solution-for-upcoming-fsma-challenges-part-3/ April 16, 2019
Manufacturing Information Beyond GMPs
Natural Products Insider April 11, 2019 https://www.naturalproductsinsider.com/herbs-botanicals/manufacturing-information-beyond-gmps Timothy Stewart
510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria
MedTech Intelligence April 11, 2019 https://www.medtechintelligence.com/column/510k-guidance-shifts-away-substantial-equivalence-in-favor-of-performance-testing-and-criteria/ Jay Mansour
Product Recall Therapy
Natural Product Insider April 5, 2019 https://www.naturalproductsinsider.com/legal-compliance/product-recall-therapy Ronald J. Levine
The FDA’s Final Link in the Chain of Food Safety and Food Imports
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 …
Regulatory, Technical and Formulations for New Infant Formula Notifications – Challenges and Opportunities
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 …
Spotlight on Nutraceuticals: Complying with New FDA Requirements for Dietary Supplement Nutrition Labels
Tablets and Capsules April 1, 2019 https://tabletscapsules.com/article/complying-new-fda-requirements-dietary-supplement-nutrition-labels/ Gisela Leon
RISK MANAGEMENT – FDA’s Quality Risk Management Approach to New Drug Applications
Drug Development and Delivery April 2019 https://drug-dev.com/fdas-quality-risk-management-approach-to-new-drug-applications/ Kaiser Aziz
Preparing For a FDA Preventive Controls Inspection
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...
Armstrong Publishes Article on the Delaney Clause in FDLI Update
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...
2019 April Ask the Expert
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...
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...
RISK MANAGEMENT – FDA’s Quality Risk Management Approach to New Drug Applications
Drug Development & Delivery April 2019 https://drug-dev.com/fdas-quality-risk-management-approach-to-new-drug-applications/ Kaiser J. Aziz
March 2019 Drug and Device Corner
Implementation of reorganization to begin for CDRH 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...
Homeopathy – What Does the Future Hold?
ISPE iSpeak Blog March 4, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/homeopathy-what-does-future-hold Susan Crane
Food Additive Reform: Time to Repeal the Delaney Clause?
FDLI Update March 1, 2019 https://www.fdli.org/2019/02/food-additive-reform-time-to-repeal-the-delaney-clause/ Steve Armstrong
How Do Legal Teams Find and Identify Good Expert Witnesses?
By Ronald J. Levine 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...
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...
Will FDA Suspend Your Food Facility Registration Based on Environmental Results?
By Kathy Knutson, Ph.D. 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...
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...
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...
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...
Sustainable Packaging Discussed in Natural Products Insider
Thomas Dunn has authored an article for Natural Products Insider on sustainable packaging for natural foods. Packaging for natural food products must protect food quality and safety while also connoting clean labels and sustainability, he says.
EAS Interview for Article on Food Labeling in Supermarket Perimeter Magazine
EAS Independent Consultant April Kates was interviewed for a recently published article on Food Labeling published in Supermarket Perimeter. EAS is very pleased to have such a strong team of labeling consultants who are often called upon for sharing their expertise.
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...
Hemp Products & Confusion Over FDA Remains
Cannabis Industry Journal https://cannabisindustryjournal.com/column/hemp-products-confusion-over-fda-remains/ February 27, 2019 Charlotte Peyton
Food Labeling (Interviewed)
Supermarket Perimeter http://www.nxtbook.com/sosland/sp/2019_02_01/index.php#/70 February 25, 2019 April Kates
Sustainable Packaging for Natural Foods
Natural Products Insider https://www.naturalproductsinsider.com/co-packing/sustainable-packaging-natural-foods February 19, 2019 Thomas Dunn