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.
The Good Food Movement Transforms Food Labeling
Natural Products Insider https://www.naturalproductsinsider.com/foods/good-food-movement-transforms-food-labeling Steve Armstrong, JD October 1, 2018
Mututal Recognition Agreements and Other FDA Activities for Monitoring the US Drug Product Supply Chain
Tablets and Capsules https://www.e-digitaleditions.com/i/1035980-tc1018/13? James Evans October 2018
September 2018 Drug and Device Corner
EAS would like to remind clients, the FDA FY 2019 establishment registration renewal period begins this month. With reference to Drug Establishments, please make sure you are aware of your obligations under the Drug Supply Chain Security Act (DSCSA) during this drug listing certification period....
Ensuring a Contract Laboratory is in Compliance
Natural Products Insider https://www.naturalproductsinsider.com/labstesting/ensuring-contract-laboratory-compliance Tara Lin Couch, Ph.D. September 26, 2018
Are Industry Initiated Environmental Swab-a-Thons a Benefit?
The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in …
Dietary Supplements Own Label Distributor (OLD) Regulatory Responsibilities: Six Critical Items and Processes
TechnoScienze https://www.teknoscienze.com/tks_article/dietary-supplements-own-label-distributor-old-regulatory-responsibilities-six-critical-items-and-processes/ Tara Lin Couch, Ph.D. September 4, 2018
What Exactly is the Foreign Supplier Verification Program (FSVP)?
By Allen Sayler Ask the Expert offers a chance for our readers to submit questions to EAS regarding areas of regulatory confusion. This month’s question is answered by Allen Sayler, Senior Director of Food Consulting Services. If you’d like to submit a question, please use the “contact us” link on...
Couch Discusses Contract Manufacturing Partnerships in Natural Products Insider Podcast
Senior Director for Dietary Supplements, Dr. Tara Lin Couch was interviewed for a Natural Products Insider podcast on contract manufacturing partnerships. Dr. Couch is one of two EAS presenters for the upcoming SupplySide West trade show taking place in Las Vegas. Stay tuned for more information...
Tajkarimi and Sayler Discuss RTEs in Natural Products Insider
Independent Consultant Mehrdad Tajkarimi and Senior Director Allen Sayler co-wrote an article for Natural Products Insider discussing Cause, Effect and Impact of RTE Operations on complying with FDA’s draft Listeria guidance. Food manufacturers are expected to operate within an entirely new scheme...
Preventive Controls – A New Ballgame for Food Safety Compliance
By Charles Breen, Independent Advisor for FSMA With the recent issuance of a Warning Letter citing violations of Part 117 subpart C (preventive controls), implementation of FDA’s Preventive Controls rule takes its next step – FDA will cite food facilities for preventive control failures. Everyone...
FDA Mutual Recognition Agreements
By James Evans, EAS Independent Consultant FDA has been implementing the Safety and Innovation Act since it was passed by Congress in 2012. The Act requires FDA to establish Mutual Recognition Agreements (MRAs) which are agreements between two or more countries to recognize a specific process or...
Sayler Discusses Fast Tracking FDA FURLS in Food Safety Tech
Senior Director for Food Consulting Services, Allen Sayler, has written an article for Food Safety Tech on FDA Fast-Track Unified and Listing Systems (FURLS) program and whether it is expediting or impeding access to overseas markets. “The FDA recently released a notification that their FURLS...
Tajkarimi Writes of Food Safety Training as a Solution for FSMA Challenges
Mehrdad Tajkarimi discusses the importance of food safety training as a solution to FSMA challenges in Part One of a three-part series for Food Safety Magazine. “There are several challenges ahead for proper food safety training at all levels,” he says. “These challenges include, but are not...
Lavieri Highlights the Impact of the Human Element in Food Safety Programs in Food Safety News
Robert Lavieri authored a guest column in Food Safety News on the important and often overlooked “human element” to food safety planning and programs. Companies spend much time and effort designing and cross-checking procedures to protect against food safety issues, but the human element or...
Adverse Events Reporting for Dietary Supplements
Natural Products Insider https://www.naturalproductsinsider.com/regulatory/adverse-event-reporting-requirements-dietary-supplements Norma Skolnik August 29, 2018
How to Survive your Worst Food Safety Nightmare
Food Quality and Safety https://www.foodqualityandsafety.com/article/tips-food-recall/ Charles Breen August 29, 2018
Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application
Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain, (i.e., mandatory and …
Fast Track to FDA FURLS—Expediting or Impeding Access to Overseas Markets
Food Safety Tech https://www.naturalproductsinsider.com/contract-manufacturing/supplyside-west-podcast-quality-systems-contract-manufacturing-partnership Allen Sayler August 14, 2018
Podcast Interview: Quality Systems in a Contract Manufacturing Partnership
Natural Products Insider https://www.naturalproductsinsider.com/contract-manufacturing/supplyside-west-podcast-quality-systems-contract-manufacturing-partnership Tara Lin Couch, Ph.D. August 8, 2018
Science Direct – Food Regulations & Enforcement
Color Coding: Adding Discipline to a Food Processor’s Preventive Control Program
Food Defense Training and the New “Focused Mitigation Strategies to Protect Food against Intentional Adulteration” Rule
Video Interview: The Potential Delay to Nutrition Facts labels should not slow compliance efforts
Updated Food Safety Training, Solution for Upcoming FSMA Challenges
Food Safety Magazine https://www.foodsafetymagazine.com/enewsletter/updated-food-safety-training-solution-for-upcoming-fsma-challenges/ Mehrdad Tajkarimi August 7, 2018
Botanical Submissions: NDI Versus GRAS in a Post-DSHEA World
AHPA Report http://ahpa.org/News/AHPAReports/TabId/136/ArtMID/607/ArticleID/1013/In-Florida-the-berries-have-hit-the-fan-in-the-August-2018-AHPA-Report.aspx Amy Scanlin August 7, 2018
Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations
As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for …
FDA 483 Responses – Missing the Mark?
By Cindy Beehner, Independent Consultant In recent months, it appears more companies are having difficulties meeting the requirements of FDA Form 483, List of Observations, response. The inspection situation is very stressful and if it ends with the dreaded “483”, it can be positively...
Are Plant-Based Proteins Milking Dairy?
By Allen Sayler, Senior Director for Food Consulting Services When FDA announced recently that the agency is seeking public comment for standards of identity overhaul that will focus in part on plant-based products that are marketed as “milk” substitutes, manufacturers of those products as well as...
EAS Co-Authors Article for FDLI Update on the Benefits of Consultants as Part of a Legal Team
EAS joined forces with Ronald J. Levine, co-chair on Herrick, Feinstein LLP’s Litigation Department to author an article published in the Food Drug Law Institute Update Magazine on how the use of consultants can benefit a legal team. Consultants provide unique insights, given their detailed...
EAS Consultants Invited Speakers at Two FDLI Conferences
EAS is pleased to be invited speakers at two upcoming Food Drug Law Institute (FDLI) Events. Andrea Yablunosky will speak at an in-house event held at FDA CFSAN on Food Labeling: Nutrient Content, Health, and Other Claims on August 7th. Bruce Silverglade will speak on the same subject as part of...