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.
EAS is Marquee Sponsor of TMA’s 103rd Annual Meeting and Conference
EAS President and COO, Dean Cirotta and Independent Consultant Karen Dixon will attend the Tobacco Manufacturers Association’s Annual Meeting and Conference taking place April 9-11, 2018 in Leesburg, VA. EAS is also a Marquee Sponsor of the event. The meeting will discuss FDA’s new policy...
Adverse Events, Serious or Not?
By Norma Skolnik This month’s Ask the Expert question on Serious Adverse Events Reporting is answered by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement industries. Prior to consulting, she...
March 2018 Drug and Device Corner
EAS would like to bring to your attention, the Statement from FDA Commissioner Scott Gottlieb, MD regarding drug compounding outsourcing facilities. The Drug Quality and Security Act (DQSA) was enacted by Congress in 2013 in response to a significant safety issue experienced by the public as the...
Homeopathy – What Does the Future Hold?
By Susan Crane, Independent Advisor for OTC Labeling It's been clear for several years that the FDA, as well as the Federal Trade Commission (FTC), are turning up the heat on homeopathic drug products. It culminated in December 2017 when the FDA published a draft guidance document for both FDA...
U.S. CODEX Office Relocated Within USDA, New Opportunities for the Food Industry
The Codex Alimentarius Commission (Codex) is a United Nations food standards setting body working under the auspices of the Food and Agriculture Organization and the World Health Organization (WHO). The official mission of Codex is to protect consumers’ health and ensure fair practices in the food...
Dietary Supplements vs. Foods — A FSMA Regulatory Challenge
In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of food, called “dietary supplements,” which created a new subcategory of FDA-regulated foods. Many parts of the Food, Drug and Cosmetic Act (FD&C) still apply to dietary supplements; however, DSHEA...
Heather Fairman Answers Q&A in Natural Products Insider
EAS Independent Consultant Heather Fairman contributed to a Q&A in Natural Products Insider on Successfully Choosing and Maintaining a Contract Manufacturing Partnership. Heather was part of a panel of experts that discussed contract manufacturing aspects that brand owners should evaluate in a...
Food Quality and Safety Publishes EAS Authored Article on Audits and the Food Safety System
EAS Independent Consultant, Rob Carper, has written an article on how audits are an integral part of the food safety system for Food Quality and Safety Magazine. “Food safety plans must be monitored and verified throughout the year, making sure the entire written food safety program is being...
What’s New at FDA
The Center for Food Safety and Applied Nutrition has released the 2017 Food Code Book which includes science-based guidance for reducing known risks of foodborne illness. Originally designed for foods offered at the retail and food service locations, it has been widely adopted by the state, local,...
EAS Consultants Instructing FDLI Introductory Courses
EAS Consulting Group is honored to be a member of the Food Drug Law Institute and is pleased to be invited speakers to a number of upcoming events. Independent Consultant, Mark Nelson, will present an introductory session on Overview of U.S. Food Law and Regulation of Food at the Intro to Food...
Does Our Company Offer Enough Training?
By Karen Dixon EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants and Senior Directors will answer one question sent in by readers (edited if applicable to remove identifying information). If you’d like to submit a question, please...
FSVP – Next Compliance Dates for Some Importers of Human and Animal Foods
By Charles Breen, Independent Advisor for FSMA The next FSMA/FSVP compliance date is March 19, 2018. FDA enforcement activities begin with: Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF); Importers of animal food...
Have a Cup of Coffee and Pray – It’s the 20th Anniversary of the Seafood HACCP Rule
By Tim Hansen, Independent Consultant HACCP, of course, stands for Hazard Analysis Critical Control Point, is a highly effective preventive control system for foods and other commodities. “Have a cup of coffee and pray” was how one skeptical USDA union official described HACCP implementation in...
FDA Responds to GAO’s Report on Insufficient Agency Oversight of Recalls
By Charles Breen, Independent Advisor for FSMA The December 2017 Department of the Inspector General report on FDA’s food recall process included some particularly harsh criticisms of the agency including inadequate authority, oversight and follow-up on voluntary food recalls. These criticisms...
FDA’S Policy on Medical Foods
By Elizabeth Campbell, EAS Independent Advisor for Labeling and Claims “Medical food” is a commonly misunderstood term as it is used on FDA regulated products. Many manufacturers want to market their products as medical foods because medical foods are exempt from the disease statement limitations...
EAS President and COO to Speak at Keller and Heckman E-Vapor and Tobacco Law Symposium
Keller and Heckman’s Second Annual E-Vapor and Tobacco Law Symposium take place in Irvine, CA February 6-7, 2018. This comprehensive 2-day course will address regulatory issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including FDA ingredient...
Armstrong to Moderate Session at FDLI Webinar on First Amendment Issues in Advertising and Product Packaging
Due to overwhelming response at the December FDLI Enforcement, Litigation, and Compliance Conference on the topic of First Amendment Issues in Advertising and Product Packaging, FDLI will be hosting a webinar on subject February 13, 2018, from 2:00-3:30 pm ET. EAS Independent Advisor Steve...
Medical Device Quality Auditing
Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting …
An Overview of Drug Master Files
DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and …
FDLI Publishes Article on The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI
The prestigious FDLI Update November/December 2017 Student Corner included an article written by EAS Regulatory Intern and recent Georgetown University graduate, Rahul. The article, The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI, discusses how pharma companies can...
Cirotta to speak at Keller & Heckman Forum on e-Vapor and Tobacco
EAS President and COO, Dean Cirotta will speak at the February 6-7, 2018 Second Annual E-Vapor and Tobacco Law Symposium in Irvine, CA. This comprehensive 2-day course will address regulatory issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers...
Pharma’s Problems with Data Integrity
By Independent Consultant, Brian Nadel Data Integrity needs to be taken seriously in the pharmaceutical industry today and always! The FDA has issued many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years....
Ask the Expert January 2018
By Allen Sayler EAS Webinar on FDA Draft Guidance: “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry” October 31, 2017 EAS received an overwhelming response to our recent webinar on controlling Listeria monocytogenes in ready-to-eat foods. As a service to the...
Produce Safety Requirements for Large Firms
By Charles Breen, Independent Advisor for FSMA The coming year will be a busy one for food firms as the compliance date for 14 components of the FSMA Final Rule come into effect. FDA has published a helpful tool, Key Dates for Compliance, which runs through 2024 and this quick, color-coded...
December 2017 Drug and Device Corner
We would like to highlight one of the Draft Guidance issued by the FDA this month.**The U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. This proposed new approach would update the FDA’s existing policy to better address...
Unraveling The Impact of FSMA On Acidified Food Regulations
This webinar hosted by EAS Consulting Group will provide you with these answers. The webinar will be presented by EAS Independent Consultant Omar A. Oyarzabal, Ph.D., a microbiologist processing authority, and FDA Consumer Safety Officer Priya Rathnam with the Office of Compliance …
FDA Allows Co-Manufacturers More Time to Comply With Supply-Chain Program Requirements
In a nod to one of the more complex aspects of current food manufacturing and FSMA compliance, FDA recently published guidance that it will exercise enforcement discretion for two years over supply-chain requirements for domestic co-manufacturers of human and animal foods, and also under the...
The Role of Regulatory Affairs in Product Development
Regulatory Affairs touches each and every product within a company, ensuring compliance with local regulations and internal policies and the creation of sound guidelines related to labeling, safety, and nutrition. Through the strategic links to trade associations, Government …
FDA Issues Guidance on Facilities Exempt from CGMP and Preventive Controls
One of the first steps for assessing a facility’s compliance status under the rules implementing the Food Safety Modernization Act is to consider whether the facility is required to comply or if it may qualify for an exemption, however narrow it may be. As a simple rule of thumb, if a food...
FDA Proposes Four-Year Compliance Delay for Produce Rule’s Water Standard
FDA issued a proposed rule September 13, 2017, that would extend the compliance dates for agricultural water requirements in the Produce Safety Rule, giving the agency four years to reconsider the water standards to ensure that they are feasible. FDA Commissioner Scott Gottlieb hinted at a...