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 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,...
Why You Should Outsource Your Food Safety Testing
As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look...
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...
Tim Lombardo Discusses Food Safety for CBD Infused Edibles in NCIA Podcast
Senior Director for Food Consulting Services, Tim Lombardo, recently joined NCIA for a podcast covering food safety of CBD-infused edibles.
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 HunterMay 6, 13, 20, 27, and June 3, 2025If you manufacture products in the OTC-drug space, including homeopathic, the challenges of FDA regulatory requirements become confusing. With a mixture of regulations...
Food Labeling Modernization Act of 2021 Introduced
‘The Food Labeling Modernization Act’ (FLMA) was introduced this month in both houses of Congress by Representative Frank Pallone (D-NJ) and Senator Richard Blumenthal (D-CT), along with Representative Rosa DeLauro (D-CT) and Senators Ed Markey (D-MA) and Senator Sheldon Whitehouse (D-RI). The...
What’s Hot in the Regulatory World
By Richard D’Alosio, EAS Independent Consultant I have always described working in regulatory as an iceberg, with the obvious black and white answers to inquiries akin to the visible iceberg floating in the water. However, underneath the water is the unknown or unregulated areas, and that is where...
Managing Pet Food Ingredients
EAS Senior Director for Food Consulting is featured in an article on pet food ingredients. From safety, to testing to CoAs, the same safety standards apply as with human foods. Read more in Food Engineering Magazine.
Did you know? Color Additives Must Have FDA Approval and (Sometimes) Batch Certification
Color additives for most FDA-regulated products (tobacco and some medical device products are exceptions) must be approved by FDA and listed in the Code of Federal Regulations. If a color additive isn’t listed, its approval must be petitioned and approved by FDA prior to its use in products...
Environmental Monitoring and Mapping Application (emma®)
By Food Safety Net Services Environmental monitoring programs (EMPs) are critical in food processing environments to ensure the prevention and detection of pathogens. Many of these programs have evolved to mitigate risk of contamination and can serve as an early warning sign of risk to food...
Do you Make Good, Clean and Healthy Claims on Your Product Labels?
You may be misrepresenting your products by making claims such as good, clean and healthy. FDA has clearly defined definitions for some claims and deciding which to make to market your products can be tricky. Read the EAS authored article in Snack Food and Wholesale Bakery and learn how you can...
Drug and Device Corner August 2021
FDA has announced most FY2022 user fee rates this month, conspicuously missing are the OMUFA 2022 user fee rates. We will continue to monitor Federal Register notices and share information as soon as it becomes available. Federal Register Vol. 86, No. 142 announcing FDA 2022 GDUFA user fee rates...
Is it a Drug or Cosmetic? EAS Podcast hosted by CPhI
As more and more companies operating in the pharmaceutical space are moving into cosmetics, the temptation is to think that life will be much easier from a regulatory and compliance perspective. However, while it is true that pharmaceuticals are more heavily regulated, this does not mean that...
Validación de limpieza CIP
Presentado por Bernardo Clavijo. Para dar cumplimiento a los requisitos legales y normativos vigentes, es importante realizar la validación de las medidas de control de la inocuidad, entre las cuales está la limpieza y desinfección de las superficies de contacto. ¿Qué significa esto para su...
What are the Requirements for a Successful DMF Submission for an Active API?
EAS independent consultant, Radhika Rajagopalan answers your questions on DMF submissions in Tablets and Capsules magazine. Under the Generic Drug User Fees Act (GDUFA), the FDA applies a holistic, life-cycle approach to the evaluation of active pharmaceutical ingredients (APIs), featuring...
Find the Right Mix: Flavors and Textures and the Discerning Consumer
By Joe Yun Ph.D. Reprinted with permission from Dairy Foods Magazine. You may have heard the statement, “milk is nature’s perfect food.” Nutritionally speaking, that is true. But is the quality of dairy products we consume always perfect? Have you noticed that when you lift a freshly baked pizza...
Pharmaceutical GMPs, Quality Control, and Data: A Deeper Look at FDA’s FY 2020 FDA Observations
By Amy Scanlin Reprinted with permission from FDLI UpdateGood Manufacturing Practices—those minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drug products.1 Though clearly articulated by FDA, a review of FY 2020 pharmaceutical inspection...
Drug and Device Corner July 2021
The FDA has planned a public webinar titled Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency. Please follow the link to register for this webinar scheduled for 25 August 2021. Recently published in the Federal Register, FDA has issued their final...
USDA News: USDA Announces $500 Million for Expanded Meat & Poultry Processing Capacity
USDA has announced a $500 million for expanded meat and poultry processing capacity as part of efforts to increase competition and level the playing field for family farmers and ranchers. This is one of several key steps that USDA intends to take that will increase competition in agricultural...
Did You Know? EFSA No Longer Considers Titanium Dioxide E 171 a Safe Food Additive
The European Food Safety Authority (EFSA) no longer considers titanium dioxide E 171 a safe food additive after safety assessments prompted by a request by the European Commission in March 2020. Using Nanotechnology as part of its assessment, the EFSA determined that titanium dioxide E 171...
Labeling Risk Management – Five Step Plan
By Ronald J. Levine Food labels are under attack. Every day new lawsuits are filed, often as class actions, as well as through regulatory actions. Legal actions concerning words such as “natural,” or “healthy” are all too common. THE FIVE STAGES OF GRIEF While some of the large food manufacturers...
CBP and FSVP: Has Your Product Undergone Substantial Transformation?
Are your FDA-regulated food products made with ingredients sourced from outside the U.S.? If so, and if they are further processed, your food product may have resulted in a new or different product that differs substantially from its original state before processing. In FDA’s and CBP’s (U.S....
FSNS Announcement
We are excited to announce that Certified Group has signed an agreement to merge with Food Safety Net Services (FSNS), a leading provider of laboratory testing services for customers in the food & beverage end-markets. As a result, the newly combined entity will grow to an impressive ~1,580...
Tara Couch Discusses FDA Enforcement of Dietary Supplements in RAPS Regulatory Focus
The pandemic has resulted in an increase in the number of misbranded dietary supplements. As a result, FDA is using updated, alternative, and remote enforcement tools to ensure compliance. Tara Couch, Senior Director for dietary supplement and tobacco services covers what you need to know in a...
Cleaning Validations – Your GMPs Depend on It
An EAS Premium Webinar Presented by Joe McGuinness, EAS Independent Consultant. For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s current Good Manufacturing Practices (cGMPs), the...
Did You Know? FDA Amends Standard of Identity for Yogurt
On June 11, 2021, FDA published in the Federal Register a final rule amending the standard of identity for yogurt, 21 CFR 131.200. The final rule, more than a decade in coming, (proposed rule was published in 2009) has been a priority under FDA’s Nutrition Innovation Strategy. Under the final...