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.
Drug and Device Corner February 2022
FDA’s New Draft Rule: “Medical Devices; Quality System Regulation Amendments” On February 22, 2022, FDA published a proposed rule that aims to harmonize the current Quality System Regulation for Medical Devices under 21 CFR part 820 with international standards, ISO 13485:2016, Medical devices –...
Are We Even on the Same Team?
Aligning Operations and Quality Drives Down Costs While Improving Efficiency By Mike Hughes, EAS Independent ConsultantHave you ever felt like your co-workers are at a different company? Maybe, even a competitor who is trying to run you out of business? Yup – I have. I am an Operations guy and the...
How To Be an Effective and Sought After Expert Witness
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony...
Blended Learning – Part of a Culture of Learning
By Nancy Higley, EAS Independent Consultant Continuous learning supports both business and employee goals. When you hire an employee, you are hiring an asset capable of continuous growth. An educated professional can be a point of difference for your business. There is no one solution for Learning...
EAS Consulting Provides Keynote Address at AFIA
EAS consultant Carolyn Kennedy provided the keynote address at the American Feed Industry Association (AFIA) conference during the International Production and Processing Expo (IPPE) in Atlanta. Speaking on human grade pet food, she discussed submissions, labeling, and the future of the industry....
Drug and Device Corner January 2022
Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 For application holders filing eCTD submissions via ESG, please...
EAS Announces Omar Oyarzabal, Ph.D. as the New Senior Consultant for Food Services
EAS is pleased to announce Omar Oyarzabal, Ph.D. as a new senior consultant for Food Consulting Services. Dr. Oyarzabal, a long-time consultant with EAS, begins this new role today. As a senior consultant, he will work directly with EAS’ Senior Director for Food Consulting Services to assure...
Roles and Responsibilities for Ensuring the Safety of Animal Food
By Johnny Braddy, DVM, MPH, Dipl. ACVPM, EAS Independent Consultant. (This Issue of the Month article is an abbreviated version of a White Paper published on the EAS website.). To help ensure that the nation’s food supply is safe, Congress amended the Food Drug & Cosmetic Act (FD&C)...
Roles and Responsibilities for Ensuring the Safety of Animal Food
Prepared by Johnny Braddy, DVM, MPH, DACVPM, EAS Independent ConsultantDecember 2021
Drug and Device Corner December 2021
REMINDER CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 Cover Letter Attachments for Controlled Correspondences and ANDA...
FDA Issues Draft Guidance on Validation and Verification of Analytical Testing Methods Used for Tobacco Products
On Dec. 21, FDA issued draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test...
FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods
The U.S. Food and Drug Administration (FDA) has issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act (FSMA). This LAAF program recognizes accreditation bodies that accredit food testing laboratories...
Preparing for TMPs
Are You Ready for TPMPs? Contact EAS for assistance with all of your regulatory needs. Download our quick reference service information sheet or visit our Tobacco services page for more detailed information on how we can help you.
Dairy Processing 101
A Virtual Training Presented by EAS Consulting GroupPresented by EAS Independent Consultants, Allen Sayler, Gabe Miller, Dave Blomquist, and Rhaisa A. Crespo, Ph.D.February 15, 17, 22 & 24, 2022From 12:00pm-3pm eastern each dayThe FDA’s Food Safety Modernization ACT (FSMA) and Safe Quality...
Titanium Dioxide – What the EU Ban Means For You
By April Kates, EAS Independent Consultant What is Titanium Dioxide? Titanium dioxide is a substance that has regulatory status in the US for many uses, including as a food additive. In 1966, It was approved to be used in foods at up to 1 percent by weight as a color additive. As a coloring agent,...
Drug and Device Corner November 2021
Final reminder that we are entering the last month of the registration renewal period for medical device facilities and drug establishments, as well as drug listing certifications. The FDA has provided an Electronic Drug Registration and Listing Instructions website for support. Clients wishing to...
Amazon Offers New Documentation Flexibility for Dietary Supplement Selling Partners
Amazon recently announced flexibility for selling partners to demonstrate of Good Manufacturing Practices (GMPs) for dietary supplements. The new policy requires submission of three demonstrations of quality, two of which are mandatory. The third requirement provides flexibility, with two options...
Dietary Supplement Good Manufacturing Practices (GMP) for Laboratories
Ensuring Regulatory CompliancePresented by Charlotte Peyton, Independent ConsultantMarch 1 & 3, 2022, from 12-4:30 pm eastern each dayEAS is offering an intensive virtual seminar covering FDA’s current Good Manufacturing Practice (GMP) requirements for Research and Development and Quality...
Regulatory Considerations for Novel Sports Nutrition Products and Ingredients
By EAS Independent Consultant, David Cockram, PhD Nearly every athlete wants something extra that will provide them with an edge over the competition. Optimizing nutrition is certainly a huge part of improving athletic performance. A well-balanced diet, with appropriate levels of carbohydrates,...
Drug and Device Corner October 2021
REMINDER that we are in the renewal period for all drug establishment, and medical device facility registrations, as well as the drug listing certification period. The agency announced this month their intention to withdraw the Temporary Guidances for Alcohol-Based Hand Sanitizers. With a thank...
Are You Producing Alcohol-Based Hand Sanitizers?
FDA has announced the withdrawal of temporary guidances for alcohol-based hand sanitizers manufactured by non-drug manufacturers during the COVID-19 public health emergency. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under these temporary policies must cease...
When is a Cosmetic Also a Drug?
Did you know that products designed to clean and beautify that ALSO affect the structure or function of the human body must bear special labeling? Per FDA’s 21 USC 359, these combination cosmetic – OTC Drug products must comply with OTC drug monographs and bear “Drug Facts” labeling for drug...
Sunscreen Quality, Safety and Efficacy
New Initiatives by FDA FDA has proposed revisions and updates to OTC-drug sunscreen requirements related to maximum sun protection factor (SPF) values, active ingredients, broad-spectrum requirements, and product labeling, among other provisions. This effort aims to ensure adequate ultraviolet A...
FDA Finalizes Two Foundational PMTA Rules
U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products, providing additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports – two of...
Dietary Supplement Virtual GMP Refresher
Presented by EAS Independent Consultant Tamika CatheyJanuary 18-19, 2022 from 11am-3pm eastern The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that “Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations,...
Social Media Considerations for FDA Regulated Products
By Susan Crane, Independent Advisor, OTC Drugs and LabelingHistorically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use of the internet and social...
USDA FSIS Revised Guidelines for Labeling Kit Food Products
Those producing nonretail-exempt, multicomponent food kits (such as stir fry and pizza) have a newly revised resource from FSIS: An eight-page booklet with criteria that helps to determine whether the kit product needs to be prepared under FSIS inspection and if so, how to label a kit product that...
Drug and Device Corner September 2021
As part of the 2020 CARES Act, section 506J has been added to the FD&C Act. This section requires manufacturers of certain medical devices to report any interruption or permanent discontinuance in manufacturing to the CDRH. The list of relevant devices can be found on this FDA website. A...
Food Safety – Of the Package By the Package and For the Package
Presented by EAS Independent Consultant, Thomas Dunn. Did you know the safety of your product begins and ends with packaging? Packaging is considered the “forgotten food ingredient” and has a myriad of US regulatory requirements including food contact substances, minimizing or preventing food...
Drug OTC GMPs and Labeling
A Five-Part Virtual Seminar SeriesPresented by Lisa El-Shall, Victoria Pankovich, Jeb HunterTuesdays in June 2026If you manufacture products in the OTC-drug space, including homeopathic, the challenges of FDA regulatory requirements become confusing. With a mixture of regulations spanning...