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.
May 2018 Drug and Device Corner
In the ongoing effort to make more affordable drugs available to the public, FDA Commissioner Scott Gottlieb, MD issued a statement on the FDA’s efforts to assist in this process. Of particular note is the FDA’s commitment to ensuring generic drug developers have access to brand drug samples for...
New Brewers Need to Know GMPs
By Charles Breen, Independent Advisor for FSMA The explosion in the numbers of new breweries is a blessing for beer drinkers and their communities. In FDA’s eye, beer is food, and while exempt from preventive control requirements, brewers must comply with good manufacturing practice regulations,...
EAS to Moderate Two Panels at IFT Annual Meeting, Exhibits at booth #S322
EAS will be well represented at the upcoming IFT Annual Meeting taking place in Chicago, July 15-18, 2018. EAS Chairman and CEO, Ed Steele, President and COO, Dean Cirotta and Senior Director for Food Consulting Services, Allen Sayler, will be manning the EAS booth (#S322) and taking questions...
EAS Authors Article in MedTech Intelligence on the New De Novo Pathway
EAS authored an article for MedTech Intelligence on FDA’s new approach to the regulatory pathway for De Novo medical device classification which simplifies the approval process for the class I or class II devices for which there is no one-to-one precedent or predicate. De Novo applications are...
Why is Codex Alimentarius Important to Me?
By Allen Sayler This month’s Ask the Expert is answered by Senior Director for Food Consulting Services, Allen Sayler, who recently returned from the 50th session of the Codex Committee on Food Additives held in Xiamen, China where 53 countries and 32 food industry observer organizations...
USDA Announces Members of NACMCF – Two EAS Independent Consultants are Included
The names of new and returning members of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) have been announced and the committee now includes two EAS Independent Consultants. Returning member, Dr. Omar Oyarzabal who is a professor at the University of Vermont and...
FDA Expands Data Dashboard to Include FSMA
A new section of the FDA Data Dashboard has been launched to help importers and manufacturers/processors meet supply-chain requirements under the FDA Food Safety Modernization Act (FSMA) by helping them more easily find compliance and enforcement information related to specific firms. Three of the...
Medical Device Innovations and the Regulatory Landscape
By Dawn Wydner, Independent Consultant I’m amazed as I watch a Health Care System and then a Spectrum commercial to what our future holds with the sophisticated, interactive medical device and technology innovations and how they will enhance the capabilities of diagnosis and treatment. My...
EAS to Exhibit at Food Defense Conference
EAS will be exhibiting at the upcoming fourth annual Food Defense Conference to be held May 22-24, 2018 in Minneapolis. Senior Director for Food Consulting Services Allen Sayler will be in attendance along with experts from around the world to discuss and learn from each other about the current...
CTP Updates Provisional Substantial Equivalence Review Process
EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket...
Tara Lin Couch, Ph.D. to Discuss Preparing for Cannabis GMPs
Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). As states begin to regulate legalized cannabis, the concern of how GMPs...
Gabe Miller Discusses Necessity of Food Safety Programs for the Cannabis industry
Gabe Miller, an expert in Food Safety Programs has written an article for the Cannabis Industry Journal on how solid food safety programs can help make cannabis products safer and save businesses a lot of time and money. Gabe spoke at the upcoming University of Madison Cleaning and Sanitation...
Fairman Authors Articles on Workplace Safety and Golden Rules for Co-Packers
Independent Consultant, Heather Fairman has published two articles recently. One in Food Processing Magazine focuses on the positive impact of workplace safety programs on corporate culture. Next, she wrote about five “golden rules” for co-packers to stay competitive and profitable for Natural...
Steve Murphy to Present on Raw Materials at ADSA in Knoxville
Steve Murphy will present a session called “Time for Change; Indicators of Public Health Concern for Raw Milk and Processed Dairy Products” at the upcoming American Dairy Science Association Annual Meeting taking place June 24-27, 2018 in Knoxville. Says Murphy, “Regulatory standards used as...
EAS Independent Experts Offer Summer Webinar Compliance Series
EAS Consulting Group is offering a full line-up of educational opportunities through our informative webinar series. These 45-minute webinars are an opportunity to get up to the minute regulatory information on the latest topics pertaining to FDA regulated industries, with time for questions after...
FDA Confirms to Congressional Representatives that Safety is the Number One Priority for Dietary Supplements
FDA recently responded to a letter from congressional representatives regarding product safety in the dietary supplement industry. In the letter, dated April 12, 2018, the agency states that safety, product integrity, and informed decision-making are the prioritization factors used to determine...
April 2018 Drug and Device Corner
Reminder! 5 May 2018 is the date for DMF (Drug Master File) and IND (Investigational New Drug) applications to comply with eCTD format submission. There has been a delay for Type III DMF files to comply. The FDA announced in April via their Guidance Document Providing Regulatory Submissions in...
Clean Label, the Challenges
By Gustavo M. Gonzalez, Ph.D. So, you decided to have clean labels for your products, now what do you do? You are not alone in your pursuits of this endeavor. A couple of years ago, I was approached by a marketing department when they wanted to make certain claims in their product lines and one of...
Guidance for Industry on Dietary Supplement Products Containing Highly Concentrated Caffeine
FDA released Guidance for Industry on highly concentrated caffeine in dietary supplements. FDA considers products which only or primarily consist of pure or highly concentrated caffeine and are sold as dietary supplements to be adulterated under section 402(f)(1)(A) of the FD&C Act [21 U.S.C....
How can implementing a GMP system for regulatory compliance also streamline business at a cannabis facility?
By Kathy Knutson This month’s Ask the Expert is answered by Independent Consultant, Kathy Knutson, Ph.D. Kathy is a lead instructor for Preventive Controls for Human Food (PCHF); Preventive Controls Qualified Individual (PCQI) and trained in the prevention of Intentional Adulteration (IA). Each...
Nutrition Facts and Supplement Facts Labels Compliance Dates Extended
The U.S. Food and Drug Administration has issued a final rule to extend the compliance dates for updating Nutrition Facts and Supplement Facts labels, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million...
Inflation Adjusted Values for Six FSMA Regulations
The FDA released inflation-adjusted values for six FSMA regulations covering 2016-2017. These values are particularly noteworthy for smaller businesses that may not be covered, may receive an exemption, or have later compliance dates based on their sales being less than the indicated value. In...
CTP Announces Actively Working Tobacco Product Manufacturing Practices
At TMAs 103rd Annual Meeting held on Tuesday, April 10, 2018, Dr. Zeller confirmed that FDA is actively working on a number of priorities that he called “Foundational Rules and Guidances”. This includes the issuing of the Tobacco Product Manufacturing Practice (TPMP) Rule which is required by...
Independent Advisor for Food Law and Regulation, Steve Armstrong, Wins Service to FDLI Award
Steve Armstrong is the winner of the 2018 Service to FDLI award, presented at this year’s FDLI Annual Conference held in Washington, D.C. Steve is the former chief law counsel at Campbell Soup Company and has been consulting with EAS, providing expert opinion and strategy in the areas of product...
Sayler Presents on 21 CFR 117 at the AHPA Dietary Supplement Regulatory Summit
Senior Director for Food Consulting Services, Allen Sayler, will speak on how FSMA impacts the dietary supplement industry during the Dietary Supplement Regulatory Summit, taking place May 16, 2018, in Washington, DC. The Dietary Supplements Regulatory Summit is the collaboration between AHPA,...
Insights into FDA’s Interpretation and Enforcement of Medical Foods
Independent Advisor for Labeling and Claims, Betty Campbell and Senior Director for Food Consulting Services, Allen Sayer have co-written an article on how FDA interprets and enforces regulations of Medical Foods in Food Safety Magazine. This narrow product category sees a lot of confusion within...
Armstrong Discusses FSMA One Year Later in FDLI Update
Independent Advisor for Food Law and Regulation, Steve Armstrong discussed how FSMA implementation has impacted food safety systems during its first year of enforcement in the prestigious FDLI Update. Mr. Armstrong is the former Chief Law Counsel for Campbell Soup Company and works with EAS client...
Quality Assurance and Net Profits Discussed in EAS-Authored Article in Dairy Foods Magazine
EAS Independent Consultant, Rudy Westervelt, discussed fulfilling quality assurance potential and generating a net profit in a recent article published in Dairy Foods Magazine. Quality assurance could — and should — drive revenue by providing information that allows plant leadership to control...
EAS Releases Videos on FSMA and Product Development Services
https://youtu.be/vm59y1I70lc EAS Independent Advisor for FSMA, Charles Breen, hosts a new informational video on EAS services in the complex area of the Food Safety Modernization Act, including FSVP, VQIP and more. FSMA is the largest overhaul to FDA’s food regulations in the last 70+ years and...
Armstrong to Present at Food Law Innovative Conference
Independent Advisor for Food Law and Regulation, Steve Armstrong, will discuss Innovative Claims, as part of a USDA Review at the April 19-20, 2018 third annual CLE Food Law Conference in Denver. His co-presenter is Jeffrey Canavan, Deputy Director, Labeling & Program Delivery with the Food...