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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.

Medical Device or a Wellness Device?

Medical Device or a Wellness Device?

Wellness devices are big business, creating an accountability partner for the user and providing real-time data to their medical provider. But where does a wellness device cross the line to a medical device and what does that mean for the manufacturer? From design, to claims to special

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PCQI Training: Is it worth it?

PCQI Training: Is it worth it?

by Elise Forward, EAS Independent ConsultantI will admit to being biased on the many benefits of becoming your food firm’s Preventive Controls Qualified Individual (PCQI). It’s an important position, one required by FDA for ALL food manufacturing and warehouse facilities. The PCQI has...

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Flour HACCP Begins with Food Safety Inspections

Flour HACCP Begins with Food Safety Inspections

Consultant Steve Hufford wrote an article on the importance of equipment inspections in support of HACCP efforts, with a discussion of their application specific to flour mills. Read more in Snack Foods and Wholesale Bakery online.

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The Human Factor of Regulatory Compliance

The Human Factor of Regulatory Compliance

Robert Lavieri discussed the human factor of meeting compliance requirements in Food Safety Magazine. Have you asked yourself how best to hold operational, maintenance, quality, and folks on floor, accountable for reliably executing their part of a compliance plan? From FDA to USDA to EPA to OSHA,...

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Of the Package, By the Package and For the Package

Of the Package, By the Package and For the Package

By Thomas Dunn, EAS Independent ConsultantProviding safe food requires both safe food packaging materials and risk prevention by that packaging.  As an integral part of the food supply chain, packaging may pose biological, chemical, or physical hazards to the food supply. But as soon as packaged...

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Drug and Device Corner March 2021

Drug and Device Corner March 2021

Client UpdatesThe FDA has finally taken steps to stop companies that use ‘FDA Certificates’ as marketing tools.  The FDA has 2 websites with further information, FDA Calls on Certain Firms to Stop Producing and Issuing Misleading “FDA Registration Certificates” and Are There "FDA Registered" or...

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Top Five Considerations for Pre-Submissions

Top Five Considerations for Pre-Submissions

By Elvira Cawthon, EAS Independent Consultant Premarket submissions for medical devices are costly, time-consuming, and denial of a submission can be devastating. Though the FDA Q-Submission (Q-Sub) Program, designed to minimize risk by enabling Sponsors and Manufacturers the opportunity to attain...

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Did You Know? Medical Foods and FDA – Regulatory Scrutiny Ahead

Did You Know? Medical Foods and FDA – Regulatory Scrutiny Ahead

A medical food per FDA is a specific category “formulated to be consumed… under the supervision of a physician and which is intended for the specific dietary management of a disease or condition” which need “distinctive nutritional requirements.” This means that medical foods are not those simply...

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Safe Foods for Canadians – What you Need to Know

Safe Foods for Canadians – What you Need to Know

The Canadian Food Inspection Agency (CFIA) is responsible for the safety of food products sold in Canada by enforcing the recently implemented Safe Foods for Canadians Regulation (SFCR). It is a compilation of 14 sets of regulations governing safety of human …

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Drug and Device Corner February 2021

Drug and Device Corner February 2021

CDER's Work to Meet User Fee Goals During the Pandemic website includes an overview of the agency’s thinking regarding manufacturing facility inspections during the age of COVID-19. As always, the FDA will use a risk-based approach to identify facilities that require pre-approval inspection for...

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USDA Regulatory Requirements for Food Safety

USDA Regulatory Requirements for Food Safety

Instructor EAS Independent Consultant Armia Tawadrous, DVM A 12-hour seminar in three-parts, taking place June 14, 16, 18, 2021 From 11am-3pm eastern each day  The sensitivity of meat and poultry products to microorganism contamination by bacteria, viruses and parasites renders them an...

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USDA Labeling Compliance Virtual Seminar

USDA Labeling Compliance Virtual Seminar

Instructor EAS Independent Consultant Susan GlennApril 5-6, 2022 12pm-3pm eastern each dayIf you develop USDA-regulated products you need to understand USDA labeling requirements. USDA labeling has its own set of allowable product names, claims and nutrition labeling requirements. EAS Consulting...

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Did You Know? Biopesticide Registration is Required by the EPA

Did You Know? Biopesticide Registration is Required by the EPA

Derived from natural materials, biopesticides, are inherently less toxic than conventional pesticides and when used as a component of Integrated Pest Management (IPM) programs, can greatly reduce conventional pesticide use and improve crop yields. EPA has regulatory authority over biopesticides as...

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Cosmetic Regulations, Labeling and Safety Virtual Seminar

Cosmetic Regulations, Labeling and Safety Virtual Seminar

How to Ensure Your Products Comply with the US RequirementsInstructors EAS Independent Advisor for Colors and Cosmetics, John Bailey, Ph.D. & EAS Independent Consultant, Catherine BaileyOctober 27, 2022 - 11:00am-3:00pm easternCosmetic products are expected to only exert superficial, not...

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Drug and Device Corner January 2021

Drug and Device Corner January 2021

EAS Client UpdatesBreaking News: FDA Places All Alcohol-Based Hand Sanitizers from Mexico on Import Alert As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand...

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Streamline Food Exports to the US

Streamline Food Exports to the US

Six Steps to Compliance SuccessEnsuring compliance with FDA’s Food Safety Modernization Act (FSMA) can be confusing, particularly for foreign-based companies trying to comply with the additional traceability requirements of FSMA’s Foreign Supplier Verification Program (FSVP). Did you know that EAS...

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FDA Withdrawal Announcement

FDA Withdrawal Announcement

The FDA published today in the Federal Register Vol. 86, No. 3 a withdrawal of their December 29, 2020 Federal Register Notice entitled Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021./p> With the FDA’s most recent announcement, the agency is informing the...

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Is your CMO Aware of Their FDA Obligation for OTC-Drug User Fees?

Is your CMO Aware of Their FDA Obligation for OTC-Drug User Fees?

Last week FDA announced the fiscal year 2021 OTC-Drug User Fee rates in a Federal Register Notice. Under the new 2021 rates: Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $14,060. Owners of a contract manufacturing facility will...

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