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.
Independent Consultant Angel Suarez Covers Food Code Guidelines
Angel Suarez was interviewed on GMPs and Food Code 2017 Guidelines in an article published in Food Safety Strategies. In the food area, the GMPs ensure that ingredients, products and packaging materials are prepared, presented and handled safely and that food products are prepared in a suitable...
Cutting Edge Methods for Detecting Food Fraud
The challenge of detecting Food Fraud has never been greater nor the economic loss to food manufacturers, importers, retailers and consumers. In the recent past, we have had to rely on the integrity of the supply chain, person to person relationships and trained sensory
Therapeutic Nutrition: Potential and Challenges for Novel New Products
David Cockram, Independent Consultant, EAS Consulting Group, LLC We live in exciting times, with new discoveries being announced daily about the relationships between nutrition, diet, health, and disease. So much so that it’s often hard to keep track of whether this food or food component is...
Did you Know? Requirements for Animal Food/Feed Manufacturers Include Preventive Controls
Preventive Controls for Animal Food/Feed is a requirement for all manufacturers of animal food/feeds. EAS expert, Jerry Poley, who assists clients with food safety audits including requirements for HACCP, FAMI QS, FPA Safe, PAACO (Professional Animal Auditor Certification Organization) as well as...
Tips to Streamlining the Drug Master File Process
The meticulous detail of a Type II Drug Master Files (DMF) enables FDA to review and assess the chemistry, manufacturing, stability, purity, impurity profile, packaging and Good Manufacturing Practices data of Active Pharmaceutical Ingredients (API) or a finished drug dosage form …
Greg Weilersbacher on Change Control for GMP Production Facilities
Many companies limit change control to documentation while handling equipment and facilities in isolation, but that practice can wreak havoc on GMP operations.
Compliance with Mobile Medical Devices Discussed in MedTech Intelligence
Device companies seeking to develop products that include a mobile app must ensure regulatory compliance with product and data safety.
Top Five Hurdles for FDA ANDA Submissions and Approvals
By Radhika Rajagopalan 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....
Couch Authors Article on GLPs for Dietary Supplement Contract Labs
Supplement brands that partner with contract labs must ensure they are following good lab practices and other quality assurance programs.
Did You Know? The FDA Uses DUNS Numbers to Verify Company Information!
Data Universal Number Systems, commonly known as DUNS are unique, site specific, nine-digit identification numbers provided by Dun & Bradstreet (D&B) and used globally. Free to obtain, FDA and other federal agencies use DUNS numbers to track and verify company name, address, phone number,...
January 2020 Drug and Device Corner
Is your labeler code up to date?!? Chances are if you have not thought about this file since you originally requested a labeler code from the FDA, it could use an update. We saw during the drug listing certification period, that several labeler codes were reflecting outdated information. Keep in...
Couch Co-Authors Article in FDLI Update on PMTAs for Deemed Products
In October the FDA Center for Tobacco Products (CTP) held a Public Meeting about Preparing Marketing Applications for Deemed Products. A summary of that meeting was co-prepared by Tara Lin Couch, Ph.D. and published FDLI Update magazine.
Steve Armstrong Interviewed on Marketing Claims
Consumers demand certain qualities—think clean label, zero sugar and non-GMO, for example, and marketing claims can affect the ways that foods and beverages are produced.
Comprehensive Equipment Utility Change Control GMP Production Facilities
Tablets and Capsules January 22, 2020 https://tabletscapsules.com/article/comprehensive-equipment-utility-change-control-gmp-production-facilities/ Greg Weilersbacher
How Food and Beverage Marketing Claims Can Affect the Production Process
Food Engineering January 17, 2020 https://www.foodengineeringmag.com/articles/98672-how-food-and-beverage-marketing-claims-can-affect-the-production-process Steve Armstrong
Codex Opportunities for Food Manufacturers
Can Codex food standards and various food safety, hygiene guidelines and codes of practice positively impact domestic food manufacturers that do not export? The short answer is “YES!” Codex provides a transparent international platform for food safety and hygiene as well as manufacturing practices, food …
Developing a Mobile Medical Device? FDA Is Watching
MedTech Intelligence January 6, 2020 https://www.medtechintelligence.com/column/developing-a-mobile-medical-device-fda-is-watching/ Amy Scanlin
When you Need an Expert – Ask EAS!
In this month’s Ask the Expert column, we thought we’d start this new year by taking the opportunity to humbly share why we at EAS are confident that our staff and consultants offer the best expert regulatory knowledge in the industry, providing proactive and accurate solutions to your most...
FDA Cites Multiple Violations for Selling CBD as Supplement, Food, Cosmetic or Animal Food Ingredient
By Gisela Leon, MS, MBA, Independent EAS Consultant On November 22, FDA published 15 warning letters in a “catch all” effort regarding cannabidiol products. The products range from articles sold as dietary supplements, conventional foods, cosmetics, and animal food. FDA sent out the 15...
December 2019 Drug and Device Corner
Guidance Document updates on the FDA website All divisions Certificates of Confidentiality (distributed for comment purposes only) - This draft guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC)....
Dietary Supplement and FSMA EAS Webinar – On-Demand
Did you know that some parts of FSMA also apply to dietary supplements? Watch our EAS on-demand webinar to ensure your understanding with requirements.
FDA’s CTP Updates Industry on Premarket Tobacco Product Applications for Deemed Products
If you missed FDA’s public meeting on PTMAs, click here for a summary co-prepared by EAS and published in the Food Drug Law Institute Update magazine.
Best Practices in Equipment Sanitation – An EAS On-line Short Course starting January 29, 2020
Equipment sanitation is at the heart of food safety and quality programs. From selecting, installing and maintaining processing equipment to documentation of FSMA compliance, these “best practices” are critical.
Contract Labs for Safe, Compliant Supplements
Natural Products Insider December 6, 2019 https://www.naturalproductsinsider.com/labstesting/contract-labs-safe-compliant-supplements Tara Lin Couch, Ph.D.
Dietary Supplements and FSMA Compliance – Fallacy or Fact?
In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed
Safety Data Sheets – A Requirement for Safe Manufacturing Operations
Food Quality and Safety Magazine published an article written by EAS Independent Consultant Robert Kapp Safety Data Sheets (SDS) covering their importance and utilization in manufacturing operations. SDS, are a critical component, required by law, containing all the basic information about a...
Ready to be an Expert Witness? Concerned about Dietary Supplement GMPs?
If you missed our recent webinars you are now able to view them free on-demand on the EAS website. Our Expert Witness bootcamp, presented by EAS Independent Consultant and General Counsel at Herrick Feinstein, Ronald Levine, and his colleague at Herrick, Leah Kelman, provided a great opportunity...
Are You Making Natural Color Claims On Cosmetic Products?
FDA has stated all color additives are synthetic, so “natural colors” in cosmetic products must be an inherent color of an ingredient, not added for coloring, says John and Catherine Bailey, EAS Independent Consultants and experts on cosmetics. Their article on natural claims was published in...
Your Food Additives May Need GRAS
As innovative food companies develop an array of products to satisfy a discerning consumer, the question of whether food additives intended for use in those products are safe for their intended uses. According to FDA, "GRAS" is an acronym for the phrase Generally Recognized As Safe. Under...
November 2019 Drug and Device Corner
REMINDER: we are at the end of the renewal period (1 Oct – 31 Dec) for medical device & drug establishment registrations, as well as drug listing certifications. Please factor holiday schedules as well as the potential of a U.S. government shutdown into your renewal timing. EAS would like to...