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.
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 We saw during the drug listing certification period, that several labeler codes were reflecting outdated information.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...
FDA Holds Public Meeting on PMTAs for Deemed Products Meeting Summary
FDLI Update November 26, 2019 https://www.fdli.org/2019/11/fda-holds-public-meeting-on-pmtas-for-deemed-products-meeting-summary/ Tara Lin Couch
Hitting FSMA Benchmarks in Warehousing and Distribution Networks
Food Safety Strategies November 15, 2019 https://www.foodsafetystrategies.com/articles/1049-hitting-fsma-benchmarks-in-warehousing-and-distribution-networks Purnendu Vasavada, Penny Vyskocil
Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters
Though FDA’s 21 CFR 111 GMPs for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance…
October 2019 Drug and Device Corner
REMINDER: we are currently in the renewal period (1 Oct – 31 Dec) for medical device & drug establishment registrations, as well as drug listing certifications. The FDA, in their commitment to assisting industry in the development of affordable, available, generic drugs, and as part of the...
Navigating CBP and Prior Notice of FDA’s Imported Products
As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of U.S. consumer and integrity of the food-based products being imported. FDA has historically seen an import rate increase of 5-10% in the last decade and in 2018, 31% of those were food products requiring prior notice.
Understanding how to navigate the FDA and US Customs import process, including how to utilize their programs to expedite the review of paperwork and shipments at the US ports of entry will be …
Why Safety Data Sheets Are Important for Safe Food Manufacturing Operations
Food Quality and Safety Magazine October 22, 2019 Robert Kapp
Equipment Sanitation May be Co-packer Liability
Gabe Miller, independent consultant and expert in equipment sanitation, published an article in Natural Products Insider on equipment sanitation and the need for co-packers to be aware of how this can impact their business – and liability. “Food processing equipment requires proper design,...