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.
New Ingredients in Pet Food Formulation: Not as easy as creating a product with a few trending ingredients
By Carolyn KennedyEveryone is looking for the next best thing when it comes to pet food. Many companies have tried to introduce new ingredients. Often, the new ingredients in pet foods mirror the trending ingredients in human food. There has been an influx of CBD and hemp treats in pet foods, with...
Did You Know? Equipment Sanitation and Dietary Supplements – Which cGMPs Apply to Me?
As a dietary supplement firm, and a subcategory of foods, how do you decide which cGMPs to follow? The answer is determined by what specifically you produce – dietary supplements or dietary ingredients. Once that is understood, the cGMP operational requirements, particularly around equipment...
GMPs for Hemp and CBD?
Developing solid GMP protocols is essential for firms operating in the hemp and CBD space. Read EAS independent consultant Charlotte Peyton’s blog published on the National Cannabis Business Industry (NCIA)’s website. Join EAS for our upcoming EAS short course on developing quality systems for CBD...
Drug and Device Corner September 2020
EAS would like to remind all eNews readers of the importance of an appointed U.S. Agent. The FDA recently deactivated the FDA registrations of 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. As we head into the FDA registration renewal period,...
EAS Becomes GRMA Trusted Partner
The Global Retailer and Manufacturer Alliance (GRMA) recently confirmed EAS as a Trusted Consulting Partner for their member organizations. As a Trusted Partner EAS assists GRMA member suppliers and vendors with regulatory operational support. Acceptance into the Trusted Partner program is through...
House Vote on Legalization of Marijuana Delayed
Of interest to the hemp, CBD and cannabis industries, the US House Democratic leaders have decided to postpone voting on legislation to decriminalize marijuana at the federal level until after the November 3, 2020 election. EAS team of consultants, under leadership of Senior Director Tara Lin...
Food Legislation in the EU – An Introduction
An EAS Short CoursePresented by Michael Hickey, EAS Independent ConsultantJanuary 12-13, 202111am - 12:30pm eastern each dayIf you sell food products in the EU, understanding EU Food legislation is critical to success. Join EAS Consulting Group’s expert in EU Food regulations, Michael Hickey for a...
California Proposition 65 and the Food Industry
Proposition 65 is a statute that all companies selling products into California must comply with by providing warnings if their products contain certain chemicals that result in consumer exposure above a certain daily threshold. Failure to comply with the stringent requirements …
Process Validation for OTC Liquids and Topical Products
Presented by EAS Independent Consultant, Miguel MontalvoDecember 9-10, 202012:00–3:00pm EasternIf you manufacture OTC liquids, such as hand sanitizers, and other topical products, an effective Process Validation Program is an FDA requirement. Do you have a robust Process Validation Program at your...
Developing Quality Systems for the CBD and Hemp Industries – EAS Short Course
As states begin to regulate legalized CBD and hemp, the concern of how Good Manufacturing Practices (GMPs) apply to these unique industries cannot be understated. While regulations vary from state to state the quality systems under which products are grown …
Hygiene Improvement, Monitoring & Tracking
While the “new norm” for food manufacturing hygienic practices is rapidly evolving, an intense focus on proactive assurance of food and employee safety is the top industry priority. With increased focus on hygienic practices comes an increased requirement to data …
Understanding and Mitigating Risks of Emerging Pathogens
The food industry has a history of testing for Enterobacteriaceae, coliforms and/or E. coli as indicator microorganisms. Since 2009 there were 40 outbreaks in the United States of pathogenic E. coli such as Shiga toxin-producing E. coli (STEC) associated with leafy greens…
Did you Know? EAS Assists with California Prop 65 Requirements
Proposition 65 requires specific warnings be applied to products sold in California that contain any one of the ~900 chemicals on the Proposition 65 list, whereby use of the product results in consumer exposure to those chemicals above Safe Harbor Levels. EAS is a regulatory partner helping firms...
Maintaining Compliance through Virtual Audits
When the phone rings at EAS Consulting Group lately it is very often someone seeking assistance with Good Manufacturing Practices. While COVID-19 has caused major disruptions to global supply chains and manufacturing capabilities, FDA regulated industries forged ahead…
Using Legal Dietary Ingredients in Sports Nutrition Products
James Hoadley, Ph.D. wrote an article on ensuring use of legal dietary supplement ingredients for Natural Product Insider. Regulators have a fine focus on dietary supplement products that are mislabeled or misbranded, and brands must be careful when it comes to ingredients and classification as a...
Cleaning-In-Place (CIP) Validation
“Validation” is a term and concept that is widely used but is also widely misused and misunderstood. Validation of food safety control measures is currently a mandatory requirement in US, other countries and in internationally accepted regulations, but also in GFSI certification schemes, i.e. SQF, BRC, FSSC22000 and IFS. Several FDA and USDA regulations including FSMA Preventive Controls, LACF/AF…
Did You Know? EAS Offers USDA Consulting Services, Including Labeling Assistance and Organic Requirements
EAS independent consultants include experts in USDA regulations. From the unique requirements of USDA labeling to food safety of domesticated meat products and shell egg products, you can be confident that EAS offers accurate and thorough advice and actionable compliance plans in accordance with...
EAS Authors Chapter in Present Knowledge in Nutrition 11th Edition Published by Elsevier
Just released on July 31, 2020, EAS Independent Consultants Betty Campbell, James Hoadley, Ph.D. and Robert Post, Ph.D. co-authored an article on Nutrition in Labeling including topics such as mandatory and optional nutrition label information in specified formats and optional nutrition-related...
How to Perform an OOS Investigation for Tablets and Capsules magazine
Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. authored an article on How to Perform an OOS Investigation for Tablets and Capsules magazine. EAS is a recognized industry leader for regulatory services to the dietary supplement industry. Contact us today for...
Hygienic Equipment Sanitation – Best Practices for Food Safety
This short course offers practical information on best practices, “real-world” examples and tips on how to enhance daily operations related to improving existing food safety and quality programs. The three-session training will focus on criteria for selecting, installing and maintaining processing …
Did You Know? EAS is now aligned with Certified Laboratories and its subsidiaries, Labs-Mart, LabStat and ABC Testing
As you read in the December 2019 edition of EASeNews, EAS is now a member of the Certified family of companies. This means clients can enjoy additional regulatory benefits of product testing and validation through our partner organizations in the U.S. and Canada. From foods to supplements, from...
Enhancing Food Safety Through Technology
If you missed EAS independent consultant Dr. Susan’s Moyer’s presentation for a Food Safety Strategies webinar on food technology and food safety, it is now available on-demand on the Food Safety Strategies website. EAS offers comprehensive solutions …
Cell-Cultured Meat Products and Plant-Based Protein Analogues
An EAS Consulting Group White Paper discusses regulatory aspects and consumer trends in cell-cultured meat products and plant-based protein analogues.
As consumer acceptance …
Selecting and Submitting an ANDA Application
The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until …
Retail Food Safety in a Post-Pandemic World
The Retail Food Industry is finally beginning to see an opening as many areas of the country are experiencing decreasing cases of COVID-19, meaning businesses can begin to safely scale up. But what does that mean and how can the retail food industry ensure safe operations in this new normal? Do you understand …
Did You Know? EAS Helps Firms Prepare for FDA Inspections Against Intentional Adulteration Rule
FDA began inspections for Intentional Adulteration (IA) Rule components in March 2020, including assessment of Food Defense mitigation strategies, verification of effectiveness and the development of corrective action steps to be taken in the event that the mitigation strategy was not implemented...
Personal Care and Healthy Aging
As the overall population of the U.S. continues to gain longevity, consumers demand personal care products that address the signs and symptoms of aging. Everyone gets older, but no one wants to feel or look older.
Consumers are willing to pay a …
Good Manufacturing Practices – Comprehensive Equipment and Utility Change Control for GMP Production Facilities
Many companies limit change control to documentation, such as batch records, SOPs, protocols and specifications, while handling equipment and change control in isolation. As a result, new equipment is often installed and connected to utilities without input from facilities, engineering, validation and …
Biosimilar Biological Products: Development & Applications
The US Food and Drug Administration (FDA) is responsible for advancing the public health by helping to speed innovations that make medicines safer and more effective and by helping the public get the accurate, science-based information it needs to use medicines to maintain and improve public...
Dietary Supplement Contract Manufacturing Partnerships and Regulatory Compliance
For a number of years, many dietary supplements have been produced by contract manufacturers. As manufacturing processes become more sophisticated (e.g., complex probiotics) and FDA regulatory requirements continue to expand, it becomes more cost-effective to use the knowledge, experience and...