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 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 …
Low Acid Canned Food and Acidified Foods – Current Topics for the Food Industry
Do you think you have a robust food safety plan to deal with your acidified foods products?
Do you have protocols in place to address …
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 …
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 …
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 …
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 …
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...
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 …