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.
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Guidance Document updates on the FDA website All divisions Certificates of Confidentiality (distributed for comment purposes only) - This draft guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC)....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,...
Couch Interviewed for Insider Podcast
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., was interviewed for a Natural Products Insider podcast on how important paper audits are to a contract lab qualification. Couch spoke at the SupplySide West show on this subject in a session titled: Trust in...
FDA Releases Plans for Draft Guidance on the Human Hazard Analysis and Risk-Based Preventive Control (HARPC) Rule – Chapter 14: Recall
FDA announced the release of the next chapter, in draft, of the Guidance for Industry "Hazard Analysis and Risk-Based Preventive Controls for Human Food" on recall plans. This newest chapter will assist the food industry establish and implement a written recall plan as required by 21 CFR 117.139....
FDA Publishes Required Records for FSVP
FDA has published a list of required records for foreign firms exporting food products for both animal and human consumption into the U.S. The Foreign Supplier Verification Program (FSVP), which is part of the Food Safety Modernization Act (FSMA), includes a number of additional requirements...
EAS Discusses Medical Device 510(k) Safety and Performance Measures in ISPE iSpeak Blog
Medical device manufacturers have a new tool available to demonstrate substantial equivalence through FDA’s 510(k) Safety and Performance measures. In a recently released Final Guidance, the Agency, as part of their effort towards stimulating innovation and reducing administrative burdens, all...
Sayler Interviewed for Article on Pathogens and Allergens in Food Safety Strategies
Allen Sayler was interviewed for an article published in Food Safety Strategies on preventing and testing for pathogens and allergens in the food industry including LIMs software and blockchain technologies and internal audits. With an increasing number of food recalls, staying vigilant with all...
Safe Foods for Canadians Act (SFCA) Discussed in Food Safety Magazine
EAS Independent Consultant, Ramakrishnan “Rama” Narasimhan published an article in Food Safety Magazine on the Safe Food for Canadians Act, including areas where it is similar to FDA’s FSMA. Did you know EAS offers food safety services for Canadian firms and has a number of Canadian independent...
Dietary Supplements and FSMA Compliance – Fallacy or Fact? – A Complimentary EAS Webinar
Do you know which of the seven major FSMA regulations were designed to support the Food Safety Modernization Act (FSMA)? Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior...
FDA’s Approach to Intentional Adulteration
Joe Famiglietti Each month EAS selects one question sent in by readers of EASeNews to answer as part of our Ask the Expert column. This month’s question on how FDA is enforcing Adulterated Foods is answered by Independent Consultant, Joe Famiglietti, who works closely with EAS clients in...
EAS offers QMS Services for Medical Devices
Quality Management Systems (QMS) for medical devices are cumbersome as layers upon layers of critical checks ensure the safety and effectiveness required for the consumer. However, in an effort to reduce overly burdensome recordkeeping processes FDA has announced a voluntary QMS switch from 21 CFR...
Safe Food for Canadians Act Regulations: An Overview
Food Safety Magazine October 15, 2019 https://www.foodsafetymagazine.com/enewsletter/safe-food-for-canadians-act-regulations-an-overview/ Ramakrishnan Narasimhan
Co-packer’s equipment may be liability to the brand
Natural Products Insider October 15, 2019 https://www.naturalproductsinsider.com/equipment/co-packers-equipment-may-be-liability-brand Gabe Miller