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.
Preparing for a PMTA Pre-Approval Inspection
Complimentary webinar presented by EAS Consulting Group and LabStat September 15, 2020 at 11:00am eastern Presented by Tara Lin Couch, Ph.D., EAS Senior Director for Dietary Supplement and Tobacco Services & Andrew Mooney, LabStat The Family Smoking Prevention and Tobacco Control Act referred...
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...
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...
Drug and Device Corner July 2020
The FDA is remaining vigilant in their monitoring of OTC hand sanitizer products. Their highest concerns, from a manufacturing and marketing perspective, are hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. They are also taking action against...
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...
Understanding and Mitigating Risks of Emerging Pathogens
September 1, 2020 at 1pm eastern Presented by EAS Independent Consultants, Kathy Knutson, Ph.D. and Kathy Glass, Ph.D. 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...
California Proposition 65 and the Food Industry
Key Issues and Practical GuidanceSeptember 24, 2020 at 1pm eastern Presented by EAS Independent Consultant Tom JonaitisProposition 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...
Low Acid Canned Food and Acidified Foods – Current Topics for the Food Industry
EAS Consulting Group and partner organization and testing laboratory, Certified Laboratories, are co-presenting a complimentary webinar that will review the basic regulatory requirements of low acid canned foods and acidified foods in the US.
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 demonstrating a solid …
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 …
EAS Update: FDA Announces Resumption of Domestic Inspections with New Risk Assessment System
FDA announced on July 10, 2020 its intention to resume prioritized domestic inspections beginning the week of July 20, 2020. The locations of inspections will be based on the COVID-19 virus’ trajectory in a given state and locality as well as the rules and guidelines that are put in place by state...
GRAS for Cannabinoids
FDA has not received and accepted any generally-recognized as safe for food-use (GRAS) notifications for purified cannabinoids (a.k.a. cannabinoid isolates) to date. Zero. Said another way, if the title of this article were a punny crossword puzzle clue, the only possible answer would be black squares…
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...
Drug and Device Corner June 2020
OTC Monograph reform is here. The FDA recently distributed an email to all drug establishments registered as OTC manufacturers in preparation for the Over-The-Counter Monograph User Fee Program (OMUFA). OTC Monograph Reform legislation passed by congress this spring has empowered the FDA to assess...
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 …
Modifications to FDA Food Labeling Requirements – Temporary Changes During COVID-19
Compliance with food ingredient, allergen and nutrition labeling rules has never been more challenging, particularly now as manufacturers may be challenged because of raw material supply changes during the pandemic. As the realities of COVID-19 became apparent, the …
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 an ANDA …