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.
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...
Food Labeling Challenges in a Pandemic
Under normal circumstances, food producers have many plates to spin in order to comply with food regulations, including food labeling requirements. Most especially, in order to assure accurate food ingredient, allergen and nutrition labeling, manufacturers must be certain they possess the most recent …
EAS GRAS Submissions for CBD Webinar Available on IFT Website
EAS consultant Robin Guy and long-time friend of EAS, Marc Ullman of Rivkin Radler LLP, presented a webinar on GRAS submission considerations for the Institute for Food Technologists. Now available on-demand (complimentary for IFT members) on the IFT website, Robin delves into the types of studies...
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...
Tom Jonaitis Quoted in Natural Products Insider Article on GRAS and NDI Pathways for CBD Products
Natural Products Insider published an article on the possibility of an FDA regulatory pathway for CBD products. EAS independent consultant and GRAS/NDI expert toxicologist, Tom Jonaitis is one of the experts quoted. Read more. Should you have interest in considering a GRAS or NDI submission for...
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...
GRAS or NDI for the CBD Industry? EAS and Frost Brown Todd Webinar Available On-Demand
Tom Jonaitis co-presented a webinar with attorneys from Frost Brown Todd LLP discussing the current regulatory status of CBD products and possible FDA regulatory pathways via Generally Recognized as Safe (GRAS) and New Dietary Ingredients (NDI) for use as an ingredient in food or supplement...
Drug and Device Corner for May 2020
FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent …
Virtual Book Tour – Food Safety Lessons for Cannabis-Infused Edibles
Join EAS for a live virtual book tour as independent consultant, Kathy Knutson launches her new book Food Safety Lessons for Cannabis-Infused Edibles covering the manufacturing evolution as cannabis moves from isolation to regulatory compliance.
The cannabis industry has unique …
EAS COVID-19 Reopening Strategies – Are you Prepared?
As states begin to ease restrictions, the dawn of a new sense of normalcy is on the horizon. For FDA and USDA regulated industries, that new normal requires immense planning and preparation, before returning to pre-pandemic operations. Is your restaurant or retail facility, staff and management...
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 …
GRAS is Greener When You Choose EAS!
EAS Support for GRAS Notices and Self-GRAS Determinations GRAS Services Information EAS Submission Support Product Development Strategic Support Regulatory Support for Law Firms EAS KNOWS GRAS – Articles and Webinars that you may find helpful Understanding GRAS Submissions - On-Demand Webinar GRAS...
Food Safety and Employee Protection for the Food Processing Industry During the COVID-19 Pandemic Presented in Spanish
Inocuidad de los Alimentos y, Protección para Empleados de la Industria que Procesa Alimentos Durante La Pandemia Del COVID-19Presented by Angel Suarez and Veronica Montellano, EAS Independent ConsultantsLa pandemia de COVID-19 ha puesto al mundo frente una amenaza sin precedentes. Como...
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 …
Temporary Policies Regarding Preventive Controls and FSVP During the COVID-19 Public Health Emergency
FDA has implemented temporary policies regarding compliance with FSMA’s Foreign Supplier Verification Program during the COVID-19 pandemic. What do these changes mean for your business and how can you best ensure foreign suppliers are appropriately …
Allen Sayler Receives IAFP Honorary Life Member Award
EAS is pleased to announce that Senior Director for Food Consulting Services, Allen Sayler, has been awarded the prestigious International Association of Food Protection (IAFP) Honorary Life Member. This award, through nomination by industry colleagues, recognizes Allen’s career achievements and...
Reality Due to Globalization
The year 2018 witnessed the 100th anniversary of the influenza H1N1 pandemic, sometimes referred to as the 1918 Spanish Flu. Despite being coined the Spanish Flu, its origins are unknown. That pandemic, which killed an estimated 50 million worldwide and 675,000 in …
Writing Effective SOPs Can Influence Compliance
EAS independent consultant, Heidi Stuttz discussed how writing effective SOPs can influence compliance and build a better organization in Drug Development Delivery. Drug firms must devote time, diligence, and meticulousness in the development of safe product design, materials …