Specializing in FDA Regulatory Matters

Next Upcoming Webinar: Unraveling The Impact of FSMA On Acidified Food Regulations – December 7, 2017

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FDA Regulated Industry Consultant

Job Purpose/Summary  Independent Consultants for EAS Consulting Group, LLC work closely and collaboratively with members of the EAS team, our clients, as well as our other independent consultants to provide expert direction and guidance to clients based on the most current and accurate regulatory environment. Consultants are 1099 independent contractors to EAS, their integrity, professionalism Read More

EAS Consulting Group, LLC Announces Timothy Stewart, Ph.D. as New Independent Advisor for Dietary Supplements

EAS Consulting Group, LLC is very pleased to welcome Timothy Stewart, Ph.D. as the new Independent Advisor for Dietary Supplements.  Dr. Stewart has been an Independent Consultant for EAS since 2013 and has proven to be an invaluable asset to dietary supplement clients, taking on the most challenging projects and providing sound solutions that offer a Read More

EAS Consulting Group Now Offers CEU Credits for Food Labeling Seminars

EAS Consulting Group, LLC is very pleased to announce the recent awarding by The Commission on Dietetic Registration (CDR) of 16 CEU credit hours for their flagship training program – the two-day Food Labeling Compliance Seminar. These CEU credits confirm recognition by the CDR, dietetics professionals, and state dietetic licensure agencies that this EAS seminar Read More

EAS Consulting Group, LLC Announces Dr. Tara Lin Couch as New Senior Director, Dietary Supplements and Tobacco Services.

EAS Consulting Group, LLC is very pleased to announce the hiring of Tara Lin Couch, Ph.D. as Senior Director, Dietary Supplements and Tobacco Services. Dr. Couch has been an independent consultant for EAS Consulting Group since 2012 and was invited to be the EAS Independent Advisor for Dietary Supplements in 2015. As a consultant, Dr. Couch Read More

Foreign Supplier Verification Program – What Does It Mean For Your Business

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This could include compliance with a Read More

Independent Advisor for FSMA, Charles Breen Participated in a Webinar on FSMA with AutoCoding Systems

EAS Independent Advisor for FSMA, Charles Breen participated in a recent webinar. The webinar reviewed  FSMA and the role of automation with AutoCoding Systems. Mr. Breen discussed the details of FSMA requirements. With attention to a focus on preventing food safety problems rather than reacting to problems after they occur. To watch a replay of the webinar head over to xtalks.com Read More

EAS Consulting Group, LLC is Very Pleased to Welcome Allen Sayler as the New Senior Director for Food and Cosmetic Consulting Services

EAS Consulting Group, LLC is pleased to welcome long time Independent Consultant, Allen Sayler as new Senior Director for Food and Cosmetic Consulting Services.  Mr. Sayler has been an independent consultant for EAS since 2012.  In that time, his expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, food Read More

EAS Consulting Group, LLC is Pleased to Welcome Steve Armstrong J.D. as the new Independent Advisor for Food Law and Regulations

EAS Consulting Group, LLC, leaders in FDA regulatory consulting services welcomes Mr. Steve Armstrong J.D. to its cadre of Independent Advisors, serving as an expert in Food Law and Regulations. Mr. Armstrong will play an integral role in EAS’ new Product Development and Labeling Service, a service designed to help food firms faced with decisions to Read More

EAS Consulting Group, LLC Welcomes Domenic Veneziano as the New Independent Advisor for Import Operations

EAS Consulting Group, LLC is very pleased to welcome Domenic Veneziano as the new Independent Advisor for Import Operations. Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience. While at FDA, he was a Captain in the US Public Health Service serving most recently as director of the FDA’s Division Read More

EAS Consulting Group Launched New Strategic Consulting Service for Food Product Development & Labeling

July 8, 2016  Media Contact: Cathryn Sacra (571) 447-5505 csacra@easconsultinggroup.com Alexandria, VA, USA – EAS Consulting Group, LLC (EAS), a leading consulting, training and auditing firm that specializes in Food and Drug Administration (FDA) regulatory matters, is now offering a new strategic consulting service to the food industry, as they struggle to develop new foods and dietary Read More

Quality Agreements in the Complex World of Dietary Supplements

One of the most fundamental concepts in the dietary supplement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the role of the Quality Unit (QU).  The QU is responsible for reviewing and approving all controlled processes and documentation; as well as making all disposition Read More

How to Successfully Respond to FDA 483s and Warning Letters

EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how Read More

EAS Consulting Group, LLC Announces New Senior Director Pharmaceutical & Device Consulting Services

EAS Consulting Group, LLC is pleased to welcome Bryan J. Coleman as the new Senior Director Pharmaceutical & Device Consulting Services. Mr. Coleman’s addition to the senior leadership team further solidifies EAS as the leading consulting company in regulatory matters pertaining to all FDA regulated areas including OTCs, pharmaceuticals, cosmetics, dietary supplements, foods, medical devices Read More

Time is running out to for the Early Bird discounted rate for FSPCA Preventive Controls for Human Food Course

EAS and the HACCP Consulting Group will present a course on compliance with FDA’s final rule on Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation. The regulation requires that certain activities be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls.” Read More

EAS Consulting Group Enters Into an Asset Purchase Agreement with Phoenix Regulatory Associates

January 12, 2016 For Immediate Release Media Contact: Cathryn Sacra (571) 447-5500 Alexandria, VA: EAS Consulting Group, LLC., (EAS) is pleased to announce that it has entered into an agreement to continue to provide regulatory services to Phoenix Regulatory Associates, Ltd., clients upon the closure of Phoenix after nearly a quarter century of operation. “Phoenix Read More

Drug Establishment Registration, NDC Numbers and Product Listings – Webinar Replay

If you are a drug manufacturer or private label distributor, you have likely had a question about FDA Establishment Registrations, National Drug Code (NDC) numbers and product listings. They can be confusing concepts! Who needs them, how do you get them, what do the various parts of the codes (labeler/product/package), mean and who is actually Read More

Tara Lin Couch, Ph.D. in GMP Video for Natural Products Insider

EAS Senior Advisor for Dietary Supplements Tara Lin Couch, Ph.D. appears in a video clip on GMPs prepared by The Natural Products Insider from an interview at the Rocky Mountain Dietary Supplement Forum, September 24-25, 2015. Dr. Couch is an organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in Read More

FDA Releases Additional FSMA Final Rules

FDA released the much anticipated final rules for Produce Safety Foreign Supplier Verification Accredited Third Party Certification Firms can now begin the diligent and precise work of gap analysis and compliance planning to ensure all procedures are updated to meet FDA’s much stricter standards. The rules are a heavy read in their entirety so FDA Read More

Managing FDA Inspections – Webinar Replay

With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in Read More

FSMA Final Rule for Preventive Controls for Human Food

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016. The final FSMA rules are available in pre-published form – FSMA Final Rules.   The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice Read More

Extension of Comment Period for Nutrition Labeling

FDA has published a notice in the Federal Register extending until October 13, 2015, the comment period on its proposed changes to the Nutrition Facts and Supplement Facts panels used in labeling conventional foods and dietary supplements Read More

Charles Breen Reviewed FSMA at Kuala Lumpur Seafood Conference

EAS Senior Consultant Charles Breen reviewed the Food Safety Modernization Act in the context of seafood in a presentation at the International Seafood Safety and Trade Conference in Kuala Lumpur, Malaysia, June 11-12, 2015. The conference focused on seafood quality and safety topics, including trade, health and environmental issues as well as product development and innovation. The Read More

EAS Consulting Group, LLC Announces New Senior Advisor for OTC Drugs and Labeling Services

EAS Consulting Group, LLC is pleased to welcome Susan Crane as the new Senior Advisor for Over-the-Counter (OTC) Drugs and Labeling. Ms. Crane has been an EAS Senior Consultant since 2014 and has been instrumental in helping clients navigate the challenging FDA regulations pertaining to OTCs, their monographs and labeling requirements. Her addition to the senior leadership team further solidifies Read More

EAS Consulting Group, LLC Announces New Senior Advisor for Dietary Supplements

EAS Consulting Group, LLC is very pleased to welcome Tara Lin Couch, Ph.D. as the new Senior Advisor for Dietary Supplements. Dr. Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought after expert on issues pertaining to Quality Read More

How to Select and Qualify a Contract Laboratory – Webinar Replay

Dietary Supplement Laboratory Webinar 5 of 5 Part Series How to Select and Qualify a Contract Laboratory EAS Senior Consultant Tara Lin Couch, Ph.D. will present a free 5-part webinar series on FDA, Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. Learn how to establish and maintain, or identify, an adequate laboratory facility with Read More

Position Available: Director, Drug/Device Consulting Services

TITLE: Director, Drug/Device Consulting Services REPORTS TO: President & COO JOB PURPOSE/SUMMARY Responsible for managing the drug and device consulting activities within EAS Consulting Group, LLC. Functions as regulatory and business leader of the drug and device group and establishes its mission and goals. This responsibility includes close working relationships with members of the EAS team, our drug Read More

EAS Consulting Group Appoints New Senior Advisor for New Product Development and Submissions

ALEXANDRIA, Va., July 13, 2015 – EAS Consulting Group, LLC is very pleased to welcome Nancy Chew as the new Senior Advisor for New Product Development and Submissions.  Ms. Chew has been an EAS Expert Consultant since 2009 and has been instrumental in helping EAS clients gain approvals for pharmaceutical and medical device applications.  Her addition to the senior Read More

Regulatory Compliance Strategies for Marketing Dietary Supplements on Social Media – Webinar Replay

The widespread use of social media has had an impact on how we interact in our personal and professional relationships. It is also having a profound effect on businesses and their relationships to customers. For those of us in FDA-regulated industries, there are implications for marketing strategies and what companies are allowed to say. While Read More

21 CFR 111 GMP Laboratory Overview – Webinar Replay

Dietary Supplement Laboratory Webinar 1 of 5 Part Series 21 CFR 111 GMP Laboratory Overview EAS Senior Consultant Tara Lin Couch, Ph.D. will present a free 5-part webinar series on FDA, Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. Learn how to establish and maintain, or identify, an adequate laboratory facility with effective Read More

FDA Strategies to Implement & Enforce the Food Safety Modernization Act – Webinar Replay

This FSMA webinar will explore FDA’s anticipated enforcement strategy following finalization of the Hazard Analysis and Risk-based Preventive Control (HARPC) regulations for manufactured foods. The final rule will require that each food facility identify a “Qualified Individual” to conduct a multi-factor hazard analysis, then design and implement a written plan to control significant hazards. The Read More

John Bailey Addresses Structure/function Claims in The Rose Sheet

EAS Senior Adviser John Bailey is featured in an article titled Regulatory Roulette: Playing In Today’s Skin-Care Market A Gamble, posted online March 17 by The Rose Sheet. Recent FDA warning letters to skin-care firms raise questions about the regulatory risks companies must assume to compete effectively in the marketplace. Bailey discusses the strategic decision Read More

Food Allergen Requirements under FSMA

by: Robert Lake, Senior Consultant While it has always been lawful to add food allergens as ingredients to human food, the Food Allergy Labeling and Consumer Protection Act (FALCPA) added section 403(w) to the Food Drug and Cosmetic Act (FD&C Act) in 2004 to specify the label declaration requirements for major food allergens. FALCPA also Read More

FSMA’s Impact on Private Label Foods

by Dan Okenu, Ph.D. FSMA is the most comprehensive statutory food safety reform since the Food Safety & Cosmetic Act of 1938. This new rule empowers the FDA with a radical shift in focus towards a more proactive science and risk-based prevention strategy, and promises to raise the bar on food safety regulatory compliance for the Read More

FDA Issues Final Guidance to Frequently Asked Questions on Demonstrating the Substantial Equivalence of a New Tobacco Product

On March 4, 2015 FDA issued a final Guidance, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions, that provides responses to frequently asked questions the agency received from manufacturers and others about demonstrating substantial equivalence (SE) for a new tobacco product. The questions relate to: label changes, product quantity changes, additives/specifications, and general questions Read More

FDA Issues New Draft Documents Related to Compounding of Human Drugs

Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states. Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public Read More

Tobacco Products Scientific Advisory Committee (TPSAC) Discusses Modified Risk Tobacco Product Applications (MRTPA)

On April 9-10, 2015 the Tobacco Products Scientific Advisory Committee (TPSAC) will meet to discuss modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 smokeless tobacco products: To view the announcement go to http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm434215.htm. Before FDA can issue an order permitting the sale of an MRTP, the agency must refer the application to TPSAC Read More

GDUFA Comment Period Reopens for Certain Topics

The Food and Drug Administration announced the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation. FDA is seeking additional written comments from all interested parties, including, but not limited to Read More

Margaret Hamburg Sends Email to FDA Staff

FDA Commissioner Margaret Hamburg sent the following email to FDA staff on February 5 announcing that she would step down next month: Dear FDA Colleagues: It has been a privilege to serve as your FDA Commissioner for almost six years. So it is with very mixed emotions that I write today to inform you that Read More

FDA’s Use Of Photography Revisited

by Joe Famiglietti, Senior Consultant Managing an FDA inspection of your establishment is a difficult task in itself, but how should you respond when the Investigator notes a potentially objectionable condition and pulls out a camera to photograph the situation. It may be the sighting of a rodent in your facility, a poor employee practice, or Read More

Tobacco User Fees Now Payable to FDA

With the passage of the Tobacco Control Act User Fee Final Rule, 21 CFR Part 1150, domestic tobacco manufacturers as well as importers must now submit their required data for user fee assessment calculation, under the Federal Food, Drug, and Cosmetic Act, to the FDA beginning fiscal year 2015. Required information includes the number of Read More

Food Facility Bi-annual Registration on-going!

FDA’s many new regulations to further strengthen the safety of the U.S. food supply under FSMA include the mandatory requirement for food facilities to register bi-annually. Those that do not register risk being “de-listed,” and thus unable to legally sell or import products in the U.S. Under FSMA, FDA also has the authority to audit Read More

DQSA and a Myriad of New Regulations

With the enactment of the Drug Quality and Security Act, pharmacy compounders find themselves in a myriad of regulations that are not well understood within the practice of compounding pharmacy. Its difficult to establish processes and revise procedures to comply with GMPs. Outsourcing pharmacies will require many changes organizationally, training and a comprehensive mind set Read More

Food Nutrition Facts Panel Webinar Wrap-Up

EAS Senior Advisor for Labeling and Claims Elizabeth Campbell instructed a fantastic webinar along with DeAnn Liska, PhD, Sr. Director, Nutrition & Scientific Affairs at BioFortis and John Szpylka, PhD, Director of Chemistry NA at Silliker in a co-sponsored EAS-Silliker production on September 23rd. It should come as no surprise that there are plenty of Read More