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.
GMPs for Combination Drug-Device Products – Understanding Compliance Requirements for Each Component
EAS published an article in MedTech Intelligence on the importance of component GMP requirements for drug-device combination products.“The rapid development of combination products—biologics, pharmaceuticals and their devices—provides great opportunity for technological advancement, opening new...
Wishing You a Healthy and Happy 2021
From our family to yours, EAS Consulting Group wishes everyone a healthy and happy New Year! 2020 will certainly be remembered as one of immense challenges and creative opportunities. From the push to develop effective testing and vaccines, to supply chain issues that upended manufacturing and...
Recall Plans and Strategies
Robert Fish, Independent Advisor, Quality and Compliance Every year FDA monitors thousands of recalls of regulated products (over 7,000/year). Though most product recalls are voluntary, the FDA can also order them. Recalls can be very damaging to the reputation of a company and its brands....
FDA OTC-Drug User Fee Rates Established for FY 2021
FDA announced the fiscal year 2021 OTC-Drug User Fee rates in a Federal Register Notice published today, 12/29/2020. The notice covers all qualifying manufacturers and processors of finished dosage form OTC monograph drugs, including contract manufacturing facilities and submitters of OTC...
Did you Know? 3 Key Considerations for Developers of Wearable Software as Medical Devices
Digital platforms for wearables can serve both medical and non-medical purposes. But, when software technology helps the wearer or medical professionals identify and track information in support the diagnosis or treatment of a disease, that software is considered a medical device and is subject to...
New USDA FSIS Requirements for Shell Eggs – Top 5 Things You Need to Know Now!
USDA Food Safety Inspection Services (FSIS) recently issued the first regulatory update of the Egg Products Inspection Act (EPIA) since 1970, called the Egg Products Inspection Regulations (EPIR) which modernizes the industry requirements and FSIS inspection of shell eggs. This landmark update...
The Cosmetic-Drug Conundrum
The subtle differences between allowable cosmetics claims and those crossing the line into drug products is tricky. The wrong claims can cause a cosmetic product to be misbranded attracting unwanted FDA attention. Once some of your marketing claims are under review, you can expect a closer...
Micro Quality Labs Joins the Certified Group Family
We are proud and excited to announce that Micro Quality Labs (MQL) has joined the Certified Laboratory family of companies. MQL is an ISO accredited, independent analytical testing laboratory, providing state-of-the-art instrumental chemical and microbiological analyses to the cosmetic, skincare,...
US FDA Proposed Traceability Rule – Overview
FDA’s proposed rule “Requirements for Additional Traceability Records for Certain Foods” mandates traceability recordkeeping requirements for certain foods such as cheeses, shell eggs, some types of fish and produce. When finalized, the Traceability Regulation will be …
Drug and Device Corner November 2020
Revisions to section 801(e)(4)(E)(iii) of the FD&C Act as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act direct FDA to provide certification for Devices Not Exported from the U.S. Manufacturers of devices not exported from the United States, as described in section...
EAS Celebrates One-Year as a Member of the Certified Group of Companies
November marked the one-year anniversary for EAS Consulting Group’s acquisition by Certified Laboratories as part of the Certified Group of companies – and what a great year it has been! While both companies knew the synergistic capabilities of EAS regulatory solutions coupled with expert...
Genome-Edited Crops and the National Bioengineered Food Disclosure Standard: Can Regulators Find the Right Balance?
Anyone who follows science news has probably heard of the phenomenal scientific advancements using CRISPR. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) exist in nature as a defense mechanism in bacteria against invading viruses. In 2012, researchers Jennifer Doudna and
Food Safety and Artificial Intelligence Published in IAFP Food Protection Trends
Members of IAFP are invited to read an article on Food Safety and Artificial Intelligence written by Independent Consultant, Mehrdad Tajkarimi, Ph.D., and published in IAFP’s Food Protection Trends. Today, the food industry has more data than capacity for analyzing and processing into meaningful...
Allen Sayler Awarded International Dairy Federation Award of Excellence
Senior Director Allen Sayler has received the Award of Excellence by the Brussels-based IDF for outstanding contributions to their programs. Allen is an internationally recognized expert in dairy and dairy process, having previously worked as the Vice President of Regulatory Affairs and...
Did You Know? Environmental Monitoring and Testing of Pathogens is a Critical Must for Ensuring FSMA Compliance
The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in the industry is that of pathogen...
Dairy Microbiology and Spoilage Article Published in Dairy Foods Magazine
EAS consultant Sarah Goreham published an article in Dairy Foods Magazine on rethinking microbiology and safety protocols to prevent dairy spoilage with particular examples given for Bacillus cereus. Prevention is, as always, is our best defense to minimize our risk with all types of contaminants.
Allen Sayer was Awarded Honorary Life Member by the IAFP
Allen Sayer was awarded Honorary Life Member by the International Association of Food Protection (IAFP) at their annual meeting. This award, through nomination by industry colleagues, recognizes Allen’s career achievements and contributions to food safety. You may view the IAFP award announcement...
Preparing for a PMTA Pre-Approval Inspection
Presented by Tara Lin Couch, Ph.D., EAS Senior Director for Dietary Supplement and Tobacco Services The Family Smoking Prevention and Tobacco Control Act referred to as the Tobacco Control Act (TCA), signed into law on June 22 …
New Ingredients in Pet Food Formulation: Not as easy as creating a product with a few trending ingredients
By Carolyn KennedyEveryone is looking for the next best thing when it comes to pet food. Many companies have tried to introduce new ingredients. Often, the new ingredients in pet foods mirror the trending ingredients in human food. There has been an influx of CBD and hemp treats in pet foods, with...
Did You Know? Equipment Sanitation and Dietary Supplements – Which cGMPs Apply to Me?
As a dietary supplement firm, and a subcategory of foods, how do you decide which cGMPs to follow? The answer is determined by what specifically you produce – dietary supplements or dietary ingredients. Once that is understood, the cGMP operational requirements, particularly around equipment...
GMPs for Hemp and CBD?
Developing solid GMP protocols is essential for firms operating in the hemp and CBD space. Read EAS independent consultant Charlotte Peyton’s blog published on the National Cannabis Business Industry (NCIA)’s website. Join EAS for our upcoming EAS short course on developing quality systems for CBD...
Drug and Device Corner September 2020
EAS would like to remind all eNews readers of the importance of an appointed U.S. Agent. The FDA recently deactivated the FDA registrations of 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. As we head into the FDA registration renewal period,...
EAS Becomes GRMA Trusted Partner
The Global Retailer and Manufacturer Alliance (GRMA) recently confirmed EAS as a Trusted Consulting Partner for their member organizations. As a Trusted Partner EAS assists GRMA member suppliers and vendors with regulatory operational support. Acceptance into the Trusted Partner program is through...
House Vote on Legalization of Marijuana Delayed
Of interest to the hemp, CBD and cannabis industries, the US House Democratic leaders have decided to postpone voting on legislation to decriminalize marijuana at the federal level until after the November 3, 2020 election. EAS team of consultants, under leadership of Senior Director Tara Lin...
Food Legislation in the EU – An Introduction
An EAS Short CoursePresented by Michael Hickey, EAS Independent ConsultantJanuary 12-13, 202111am - 12:30pm eastern each dayIf you sell food products in the EU, understanding EU Food legislation is critical to success. Join EAS Consulting Group’s expert in EU Food regulations, Michael Hickey for a...
California Proposition 65 and the Food Industry
Proposition 65 is a statute that all companies selling products into California must comply with by providing warnings if their products contain certain chemicals that result in consumer exposure above a certain daily threshold. Failure to comply with the stringent requirements …
Process Validation for OTC Liquids and Topical Products
Presented by EAS Independent Consultant, Miguel MontalvoDecember 9-10, 202012:00–3:00pm EasternIf you manufacture OTC liquids, such as hand sanitizers, and other topical products, an effective Process Validation Program is an FDA requirement. Do you have a robust Process Validation Program at your...
Developing Quality Systems for the CBD and Hemp Industries – EAS Short Course
As states begin to regulate legalized CBD and hemp, the concern of how Good Manufacturing Practices (GMPs) apply to these unique industries cannot be understated. While regulations vary from state to state the quality systems under which products are grown …
Hygiene Improvement, Monitoring & Tracking
While the “new norm” for food manufacturing hygienic practices is rapidly evolving, an intense focus on proactive assurance of food and employee safety is the top industry priority. With increased focus on hygienic practices comes an increased requirement to data …
Understanding and Mitigating Risks of Emerging Pathogens
The food industry has a history of testing for Enterobacteriaceae, coliforms and/or E. coli as indicator microorganisms. Since 2009 there were 40 outbreaks in the United States of pathogenic E. coli such as Shiga toxin-producing E. coli (STEC) associated with leafy greens…