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.
FDA to Begin Inspections for Intentional Adulteration in March 2020
FDA recently announced that verification of compliance with the Intentional Adulteration (IA) rule will begin in March 2020. Addressing hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health, the IA rule...
Stewart Discusses Dietary Supplement GMPs in Natural Products Insider
Senior Advisor for Dietary Supplements, Tim Stewart, discussed GMPs in Natural Products Insider. FDA has been asking for additional information beyond GMPs in recent inspections, inquiring on botanical forms and safety. Stewart discusses compliance challenges and best practices. In addition, Tim...
Insider Podcast on 25 Years of DSHEA Features Senior Director, Tara Lin Couch, Ph.D.
Tara Lin Couch was interviewed for a Natural Products Insider podcast on her reflections of 25 years of DSHEA. Recorded at SupplySide East, she discusses how the dietary supplement industry, pre-DSHEA, was the “wild, wild west” and that 21 CFR 111, Current Good Manufacturing Practices, completely...
FDA Proposing to Change the 510(k) Submission Process for Medical Devices
By George Yanulis Each month, EAS selects one question sent in by readers to be answered by one of our experts. This month’s question is answered by George Yanulis D.Eng., an expert in medical device safety and the 510(k) process. Question: Why is FDA proposing to change the 510(k) submission...
Final Rule on OTC Hand Sanitizers Issued
FDA issued a Final Rule, effective April 13, 2019, which aims to ensure the safety and effectiveness of OTC hand sanitizers, formally known as topical consumer antiseptic rub products. These products are intended for use without water and marketed under the FDA’s OTC Drug Review. Active...
Did You Know? EAS Offers Verification and Validation Services of Electronic Signatures Under 21 CFR Part 11
Increasing usage of electronic methods to capture and produce critical data, which are subject to regulatory scrutiny led to the effect of Title 21 CFR Part 11. This part of the Code of Federal Regulations establishes the United States Food and Drug Administration (FDA) regulations on electronic...
Levine Authors Article on Product Recalls in Natural Products Insider
Independent Consultant Ronald Levine authored an article on the very serious subject of product recalls published in the Natural Products Insider illustrated through a fictitious conversation between a hypothetical company’s CEO and their attorney as they plan for a recall response.
FDA Proposed Approach Aims to Improve Efficiencies to Advance Pharma Manufacturing
iSpeak Blog April 30, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/fda-proposed-approach-aims-improve-efficiencies-advance-pharma Neha Mookuparambil
Supply chain transparency: A practice of trust through legitimacy, from ‘farm to fork’
Natural Products Insider Apr 22, 2019 https://www.naturalproductsinsider.com/supply-chain/supply-chain-transparency-practice-trust-through-legitimacy-farm-fork Heather Fairman
Supply Chain Transparency: A Practice of Trust Through Legitimacy, From ‘Farm to Fork’
Natural Products Insider April 22, 2019 https://www.naturalproductsinsider.com/supply-chain/supply-chain-transparency-practice-trust-through-legitimacy-farm-fork Heather Fairman
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...